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Diamicron 60 mg tablet Uses, Dosage, Side Effects &Warnings
Drug Online
Diamicron 60 mg tablet >> Generic drug of the therapeutic class: Metabolism and nutrition active ingredients: Gliclazide
Important to know about Diamicron tablet ?
DIAMICRON 60 mg is indicated in certain forms of diabetes (non-insulin-dependent type 2 diabetes) in adults, when diet, exercise and weight loss alone are not sufficient to achieve blood glucose levels. normal blood sugar).
What is the use of diamicron and indication ?
What is the use of diamicron
Non-insulin-dependent (type 2) diabetes in adults, when diet, exercise and weight reduction alone are not sufficient to achieve glycemic control.
How much diamicron can I take “Dosage”?
The daily dose of DIAMICRON 60 mg can range from ½ to 2 tablets per day, or 30 to 120 mg in a single oral intake at breakfast time.
It is recommended to swallow the tablet (s) without crushing or chewing.
If you miss a dose, the next day dose should not be increased.
As with any hypoglycemic agent, the dose should be adjusted according to the individual metabolic response of each patient (glycemia, HbA1c).
Initial dose
The recommended starting dose is 30 mg daily (½ tablet DIAMICRON 60 mg).
· If the glycemic control is satisfactory, this dose can be adopted as a maintenance treatment,
· If the glycemic control is not satisfactory, the dose may be increased to 60, 90 or 120 mg per day, in successive increments, with an interval of at least 1 month between each level , except in patients for whom blood glucose does not decrease after two weeks of treatment. In this case, it is possible to propose an increase in the dose at the end of the second week of treatment.
The maximum recommended dose is 120 mg daily.
A modified-release tablet of DIAMICRON 60 mg is equivalent to two modified-release tablets of DIAMICRON 30 mg. The breakability of DIAMICRON 60 mg modified release tablet ensures flexibility of the dose.
DIAMICRON 80 mg Relay, tablets by DIAMICRON 60 mg, scored tablets with modified release
One tablet of DIAMICRON 80 mg is comparable to 30 mg of the modified release formulation (ie ½ tablet of DIAMICRON 60 mg). Therefore, the relay can be done provided you follow carefully the evolution of blood glucose.
Relay of another oral anti-diabetic by DIAMICRON 60 mg
DIAMICRON 60 mg can take over from another oral antidiabetic treatment.
In this case, the dose and half-life of the previous antidiabetic agent should be taken into account.
The relay will generally be without a transition period, preferably starting with a dose of 30 mg. The dose will then be adjusted as indicated above, depending on the glycemic response of each patient.
In the case of relays of a sulphonylurea with a prolonged half-life, a therapeutic window of a few days may be necessary in order to avoid an additive effect of the two products which may lead to hypoglycaemia.
During this relay, it is recommended to follow the same procedure as when starting a treatment with DIAMICRON 60 mg, ie to start at the dose of 30 mg per day, then to increase the dose in successive stages, depending on the metabolic results.
Association with other oral antidiabetic agents
DIAMICRON 60 mg may be associated with biguanides, alpha-glucosidase inhibitors or insulin.
In patients inadequately balanced with DIAMICRON 60 mg, insulin-associated therapy may be initiated under strict medical supervision.
Special populations
Elderly
DIAMICRON 60 mg will be prescribed according to the same regimen as in subjects under 65 years of age.
Patients with renal insufficiency
In patients with mild to moderate renal impairment , the dosing regimen will be the same as in subjects with normal renal function, but with careful monitoring.
These data have been confirmed in clinical trials.
Patients at risk of hypoglycemia:
· States of undernutrition or malnutrition,
· Severe or poorly compensated endocrine pathologies (ante-pituitary insufficiency, hypothyroidism, adrenal insufficiency),
· Withdrawal from prolonged and / or high dose corticosteroid therapy,
· Severe vascular disease (severe coronary artery disease, severe carotid artery disease, diffuse vascular disease);
It is recommended that treatment be started at the minimum dose of 30 mg / day.
Pediatric population
The safety and effectiveness of DIAMICRON 60 mg have not been established in children and adolescents.
There are no data in children .
How it works Diamicron 60 mg
Pharmacotherapeutic group: sulfonylurea – urea derivative, ATC code: A10BB09
Gliclazide is a sulphonylurea, an oral antidiabetic, with an endocyclic nitrogen-containing heterocycle, which differentiates it from other sulphonamides. Gliclazide decreases blood glucose by stimulating insulin secretion by the beta cells of the islets of Langerhans. The increase in insulin and C-peptide secretion following a meal persists after 2 years of treatment.
In addition to these metabolic properties, gliclazide has hemovascular properties.
Effects on insulin release
In type 2 diabetes, in the presence of glucose, gliclazide restores the early peak of insulin secretion, and increases the second phase of insulin secretion. A significant increase in insulin response is observed in response to a meal or glucose uptake.
Hemovascular properties
Gliclazide decreases the process of microthrombosis by two mechanisms that could be involved in the complications of diabetes:
. A partial inhibition of aggregation and platelet adhesiveness and a reduction in platelet activation markers (beta thromboglobulin, thromboxane B 2 );
· An action on the fibrinolytic activity of the vascular endothelium with an increase in t-PA activity.
What are the side effects of diamicron?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed secondary effect is hypoglycemia. For symptoms and signs, see section ” Warnings and Precautions “.
What are the side effects of diamicron
If these symptoms are not treated, they can develop into drowsiness, loss of consciousness or even coma.
In case of severe or prolonged hypoglycaemia, even temporarily controlled by sugar absorption, you should contact a doctor immediately.
Liver disorders
Isolated cases of abnormal liver function, which may result in yellow discoloration of the eyes and skin, have been reported. If you have these symptoms, consult your doctor immediately. Symptoms usually go away after treatment. Your doctor will decide if you should stop your treatment.
Skin disorders
Cases of skin reactions such as rash, redness, itching, hives and angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, tongue or throat that may cause difficulty breathing) were reported. Eruption may progress to widespread blistering or peeling of the skin.
Signs of severe hypersensitivity reactions ( DRESS) have been reported exceptionally : they start with flu-like symptoms and a rash on the face, followed by an extensive eruption with elevated temperature.
Blood disorders
Decreasing the number of cells in the blood (eg, platelets, white and red blood cells) can cause pallor, prolonged bleeding, bruising, sore throat and fever. These symptoms usually disappear after treatment.
Digestive disorders
Abdominal pain, nausea, vomiting, indigestion, diarrhea and constipation. These effects may be reduced when DIAMICRON® 60 mg scored release tablet is taken with a meal as recommended.
Vision disorders
Your vision may be affected for a short time especially during the initiation of treatment. This effect is due to changes in blood glucose.
As with other sulfonylureas, the following side effects have been observed: Severe changes in the number of blood cells and allergic inflammation of the blood vessel wall, decreased sodium in the blood (hyponatremia), symptoms of liver failure (eg jaundice) which, in most cases, disappear when sulfonylureas are discontinued, but in isolated cases can lead to life-threatening liver failure.
Diamicron Interactions
The following products may increase hypoglycaemia
Association contraindicated
+ Miconazole (general route, oral gel)
Increased hypoglycaemic effect with possible occurrence of hypoglycemic events, or even coma.
Associations advised against
+ Phenylbutazone (general route)
Increased hypoglycaemic effect of sulfonylureas (displacement of their plasma protein binding and / or reduction of their elimination).
Use preferably another anti-inflammatory if not to prevent the patient and to reinforce the self-monitoring: to adapt if necessary the dosage during the treatment by the anti-inflammatory and after its stop.
+Alcohol
Increased hypoglycemic reaction (inhibition of compensatory reactions) that may facilitate hypoglycemic coma.
Avoid taking alcoholic drinks and drugs containing alcohol.
Associations requiring precautions for use
+Because of the increase in the hypoglycemic effect, in some cases, hypoglycaemia may occur during concomitant treatment with the following medications
Other antidiabetic agents (insulin, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 agonists), beta-blockers, fluconazole, angiotensin-converting enzyme inhibitor (captopril, enalapril), H2, MAOI, sulfonamides, clarithromycin and nonsteroidal anti-inflammatory drugs.
2) The following products may cause an increase in blood glucose.
Association advised against
+Danazol
Diabetogenic effect of danazol.
If the combination can not be avoided, warn the patient and strengthen glycemic and urinary monitoring.
If necessary, adjust the dose of the antidiabetic medicine during treatment with danazol and after discontinuation.
Associations requiring precautions for use
+Chlorpromazine (neuroleptics)
At high dosages (> 100 mg chlorpromazine daily), elevated blood glucose (decreased insulin release).
Prevent the patient and strengthen glycemic monitoring. If necessary, adjust the dosage of the antidiabetic during treatment with the neuroleptic and after stopping.
+Glucocorticoids (general and local: intra-articular, cutaneous and rectal enema) and tetracosactide:
Elevation of blood glucose with sometimes ketosis (decreased tolerance to carbohydrates by corticosteroids).
Prevent the patient and strengthen glycemic monitoring, especially at the beginning of treatment. If necessary, adjust the dose of the antidiabetic medication during treatment with corticosteroids and after discontinuation.
+Ritodrine, salbutamol, terbutaline:
(Way IV).
Elevation of glycemia by beta-2 stimulants.
Strengthen glycemic surveillance. Possibly switch to insulin.
Associations to consider
+Anticoagulants (warfarin …)
Hypoglycemic sulfonamides may increase the anticoagulant effect during treatment.
Dosage adjustment of the anticoagulant may be necessary.
Diamicron Warnings and Precautions
Hypoglycaemia:
This treatment will only be prescribed if the patient is likely to eat regularly (including having breakfast). It is important to regularly absorb carbohydrates, the risk of hypoglycemia being increased in case of late meals, insufficient food or low carbohydrates. Hypoglycaemia may occur more particularly during a low-calorie diet, after a major or prolonged effort, after ingestion of alcohol, or during the administration of a combination of hypoglycemic agents.
Hypoglycaemia may occur after administration of sulphonylurea (see section 4.8). Some episodes can be severe and prolonged. Hospitalization may then be necessary and the resucrage must be continued over several days.
Careful selection of patients, the dose used and adequate patient information are necessary to reduce the risk of hypoglycaemia.
Factors favoring the risk of hypoglycemia:
· Refusal or inability of the patient to cooperate (especially in the elderly);
· Malnutrition, irregular meal schedule, skipped meals, fasting period or diet modification;
· Imbalance between exercise and carbohydrate intake;
· Renal insufficiency;
· Severe hepatic insufficiency;
· Overdose with DIAMICRON®;
· Certain endocrine disorders: thyroid disorders, pituitary and adrenal insufficiency;
· Concomitant use of other medicinal products .
Renal and Hepatic Impairment: The pharmacokinetics and / or pharmacodynamics of gliclazide may be impaired in patients with hepatic impairment or severe renal impairment. In these patients, since hypoglycemia may be prolonged, appropriate management should be instituted.
Patient information:
The risk of hypoglycaemia, its symptoms (see section 4.8), its treatment, and the conditions that predispose it must be explained to the patient and his / her family.
In particular, the patient should be informed about the importance of adherence to the diet, the need for regular physical exercise and regular monitoring of blood glucose.
Glycemic imbalance:
The glycemic balance of a patient treated with an oral antidiabetic agent may be modified if the following events occur: concomitant administration of St. John’s wort ( Hypericum perforatum ) preparations , fever, trauma, infection or surgery .
In some cases, it may be necessary to use insulin.
The hypoglycaemic efficacy of any oral antidiabetic drug, including gliclazide, may be impaired over time in many patients: this may be related to worsening of diabetes or a decrease in response to treatment. This phenomenon is called secondary failure to distinguish it from primary failure, in which the drug is ineffective from the first use. Before classifying a patient as a secondary failure, options for dose adjustment and dietary monitoring will be evaluated.
Dysglycemia :
Blood sugar disturbances , including hypoglycemia and hyperglycemia, have been reported in diabetic patients receiving concomitant fluoroquinolone therapy , particularly in elderly patients . Thus , careful monitoring of blood glucose is recommended in all patients receiving both DIAMICRON 60 mg and a fluoroquinolone .
Biological analyzes:
Measurement of glycated hemoglobin (or fasting blood glucose) is recommended for assessing glycemic control. Glycemic self-monitoring can also be practiced.
Drugs in the sulfonylurea class are likely to cause haemolytic anemia in patients with G6PD (glucose-6-phosphate dehydrogenase) enzyme deficiency. Since gliclazide belongs to this class, caution should be exercised in patients with G6PD deficiency and treatment in another therapeutic class than sulfonylureas should be considered.
Drive and use machines
DIAMICRON 60 mg has no or negligible influence on the ability to drive and use machines. However, patients should be sensitized to the symptoms of hypoglycemia and should exercise caution when driving and / or using machines, especially at the beginning of treatment.
Diamicron and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
There are no data or limited data (fewer than 300 pregnancies) on the use of gliclazide in pregnant women; few data exist with other sulfonylureas.In animals, gliclazide is not teratogenic ( see Preclinical safety ).
As a precaution, it is best to avoid using gliclazide during pregnancy.
Diabetes control should be obtained before conception to reduce the risk of birth defects due to poorly balanced diabetes.
During pregnancy, oral antidiabetic agents are not appropriate and insulin is the treatment of choice for diabetes. It is recommended to relay oral antidiabetic therapy with insulin when a pregnancy is planned or when it is discovered.
Breastfeeding:
The excretion of gliclazide or its metabolites in breast milk is not known. Because of the risk of neonatal hypoglycaemia, gliclazide is therefore contraindicated in breastfeeding women.A risk in the newborn / infant can not be ruled out.
Fertility:
No effects on fertility or reproduction were observed in male and female rats ( see Preclinical safety ).
What should I do if I miss a dose?
If you forget to take DIAMICRON 60 mg, scored release tablet:
It is important to take your medicine every day on a regular basis so that the treatment works better.
However, if you forget to take DIAMICRON 60 mg, the next day resume your treatment as usual. Do not take a double dose to make up for the single dose you forgot to take.
What happens if I overdose from Diamicron ?
If you take more DIAMICRON 60 mg, modified release scored tablet than you should:
If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Excessive dose results in hypoglycaemia described in section 2. It should be treated immediately with sugar (4 to 6 pieces) or a sugary beverage and followed by a snack. or a substantial meal.
If the patient is unconscious, immediately notify a doctor and call for emergency assistance.
The same precautions should be taken if someone, for example a child, has taken the medicine involuntarily. Do not give food or drink to an unconscious patient.
It must be ensured that there is always an informed person who can call a doctor in case of emergency.
What is Forms and Composition Diamicron?
FORMS and PRESENTATIONS
Breakable * tablet with modified release (elongated, white, scored, 15 mm long and 7 mm wide, engraved “DIA 60” on both sides): Boxes of 30 and 90, under pads. Hospital model: Box of 100.
* The tablet can be divided into two equal half-doses.
COMPOSITION
p cp gliclazide 60 mg
Excipients: lactose monohydrate, maltodextrin, hypromellose, magnesium stearate, colloidal anhydrous silica.
Excipient with known effect: lactose.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
The post Diamicron 60 mg tablet Uses, Dosage, Side Effects &Warnings appeared first on Drug Online.
from Drug Online https://bit.ly/3exeou8 via Edrug Online
from Faculty of Medicine https://bit.ly/2ZU9qDV via Internal Medicine
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Derinox nasal spray Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
Derinox nasal spray>>Generic drug of the therapeutic class: Otorhinolaryngology active ingredients: Prednisolone , Naphazoline
Important to know about Derinox ?
It is indicated as short-term local adjunctive treatment for congestive (stuffy nose) and acute inflammatory conditions in colds in adults and adolescents over 15 years of age.
