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Montelukast Sodium


Each 4mg chewable tablet contains 4.2mg montelukast (as sodium) equivalent to 4mg montelukast.

Each 5mg chewable tablet contains 5.2mg montelukast (as sodium) equivalent to 5mg montelukast.

Each 10mg film-coated tablet contains 10.4mg montelukast (as sodium) equivalent to 10mg montelukast.

Montelukast (Montemax) is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age or older.

Montelukast (Montemax) 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 in 6 months of age and older.

Montelukast (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 one tablet daily in the evening.
Adults and 15 years and older with asthma and allergic rhinitis: 10mg tablet daily.
Patients below 15 years old with asthma and allergic rhinitis: one 5mg chewable tablet daily. No dosage adjustment within this age group is necessary.
Children between 2 to 5 years old with asthma and allergic rhinitis: one 4mg chewable tablet daily.

Clinical monitoring when montelukast is administered with a potent hepatic enzyme inducers such as phenytoin, Phenobarbital, or rifampicin.

Peak plasma concentrations of montelukast are achieved in 2 to 4 hours after oral administration. The mean oral bioavailability is 64%. Montelukast is more than 99% bound to plasma proteins. It is extensively metabolized by cytochrome P450 isoenzymes CYP3A4, CYP2A6 and CYP2C9 and is excreted principally in faeces via the bile, Metabolism was reduced and the elimination half-life prolonged in patients with mild to moderate hepatic impairment.

Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

Edema, agitation and restlessness, allergy including anaphylaxis, angioedema and urticaria, chest pain, tremor, dry mouth, vertigo and arthralgia.

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.

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.

Hypersensitivity to any component of Montemax.

Tablet 4mg chewable: box of 30's in blisters
Tablet 5mg chewable: box of 30's in blisters
Tablet 10mg film-coated: box of 30's in blisters

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