Gillette Endurance Clear Brisa Tropical
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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 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.
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 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.
Sources
Gillette Endurance Clear Brisa Tropical Manufacturers
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Procter And Gamble Manufacturing Company
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Gillette Endurance Clear Brisa Tropical | Legacy Pharmaceutical Packaging, Llc
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) in Patients 15 Years of Age and OlderFor prevention of EIB, a single 10 mg dose of montelukast should be taken at least 2 hours before exercise. 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 β-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.
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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