Derinox spray
Derinox indication and Uses
Short-term local symptomatic treatment of congestive and inflammatory states during acute rhinitis in adults and adolescents over 15 years of age.
Derinox Dosage :
RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS OLD.
Adults and adolescents over 15 years old: 1 spray in each nostril, 3 to 6 times a day.
The maximum duration of treatment is 3 to 5 days.
Administration mode
Nasal sprays are done with the bottle in a vertical position, the head slightly bent forward, to avoid swallowing the product.
How it works Derinox :
Pharmacotherapeutic group: DECONGESTANTS AND OTHER PREPARATIONS FOR TOPICAL USE, ATC code: R01AD52
This drug is a combination of a sympathomimetic alpha, vasoconstrictor decongestant and a glucocorticoid with anti-inflammatory activity on the nasal mucous membranes.
Derinox Side Effects :
Linked to the presence of naphazoline
Cardiac disorders
Palpitations.
Tachycardia.
Myocardial infarction.
Visual disorders
Glaucoma crisis by closing the angle.
Gastrointestinal disorders
Oral dryness.
Nausea
Vomiting.
Nervous system disorders
Hemorrhagic stroke, exceptionally in patients who have used pseudoephedrine hydrochloride proprietary medicinal products;these cerebrovascular accidents have occurred during overdose or misuse in patients with vascular risk factors.
Ischemic vascular accidents.
Headache.
Convulsions.
Psychiatric disorders
Anxiety.
Restlessness.
Behavioral disorders.
Hallucinations.
Insomnia.
A fever, an overdose, a drug combination likely to reduce the epileptogenic threshold or to promote an overdose, have often been found and seem to predispose to the occurrence of such effects.
Urinary disorders
Dysuria (especially in cases of urethroprostatic disorders).
Urinary retention (especially in cases of urethroprostatic disorders).
Skin disorders
Sweats.
Exanthema.
Pruritus.
Urticaria.
Vascular disorders
Hypertension (hypertensive thrust).
Local Effects
Sensation of nasal dryness.Exceptionally, local allergic manifestations.
Linked to the presence of prednisolone
Local Effects
Possibility of epistaxis, irritation or burning sensation of the nose, dryness of the nasal mucosa, disturbances of taste and smell.
In case of nasal and pharyngeal Candida albicans infections, nasal corticosteroids should be discontinued and the appropriate treatment initiated.
Systemic effects
The risk of systemic effects related to nasal corticosteroid is not excluded (see section 4.4).This risk is increased with concurrent administration of corticosteroids or inhaledlet alone systemically.
The risk of latent adrenocorticotropic insufficiency after prolonged administration should be considered in case of intercurrent infection, accident or surgery.
Very rare frequency: cataract and glaucoma.
Psychiatric disorders
Derinox Interactions :
Related to the presence of naphazoline
Associations contraindicated
Indirect Sympathomimetics
[Phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine) and methylphenidate]
Risk of vasoconstriction and / or hypertensive relapses.
Associations advised against
Non-selective MAOIs (iproniazide)
Hypertensive crises (inhibition of the metabolism of pressurized amines). Due to the long action of MAOIs, this interaction is still possible 15 days after the cessation of the MAOI.
· Alkaloids of ergot dopaminergic rye (bromocriptine, cabergoline, lisuride, pergolide)
Risk of vasoconstriction and / or hypertensive relapses.
Alkaloids of the ergot of vasoconstrictor rye (dihydroergotamine, ergotamine, methylergometrine, methysergide)
Risk of vasoconstriction and / or hypertensive relapses.
Derinox Warnings and Precautions :
Special warnings
Observe the instructions for use and the doses recommended in this leaflet.
Do not swallow.
As soon as the packaging is opened, and even more so the first time a nasal preparation is used, microbial contamination is possible. Do not keep a nasal preparation for too long, especially not to reuse it for another treatment.
DO NOT LEAVE THIS MEDICINE WITHIN THE SCOPE OR SIGHT OF CHILDREN.
It is imperative to strictly adhere to the dosage, the maximum duration of treatment of 3 to 5 days and contraindications.
During the treatment, in case of feeling of acceleration of the heart beat, palpitations, appearance or increase of headaches, appearance of nausea, behavioral disorders,
STOP THE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.
PREVENT YOUR DOCTOR , if you suffer:
high blood pressure,
cardiac disorders, hyperthyroidism (hyperfunctioning of the thyroid gland),
personality disorders,
of diabetes.
In case of superinfection (purulent bloating), fever or concomitant bronchopulmonary infection, tell your doctor.
PREVENT YOUR DOCTOR , if you take:
a drug based on non-selective MAOIs (iproniazide),
a treatment containing an alkaloid of ergot of rye:
dopaminergic, such as bromocriptine, cabergoline, lisuride or pergolide, (eg antiparkinsonian),
vasoconstrictor, such as dihydroergotamine, ergotamine, methylergometrine, methysergide), (for example an antimigraine agent).
In case of purulent nasal discharge, persistence of fever, lack of improvement after 3 to 5 days of treatment, CONSULT YOUR DOCTOR.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Drive and use machines
Not applicable.
Derinox and PREGNANCY / BREAST FEEDING / FERTILITY
Pregnancy :
There is no reliable data on teratogenesis in animals.In clinical practice, the use of naphazoline in a limited number of pregnancies has apparently not revealed any particular malformative or fetotoxic effect to date.
However, further studies are needed to assess the consequences of exposure during pregnancy.
Therefore, due to the long duration of action of this drug and possible neonatal effects related to the powerful vasoconstrictive properties of this molecule, the use of naphazoline is not recommended during pregnancy.
Breastfeeding:
There are no data regarding the passage into naphazoline breast milk. Therefore, it is not recommended to give naphazoline during the breastfeeding period.
What should I do if I miss a dose?
Do not use a double dose to make up for the dose you forgot to use. Continue your treatment according to your prescription.
What happens if I overdose from Derinox ?
Immediately consult your doctor or pharmacist.
In any case, comply with your doctor’s prescription. Do not increase or decrease the dose without the advice of your doctor or pharmacist.
What is Forms and Composition Derinox?
FORMS and PRESENTATIONS
Solution for nasal spray: 15 ml bottle of solution (on average 150 sprays) and dosing pump fitted with a dip tube and a nasal tip delivering 100 µl of solution.
COMPOSITION
p pulv Prednisolone (DCI) 0,02 mg Naphazoline (DCI) nitrate 0,025 mg
Excipients: cetrimide, 96% ethanol, glycerol, sodium edetate, anhydrous sodium dihydrogen phosphate, sodium hydroxide, distilled water.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
The post Derinox nasal spray Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.
from Drug Online https://bit.ly/2At1TRB via Edrug Online
from Faculty of Medicine https://bit.ly/3exVpzJ via Internal Medicine
0 notes
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Xyzal 5 mg drug reviews Uses, Dosage, Side Effects & Warnings
Drug Online
Xyzal 5 mg drug reviews Generic drug of the therapeutic class: Allergology active ingredients:Levocetirizine
Xyzal 5 mg reviews &Important to know ?
XYZAL 5 mg film-coated tablets are indicated for the treatment of the symptoms of allergic rhinitis (including persistent allergic rhinitis).
XYZAL film-coated tablets are also indicated for the treatment of urticaria symptoms such as itching and redness.
What is Xyzal used for & indication ?
Xyzal, 5 mg film-coated tablets is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children 6 years of age and older.
What is Xyzal used for
Xyzal reviews Dosage :
Oral way.
The tablets will be swallowed with a drink and can be taken during or after meals. It is advisable to take the daily dose in one take.
Adults and children over 12 years old:
5 mg per day, ie 1 film-coated tablet.
Elderly:
A dose adjustment is recommended in elderly patients with moderate to severe renal impairment (see “renal impairment” below).
Children from 6 to 12 years old:
xyzal 5 mg per day, ie 1 film-coated tablet.
The film-coated form does not allow dosage adjustment for children aged 2 to 6 years. It is recommended to use a pediatric form of levocetirizine.
Renal insufficiency:
The interval between doses should be adjusted according to renal function as shown in the table below.
To use this table, it is necessary to calculate the creatinine clearance (CL cr ) of the patient in ml / min. The LC cr (ml / min) can be estimated from the value of serum creatinine (in mg / dl) according to the following formula:
[140 – age (years)] x weight (kg)
CL cr = ———————————————– x ( 0.85 for women )
72 x serum creatinine (mg / dl)
Dosage adjustment in patients with renal impairment:
Group Creatinine clearance (ml / min) Dose and frequency of administration Normal kidney function $ 80 1 tablet once a day Mild renal insufficiency 50-79 1 tablet once a day Moderate renal insufficiency 30-49 1 tablet once every 2 days Severe renal insufficiency <30 1 tablet once every 3 days End Stage Renal Insufficiency and Dialysis Patients <10 Against-indicated
In children with renal impairment, the dose will be adjusted individually based on the patient’s renal clearance and weight. There are no specific data in children with kidney failure.
Hepatic insufficiency
No dose adjustment is necessary in patients with isolated hepatic impairment.
Duration of the treatment
Intermittent allergic rhinitis, defined by the presence of symptoms less than 4 days per week or over a period of less than 4 weeks, will be treated according to the pathology and its history. The treatment can be stopped once the symptoms have disappeared and resumed at the reappearance of symptoms. In case of persistent allergic rhinitis (defined by the occurrence of symptoms more than 4 times per week and over a period of more than 4 weeks), continuous treatment may be offered to the patient during the period of allergen exposure.
Clinical experience is 6 months of treatment with 1 tablet 5 mg levocetirizine daily.
With cetirizine (a racemic form), there is clinical experience of up to one year of treatment for chronic urticaria and chronic allergic rhinitis.
how xyzal 5 mg works ?
Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives, ATC code: R06AE09 .
Action mechanism
Levocetirizine, the R-enantiomer of cetirizine, is a potent and selective antagonist of peripheral H 1 receptors .
Receptor binding studies revealed that levocetirizine has a high affinity for human H 1 receptors (Ki = 3.2 nmol / l). Levocetirizine has a 2-fold higher affinity than cetirizine (Ki = 6.3 nmol / l). The dissociation half-life of levocetirizine from H 1 receptors is 115 ± 38 min.
The receptor occupancy after single administration of levocetirizine has been shown to be 90% after 4 hours and 57% after 24 hours.
Pharmacodynamic studies in healthy volunteers showed comparable activity between cetirizine and levocetirizine at half-dose, both in the skin and nose.
Pharmacodynamic effects
The pharmacodynamic properties of levocetirizine have been studied in randomized controlled trials.
A study compared the effects of levocetirizine 5 mg, 5 mg of desloratadine and a placebo on the reaction erythematous papular induced histamine. Treatment with levocetirizine significantly reduced the formation of papules and erythema with maximum intensity in the first 12 hours and maintained for 24 h ( p <0.001) compared to placebo and desloratadine.
In a controlled study against placebo in pollen exposure room, the onset time of symptoms was 1 hour after administration of 5 mg of levocetirizine.
In vitro studies (Boyden’s chamber and cell culture technique) show that levocetirizine inhibits eotaxin-induced transendothelial migration of eosinophils through dermal and bronchial cells. In an in vivo experimental placebo- controlled pharmacodynamic study in 14 adult patients (dermal chamber technique), three main inhibitory effects of levocetirizine 5 mg were detected in the first 6 hours of the exposure-induced reaction. pollen: inhibition of VCAM-1 release, modulation of vascular permeability and decrease in recruitment to eosinophils.
Efficacy and clinical safety
The efficacy and safety of levocetirizine has been demonstrated in several clinical studies double-blind, controlled versus placebo in adult patients with seasonal allergic rhinitis, perennial or persistent. Levocetirizine significantly improved the symptoms of allergic rhinitis, including nasal obstruction in some studies.
A 6-month clinical study in 551 adult patients (276 patients treated with levocetirizine) with persistent allergic rhinitis (symptoms present 4 days a week for at least 4 consecutive weeks) and sensitized to dust mites and grass pollen showed that Levocetirizine 5 mg was significantly more clinically and statistically effective than placebo in improving the overall symptom score for allergic rhinitis throughout the study, without tachyphylaxis. Throughout the study, levocetirizine significantly improved the quality of life of patients.
In a placebo-controlled clinical study in 166 patients with chronic idiopathic urticaria, 85 patients were treated with placebo and 81 patients received levocetirizine 5 mg once daily for 6 weeks. Levocetirizine treatment significantly reduced the severity of pruritus during the first week and throughout the course of treatment compared with placebo. Levocetirizine also improved the quality of life related health outcomes assessed using the Dermatology Life Quality Index compared to placebo.
Chronic idiopathic urticaria has been studied as a model for urticarial manifestations. Since histamine release is the factor responsible for urticarial manifestations, the efficacy of levocetirizine in the symptomatic treatment of chronic idiopathic urticaria can be extrapolated to other forms of urticaria.
ECGs did not show any relevant effects of levocetirizine on the QT interval.
Pediatric population
The efficacy and safety of pediatric levocetirizine tablets in pediatric patients was studied in two placebo-controlled clinical studies in children aged 6 to 12 years with seasonal or perennial allergic rhinitis. In both studies, levocetirizine treatment significantly improved symptoms and quality of life related to health status.
In children under 6, clinical safety has been established on the basis of several short or long-term therapeutic studies:
A clinical trial in which 29 children aged 2-6 years with allergic rhinitis were treated with levocetirizine 1.25 mg twice daily for 4 weeks;
A clinical trial in which 114 children aged 1-5 years with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg twice daily for 2 weeks;
A clinical trial in which 45 children aged 6 to 11 months with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg once daily for 2 weeks;
A long-term (18-month) clinical trial of 255 atopic patients treated with levocetirizine, 12-24 months of age at baseline.
The safety profile was similar to that observed in short-term studies in children aged 1 to 5 years.
What are the side effects of Xyzal?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequent (may affect up to 1 in 10 people)
Dry mouth, headache, tiredness and drowsiness / falling asleep
Uncommon (may affect up to 1 in 100 people)
Exhaustion and stomachaches
Not known (frequency of occurrence can not be estimated from the available data)
Palpitations, increased heart rate, convulsions, tingling and tingling, dizziness, syncope, tremors, dysgeusia (taste alteration), vertigo (feeling of rotation or movement), visual disturbances, blurred vision, pain or difficulty in passing urine, inability to completely empty the bladder, swelling, pruritus (itching), redness, hives (swelling, redness and itching of the skin), rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or restless behavior , hallucinations, depression, insomnia, recurrent ideas or suicidal concerns, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Pruritus (intense itching) after stopping treatment.
At the first sign of an allergic reaction, stop taking XYZAL and contact your doctor. Allergic symptoms may include swelling of the mouth, tongue, face and / or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure which may lead to collapse or a potentially fatal shock.
Xyzal medication interactions
No interaction studies were performed with levocetirizine (in particular, no study with CYP3A4 inducers); studies with cetirizine (racemic form) revealed no clinically relevant interactions (with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole and pseudoephedrine). A slight decrease in the clearance of cetirizine (16%) was observed with theophylline taken repeatedly (400 mg once daily), whereas the bioavailability of theophylline was not affected by concomitant administration of theophylline. cetirizine.
In a multiple-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of cetirizine exposure increased by approximately 40%, while the bioavailability of cetirizine increased by approximately 40%. ritonavir was slightly impaired (-11%) following concomitant administration of cetirizine.
The absorption rate of levocetirizine is not decreased by diet, although its rate of absorption is reduced.
Concomitant use of alcohol or other central nervous system (CNS) depressants with cetirizine or levocetirizine may result in increased impairment of alertness or performance in sensitive patients.
Xyzal Warnings and Precautions
Special warnings
XYZAL 5 mg , film-coated tablet is not suitable for children under 6 years of age, the tablet form does not allow the adaptation of the dose.
