Great Value Ultra Concentrated Orange Scent
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Montelukast sodium tablets are indicated for the prophylaxis and chronic treatment of asthma in patients 15 years of age and older.
Montelukast sodium 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 tablets are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 15 years of age and older and perennial allergic rhinitis in patients 15 years of age and older.
History
There is currently no drug history available for this drug.
Other Information
Montelukast sodium, USP 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, 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, 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 tablet contains 10.4 mg montelukast sodium, USP which is equivalent to 10 mg of montelukast, and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose, disodium edetate and magnesium stearate. The film coating consists of: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide, red ferric oxide and yellow ferric oxide.
Sources
Great Value Ultra Concentrated Orange Scent Manufacturers
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Sun Products Corporation
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Great Value Ultra Concentrated Orange Scent | Macleods Pharmaceuticals Limited
2.1 AsthmaMontelukast sodium should be taken once daily in the evening. The following dose is are recommended:
2.2 Exercise-Induced Bronchoconstriction (EIB)
For adults and adolescents 15 years of age and older: one 10-mg 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.For prevention of EIB, a single 10 mg dose of montelukast should be taken at least 2 hours before exercise.
2.3 Allergic Rhinitis
The following dose is recommended :
For adults and adolescents 15 years of age and older: one 10-mg tablet.
An additional dose of montelukast 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 ß-agonist. Safety and effectiveness in patients younger than 15 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.
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.For 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 dose 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.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following dose 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.
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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