Information about Asmalair
Composition:
Asmalair 10mg film-coated tablet contains: 10.4 mg montelukast sodium, which is equivalent to 10 mg montelukast.
Asmalair 5 mg chewable tablet contains: 5.2 mg montelukast sodium, which is equivalent to5 mg montelukast.
Asmalair 4 mg chewable tablet contains: 4.2 mg montelukast sodium, which is equivalent to 4 mg montelukast.
Asmalair 4 mg Sachet contains: 4.2 mg montelukast sodium, which is equivalent to 4 mg montelukast.
Description:
Montelukast Sodium is a selective and orally active leukotrienereceptor antagonist that inhibits the Cysteinyl leukatrine (CysL.T1) receptor.
Mechanism of action:
The Cysteinyl leukotrines (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and released from various cells,including mast cells and eosinophils. CysL.Ts have been correlated with the pathophysiology of asthma and allergic rhinitis. Montelukast binds with high affinity and selectivity to the CysL.T1 receptor (in preference to other pharmacologically important airway receptors(.
Montelukast inhibitsphysiologic actions of LTD4 at the CysL.T1 receptor without any agonist activity.
Pharmacokineties:
Absorption:
Montelukast is rapidly absorbed following oral administration. The mean peak concentration (Cmax) is achieved in 3 or 4 hours (Tmax). The mean oral bio availability is 64%.
The Bioavailability and Cmax are not influenced by a standard meal in the morning.
Distribution:
Montelukast is more than 99% bound to plasma proteins. Its steady state volume of distribution average 8 to 11 liters.
Metabolism:
Montelukast is extensively metabolized in liver. In studies with therapeutic doses, plasma concentrations of metabolites of montelukast are undetectable at steady state in adults and pediatric patients.
Elimination:
The Plasma clearance of Montelukast averages 45ml/min in healthy adults. Montelukast and its metabolites are almost excreted exclusively via the bite.
Indications:
Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
It is indicated for the prevention of exercise induced broncho constriction in patients 15 years of age and older.
It is indicated for the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older,and perennial allergic rhinitis in adults and pediatric patients 6 months of age and older.
Contraindications:
Hyper sensitivity to any component of this product.
Precautions:
Montelukast is not indicated in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with Montelukast canbe continued during acute exacerbations of asthma, and if these exacerbations occur after exercise, the patient should have available for the rescue a short acting inhaled B-agonist. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids, While the doses inhaled corticosteroid may be reduced gradually under medical supervision.
Patients with known aspirin sensitivity, should continue avoidance of aspirin or NSAIDs.
Neuropsychiatric events, may occur when Montelukast is administered.
Drug Interactions:
Montelukast has been administered with other therapies used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug-interaction studies, the recommended clinical dose of montelukast did not have clinically important effects on the pharmacokinetics of the following drugs: theophylline, prednisone,prednisolone, oral contraceptives (norethindrone 1 mg/ethinyl estradiol 35mcg), terfenadine, digoxin, and warfarin.
Adverse Reactions:
The most common adverse reactions include: asthenia, fatigue, fever, abdominal pain, dyspepsia, infectiousgastroenteritis, dental pain, dizziness, headache, influenza,nasal congestion, cough, rash, Pyuria, increased ALT and increased AST.
Overdosage:
No specific information is available on the treatment of overdosage with montelukast. In chronic asthma studies, montelukast has been administered at doses up to 200 mg/day to adult patients for 22 weeks and, in short-term studies, up to 900 mg/day to patients for approximately a week without clinically important adverse experiences. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.
Use in Specific Populations:
Pregnancy:
Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women.
Nursing Mothers:
It is not known if montelukast is excreted in human milk. caution should be exercised when montelukast is given to a nursing mother.
Hepatic Insufficiency:
No dosage adjustment is required in patients with mild-to-moderatehepatic insufficiency.
Renal Insufficiency:
No dosage adjustment is recommended in patients with renal insufficiency.
Dosage and Administration:
Asthma:
Asmalair should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one sachet4-mg oral granules.
Exercise-InducedBronchoconstriction (EIB):
For prevention of EIB, a single dose of Asmalair should be taken at least 2 hours before exercise.
The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
Allergic Rhinitis:
For allergic rhinitis, Asmalair should be taken once daily.
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one sachet4-mg oral granules.
The following doses for the treatment of symptoms of perennial allergic rhinitisare recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet or one sachet4-mg oral granules.
For pediatric patients 6 to 23 months of age: one packet of 4-mg oral granules.
Package:
ChewableTablets 4 mg: Pack of 20 Chewable Tablets.
ChewableTablets 5 mg: Pack of 20 Chewable Tablets.
Tablets10 mg: Pack of 20 F.C Tablets.
Storage:
Should be stored at 25oC
Protect from moisture and light .
Store in original package.