Drive and use machines
Comparative clinical studies with levocetirizine at the recommended dosage have not revealed any impairment of alertness, reaction time or ability to drive.
However, some patients may experience somnolence, fatigue, and asthenia during levocetirizine therapy. Therefore, patients who intend to drive a vehicle, engage in potentially hazardous activities, or use machines should consider their response to the medication.
Xyzal and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
No or very little data is available on the use of levocetirizine during pregnancy (less than 300 cases of pregnancy). However, for cetirizine (racemic form of levocetirizine), the available data are numerous (more than 1000 cases of pregnancy) and have not shown evidence of malformative effect or fœto-neonatal toxicity.
Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryonic and fetal development, parturition and postnatal development ( see Preclinical Safety ).
The use of levocetirizine may be considered during pregnancy, if necessary.
Breastfeeding:
Cetirizine (the racemic form of levocetirizine) has been shown to be excreted in breast milk. Therefore, it is likely that levocetirizine is also. Adverse effects associated with levocetirizine are likely to occur in breastfed infants. Therefore, caution is advised when prescribing levocetirizine in breastfeeding women.
Fertility:
No clinical data is available for levocetirizine.
What should I do if I miss a dose?
Do not take a double dose to make up for the dose you forgot to take.
xyzal overdose side effects ?
Overdosage can lead to drowsiness and drowsiness in the adult and to drowsiness and drowsiness.
Contact your doctor if you have taken more tablets than needed.
What is Forms and Composition Xyzal?
FORMS and PRESENTATIONS
xyzal 5 mg film-coated tablet (white to off-white, oval, engraved “Y” on one side): Boxes of 14 and 28, in blister packs.
COMPOSITION p cp Levocetirizine dihydrochloride 5 mg
Excipients: Core: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate. Film coating : Opadry ® Y-1-7000 (hypromellose compound (E464), titanium dioxide (E171), macrogol 400).
Excipient with known effect: lactose monohydrate (63.50 mg / cp).
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
The post Xyzal 5 mg drug reviews Uses, Dosage, Side Effects & Warnings appeared first on Drug Online.
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Seretide drug Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
seretide drug class >>Generic drug of the therapeutic class: Pulmonology active ingredients: Fluticasone , Salmeterol
Important to know about Seretide ?
Asthma.
You must use Seretide every day as directed by your doctor. This will properly control your asthma.
Seretide prevents the occurrence of shortness and hissing. It does not work when you already have a shortness of breath or hissing sound. In these cases, you should use your fast-acting, short-acting bronchodilator, such as salbutamol.
What is Seretide used for and indication ?
What is Seretide used for
Seretide and Seretide Diskus:
Asthma:
Continuous treatment of asthma, in situations where the inhaled administration of a combination corticosteroid and long-acting ß-2 agonist bronchodilator is warranted:
in patients inadequately controlled by inhaled corticosteroid therapy and a short-acting ß-2 agonist bronchodilator by inhalation “on demand”, or
in patients controlled by the administration of inhaled corticosteroids associated with continuous therapy with inhaled long-acting ß-2 agonist.
Note :
Seretide Inhalation Suspension 50 μg / 25 μg / dose and Seretide Diskus 100 μg / 50 μg / dose are not suitable for the treatment of severe adult and pediatric asthma.
Seretide Diskus at 500 μg / 50 μg / dose:
Chronic Obstructive Pulmonary Disease (COPD):
Symptomatic treatment of COPD in patients whose FEV1 (measured before bronchodilator administration) is less than 60% of the theoretical value, and who has a history of repeated exacerbations and significant symptoms despite continuous bronchodilator therapy.
seretide dosage 250/50/25
Inhaled route only.
The patient should be informed that to observe an optimal treatment effect, Seretide should be administered daily even when symptoms are improved.
The doctor should regularly check that the prescribed dosage of Seretide is well adapted to the clinical condition of the patient. It will only be changed with medical advice.
The minimum effective dosage should always be sought. When symptoms are controlled by the lowest recommended dose twice daily, then inhaled corticosteroid alone will be considered.
It may also be considered to reduce the dosage of Seretide once a day, if the physician considers it necessary to maintain a long-acting beta-2 mimetic treatment for symptom control.
The time of taking Seretide will then depend on the frequency of appearance of symptoms. If the predominance of symptoms is nocturnal, Seretide will be given in the evening; if it is diurnal,
The dosage of Seretide that will be prescribed to the patient should correspond to the dose of fluticasone propionate adapted to the severity of his asthma. It should be emphasized that Seretide 50 micrograms / 25 micrograms / dose is not suitable for the treatment of severe adult and pediatric asthma. In asthmatics, fluticasone propionate (FP) is as effective as other inhaled corticosteroids at approximately half the daily dose. For example, administered by inhalation, 100 micrograms of fluticasone propionate are approximately equivalent to 200 micrograms of beclometasone dipropionate (BDP) (CFC formulation) or budesonide.
Recommended dosage:
Asthma
seretide dosage Adults and Teens 12 years and older:
Two inhalations of 50 μg of fluticasone propionate and 25 μg of salmeterol twice daily..or
Two inhalations of 125 μg fluticasone propionate and 25 μg salmeterol 2 times daily..or
Two inhalations of 250 μg of fluticasone propionate and 25 μg of salmeterol twice daily..or
Seretide may be considered as an initiation therapy for a short trial period in adults and adolescents with moderate persistent asthma (defined by the presence of daytime symptoms, daily use of a short-term bronchodilator).
action in symptomatic relief treatment and moderate to severe bronchial obstruction) and in whom it appears essential to obtain a rapid control of asthma. In these cases, the recommended initial dose is two inhalations of 25 micrograms of salmeterol and 50 micrograms of fluticasone propionate, twice daily.
When control of asthma is achieved, treatment should be re-evaluated to consider reducing treatment to inhaled corticosteroid alone. It is important that patients are followed regularly during the treatment reduction period.
There is no clear benefit of Seretide for initiation therapy compared with fluticasone propionate inhaled alone when 1 to 2 of the severity criteria discussed above are not present. In the majority of cases, the first-line treatment remains the administration of inhaled corticosteroids alone. Seretide is not intended for first-line treatment of mild asthma. The 50 microgram / 25 microgram Seretide is not suitable for adults and children with severe asthma; the appropriate dose of inhaled corticosteroids should be adjusted individually before
Children 4 years old and over:
Two inhalations of 50 μg of fluticasone propionate and 25 μg of salmeterol twice daily.
In children, the recommended maximum dose of inhaled fluticasone propionate is 100 micrograms twice daily.
No data are available on the use of Seretide in children under 4 years of age.
Children under 12 may have difficulty coordinating the triggering of the inhalation device with their inspiration. The use of an inhalation chamber with Seretide suspension for inhalation in a pressurized bottle is recommended in patients who have or may have difficulty coordinating their inspiration with the triggering of the inhalation device. A recent clinical study showed that pediatric patients who used an inhalation chamber had similar exposure to adults who did not use an inhalation chamber and pediatric patients who had used a Diskus device. confirming that the inhalation chamber compensates for a poor technique of
Volumatic or AeroChamber Plus inhalation chambers can be used. Limited data has shown increased systemic exposure when inhaled using the AeroChamber Plus inhalation chamber compared to the Volumatic inhalation chamber (see Warnings and Precautions section ). .
Patients should be informed of the procedures for the use and maintenance of their inhalation device and their inhalation chamber. It should also be checked that the patient is using the inhalation chamber properly so that the product is delivered optimally to the lung. Whenever possible, patients should continue to use the same type of inhalation chamber, as switching from one chamber to another may vary the dose of inhaled product (see Warnings and Precautions section). employment ). When introducing or changing the inhalation chamber, the minimum effective dose should always be sought.
Populations at risk:
There is no need to adjust doses in elderly or renally impaired patients. No data are available on the use of Seretide in patients with hepatic impairment.
seretide how to use
Patients should be informed about how the metered dose inhaler works (see leaflet).
During inhalation, the patient should preferably sit or stand. The aerosol has been designed for use in a vertical position.
Verification of the operation of the device:
Before first use, in order to check the proper functioning of the device, release puffs of product in the air until the meter indicates 120 doses. For this, after having removed the cap of the mouthpiece by exerting a pressure on each side, shake the inhaler well, hold the device between the fingers by positioning the thumb at the base of the device under the mouthpiece, then press on the cartridge. Shake the device right before activating to release each puff. If the device has not been used for a week or more, remove the cap from the mouthpiece, the patient should shake the inhaler and release two puffs of product into the air. The number of doses released is counted each time the device is triggered.
Use of the aerosol:
The patient should remove the cap from the mouthpiece by exerting pressure on each side.
The patient should check that there is no foreign body inside or outside the device, including the mouthpiece, to ensure that it is clean.
The patient should shake the aerosol well to remove any foreign matter and ensure mixing of the suspension components in the vial.
The patient should hold the aerosol straight between the fingers and thumb with his thumb at the base, under the mouthpiece.
The patient should exhale as much as possible then place the mouthpiece in his mouth between the teeth and close the lips around. Tell the patient that they should not bite the mouthpiece.
Right after starting to inhale through the device through the device, the patient should firmly press down on the top of the metered dose inhaler to release the product, while inhaling regularly and deeply.
While holding his breath, the patient will remove the inhaler from his mouth. The patient will hold his breath as much as possible.
If the patient is to take a second inhalation, he / she should keep the MDI straight and wait about 30 seconds before repeating steps 3 to 7.
The patient should replace the cap on the mouthpiece immediately afterwards by firmly pressing the cap, making sure that it is in the correct position .. There is no need to exert a significant force to replace the cap on the mouthpiece, a simple “click” is enough to ensure the closure of the mouthpiece by the cap.
IMPORTANT
Steps 5, 6 and 7 should not be performed in a hurry. It is important for the patient to start breathing as slowly as possible before triggering the device. The patient will have to train the first time in front of a mirror. If he sees a bit of “smoke” coming out of the top of the metered dose inhaler or at the corner of his mouth, he must start again from step 2.
Patients should consider replacing the metered dose inhaler when the dose counter reads 020. When all available doses in the device have been dispensed, the meter displays 000. The metered aerosol must be replaced when the meter reads 000 .
Patients should never try to change the numbers on the meter or detach it from the metal cartridge. The counter can not be reset and remains permanently attached to the cartridge.
Cleaning :
The device should be cleaned at least once a week.
Remove the cap from the mouthpiece.
Do not remove the cartridge from its plastic adapter.
Wipe the inside and outside of the mouthpiece and plastic adapter with a clean, dry tissue or tissue.
Replace the mouthpiece cap, making sure that it is correctly positioned in the correct direction. There is no need to exert a significant force to replace the cap on the mouthpiece, a simple “click” is enough to ensure the closure of the mouthpiece by the cap.
DO NOT PUT THE METAL CARTRIDGE IN WATER.
how does seretide works
Pharmacotherapeutic group: Adrenergic and other drugs for obstructive airways syndromes
ATC Code: R03AK06
Clinical studies conducted with the propionate combination of fluticasone / salmeterol in asthma:
A 12-month study (Gaining Optimal Asthma controL, GOAL) in 3416 adult and adolescent patients with persistent asthma compared the safety and efficacy of Seretide with inhaled corticosteroid alone (fluticasone propionate) to evaluate the possibility of achieving the goals of asthma management. The dosage of treatment was increased every 12 weeks until full control ** was obtained or the highest dose in the study was reached. GOAL showed that there were more patients achieving asthma control when treated with Seretide than with inhaled corticosteroids alone, with lower doses of corticosteroids.
“Good Control” of asthma was achieved more rapidly in patients treated with Seretide than in patients treated with inhaled corticosteroids alone. The time required for 50% of subjects in the study to reach their first week of “good control” was 16 days for subjects treated with Seretide and 37 days for those treated with inhaled corticosteroids (ICS). In the subgroup of asthmatic patients not previously treated with inhaled corticosteroids, this time was 16 days (Seretide) and 23 days (CSI), respectively.
The overall results of the study were as follows:
Percentage of patients achieving * Good Control (BC) and ** Total Control (CT) of asthma over 12 months
Treatment before inclusion in the study
FP 4 / Salmeterol
FP 4
BC
CT
BC
CT
No CSI 1 (ß2 CDA 2 alone)
78%
50%
70%
40%
Low dose ICS (≤ 500 μg BDP 3 or equivalent per day)
75%
44%
60%
28%
Medium dose ICS (> 500-1000 μg BDP 3 or equivalent per day)
62%
29%
47%
16%
Overall results (regardless of previous treatment)
71%
41%
59%
28%
CSI: inhaled corticosteroids
ß2 CDA: Beta-2 short-acting agonist
BDP: beclometasone dipropionate
FP: Fluticasone Propionate
* Good asthma control: occasional symptoms or occasional use of a short-acting beta-2 agonist bronchodilator, or pulmonary function less than 80% of the theoretical values, without nocturnal awakening, exacerbation or adverse effect a modification of treatment.
** Total control of asthma: no symptoms, no use of a short-acting beta-2 agonist bronchodilator, pulmonary function greater than or equal to 80% of the theoretical values, no nocturnal awakening, no exacerbation no adverse effect leading to a change in treatment.
The results of this study suggest that Seretide 100 micrograms / 50 micrograms / dose, twice a day, may be considered for initiation of DMARD therapy in patients with moderate persistent asthma who experience essential control. asthma (see Dosage and administration section ).
Une étude en double aveugle, randomisée en groupes parallèles, conduite chez 318 patients d’au moins 18 ans, atteints d’asthme persistant, a évalué la sécurité et la tolérance de l’administration de deux inhalations deux fois par jour (double dose) de Seretide pendant deux semaines. Cette étude a montré que le doublement de la dose de Seretide (quel que soit le dosage), sur une durée allant jusqu’à 14 jours, entraîne par rapport à l’administration d’une inhalation deux fois par jour, une légère augmentation des effets indésirables liés à l’activité bêta-mimétique (tremblements : 1 patient [1 %] vs 0, palpitations : 6 [3 %] vs 1 [<1 %], crampes musculaires : 6 [3 %] vs 1 [<1 %]) et une incidence similaire des effets indésirables liés au corticoïde inhalé (candidose orale : 6 [6 %] vs 16 [8 %], raucité de la voix : 2 [2 %] vs 4 [2 %]). La faible augmentation des effets indésirables liés à l’activité bêta-mimétique doit être prise en considération, s’il est envisagé de doubler la dose prescrite de Seretide chez des patients adultes qui nécessiteraient une augmentation de la corticothérapie inhalée pendant une courte période (jusqu’à 14 jours).
Multicenter trial in asthma with salmeterol (“Salmeterol Multi-Center Asthma Research Trial, SMART”)
The SMART study was a multi-center, randomized, double-blind, parallel group, placebo-controlled study conducted in the United States over 28 weeks. 13176 patients received salmeterol (50 micrograms twice daily) and 13179 patients received placebo administered in addition to their usual anti-asthmatic treatment. To be included in the study, patients had to be at least 12 years old, be asthmatic and have ongoing anti-asthmatic treatment (excluding long-acting beta-2 agonist therapy). action). Inhaled corticosteroid therapy was not mandatory during the study, although the use of corticosteroids was nevertheless recorded at study entry. The main criterion of judgment of the
Results of the SMART study on the primary endpoint:
Patient groups
Main criterion:
Number of events /
number of patients
Relative risk
(95% Confidence Interval)
salmeterol
placebo
Overall population included
50/13176
36/13179
1.40 (0.91, 2.14)
Patients using inhaled corticosteroids
23/6127
19/6138
1.21 (0.66, 2.23)
Patients not using inhaled corticosteroids
27/7049
17/7041
1.60 (0.87, 2.93)
Subgroup of African-American patients
20/2366
5/2319
4.10 (1.54, 10.90) **
** statistically significant at 95%
Other results of the SMART study according to whether or not inhaled corticosteroids were taken at baseline:
Secondary criteria:
Number of events / number of patients
Relative risk
(95% Confidence Interval)
salmeterol
placebo
Number of deaths related to a respiratory cause
Patients using inhaled corticosteroids
10/6127
5/6138
2.01 (0.69, 5.86)
Patients not using inhaled corticosteroids
14/7049
6/7041
2.28 (0.88, 5.94)
Combined criterion combining asthma episodes that have led to death or life-threatening
Patients using inhaled corticosteroids
16/6127
13/6138
1.24 (0.60; 2.58)
Patients not using inhaled corticosteroids
21/7049
9/7041
2.39 (1.10, 5.22) **
Number of deaths related to asthma
Patients using inhaled corticosteroids
4/6127
3/6138
1.35 (0.30, 6.04)
Patients not using inhaled corticosteroids
9/7049
0/7041
*
* = relative risk could not be calculated due to no event in the placebo group.
