Montelukast Sodium Chewable
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.
Montelukast sodium chewable tablets are 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 chewable tablets are 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.
History
There is currently no drug history available for this drug.
Other Information
Montelukast sodium, USP is the active ingredient in montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene 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 C35H35ClNNaO3S, and its molecular weight is 608.18. The structural formula is:
Montelukast sodium, USP is a hygroscopic, optically active light yellow colored powder. Montelukast sodium, USP is freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile.
Each 4-mg and 5-mg montelukast sodium chewable tablet contains 4.2 and 5.2 mg montelukast sodium, respectively, which are equivalent to 4 and 5 mg of montelukast, respectively. Both chewable tablets contain the following inactive ingredients: aspartame, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, red ferric oxide, and strawberry flavor.
Sources
Montelukast Sodium Chewable Manufacturers
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Jubilant Cadista Pharmaceuticals Inc.
![Montelukast Sodium Chewable (Montelukast Sodium) Tablet, Chewable [Jubilant Cadista Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Montelukast Sodium Chewable | Jubilant Cadista Pharmaceuticals Inc.
2.1 AsthmaMontelukast sodium chewable tablets should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: 10-mg.For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB)For prevention of EIB, a 10 mg dose of montelukast sodium chewable tablets should be taken at least 2 hours before exercise.
An additional dose of montelukast sodium chewable tablets should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium chewable tablets daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium chewable tablets for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
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.
2.3 Allergic RhinitisFor allergic rhinitis, montelukast sodium chewable tablets should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.
2.4 Asthma and Allergic Rhinitis
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older:10‑mg.
For pediatric patients 6 to 14 years of age: one 5‑mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4‑mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: 10‑mg.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.Patients with both asthma and allergic rhinitis should take only one montelukast sodium chewable tablets dose daily in the evening.
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