Brand Name– SB-Monec 10
Generic Name with Specification– Montelukast Sodium USP
SB-Monec 10 Tablet: Each film coated tablet contains Montelukast Sodium USP equivalent to Montelukast 10 mg.
Montelukast is a leukotriene receptor antagonist indicated for:
- Prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
- 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.
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.
Hypersensitivity to any component of this product.
USE IN PREGNANCY AND LACTATION
Montelukast is classified as pregnancy category B. The drug has been shown to cross the placenta of pregnant rats and rabbits, but there have been no reports of its use in pregnant women. Montelukast is also known to be excreted into breast-milk, but only limited information is available on the significance of this finding. Caution should be used prior to initiating Montelukast therapy in nursing mothers.
SB-Monec 10 Tablet: Each box contains 30 film coated tablets in Alu-Alu blister pack.