** The results are statistically significant at 95%. The secondary criteria in the table above reached statistical significance in the entire study population.
The secondary criteria of “death or vital threats from all causes”, “all-cause death” or “all-cause hospitalization” did not reach statistical significance for the entire study population.
Action mechanism
Seretide contains salmeterol and fluticasone propionate which have different modes of action:
salmeterol
Salmeterol is a selective long-acting agonist (12 hours) for beta-2 adrenergic receptors. It has a long side chain that links it to the receiver’s exo-site.
Salmeterol produces bronchodilation which persists for about 12 hours. This duration is greater than that generally observed with short-acting beta-2 mimetics administered at the usual dosages.
Fluticasone propionate
Fluticasone propionate administered by the inhaled route at the recommended doses exerts a glucocorticoid activity causing a local anti-inflammatory effect at the level of the bronchial mucosa. As a result, asthma symptoms and exacerbations are reduced while systemic effects are limited compared to systemic corticosteroid use.
Does Seretide have side effects?
yes it’s and this’s Description of adverse effects
Like all medicines, SERETIDE 50 micrograms / 25 micrograms / dose, suspension for inhalation in a pressurized bottle can cause side effects, but they do not occur systematically in everyone.
To prevent the occurrence of side effects, your doctor will prescribe the lowest possible dose to control your asthma.
Allergic Reactions: You may find that your breathlessness worsens suddenly after you use Seretide. You can perceive bronchial wheezing and coughing. You may also experience itching and swelling (usually on the face, lips, tongue, or throat). If you experience these symptoms or if they suddenly appear after using Seretide, tell your doctor immediately. Allergic reactions to Seretide are very rare (they affect less than 1 in 10,000 people).
Other side effects are described below:
Very common effects (affects more than 1 in 10 people):
· Headache usually decreases with further treatment.
· An increase in colds has been reported in patients with Chronic Obstructive Pulmonary Disease (COPD) treated with Seretide.
Common effects (affect less than 1 in 10 people):
· Candidiasis of the mouth and throat (sometimes painful). Also tongue and throat irritated, and hoarse voice. Rinse your mouth with water and spit it out immediately after each shot can help prevent these effects. Your doctor may prescribe antifungal therapy to treat candidiasis.
· Tremors and fast or irregular heartbeat (palpitations). This is usually not serious and decreases with further treatment.
· Muscle cramps.
The following side effects have also been reported with Seretide in patients with Chronic Obstructive Pulmonary Disease (COPD):
· Pneumonia and bronchitis (respiratory infection). Tell your doctor if you experience any of the following: increased sputum, changes in sputum, fever, chills, increased cough, increased breathing difficulty.
· Bruising (blue on the skin) and fractures
· Inflammation of the sinuses (feeling of tension or heaviness in the face, cheeks and behind the eyes, sometimes accompanied by pulsating pain).
· Decrease in the amount of potassium in your blood (which can be manifested by palpitations, muscle weakness, cramps).
Infrequent effects (affect less than 1 in 100 people):
· Rashes of the urticaria type.
· Rapid acceleration of heart rate (tachycardia).
Very rare effects (affects less than 1 in 10,000 people):
· Sudden difficulty with breathing or wheezing immediately after inhaling the drug. In this case, stop using Seretide. Use your bronchodilator medication called “rescue” to help you breathe and tell your doctor immediately.
· Seretide can affect the normal production of steroid hormones by the body (produced by the adrenal glands), especially if you have taken it at high doses and over long periods. The effects include:
o a slowdown in the growth of the child and the teenager,
o a thinning of the bone structure,
o a cataract (opacification of the lens of the eye generally causing visual discomfort), and glaucoma (an eye condition related to an increase in intraocular pressure),
o weight gain,
o a rounding (moon-shaped appearance) of the face (Cushing’s syndrome).
· Your doctor will regularly check that you do not have these side effects and that you are using Seretide at the lowest dose to control your asthma.
· Irregular heart rhythm (arrhythmias). Tell your doctor, but there is no need to stop your treatment unless your doctor tells you to stop.
· Increased sugar (glucose) in your blood (hyperglycemia). If you have diabetes, more frequent checks of your blood sugar level and a possible adjustment to your anti-diabetic treatment may be necessary. Feelings of worry, sleep disturbances and behavioral changes, such as unusual activity and irritability (these effects occur mainly in children).
· Pain and inflammation of the joints, muscle pain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
seretide drug interactions
Beta-blockers, selective or not, should be avoided in patients with asthma unless absolutely necessary.
Concomitant administration of other beta-adrenergic agents may potentiate beta-2-mimetic effects.
Fluticasone propionate
Under normal conditions of use, fluticasone propionate plasma concentrations achieved after inhaled administration are low due to a significant presystemic first-pass effect (hepatic and intestinal) and high plasma clearance by extensive metabolism. mediated by cytochrome P450 3A4. As a result, the risk of clinically significant interactions with fluticasone propionate appears to be low.
Nevertheless, an interaction study in healthy volunteers receiving nasal fluticasone propionate showed that ritonavir (a very potent inhibitor of cytochrome P450 3A4) at a dose of 100 mg twice daily increased several hundred times plasma concentrations of fluticasone propionate, resulting in a marked decrease in plasma cortisol levels. There is no data documenting the interaction with fluticasone propionate administered by inhalation, but a significant increase in plasma concentrations is expected; cases of Cushing’s syndrome and inhibition of adrenal function have been reported. The concomitant administration of fluticasone propionate and ritonavir should therefore be avoided,
A low-dose study conducted in healthy volunteers showed that ketoconazole, a somewhat less potent inhibitor of cytochrome P450 3A4, increased the systemic exposure of a dose of inhaled fluticasone propionate by 150%. The reduction in plasma cortisol was greater than that observed after administration of fluticasone propionate alone. An increase in systemic exposure and the risk of systemic adverse reactions is expected when concomitant administration of other potent cytochrome P450 3A4 inhibitors (eg, itraconazole). Caution is advised and long-term combination therapy should be avoided as much as possible.
salmeterol
·Strong inhibitors of cytochrome P450 3A4
Concomitant administration of ketoconazole (400 mg orally once daily) and salmeterol (50 μg inhaled twice daily) in 15 healthy volunteers for 7 days resulted in a significant increase in plasma concentrations of salmeterol (Concentration maximum (Cmax) increased by a factor of 1.4 and area under the curve (AUC) increased by a factor of 15). This observation therefore suggests an increased risk of systemic effects of salmeterol, such as QT prolongation and palpitations, compared with salmeterol or ketoconazole alone (see Warnings and Precautions section). ).
There was no clinically significant effect on blood pressure, heart rate, blood glucose, and serum potassium. Concomitant administration of ketoconazole did not result in an extension of the half-life of salmeterol elimination or its accumulation after repeated dosing.
The combination of ketoconazole with salmeterol should be avoided unless the expected benefits outweigh the potential risk of systemic effects of salmeterol. A similar risk of interaction is expected with other potent cytochrome P450 3A4 inhibitors (eg with itraconazole, telithromycin, ritonavir).
· Moderate inhibitors of cytochrome P450 3A4
Concomitant administration of erythromycin (500 mg orally three times a day) and salmeterol (50 μg twice daily) in 15 healthy volunteers for 6 days resulted in a small but not statistically significant increase. plasma concentrations of salmeterol (Cmax increased by a factor of 1.4 and AUC increased by a factor of 1.2). No serious adverse events were associated with concomitant administration with erythromycin.
Seretide Warnings and Precautions
The adaptation of an anti-asthmatic treatment is done in stages according to the clinical state of the patient who will be regularly reassessed by a medical follow-up and the control of the respiratory function.
Seretide is not suitable for the treatment of asthma attacks and episodes of paroxysmal dyspnea. In these situations, the patient should use a short-acting, fast-acting bronchodilator to treat acute symptoms. The patient will be informed that he must therefore have at his disposal a fast-acting, short-acting bronchodilator for use in an asthma attack.
Treatment with Seretide should not be initiated during an exacerbation phase, or when there is a significant worsening or deterioration of asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment with Seretide. Patients should be advised that if symptoms of asthma persist or worsen during treatment with Seretide, they should continue their treatment but seek advice from their doctor.
An increase in short-acting, fast-acting bronchodilator use to treat symptoms is a sign of destabilization of the disease. In this case, the patient will have to consult his doctor. A more or less rapid deterioration in symptom control should raise the risk of progression to severe acute asthma that may be life-threatening and therefore require urgent medical consultation. It will be advisable then to consider an increase of the corticotherapy. Similarly, if symptom control is still insufficient following treatment with Seretide, medical consultation is necessary and the prescription of additional corticosteroids should be considered.
As soon as the symptoms of asthma are controlled, a gradual decrease in the dose of Seretide should be considered. It is important that patients are followed regularly during the treatment reduction period. The minimum effective dose of Seretide should be used .
Seretide treatment should not be interrupted abruptly.
Like other corticosteroids for inhaled administration, Seretide should be used with caution in patients with pulmonary tuberculosis.
Rarely, Seretide can cause heart rhythm disorders such as supraventricular tachycardia, extrasystoles and atrial fibrillation, as well as a moderate and transient decrease in serum potassium at high therapeutic doses. Therefore, Seretide should be used with caution in cases of severe cardiovascular disease, cardiac arrhythmias, diabetes, hyperthyroidism, uncorrected hypokalaemia, or in patients at risk of hypokalemia.
Increases in blood glucose have been reported very rarely . This must be taken into account when prescribing to diabetic patients.
As with other inhaled products, increased bronchial whistling indicating bronchospasm following inhalation of the powder should lead to discontinuation of Seretide treatment and clinical examination of the patient. Treatment should be re-evaluated to consider alternative therapy as appropriate.
Caution should be taken when releasing Seretide for systemic corticosteroids, particularly in patients who may have impaired adrenal function.
Inhaled corticosteroid therapy may have systemic effects, especially during long-term high-dose therapy. The occurrence of these effects remains less likely than during oral corticosteroid therapy. Cushing’s syndrome, a cushingoid picture, an inhibition of adrenal function, a decrease in bone mineral density, a cataract and glaucoma can be observed. As a result, the patient will be followed regularly and the minimum effective dosage should always be sought.
Prolonged administration of high doses of inhaled corticosteroids may result in inhibition of adrenal function by promoting the occurrence of acute adrenal insufficiency. Cases of inhibition of adrenal function and acute adrenal insufficiency have also been very rarely described with fluticasone propionate doses of between 500 and 1000 micrograms. Adrenal insufficiency attacks can be triggered by trauma, surgery, infection or any rapid decrease in dosage. The clinical picture is usually atypical and may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, hypotension, disturbance of consciousness, hypoglycemia and convulsions.
Fluticasone propionate and salmeterol are mainly absorbed by the pulmonary route. The use of an inhalation chamber associated with the metered dose inhaler may increase the dose of product delivered to the lung, thereby increasing the risk of systemic adverse reactions. Single-dose kinetic data showed twice as much systemic exposure when Seretide was administered using the AeroChamber Plus inhalation chamber compared to the Volumatic inhalation chamber.
The use of inhaled fluticasone propionate reduces the need for oral corticosteroids to treat asthma, but it does not prevent the risk of developing adrenal insufficiency when patients treated with long-term oral corticotherapy. This risk also exists in patients who have received high doses of emergency corticosteroids. The risk of persistence of adrenal suppression should be kept in mind in emergency situations and / or likely to trigger a state of stress. Appropriate corticosteroid replacement therapy should be considered. A specialized opinion may be required.
Ritonavir can dramatically increase plasma concentrations of fluticasone propionate. Therefore, unless the expected benefit to the patient outweighs the risk of systemic effects of corticosteroid therapy, concomitant administration should be avoided. The risk of systemic effects of corticosteroid therapy is also increased when concomitant administration of fluticasone propionate with other potent cytochrome P450 3A4 inhibitors .
An increase in cases of low respiratory infections (especially pneumonia and bronchitis) was observed in a 3-year study (TORCH study) in patients with COPD treated with Seretide, compared to those receiving placebo . In this study, the risk of developing pneumonia, regardless of treatment, was highest in elderly patients, patients with low body mass index (<25 kg / m2) and those with very severe disease (FEV 1 < 30% of the theoretical value). The possibility of pneumonia or other low respiratory infections in patients with chronic obstructive pulmonary disease (COPD) should be carefully monitored as the clinical manifestations of infection are often confused with a simple exacerbation. The occurrence of pneumonia in a patient with severe COPD should lead to re-evaluation of Seretide therapy.
Data from a large-scale clinical trial (“Salmeterol Multi-Center Asthma Research Trial, SMART”) suggested an increased risk of serious respiratory adverse events or respiratory-related death in African patients. treated with salmeterol compared to placebo . It could not be determined whether these observations were of pharmacogenetic origin or resulted from other intercurrent factors. If symptoms of asthma persist or worsen during treatment with Seretide, patients of African-African or Afro-Caribbean origin should continue Seretide treatment while promptly seeking medical attention.
Co-administration of systemic ketoconazole significantly increases systemic exposure to salmeterol, which may increase the risk of systemic effects (eg prolongation of QTc interval and palpitations). Therefore, concomitant administration of ketoconazole or other potent inhibitors of cytochrome P450 3A4 should be avoided unless the expected benefits outweigh the potential risk of systemic effects of salmeterol .
Athletes’ attention will be drawn to the fact that this specialty contains two active ingredients that can induce a positive reaction of the tests performed during doping controls.
Pediatric population
Children and adolescents under 16 years of age receiving high doses of fluticasone propionate (usually ≥ 1000 micrograms daily) are at particular risk. Systemic effects may occur, especially during long-term high-dose treatments. Cushing’s syndrome, a cushingoid picture, an inhibition of adrenal function, acute adrenal insufficiency and stunting in children and adolescents can be observed.
The growth of children receiving long-term inhaled corticosteroid therapy should be monitored regularly. Inhaled corticosteroid therapy should be reduced to the lowest dose for effective asthma control.
Drive and use machines
There are no studies evaluating the effects of this drug on the ability to drive and use machines.
Seretide and PREGNANCY / BREAST FEEDING / FERTILITY:
Fertility:
There is no data in humans. However, animal studies have shown no effect of salmeterol or fluticasone propionate on fertility.
Pregnancy :
A moderate amount of data obtained in pregnant women (between 300 and 1000 cases of documented pregnancies) do not report the malformative or fetononatal toxicity of salmeterol and fluticasone propionate. Studies in animals on reproductive functions have shown a toxicity of ß-2-mimetics and glucocorticoids ( see Preclinical safety ).Use of Seretide during pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the fetus.
In pregnant women, the minimum effective dose of fluticasone propionate should be sought for satisfactory control of the symptoms of asthma.
Breastfeeding:
The passage of salmeterol and fluticasone propionate and their metabolites into breast milk is not known.Studies have shown that salmeterol and fluticasone propionate, and their metabolites, are excreted in the milk of lactating rats.
