MonteneTM 5 Tablet: Each chewable tablet contains Montelukast Sodium USP equivalent to Montelukast 5 mg
The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils. These eicosanoids bind to cysteinyl leukotriene receptors (CysLT) found in the human airway.
Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity.
Montelukast is a leukotriene receptor antagonist indicated for:
- Prophylaxis and chronic treatment of asthma in patients 12 months of age and
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB) in patients 6
years of age and older.
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal Allergic Rhinitis (SAR) in
patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6
months of age and older.
DOSAGE & ADMINISTRATION
- Asthma: Once daily in the evening for patients 12 months and older.
- Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older.
- Seasonal Allergic Rhinitis: Once daily for patients 2 years and older.
- Perennial Allergic Rhinitis: Once daily for patients 6 months and older.
- 15 years and older: One 10-mg tablet.
- 6 to 14 years: One 5-mg chewable tablet.
- 2 to 5 years: One 4-mg chewable tablet.
Hypersensitivity to any component of this product.
Montelukast appears to be well tolerated. In clinical trials, the most common adverse effect reported was headache, occurring in approximately 18% of patients. Rash, dyspepsia, dizziness, and abdominal pain were all reported in less than 2% of patients. Elevated liver transaminases have been reported with montelukast use, but not at a greater incidence than with placebo. A small percentage of pediatric patients have experienced diarrhea, sinusitis and otitis media during montelukast clinical trials.
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available.
Store below 250 C at a cool and dry place, away from light and moisture. Keep out of reach of children.
MonteneTM 5 tablet: Box containing 20 tablets in Alu-Alu blister pack.