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Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older.
There is currently no drug history available for this drug.
Montelukast sodium USP, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinylleukotriene CysLT1 receptor.
Montelukast sodium USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl) ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic acid, monosodium salt.
The empirical formula is C35H35CINNaO3S, and its molecular weight is 608.18. The structural formula is:
Montelukast sodium USP is a hygroscopic, optically active, white to off-white powder. Montelukast sodium USP is soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
Each 10 mg film-coated montelukast sodium tablet contains 10.4 mg montelukast sodium USP, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film coating consists of: hypromellose, iron oxide yellow, iron oxide red, iron oxide black , polyethyleneglycol 400 and titanium dioxide.
Each 4 mg and 5 mg montelukast sodium chewable tablet contains 4.2 and 5.2 mg montelukast sodium USP, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, cherry flavor, croscarmellose sodium, hydroxypropyl cellulose, mannitol, magnesium stearate, microcrystalline cellulose and red ferric oxide.