A risk for breastfed newborns / infants can not be ruled out. The decision to discontinue breastfeeding or treatment with Seretide will be based on the expected benefit of breastfeeding for the child compared to the treatment for the breastfeeding woman.
What should I do if I miss a dose?
If you forget to take your medicine
take the next dose at the usual time.
Do not take a double dose to make up for the single dose you forgot to take.
What happens if I overdose from Seretide ?
It is important to use the device as your doctor has shown you. If you accidentally take more than the recommended dose, tell your doctor or pharmacist. You may notice an increased heart rate and tremors. You may also experience headaches, muscle weakness and joint pain.
If you have taken large doses for a long time, talk to your doctor or pharmacist. High doses administered in the long term may result in a decrease in the steroid hormones secreted by the adrenal glands.
What is Forms and Composition Seretide?
FORMS and PRESENTATIONS
Seretide: Inhalation suspension at 50 μg / 25 μg / dose, at 125 μg / 25 μg / dose and at 250 μg / 25 μg / dose (white to whitish): Pressurized 8 ml (120 doses) vial with metering valve. The cartridge is inserted in a purple plastic applicator with a mouthpiece closed by a cap, with a dose counter to indicate the number of doses remaining. Seretide Diskus: Inhalation powder at 100 μg / 50 μg / dose, 250 μg / 50 μg / dose and 500 μg / 50 μg / dose: Distributor (Diskus) of 60 single-dose containers (regularly spaced), under heat-sealed film. Hospital models: Distributor (Diskus) of 28 single-dose containers, under heat-sealed film.
COMPOSITION
Seretide:
p dose * p dose delivered Fluticasone (DCI) propionate 50 μg 44 μg or 125 μg 110 μg or 250 μg 220 μg Salmeterol (INN) xinafoate expressed as salmeterol 25 μg 21 μg
* Issued by the metering valve. Excipient (common): norflurane (HFA 134a, propellant).
Seretide Diskus:
p dose * p dose delivered ** Fluticasone (DCI) propionate 100 μg 92 μg or 250 μg 231 μg or 500 μg 460 μg Salmeterol (INN) xinafoate expressed as salmeterol 50 μg 47 μg
* Contained in each single-dose container.
** At the mouthpiece. Excipient (common): lactose monohydrate (containing milk proteins).
Lactose content: up to 12.5 mg / dose.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Coversyl tablets reviews : Uses, Dosage, Side Effects & Warnings
Drug Online
coversyl tablets: Generic drug of the therapeutic class: Cardiology and angiology active ingredients: Perindopril
When should Coversyl be taken?
the reduction of the risk of cardiac events, such as infarction, in patients with stable coronary artery disease (the blood supply to the heart is reduced or blocked) and having a history of infarction and / or intervention aimed at improve blood supply to the heart by dilating the blood vessels.
and other thing’s like:
the treatment of arterial hypertension,
the treatment of heart failure (the heart is unable to provide enough blood to meet the needs of the body)
what is coversyl tablets used for
coversyl 2.5 mg, 5 mg and 10 mg tablets:
what is coversyl tablets used for
Hypertension:
Treatment of high blood pressure.
Stable coronary disease:
Reduced risk of cardiac events in patients with a history of myocardial infarction and / or revascularization.
2.5 mg and 5 mg tablets:
Heart failure :
Treatment of symptomatic heart failure.
coversyl dose :
It is recommended that COVERSYL 5 mg film-coated tablets be taken once daily in the morning before meals.
The dosage should be appropriate to the patient’s profile (see Warnings and Precautions section ) and his or her blood pressure response.
Hypertension
COVERSYL 5 mg can be used alone or in combination with other antihypertensive drugs.
The recommended starting dose is 5 mg daily in one morning dose.
Patients whose renin-angiotensin-aldosterone system is highly stimulated (in particular, renovascular hypertension, water-soluble depletion, cardiac decompensation or severe hypertension) may experience a sudden fall in blood pressure after the first dose. An initial dose of 2.5 mg is recommended in these patients and initiation of treatment will be under medical supervision.
The dosage may be increased to 10 mg once daily after one month of treatment.
Symptomatic hypotension may occur after treatment with COVERSYL 5 mg, particularly in patients treated with diuretics. Special attention is warranted in these patients who may experience water-soluble depletion.
If possible, diuretic therapy should be discontinued 2 to 3 days before initiation of treatment with COVERSYL 5 mg (see Warnings and Precautions ).
In hypertensive patients for whom the diuretic can not be stopped, treatment with COVERSYL should be initiated at a dose of 2.5 mg. Renal function and serum potassium should be monitored. The dosage of COVERSYL will then be adjusted according to the blood pressure response. If necessary, treatment with diuretics will be reintroduced.
In the elderly, treatment will be initiated at a dosage of 2.5 mg then it can be increased gradually to 5 mg after one month of treatment and then 10 mg if necessary, depending on the state of renal function (see table below).
Symptomatic heart failure
It is recommended to initiate treatment with COVERSYL, generally used in combination with a non-potassium-sparing diuretic and / or digoxin and / or beta-blocker, under strict medical supervision, at an initial dosage of 2.5 mg in a morning catch. Depending on the tolerability, this dosage may be increased with a minimum interval of 2 weeks from 2.5 mg to 5 mg per day. The dosage will be adapted according to the patient’s response to the treatment.
In patients with severe heart failure, and in those considered at high risk (patients with renal failure and a tendency to have electrolyte disturbances, patients receiving concomitant treatment with diuretics and / or vasodilators), treatment should be established under strict medical supervision (see Warnings and precautions for use ).
Patients at high risk of symptomatic hypotension, such as patients with water-soluble depletion with or without hyponatremia, patients with hypovolemia or patients treated with high-dose diuretics should be equilibrated, if possible before initiation of treatment with COVERSYL. Blood pressure, renal function and serum potassium should be closely controlled, both before and during treatment with COVERSYL 5 mg (see Warnings and Precautions ).
Stable coronary disease
Treatment with COVERSYL should be initiated at a dose of 5 mg once daily for two weeks, then increased to 10 mg once daily, depending on renal function and whether the 5 mg dose is well tolerated.
Elderly patients will receive 2.5 mg once daily for one week, then 5 mg daily the following week, then the dose will be increased to 10 mg once daily depending on renal function (see Table 1 kidney failure “).
The dosage will be increased only if the previous dose is well tolerated.
Dosage adjustment in renal failure
The dosage in patients with renal impairment should be adjusted according to creatinine clearance as outlined in Table 1 below:
Table 1: Dosage Adjustment in Renal Failure
Creatinine clearance (ml / min) Recommended dosage ClCR ≥ 60 5 mg daily 30 <ClCR <60 2.5 mg daily 15 <ClCR <30 2.5 mg every other day Hemodialysis patients * ClCR <15 2.5 mg on days of dialysis
* The dialysis clearance of perindoprilat is 70 ml / min. For hemodialysis patients, the drug should be taken after dialysis.
Dosage adjustment in hepatic insufficiency
No dose adjustment is necessary in patients with hepatic impairment (see Warnings and Precautionsand Pharmacokinetic Properties sections ).
Children and adolescents (under 18 years old)
Efficacy and safety of use have not been established in children and adolescents. As a result, use in children and adolescents is not recommended.
how coversyl works?
Pharmacotherapeutic Class: Non-Associated Conversion Enzyme Inhibitors (IEC), ATC Code: C09AA04
Action mechanism
Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (Angiotensin Converting Enzyme ECA). This conversion enzyme, or kinase, is an exopeptidase that allows the conversion of angiotensin I to vasoconstrictor angiotensin II causing degradation of vasodilator bradykinin to an inactive heptapeptide.
Inhibition of ACE induces a decrease in angiotensin II in plasma, leading to an increase in renin plasma activity (by inhibition of negative feedback control of renin release) and a decrease in secretion aldosterone. Since ECA inactivates bradykinin, inhibition of ACE also leads to an increase in the activity of local and circulating kallikrein-kinin systems (and consequently to activation of the prostaglandin system). This mechanism may contribute to the hypotensive action of ACE inhibitors and is partially responsible for some of their side effects (such as coughing).
Perindopril works through its active metabolite, perindoprilat. The other metabolites do not show ACE inhibition in vitro .
Efficacy and clinical safety
Hypertension
Perindopril is active at all stages of hypertension: mild, moderate, severe; there is a reduction in systolic and diastolic pressure, both supine and orthostatic.
Perindopril reduces peripheral vascular resistance, leading to a decrease in blood pressure. As a result, peripheral blood flow increases, with no effect on heart rate.
In general, renal blood flow increases with a glomerular filtration rate (GFR) usually remaining unchanged.
The antihypertensive activity is maximal between 4 and 6 hours after a single dose and is maintained for at least 24 hours: the valley / peak ratio is of the order of 87-100%.
The decrease in blood pressure occurs quickly. In responder patients, blood pressure normalization occurs during the first month of treatment, and is maintained without escape.
Stopping treatment is not accompanied by a rebound effect on blood pressure.
Perindopril reduces left ventricular hypertrophy.
In humans, the vasodilatory properties of perindopril have been confirmed. It improves the elasticity of large arterial trunks and decreases the media / lumen ratio of small arteries.
The combination with a thiazide diuretic produces an additive synergy. The combination of ACE inhibitor and thiazide also decreases the risk of hypokalemia induced by diuretic therapy.
Heart failure
Perindopril reduces cardiac work by decreasing pre-load and post-load.
Studies in heart failure have demonstrated:
· A decrease in left and right ventricular filling pressures,
· A decrease in total peripheral vascular resistance,
· An increase in cardiac output and an improvement in the cardiac index.
In comparative studies, the first 2.5 mg administration of perindopril arginine to patients with mild to moderate heart failure was not associated with a significant decrease in blood pressure compared with placebo.
Patients with stable coronary artery disease
The EUROPA multicenter, international, randomized, double-blind, placebo-controlled clinical trial lasted 4 years.
Twelve thousand two hundred and eighteen (12218) patients over 18 years of age were randomized to perindopril 8 mg (equivalent to perindopril arginine 10 mg) (n = 6110) or placebo (n = 6108).
The patients in the study had coronary artery disease with no clinical sign of heart failure. In total, 90% of patients had a history of myocardial infarction and / or a history of coronary revascularization. Most patients received the studied treatment in addition to their usual therapy including platelet aggregation inhibitors, lipid-lowering drugs and beta-blockers.
The primary efficacy endpoint was a combined endpoint of cardiovascular mortality, nonfatal myocardial infarction, and / or recovered cardiac arrest. Treatment with perindopril 8 mg (equivalent to perindopril arginine 10 mg) once daily resulted in a significant absolute reduction of the primary endpoint of 1.9% (relative risk reduction of 20%, 95% CI [9.4, 28.6] – p < 0.001).
Compared to placebo, an absolute reduction of 2.2% corresponding to a RRR of 22.4% (95% CI [12.0, 31.6] – p < 0.001) of the primary endpoint was observed in patients with a history of myocardial infarction and / or revascularization.
Pediatric population
The safety and efficacy of perindopril have not been established in children and adolescents under 18 years of age.
In an open-label, non-comparative clinical study, 62 hypertensive children aged 2 to 15 years with a glomerular filtration rate> 30 ml / min / 1.73 m2 received perindopril at an average dose of 0.07 mg / kg.
The dose was adapted for each patient according to his profile and his blood pressure response up to a maximum dose of 0.135 mg / kg / day.
59 patients completed the initial phase of 3 months of treatment and 36 patients completed the extension phase of the study, corresponding to a follow-up of at least 24 months (average duration of the study: 44 months).
Systolic and diastolic blood pressure remained stable from baseline to last assessment in patients previously treated with other antihypertensive agents and decreased in patients who had never received antihypertensive therapy.
More than 75% of children had a systolic and diastolic blood pressure lower than the 95th percentile in their last assessment.
The safety of use was consistent with the known safety profile of perindopril.
Data from clinical trials related to double blockade of the renin-angiotensin-aldosterone system (RAAS):
The use of a combination of a converting enzyme inhibitor (ACE) with an angiotensin II receptor antagonist (ARB II) was analyzed in two large randomized controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes).
The ONTARGET study was conducted in patients with a history of cardiovascular disease or cerebrovascular disease, or type 2 diabetes with target organ involvement. The VA NEPHRON-D study was conducted in type 2 diabetic patients with diabetic nephropathy.
In comparison with monotherapy, these studies did not show any significant beneficial effect on renal and / or cardiovascular outcomes and mortality, whereas an increased risk of hyperkalemia was observed. , acute renal failure and / or hypotension.
These results are also applicable to other IEC and ARA II, given the similarity of their pharmacodynamic properties.
ACE inhibitors and ARBs should not be used in patients with diabetic nephropathy.
The ALTITUDE study was conducted to evaluate the benefit of adding aliskiren to standard ACE inhibitors or AIIRAs in type 2 diabetes and chronic renal failure, with or without cardiovascular disorders. This study was stopped prematurely due to an increased risk of adverse events. Cardiovascular deaths and strokes were more common in the aliskiren group than in the placebo group; adverse events and some serious adverse events such as hyperkalemia, hypotension and
What are the side effects of taking Coversyl?
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any of the following potentially serious side effects, stop taking COVERSYL 5 mg film-coated tablets immediately and contact your doctor immediately:
· Swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema), (see section 2 “Warnings and Precautions” (uncommon – may affect up to 1 in 100 patients) )
· Severe dizziness or fainting due to lhypotension (common – may affect up to 1 in 10),
· Unusually fast or irregular heartbeat, chest pain (angina), or infarction (very rare – may affect up to 1 in 10,000 patients),
· Weakness of the arms or legs, or delocution problems that may be signs of a possible stroke (very rare – may affect up to 1 in 10,000 patients),
· Sudden wheezing, chest pain, shortness of breath or breathing difficulties (bronchospasm) (uncommon – may affect up to 1 in 100 patients),
· Inflammation of the pancreas may result in severe abdominal and dorsal pain with very high discomfort (very rare – may affect up to 1 in 10,000 patients),
· Yellowing of the skin or eyes (jaundice) may be a sign of hepatitis (very rare – may affect up to 1 in 10,000 patients),
· Rashes often starting with red spots and itching on the face, arms or legs (erythema multiforme) (very rare – may affect up to 1 in 10,000 patients).
Tell your doctor if you notice any of the following side effects:
Frequent (may affect up to 1 in 10 patients):
· Headache,
· Discomfort,
· Vertigo,
· Tingling and tingling sensations,
· Visual disturbances,
· Hissing (feeling of noise in the ears) and ringing of the ear,
· Cough,
· Difficulty breathing (dyspnea),
· Gastrointestinal disturbances (nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or difficult digestion, diarrhea, constipation),
· Allergic reactions (such as rash, itching),
· Muscle cramps,
· Tiredness
Uncommon (may affect up to 1 in 100 patients):
· Mood disorders,
· Sleep disorders,
· Dry mouth,
· Severe itching or severe rash,
· Blistering on the skin,
· Kidney problems,
· Impotence,
· Perspiration,
· Deosinophilic excess (category of white blood cells),
· Sleepiness,
· Fainting,
· Palpitations,
· Tachycardia,
· Vasculitis (inflammation of the blood vessels),
· Photosensitivity reaction (increased sensitivity of the skin to the sun),
· Arthralgia (joint pain),
· Myalgia (muscle pain),
· Chest pain,
· Malaise,
· Peripheral edema,
· Fever,
· Fall,
· Modification of biological parameters: increase of reversible potassium at the end of treatment, decrease of sodium level, hypoglycaemia (very low blood sugar level) in diabetic patients, elevation of blood creatinine level, elevation of blood levels duration.
Rare (may affect up to 1 in 1000 patients):
· Worsening of psoriasis,
· Changes in biological parameters: increased levels of liver enzymes, elevated serum bilirubin.
