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Uses
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 6 years of age and older.
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.
History
There is currently no drug history available for this drug.
Other Information
Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.
Montelukast sodium 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 is a hygroscopic, optically active, white to off-white powder. Montelukast sodium is freely 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, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide, yellow ferric oxide, and carnauba wax.
Each 4-mg and 5-mg chewable montelukast sodium 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: mannitol, microcrystalline cellulose, hydroxypropyl cellulose, red ferric oxide, croscarmellose sodium, cherry flavor, aspartame, and magnesium stearate.
Sources
First Aid Eye Wash Manufacturers
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Unifirst First Aid Corporation
First Aid Eye Wash | Bionpharma Inc.
2.1 AsthmaMontelukast sodium should be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
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 single dose of montelukast sodium should be taken at least 2 hours before exercise.
The following doses are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
An additional dose of montelukast sodium should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium 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 6 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
2.3 Allergic RhinitisFor allergic rhinitis, montelukast sodium 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.
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: one 10-mg tablet.
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: one 10-mg tablet.
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.
2.4 Asthma and Allergic RhinitisPatients with both asthma and allergic rhinitis should take only one montelukast sodium dose daily in the evening.
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