Full Prescribing Info
Montelukast sodium.
Each 4 mg chewable tablet contains 4.2 mg montelukast (as sodium) equivalent to 4 mg montelukast.
Each 5 mg chewable tablet contains montelukast (as sodium) 5.2 mg equivalent to montelukast 5 mg.
Each 10 mg film-coated tablet contains montelukast (as sodium) 10.4 mg equivalent to montelukast 10 mg.
Pharmacokinetics: Peak plasma concentrations of montelukast are achieved in 2-4 hrs after oral administration. The mean oral bioavailability is 64%, montelukast is >99% bound to plasma proteins. It is extensively metabolized by cytochrome P450 isoenzymes CYP3A4, CYP2A6 and CYP2C9 and is excreted principally in the feces via the bile. Metabolism was reduced and the elimination t½ prolonged in patients with mild to moderate hepatic impairment.
Prophylaxis and chronic treatment of asthma in adults and pediatric patients ≥12 months.
Relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients ≥2 years) and perennial allergic rhinitis in adults and pediatric patients in ≥6 months.
Dosage/Direction for Use
Montemax should be taken once daily.
For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and allergic rhinitis should take only 1 tab daily in the evening.
Adults and Patients ≥15 years with Asthma and Allergic Rhinitis: 10 mg tablet daily.
Patients <15 years with Asthma and Allergic Rhinitis: One 5 mg chewable tablet daily. No dosage adjustment within this age group is necessary.
Children between 2-5 years with Asthma and Allergic Rhinitis: One 4 mg chewable tablet daily.
Hypersensitivity to any component of Montemax.
Special Precautions
Use in pregnancy & lactation: There is no adequate and well-controlled studies in pregnant women, therefore, montelukast should be used during pregnancy only if clearly needed. It is not known if montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when montelukast is given to a nursing mother.
Use in the elderly: No overall differences in safety or effectiveness were observed between the elderly and the younger persons, but greater sensitivity of some other individuals cannot be ruled out.
Adverse Reactions
Edema, agitation, restlessness, allergy including anaphylaxis, angioedema and urticaria, chest pain, tremor, dry mouth, vertigo and arthralgia.
Drug Interactions
Clinical monitoring when montelukast is administered with a potent hepatic enzyme inducers eg, phenytoin, phenobarbital or rifampicin.
Store at temperatures not exceeding 30°C. Protect from moisture and light.
MIMS Class
Antiasthmatic & COPD Preparations
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
FC tab 10 mg x 30's. Chewable tab 4 mg x 30's. 5 mg x 30's.
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