Very rare (may affect up to 1 in 10,000 patients):
· Confusion,
· Eosinophilic pneumonia (a rare type of pneumonia),
· Rhinitis (stuffy nose or runny nose),
· Renal insufficiency,
· Changes in blood constants such as a decrease in the number of white and red blood cells, a decrease in hemoglobin, a decrease in the number of blood platelets.
coversyl drug interactions
Data from clinical trials have shown that renin-angiotensin-aldosterone system double-blocking (RAAS) by the concomitant use of angiotensin II receptor antagonists, angiotensin II aliskiren is associated with a higher incidence of adverse events such as hypotension, hyperkalemia, and impaired renal function (including acute renal failure) compared with the use of a single drug acting on the RAAS (see sections Contraindications , Warnings and Precautions for Use and Pharmacodynamic Properties ).
coversyl interactions other drugs
Drugs causing hyperkalemia
Certain drugs or therapeutic classes may increase the appearance of hyperkalemia such as:
aliskiren.
potassium salts.
potassium-sparing diuretics.
ACE inhibitors.
ARBs II.
nonsteroidal anti-inflammatory drugs (NSAIDs).
heparins immunosuppressants such as ciclosporin or tacrolimus and trimethoprim.
The combination of these drugs increases the risk of hyperkalemia.
Contraindicated combinations (see Contraindications section )
Aliskiren
The risk of hyperkalemia, deterioration of renal function and cardiovascular morbidity and mortality increases in patients with diabetes or renal insufficiency,
Associations not recommended (see section Warnings and precautions for use )
Aliskiren
The risk of hyperkalaemia, deterioration of renal function and cardiovascular morbidity and mortality increases in patients other than diabetic patients or patients with renal insufficiency.
Treatment associating an IEC with an ARA II
It has been reported in the literature that in patients with diagnosed atherosclerosis, heart failure or in diabetic patients with organic lesions, concomitant treatment with ACEI and ARB II is associated with a higher frequency of hypotension, syncope, hyperkalemia, and impaired renal function (including acute renal failure) compared to monotherapy with a molecule acting on the renin-angiotensin-aldosterone system. Double blockage (eg combination of an ACEI with an ARB II) should be limited to individual and defined cases, with increased monitoring of renal function, potassium level and blood pressure.
Estramustine
Risk of increased side effects such as angioneurotic edema (angioedema).
Racecadotril
ACE inhibitors (eg perindopril) are known to cause angioedema. This risk may be increased when used concomitantly with racecadotril (a drug used for acute diarrhea).
MTOR inhibitors (eg sirolimus, everolimus, temsirolimus)
Patients treated concomitantly with an mTOR inhibitor may have a higher risk of angioedema (see Warnings and Precautions section ).
Potassium sparing diuretics (eg triamterene, amiloride …), potassium (salts)
Hyperkalemia (potentially fatal), especially in a context of renal failure (cumulative hyperkalemic effects).
The combination of perindopril with the medicines mentioned above is not recommended (see Warnings and Precautions ). If concomitant use is indicated, however, these medicinal products should be used with caution and periodic serum potassium control should be performed. For the use of spironolactone in heart failure see below.
Lithium
Reversible increases in serum lithium concentrations and therefore toxicity have been reported during concomitant administration of lithium with ACE inhibitors. The use of perindopril with lithium is not recommended, but if the association proves necessary, careful monitoring of lithium levels should be performed (see section Warnings and precautions for use ).
Associations advised against
Antidiabetic drugs (insulins, oral hypoglycemic agents)
Epidemiological studies have suggested that the combination of ACE inhibitors and antidiabetic drugs (insulins, oral hypoglycaemic agents) may cause an increase in the hypoglycemic effect with a risk of hypoglycaemia. This phenomenon seems to occur more particularly during the first weeks of the combination of these treatments and in patients with renal insufficiency.
Baclofen
Increased antihypertensive effect. If necessary, monitor the blood pressure and adjust the dosage of the antihypertensive drug.
Non-potassium sparing diuretics
Patients treated with diuretics, particularly those with hypovolemia and / or water-soluble depletion, may be subject to a severe decrease in blood pressure after initiation of treatment with an ACE inhibitor. The hypotensive effect may be decreased by discontinuing the diuretic, increasing the volume or salt intake before initiating treatment with low and progressive doses of perindopril.
In arterial hypertension , when previous diuretic therapy may have caused hypovolemia and / or water-soluble depletion, the diuretic must be discontinued before initiating an ACE; in this case, a non-potassium-sparing diuretic may then be reintroduced or the IEC should be initiated at a low dose gradually increased.
In the diuretic treatment of congestive heart failure, the ACE inhibitor should be initiated at a very low dose and after reducing the dose of the associated potassium-sparing diuretic.
In all cases, renal function (creatinine level) should be monitored during the first few weeks of treatment with IEC.
Potassium-sparing diuretics (eplerenone, spironolactone)
With eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily and with low doses of IEC:
In the treatment of NYHA class II-IV heart failure with an ejection fraction <40%, and previously treated with an ACE inhibitor and loop diuretic, there is a risk of hyperkalemia, potentially life-threatening especially in case of non-compliance with the prescription recommendations of this association. Before initiating the combination, check for the absence of hyperkalemia and renal failure. Strict control of serum potassium and serum creatinine is recommended once a week in the first month of treatment and once a month in subsequent months.
Non-steroidal anti-inflammatory drugs (NSAIDs) including aspirin ³ 3 g / day
When ACE inhibitors are administered concurrently with NSAIDs (such as acetylsalicylic used as an anti-inflammatory, COX-2 inhibitors, and non-selective NSAIDs), an attenuation of the antihypertensive effect may occur.
Concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of worsening renal function, including a risk of acute renal failure, and an increase in serum potassium, particularly in patients with pre-existing impairment. existing renal function. The combination should be administered with caution, especially in the elderly. Patients should be properly hydrated and measures should be taken to control renal function at the start of treatment and periodically thereafter.
Associations subject to precautions for use
Antihypertensives and vasodilators
Concomitant use of these agents may increase the hypotensive effects of perindopril. Concomitant use of nitroglycerin and other nitrates, or other vasodilators, may decrease blood pressure.
Gliptins (linagliptin, saxagliptin, sitagliptin, vildagliptin)
Increased risk of angioedema due to decreased activity of dipeptidylpeptidase IV (DPP-IV) caused by gliptin in patients co-treated with ACE.
Tricyclic Antidepressants / Antipsychotics / Anesthetics
Concomitant use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to an increase in blood pressure reduction (see Warnings and Precautions section ).
Sympathomimetics
Sympathomimetics may reduce the antihypertensive effects of ACE.
Golden Salts
Nitritoid reactions (symptoms including facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients receiving gold injections (sodium aurothiomalate) and an ACE inhibitor (including perindopril) concomitantly.
Coversyl Warnings and Precautions
Stable coronary disease
If an unstable dangor episode (major or non-major) occurs during the first month of treatment with perindopril, a thorough benefit-risk assessment should be performed before continuing treatment.
hypotension
ACE inhibitors can cause a drop in blood pressure. Symptomatic hypotension is rarely observed in uncomplicated hypertensive patients, but occurs preferentially in patients with volume depletion ie treated with a diuretic, under a salt-restricted diet, on dialysis, with diarrhea or vomiting, or in those with severe renin-dependent hypertension.
Symptomatic hypotension has been observed in patients with heart failure, with or without associated renal failure.
It occurs preferentially in these patients who have a severe degree of cardiac insufficiency, related to the use of high doses of diuretics of lanse, hyponatremia or functional renal failure.
Linitiation of treatment and dosage adjustment should be performed under strict medical supervision in patients at high risk of symptomatic hypotension.
The same precautions apply to patients with cardiac dischemia or cerebrovascular disease in whom excessive blood pressure drop can lead to myocardial infarction or stroke.
If hypotension occurs, the patient should be placed supine and, if necessary, receive an intravenous infusion of 9 mg / ml (0.9%) sodium chloride solution.
Transient hypotension is not a contraindication to continued treatment, which can usually be continued without problems once the blood pressure increases after the increase in volume.
A further decrease in blood pressure may occur with COVERSYL 5 mg in some heart failure patients with normal or low blood pressure.
This expected effect does not generally require the cessation of treatment.
If hypotension becomes symptomatic, a dose reduction or discontinuation of COVERSYL 5 mg may be necessary.
Stenosis of the aortic and mitral valves / hypertrophic cardiomyopathy
As with other ACE inhibitors, COVERSYL 5 mg should be given with caution in patients with mitral valve stenosis and left ventricular flow obstruction such as aortic stenosis or hypertrophic cardiomyopathy.
Renal failure
In case of renal insufficiency, (creatinine clearance <60 ml / min) the initial dose of perindopril should be adjusted according to the patient’s creatinine clearance and then depending on the patient’s response to treatment . Periodic monitoring of potassium and creatinine is a routine part of these patients.
Hypotension secondary to initiation of ACE inhibitor therapy may lead to impaired renal function in heart failure patients. In such cases, acute renal failure, usually reversible, has been observed.
Increases in blood urea and serum creatinine, usually reversible at the end of treatment, have been observed in some patients with bilateral renal artery stenosis or single kidney stenosis treated with ACE inhibitors.
This has been observed in particular in patients with renal insufficiency.
There is an increased risk of severe hypotension and renal insufficiency if renovascular hypertension is also present.
In these patients, treatment should be initiated under strict medical supervision with a low dosage and a gradual increase thereof. Since diuretic therapy is an additional risk factor, it should be discontinued and renal function should be monitored during the first few weeks of treatment with COVERSYL 5 mg.
Often small and transient increases in blood-serum creatinine levels, especially when COVERSYL 5 mg was associated with a diuretic, have been observed in some hypertensive patients with no history of renovascular disease. This particularly concerns patients with pre-existing renal insufficiency. Dose reduction and / or discontinuation of diuretic and / or COVERSYL 5 mg may be necessary.
Hemodialysis patients
Anaphylactoid reactions have been reported in dialysis patients with high permeability membranes and concomitantly treated with an IEC. Another type of dialysis membrane or antihypertensive agent of different class should be used in these patients.
Kidney transplantation
There are no data on the administration of COVERSYL 5 mg in patients with recent kidney transplantation.
Hypersensitivity / angioneurotic edema
Angio-edema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx has been reported rarely in patients treated with ACE, COVERSYL 5 mg included.
This can happen at any time during treatment. In such cases, COVERSYL 5 mg should be discontinued immediately and the patient should be monitored until symptoms are completely resolved.
When the edema is only interested in the face and the lips, the evolution is generally regressive without treatment, although antihistamines have been used to relieve the symptoms.
Langio-edema associated with laryngeal edema can be fatal. When the tongue, glottis or larynx is affected, which can cause airway obstruction, emergency treatment should be given promptly. This may include adrenaline administration and / or airway clearance. The patient must be kept under strict medical supervision until the complete disappearance of symptoms.
Patients with a history of angioedema not associated with an ACE inhibitor are at an increased risk of angioedema under ACE.
An intestinal angio-edema has been reported rarely in patients treated with a conversion enzyme inhibitor. These patients had abdominal pain (with or without nausea or vomiting); in some cases it was not preceded by facial angioedema and C-1 esterase levels were normal. The diagnosis was made by an abdominal CT scan, an ultrasound, or during surgery and the symptoms disappeared at the end of the ECI.
Intestinal Langio-edema should be part of the differential diagnosis in case of abdominal pain in a patient under IEC.
Concomitant use of mTOR inhibitors (eg sirolimus, everolimus, temsirolimus)
Patients treated concomitantly with an mTOR inhibitor (eg sirolimus, everolimus, temsirolimus) may have a higher risk of angioedema (eg, airway or tongue edema, with or without respiratory failure).
Anaphylactoid Reactions During Apheresis of Low-Density Lipoprotein (LDL)
Rarely, life-threatening anaphylactoid reactions have been reported in those receiving ACE inhibitors during low density lipoprotein apheresis with adsorption on dextran sulfate. These reactions can be avoided by transiently interrupting IEC treatment before each apheresis.
Anaphylactoid reactions during desensitization
Some patients on ACE during desensitization therapy (eg with hymenoptera venom) have had anaphylactoid reactions. These reactions could be avoided in these patients by transiently interrupting the ACE inhibitors during desensitization, but they reappeared when the treatment was inadvertently resumed.
Hepatic insufficiency
ACE inhibitors have been rarely associated with a syndrome that begins with cholestatic jaundice and may lead to fulminant necrotizing hepatitis and (sometimes) death. The mechanism of this syndrome is unclear. Patients taking ACE inhibitors who develop jaundice or have marked hepatic enzyme elevations should discontinue IEC therapy and receive appropriate medical supervision (see section 4.8).
Neutropenia / Agranulocytosis / Thrombocytopenia / Anemia
Neutropenia / agranulocytosis, thrombocytopenia and anemia have been reported in some patients on ACE. In patients with normal renal function and no other risk factors, neutropenia is rarely observed. Perindopril should be used with extreme caution in patients with vascular collagen diseases, in immunosuppressed patients, in patients treated with allopurinol or procainamide, or in patients with a combination of these risk factors, particularly in patients with case of pre-existing renal failure. Some of these patients developed serious infections, which in a few cases did not respond to intensive antibiotic treatment. If perindopril is used in these patients,
Ethnic particularities
ACE inhibitors cause greater angioedema in black patients.
As with other ACE inhibitors, perindopril may be less effective in lowering blood pressure in black patients, because of the possibility of a higher prevalence of low renin levels in this type of population.
Cough
A cough has been reported with the use of IEC. Characteristically, the cough is non-productive, persistent and disappears after treatment. IEC-induced cough should be part of the differential diagnosis of cough.
Surgery / Anesthesia
In patients undergoing major surgery or anesthesia with agents causing hypotension, COVERSYL 5 mg may block the production of langiotensin II secondary to renin release. Treatment should be discontinued one day before surgery. If hypotension occurs and is attributed to this mechanism, it can be corrected by an increase in the volume.
hyperkalemia
Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including perindopril. The risk factors for hyperkalemia are renal failure, deterioration of renal function, age (> 70 years), diabetes, intercurrent events such as dehydration, acute cardiac decompensation, metabolic acidosis, concomitant use of potassium-sparing diuretics (eg for example: spironolactone, eplerenone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium or other treatments that increase serum potassium (eg heparin). The use of potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium, especially in patients with impaired renal function, can cause a significant rise in serum potassium. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias. If concomitant use of the agents mentioned above is deemed necessary, they should be used with caution and frequent monitoring of serum potassium should be performed.
Diabetic patients
In diabetic patients treated with oral antidiabetic drugs or insulin, blood glucose control should be closely monitored during the first month of ICI treatment.
Lithium
The combination of lithium and perindopril is generally not recommended.
Potassium-sparing diuretics, potassium supplements or substitutes containing potassium salts
Combination of perindopril with potassium-sparing diuretics, potassium supplements or potassium-containing substitutes is generally not recommended.
Double blockade of the renin-angiotensin-aldosterone system (RAAS)
It has been established that the combination of conversion enzyme (ACE) inhibitors, langiotensin-II receptor antagonists (ARA II) or daliskiren increases the risk of hypotension, hyperkalemia and impaired renal function (including the risk of acute renal failure). As a consequence, the double blockade of the RAIS by the association of ECI, DARA II or daliskiren is not recommended (see sections 4.5 and 5.1).
Nevertheless, if such an association is considered absolutely necessary, it can be done only under the supervision of a specialist and with a close and frequent control of the renal function, blood lionogram and arterial pressure. ACE inhibitors and ARBs should not be used in patients with diabetic nephropathy.
Pregnancy
ACE inhibitors should not be started during pregnancy. Unless IEC therapy is considered essential, it is recommended that patients considering pregnancy change their antihypertensive therapy for a drug with a well-established safety profile during pregnancy. If pregnancy is diagnosed, treatment with IEC should be stopped immediately and if necessary, alternative treatment should be started (see sections 4.3 and 4.6).
excipients
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
INTERACTIONS WITH OTHER DRUGS AND OTHER FORMS OF INTERACTION
Data from clinical trials have shown that double blockade of the renin-angiotensin-aldosterone system (RAAS) by concomitant use of conversion enzyme inhibitors, langiotensin II receptor antagonists or daliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalemia, and renal function impairment (including acute renal failure) compared to the use of a single drug acting on the RAAS.
Drugs causing hyperkalemia
Certain drugs or therapeutic classes may increase the appearance of hyperkalemia such as: laliskiren, potassium salts, potassium-sparing diuretics, ACE inhibitors, ARBs II, nonsteroidal anti-inflammatory drugs (NSAIDs), heparins, immunosuppressants such as ciclosporin or tacrolimus and trimethoprim. The association of these drugs increases the risk of hyperkalemia.
Contraindicated combinations .
Golden salts
Nitritoid reactions (symptoms including facial flushing, nausea, vomiting, and hypotension) have been reported rarely in patients receiving dor injection (sodium aurothiomalate) and an ACE inhibitor (including perindopril) concomitantly.
Drive and use machines
COVERSYL does not directly affect alertness, but feelings of vertigo or fatigue in relation to a drop in blood pressure may occur in some patients.
Therefore, the ability to drive or use machines can be reduced.
Coversyl and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
The use of ACE inhibitors is not recommended during the 1 st trimester of pregnancy ( see Warnings and Precautions ). The use of ACE inhibitors is against-indicated to 2 e and 3 e trimesters of pregnancy ( see Contraindications , Warnings and Precautions ).
Available epidemiological data on the risk of malformation after exposure to ACE in the 1 st trimester of pregnancy are inconclusive. However, a small increase in the risk of congenital malformations can not be ruled out. Unless IEC therapy is considered essential, it is recommended that patients considering pregnancy change their antihypertensive therapy for a drug with a well-established safety profile during pregnancy. If pregnancy is diagnosed, treatment with IEC should be stopped immediately and, if necessary, alternative treatment should be started.
The exposure to ACE inhibitors during the 2 e and 3 e trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull) and toxicity in the newborn ( renal insufficiency, hypotension, hyperkalemia): see Preclinical safety . If ACE inhibitor exposure from 2 th trimester of pregnancy, it is recommended to perform a fetal ultrasound check of renal function and the bones of the skull. Infants born to mothers treated with IEC should be monitored for blood pressure ( see Contraindications , Warnings and Precautions ).
Breastfeeding:
Due to the lack of information available on the use of Coversyl during breastfeeding, Coversyl is not recommended. It is best to use other treatments with a well-established safety profile during breastfeeding, especially in the newborn or preterm infant.
Fertility:
There is no effect on reproductive function or fertility.
What should I do if I miss a dose?
It is important to take your medicine every day as regular treatment is more effective. However, if you have forgotten to take COVERSYL 5 mg film-coated tablets, the next day simply resume your treatment as usual.
Do not take a double dose to make up for the dose you forgot to take.
What happens if I overdose from Coversyl ?
If you have taken too many tablets, contact your nearest hospital or doctor immediately. The most likely event, in case of overdose, is hypotension which may result in dizziness or lightheadedness. If this happens, lie down with your legs up.
What is Forms and Composition Coversyl?
FORMS and PRESENTATIONS
2.5 mg film-coated tablet (round and convex, white) and 10 mg (round, biconvex, one heart engraved on one side and the Servier logo on the other, green): 30 tablets pillboxes, packs of 1 and 3 pillboxes. 5 mg film-coated tablet (stick-shaped, scored on both sides, Servier logo engraved on one side, light green): 30 tablets pill boxes, 1 and 3 pill boxes.
COMPOSITION
p cp Perindopril (INN) arginine 2.5 mg or 5 mg or 10 mg (Perindopril: 1.66975 mg / tablet 2.5 mg, 3.395 mg / tablet 5 mg, 6.790 mg / tablet 10 mg)
Excipients (common): Core: lactose monohydrate, magnesium stearate, maltodextrin, hydrophobic colloidal silica, sodium carboxymethyl starch (type A). Film coating: macrogol 6000, glycerol, hypromellose, magnesium stearate, titanium dioxide, cupric chlorophyllin (cp 5 mg and 10 mg).
Excipients with known effect: lactose monohydrate (36.29 mg / cw 2.5 mg, 72.58 mg / cd 5 mg, 145.16 mg / cp 10 mg).
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
The post Coversyl tablets reviews : Uses, Dosage, Side Effects & Warnings appeared first on Drug Online.
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tanakan 40mg tablete Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
tanakan 40mg tablete Generic drug of the Therapeutic class: Cardiology and angiology active ingredients: Ginkgo
Important to know about Tanakan
What vitamin is best for memory?
tanakan medicine is indicated for the symptomatic treatment of certain cognitive disorders in the elderly (particularly memory disorders), except for any type of confirmed dementia, drug-related disorders, depression or metabolic disorders.
What is tanakan tablets used for and what is Tanakan medicine indication ?
Herbal medicine used in the symptomatic treatment of cognitive disorders in the elderly, with the exception of patients with confirmed dementia, Parkinson’s disease, iatrogenic cognitive disorders or secondary to depression or metabolic disorders. Tanakan is indicated for adults and the elderly.
tanakan 40mg daily dosage
Oral way
3 tablets a day, to be distributed during the day.
The tablets are to be taken with half a glass of water at the time of the meals.
How it works Tanakan
?
Pharmacotherapeutic group: other dementia drugs, ATC code: N06DX02. The mechanism of action is not known.
In humans, pharmacological data show an electroencephalogram with increased vigilance in the elderly, a decrease in blood viscosity and an increase in vascularization of specific brain areas in healthy men (60-70 years of age). ), and a decrease in platelet aggregation.
In addition, vasodilator effects on the blood vessels of the forearms causing an increase in blood volume have been shown.
WHAT’S tanakan 40 mg tablet side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets them. Summary of the security profile The most common side effects are abdominal pain, diarrhea and dizziness.
If you develop a severe allergic reaction (angioedema) manifested by swelling of the face, lips, tongue or throat, stop taking this medicine immediately and seek medical advice urgently.
Other possible side effects:
· Frequent (may affect up to 1 in 10 people)
allergic reaction
Difficulty breathing
Headache
Syncope
Indigestion
Nausea
Eczema
itching
· Uncommon (may affect up to 1 in 100 people)
Urticaria
Rash
By reporting side effects, you can help provide more information on the safety of the medicine.
tanakan medication Interactions
If this medication is taken concomitantly with anticoagulants (phenprocoumon, warfarin) or anti-platelet drugs (clopidogrel, acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs), their effect may be affected.
Studies available with warfarin do not show any interaction between warfarin and products containing ginkgo, but sufficient monitoring is recommended when treating with a ginkgo-containing medicine at the beginning, end, a dose change or change of medication.
An interaction study with talinolol shows that ginkgo can inhibit intestinal P-glycoproteins. This may increase exposure to P-glycoprotein sensitive drugs in the gut such as dabigatran etexilate.
Precautions should be taken when ginkgo and dabigatran are combined.
An interaction study showed that the Cmax of nifedipine can increase with ginkgo.
In some individuals the increase may be up to 100% with vertigo and increased intensity of hot flashes.
Concomitant use of ginkgo preparations with efavirenz is not recommended; the plasma concentration of efavirenz may decrease due to the induction of cytochrome CYP3A4 (see Warnings and Precautions ).
Tanakan Warnings and Precautions
This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
In patients with predisposition to bleed (haemorrhagic site) and concomitant anticoagulant and anti-platelet therapy, a physician should be consulted before taking this medication.
Preparations containing ginkgo may increase the predisposition to bleed. As a precaution, this medication should be stopped 3 to 4 days before surgery.
In epileptic patients, the appearance of additional seizures favored by ingestion of preparations containing ginkgo can not be ruled out.
Concomitant use of preparations containing ginkgo with lefavirenz is not recommended .
Tanakan Warnings and Precautions
Drive and use machines:
Effects on the ability to drive and use machines have not been studied.
Tanakan and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
Ginkgo extract may decrease the ability of platelets to aggregate.
The predisposition to bleed may increase. Studies in animals are insufficient with respect to reproductive toxicity ( see Preclinical Safety )
.Use during pregnancy is contraindicated ( see Contraindications ).
Breastfeeding:
There are no data on the excretion of ginkgo metabolites in breast milk.
A risk for newborns and children can not be ruled out.
In the absence of sufficient data, use during breastfeeding is discouraged.
Fertility:
There is no specific study in ginkgo man to evaluate its effects on fertility.
Effects in female mice have been shown ( see Preclinical safety ).
What happens if I overdose from Tanakan ?
No case of overdose has been reported.
What is Forms and Composition Tanakan ?
COMPOSITION:
Active substance
Gingko ( Ginkgo biloba L.) (quantified extract of) titrated to 24% ginkgo glycosides and 6% Ginkgolides-bilobalide 40.00 mg For a coated tablet.
Other components
Lactose monohydrate, microcrystalline cellulose, corn starch, anhydrous colloidal silica, talc, magnesium stearate, hypromellose, macrogol 400, macrogol 6000, titanium dioxide, red iron oxide.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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The post tanakan 40mg tablete Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.
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PROPOFAN Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
Generic PROPOFAN drug of the Therapeutic class: Analgesics active ingredients: Dextropropoxyphene , Paracetamol , Caffeine
propofan drug Uses and indication
propofan drug Uses and indication
Symptomatic treatment of pain of moderate to intense intensity, or not responding to the use of peripheral analgesics alone.
propofan dosage
Oral way.
Reserved for adults and adolescents from 15 years old.
The tablets should be swallowed as is, with a large glass of water, during a meal.
1 to 2 tablets per dose. On average 4 tablets a day divided into 2 to 4 doses.
Do not exceed 6 tablets a day.
The catches must be spaced at least 4 hours apart, at best 8 to 12 hours.
In cases of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between 2 doses will be at least 8 hours.
how does propofan work
Pharmacotherapeutic group: DEXTROPROPOXYPHENE IN ASSOCIATION.
ATC Code: N02AC54.
(N: Central nervous system).
propofan drug is a combination of 3 active ingredients:
paracetamol : ANALGESIC AND ANTIPYRETIC,
dextropropoxyphene : ANALGESIC OPIOID,
caffeine : PSYCHOSTIMULANT.
What are the side effects of propofan ?
PARACETAMOL RELATED :
Few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.
Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.
RELATED TO DEXTROPROPOXYPHENE :
The most common: nausea, vomiting.
More rarely: constipation, abdominal pain, rash, headache, asthenia, euphoria, minor vision disorders, disorientation, somnolence, dizziness, severe hypoglycemia, cholestatic or mixed hepatitis.
CAFEIN RELATED :
rare cases of insomnia,
possibility of palpitations.
propofol interactions
PARACETAMOL-RELATED :
INTERACTIONS WITH PARACLINICAL EXAMINATIONS :
Paracetamol may interfere with the glucose-oxidase-peroxidase assay at abnormally high concentrations.
Taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method.
ASSOCIATIONS WITH PRECAUTIONS FOR USE :
Oral anticoagulants :
Risk of an increase in the effect of oral anticoagulant and haemorrhagic risk when taking paracetamol at maximum doses (4 g / d) for at least 4 days.
More frequent control of the INR. Possible adaptation of oral anticoagulant dosage during paracetamol treatment and after discontinuation.
RELATED TO DEXTROPROPOXYPHENE :
CONTRAINDICATED ASSOCIATION :
Morphine agonists-antagonists (buprenorphine, nalbuphine, pentazocine) :
Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.
ASSOCIATIONS DEVOTED :
–Alcohol :
Increase by alcohol of sedative effect of opioid analgesics.
Impairment of alertness can make driving and using machines dangerous.
How long after propofol Can I drink alcohol?
Avoid taking alcoholic drinks and drugs containing alcohol.
– Carbamazepine :
Increased plasma concentrations of carbamazepine with signs of overdose by inhibition of its hepatic metabolism.
Clinical surveillance and possible reduction of the dosage of carbamazepine.
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
– Other morphine derivatives (including antitussives and substitution treatments), benzodiazepines, barbiturates:
Increased risk of respiratory depression, which can be fatal in case of overdose.
– Other central nervous system depressants, such as other morphine derivatives (including antitussives and substitution treatments), sedative antidepressants, sedative antihistamines H1, anxiolytics, hypnotics, neuroleptics, central antihypertensives, thalidomide, baclofen :
Increased central depression. Altered alertness can make driving and using machines dangerous.
RELATED CAFFEINE :
ASSOCIATION NOT RECOMMENDED :
Enoxacin :
Significant increase in caffeine levels in the body that can lead to excitement and hallucinations (decreased hepatic metabolism of caffeine).
ASSOCIATIONS TO BE TAKEN INTO ACCOUNT :
Ciprofloxacin, norfloxacin :
Significant increase in caffeine levels in the body (decrease in hepatic metabolism of caffeine).
propofan warnings and Precautions :
propofan warnings:
The risk of predominantly psychological dependence appears only for higher dosages than recommended and for long-term treatments.
propofan precautions:
– Related to the presence of dextropropoxyphene :
Alcohol absorption during treatment is not recommended.
Propofan should be avoided in patients with suicidal tendencies, in patients treated with tranquilizers,
antidepressants or central nervous system depressants.
– Related to the presence of paracetamol :
Interactions of paracetamol with paraclinical examinations: taking paracetamol may interfere with the determination of blood uric acid by the phosphotungstic acid method and the determination of glucose by the
glucose oxidase-peroxidase method.
– Pregnancy: A prospective epidemiological study, involving a few hundred women, did not show any teratogenic effect of dextropropoxyphene and paracetamol administered alone.
Paracetamol, an analgesic that has no anti
-inflammatory properties, does not appear to pose a fetal risk when used during the 2nd and 3rd trimesters.
In clinical studies, the analysis of a high number of exposed pregnancies apparently did not reveal any particular malformative or fetotoxic effect of caffeine.
Although similar to morphinomimetics, the occasional administration of dextropropoxyphene, under common prescribing conditions, does not pose a risk of neonatal withdrawal.
Caffeine abuse can cause fetal and neonatal tachycardia.
However, compared to a normal population, no increase in spontaneous miscarriages, prematurity and number of children with hypotrophy has been reported
. As a result, this medication can be prescribed during pregnancy if needed, in short treatment and at the recommended doses.
Drive and use machines:
PROPOFAN has an important influence on the ability to drive and use machines. Driving or using machines is contraindicated during the day of propofol anesthesia. If other medications have been combined, driving may be discouraged for a longer period. The effects of propofol usually disappear after 12 hours.
PROPOFAN and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
Studies in animals have not shown any teratogenic effect.
In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected.
Indeed, to date, the substances responsible for malformations in humans have been teratogenic in animals in well-conducted studies on two species.
In clinical practice, there are currently no data of sufficient relevance to evaluate the possible malformative or fetotoxic effect of propofol when administered during pregnancy.
Therefore, as a precaution, it is best not to use propofol during pregnancy (except of course in case of termination of pregnancy) unless absolutely necessary.
Propofol passes through the placenta and can cause neonatal depression.
Breastfeeding:
The use of propofol in nursing women is not recommended.
Studies have shown that small amounts of propofol are excreted in the milk of lactating women.
Therefore, women should not breastfeed for 24 hours after taking propofol. The milk produced during this period will have to be discarded.
propofan overdose side effects
Poisoning is to be feared in the elderly and young children (therapeutic overdose or accidental intoxication frequent in toddlers) where it can be dramatic or even fatal.
– Paracetamol Overdose Symptoms :
Nausea, vomiting, anorexia, pallor, abdominal pain usually appear within the first 24 hours.
Overdose, starting with 10 g of paracetamol in a single dose in adults and 150 mg / kg of body weight in a single dose in children, causes hepatic cytolysis which may result in complete and irreversible necrosis Hepatocellular insufficiency, metabolic acidosis, encephalopathy that can lead to coma and death.
At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and a decrease in the prothrombin level that may occur 12 to 48 hours after ingestion.
– Dextropropoxyphene overdose symptoms :
Disorders of consciousness ranging from somnolence to coma.
Nausea, vomiting, abdominal pain, respiratory depression ranging from simple dyspnea to apnea.
Myosis, convulsions, delirium, cyanosis, collapse, death by cardiac arrest.
– Emergency Driving :
Immediate transfer to hospital.
Rapid evacuation of the product ingested by gastric lavage and activated charcoalper os .
Before beginning treatment, draw a tube of blood for plasma determination of paracetamol and dextropropoxyphene.
Treatment of overdose includes the early administration of the paracetamol antidote, N-acetylcysteine IV or oral, if possible before the tenth hour and the administration of naloxone, antidote for dextropropoxyphene.
Respiratory support.
Do not use analeptics or central nervous system stimulants as they may precipitate fatal convulsions.
What is Forms and Composition PROPOFAN ?
FORMS and PRESENTATIONS
IV Injectable Emulsion 20 mg / ml: Pre-filled 50 ml syringe.
COMPOSITION
p ml propofol 20 mg A pre-filled syringe of 50 ml contains 1 g of propofol
Excipients: refined soybean oil, purified egg phosphatides, glycerol, sodium hydroxide, disodium edetate, water for injections.
Excipients with known effect: refined soybean oil, sodium.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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Zaldiar Tablets Uses, Dosage, Side Effects, Precautions & Warnings
Drug Online
zaldiar tablets english
Generic drug of the therapeutic class: Analgesics active principles: Tramadol , Paracetamol laboratory: Grunenthal
Is Zaldiar the same as tramadol? and Important to know
ZALDIAR is a combination of 2 analgesics, tramadol and paracetamol, which work together to relieve your pain.
ZALDIAR is indicated for the treatment of moderate to severe pain when your doctor thinks that a combination of tramadol and paracetamol is needed.
ZALDIAR is reserved for adults and adolescents from 12 years old.
What is Zaldiar tablets 37 5mg/325mg used for and indication?
Symptomatic treatment of moderate to severe pain. The use of Zaldiar should be limited to patients with moderate to severe pain requiring treatment with a combination of paracetamol and tramadol ( see Pharmacodynamics ).
zaldiar tablets dosage
RESERVED FOR ADULTS and ADOLESCENT (from 12 years old)
Use of ZALDIAR should be limited to patients with moderate to severe pain requiring treatment with paracetamol and tramadol.
The dose should be individually adjusted according to the intensity of the pain and the individual sensitivity of the patient.
The recommended starting dose is 2 tablets of ZALDIAR. Additional doses may be administered as needed, without exceeding 8 tablets per day (300 mg tramadol and 2600 mg paracetamol).
The catches must be spaced at least 6 hours apart.
ZALDIAR should under no circumstances be administered longer than is strictly necessary (see Warnings and Precautions ). If the nature or severity of the disease requires repeated treatment or prolonged treatment, careful and regular monitoring should be carried out (with treatment breaks if possible) to check whether continuation of treatment is necessary.
zaldiar tablets dosage
children:
The safety and efficacy of ZALDIAR have not been established in children under 12 years of age. Treatment is not recommended in this population.
Elderly
The usual dosage may be used although a 17% increase in the elimination half-life of tramadol has been observed in healthy subjects over 75 years of age after oral administration.
In patients over 75 years of age, a minimum interval of 6 hours between dosages is recommended because of the presence of tramadol.
Renal failure:
Due to the presence of tramadol, the use of ZALDIAR is not recommended in cases of severe renal impairment (creatinine clearance <10 ml / min).
In patients with moderate renal impairment (creatinine clearance between 10 and 30 ml / min), the interval between doses should be 12 hours. Since tramadol is eliminated very slowly by hemodialysis or haemofiltration, post-dialysis is not usually necessary to maintain analgesia.
Hepatic insufficiency:
ZALDIAR should not be used in patients with severe hepatic impairment . In patients with moderate hepatic impairment, an increase in the interval between doses should be carefully considered (see Warnings and Precautions ).
Administration mode:
Oral way.
The tablets should be swallowed as is, with a sufficient amount of liquid. They should not be split or chewed.
How it works Zaldiar Tablets :
Pharmacotherapeutic group: Tramadol in combination , ATC code: N02AX52
ANALGESIC
Tramadol is an opioid analgesic of central action. Tramadol is a nonselective agonist for the μ, δ and κ morphine receptors, with a higher affinity for μ receptors. In addition, the other mechanisms contributing to the analgesic effects of the product are inhibition of neuronal norepinephrine reuptake and increased serotonin release. Tramadol has an antitussive effect. Unlike morphine, a wide range of analgesic doses of tramadol have no respiratory depressant effect. Gastrointestinal motility is not changed either.
The effects on the cardiovascular system are generally weak.
The power of tramadol would be 1/10 to 1/6 of that of morphine.
The exact mechanism of action of the analgesic properties of paracetamol remains to be established; it could involve central and peripheral actions.
ZALDIAR is a level II analgesic in the WHO scale and should be considered as such by the prescriber.
zaldiar tablets side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
zaldiar tablets side effects
Very common: may affect more than 1 in 10 patients;
but first Does Zaldiar make you sleepy?
· Nausea,
· Feeling dizzy, drowsy.
Frequent: may affect up to 1 in 10 patients
· Vomiting, difficult digestion (constipation, bloating, diarrhea), abdominal pain, dry mouth,
· Itching, sweating (hyperhidrosis),
· Headaches, tremors,
· Confusional state, sleep disturbances, mood changes (anxiety, nervousness, euphoria).
Uncommon: may affect up to 1 in 100 patients
· Increased blood pressure, heart rhythm disorders,
· Tingling, numbness, tingling sensation in the limbs, tinnitus, involuntary muscle contractions,
· Depression, nightmares, hallucinations (perception of things that do not exist in reality), amnesia,
· Breathing difficulty.
· Difficulty swallowing, blood in the stool,
· Skin reactions (rashes, urticaria for example),
· Increase in liver enzymes.
· Albumin in urine, difficulty or pain when you urinate,
· Chills, hot flashes, chest pains
Rare: may concern up toto 1 patient in 1000;
· Convulsions, difficulty coordinating movements, transient loss of consciousness (syncope)
· Drug dependence,
· Delirium,
· Blurred vision, narrowing of the pupil (myosis),
· Speech disorders,
· Excessive dilation of the pupil (mydriasis).
Frequency unknown: Frequency can not be estimated from the available data :
· Decreased blood sugar level (hypoglycemia)
The following side effects have been reported in people taking medicines containing only hydrochloride detramadol or paracetamol. Contact your doctor if you experience any of these effects while taking ZALDIAR:
· Feeling weak when you get up after lying down or sitting down, heart rate decrease, appetite change, muscle weakness, slowed or weakened breathing, mood changes, activity changes, changes in mood perception, aggravation of existing asthma.
· Using ZALDIAR with a treatment that thins the blood (eg coumarin derivatives, warfarin) may increase the risk of bleeding. You should immediately report to your doctor any prolonged or unexpected bleeding.
· In rare cases, a rash, a sign of an allergic reaction, may develop with sudden swelling of the face and neck, difficulty breathing or decreased blood pressure and fainting. If you are concerned, stop your treatment and consult your doctor immediately. You must not continue taking this treatment.
In rare cases, taking a drug containing tramadol hydrochloride can cause dependence and make it difficult to stop treatment.
Some people have also had panic attacks, hallucinations, unusual sensations such as itching, tingling or numbness, and a ringing of ears. If you experience this type of symptoms after stopping, contact your doctor.
Exceptionally, blood tests may have revealed abnormalities, such as an abnormally low platelet count, which can cause bleeding from the nose or gums.
Very rare cases of serious skin reactions have been reported with paracetamol.
Rare cases of respiratory depression have been reported with tramadol.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers –
By reporting side effects, you can help provide more information on the safety of the medicine.
Zaldiar Tablets Interactions :
Associations contraindicated
Non-selective MAOIs
Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.
MAOI selective A
By extrapolation from non-selective MAOIs
Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.
Selective MAOI B
Manifestations of central excitement evoking serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion, even coma.
In case of recent treatment by the MAOIs, observe a delay of 2 weeks before starting treatment with tramadol.
Associations advised against
Alcohol
Alcohol enhancement of the sedative effect of opioid analgesics.
Altered alertness can make driving dangerous and the use of machinery dangerous.
Avoid taking alcoholic drinks and drugs containing alcohol.
Carbamazepine and other enzyme inducers
Risk of decreased efficacy and duration of action due to decreased plasma concentrations of tramadol.
Morphine agonist-antagonists (buprenorphine, nalbuphine, pentazocine).
Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.
Associations to consider
Isolated cases of serotonin syndrome with a chronological link to therapeutic doses of tramadol have been reported in association with other serotoninergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and triptans. Signs of serotonin syndrome may include:
Confusion, agitation, fever, sweat, ataxia, hyperreflexia, myoclonus and diarrhea.
Other morphine derivatives (including antitussives and substitution treatments), benzodiazepines, barbiturates.
Increased risk of respiratory depression, which can be fatal in case of overdose.
Other central nervous system depressants, such as other morphine derivatives (including antitussive drugs and substitution treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, central antihypertensives, thalidomide, baclofen.
These medications may increase the central depression. Altered alertness can make driving dangerous and the use of machinery dangerous.
Depending on the clinical needs, an evaluation of the prothrombin level should be carried out periodically in case of co-administration of ZALDIAR with warfarin-type derivatives, with lengthening of the INR reported.
Other drugs known to inhibit CYP3A4,
Such as ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the O-demethylated active metabolite. The clinical significance of this interaction has not been studied.
Drugs that lower the epileptogenic threshold, such as bupropion, antidepressants, serotonin reuptake inhibitors, tricyclic antidepressants and neuroleptics.
Concomitant use of tramadol with these drugs may increase the risk of seizures. The rate of absorption of paracetamol can be increased by metoclopramide or domperidone and the absorption rate decreased by cholestyramine.
In a limited number of studies, pre- or post-operative use of the anti-emetic 5HT3 receptor antagonist (ondansetron) necessitated an increase in tramadol doses in patients treated for postoperative pain.
Zaldiar Warnings and Precautions :
Special warnings :
For adults and adolescents from 12 years. The maximum dose of 8 tablets of ZALDIAR should not be exceeded. To avoid the risk of accidental overdose, patients should be advised not to exceed the recommended dose and not to use other medicines containing paracetamol (including over-the-counter medications) or tramadol without the doctor’s advice.
ZALDIAR is not recommended in patients with severe renal impairment (creatinine clearance <10 ml / min).
ZALDIAR should not be administered in patients with severe hepatic impairment . The risks associated with paracetamol overdose are higher in patients with non-cirrhotic alcoholic liver injury. In patients with moderate hepatic impairment, careful consideration should be given to lengthening the dosing interval.
ZALDIAR is not recommended in cases of severe respiratory failure.
Tramadol is not suitable for substitution treatment in patients with opioid dependence. Indeed, although opioid antagonist, tramadol hydrochloride can not correct the withdrawal symptoms of opioids .
Seizures have been reported mainly in predisposed patients treated with tramadol and / or treated with drugs that may lower the seizure threshold, particularly selective serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, central analgesics or local anesthetics. Treatment-experienced epileptic patients or patients who may experience seizures should be treated with ZALDIAR only when absolutely necessary. Seizures have been reported in patients receiving tramadol hydrochloride at the recommended doses. The risk may be increased when doses of tramadol hydrochloride exceed the maximum recommended dose.
Concomitant administration of agonist-antagonist morphines (nalbuphine, buprenorphine, pentazocine) is not recommended .
Precautions for use:
Habituation and physical and / or mental dependence can develop, even at therapeutic doses. The clinical need for analgesic treatment should be reassessed on a regular basis. In patients with opioid dependence and in patients with a history of abuse or dependence, treatment should be short-term and under strict medical supervision.
ZALDIAR should be used with caution in opioid-dependent patients, in patients with head trauma, in patients prone to seizures, in patients with bile duct dysfunction, in a state of shock, with an alteration of the original consciousness. unknown, central or peripheral disorders of the respiratory function or an increase in intracranial pressure.
Overdosage with paracetamol may cause liver toxicity in some patients.
Withdrawal symptoms similar to those seen during opioid withdrawal may occur even at therapeutic doses and for short-term treatment. Withdrawal symptoms can be avoided by gradually decreasing the doses at the end of treatment, especially after long periods of administration. Rare cases of dependence and abuse have been reported .
In one study, the use of tramadol during a general anesthesia with enflurane and nitrous oxide promoted intraoperative memory. In the meantime, new data is needed to prevent tramadol use during shallow anesthesia.
ZALDIAR contains lactose. Patients should not take this medicine for hereditary history such as galactosemia, lactase deficiency or glucose-galactose malabsorption.
Drive and use machines:
Tramadol may cause drowsiness or dizziness, which may be exacerbated by alcohol or other central nervous system depressants. In the event of these symptoms, the patient must not drive or use machines.
Zaldiar and PREGNANCY / BREAST FEEDING / FERTILITY:
Pregnancy :
Since Zaldiar is a fixed combination of tramadol-based active ingredients, this medicine should not be used during pregnancy.
Data on paracetamol:
The results of the epidemiological studies have not revealed the deleterious effect of paracetamol used at the recommended doses.
Tramadol data:
Tramadol should not be used during pregnancy as there are no data of sufficient relevance to evaluate the safety of tramadol in pregnant women.
Administered before or during delivery, tramadol does not affect uterine contractility. In neonates, it can induce changes in respiratory rate usually not clinically significant. Prolonged use during pregnancy may result in withdrawal syndrome in the newborn.
Breastfeeding:
Since Zaldiar is a fixed combination of active ingredients containing tramadol, this medicine should not be administered during breastfeeding.
Data on paracetamol:
Paracetamol is excreted in breast milk in non-clinically significant amounts. To date, published data do not contraindicate breastfeeding in women using drugs containing only paracetamol.
Tramadol data:
Tramadol and its metabolites are found in low amounts in breast milk. During breastfeeding, approximately 0.1% of the dose administered to the mother could be ingested by the newborn. Tramadol should not be administered during breastfeeding.
What should I do if I miss a dose?
If you forget to take the tablets, the pain may reappear. Do not double the dose you forgot to take. Continue your treatment as before.
What happens if I overdose from Zaldiar ?
See your doctor or pharmacist immediately, even if you feel well. There may be a risk of liver injury whose symptoms will appear later.
What is Forms and Composition Zaldiar?
FORMS and PRESENTATIONS
37.5 mg / 325 mg film-coated tablet (light yellow): Box of 20, in blister packs.
Hospital model: Box of 60.
COMPOSITION
p cp Tramadol (DCI) hydrochloride 37.5 mg Paracetamol (INN) 325 mg
Excipients: Core: pulverized cellulose, pregelatinized starch, sodium carboxymethyl starch (type A), corn starch, magnesium stearate. Film coating :hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), propylene glycol, talc.
Lactose content: 1.784 mg / cp (as monohydrate: 1.878 mg / cp).
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
It treats possible side effects and drug interactions that require attention and its effect on continuous use.
The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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The post Zaldiar Tablets Uses, Dosage, Side Effects, Precautions & Warnings appeared first on Drug Online.
from Drug Online https://bit.ly/2X7fvdh via Edrug Online
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