Gillette Endurance Clear Brisa Tropical

Gillette Endurance Clear Brisa Tropical

Gillette Endurance Clear Brisa Tropical Recall

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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

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Asthma

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older.

1.2 Exercise-Induced Bronchoconstriction (EIB)

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.

1.3 Allergic Rhinitis

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:

structure

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.

Gillette Endurance Clear Brisa Tropical Manufacturers


  • Procter And Gamble Manufacturing Company
    Gillette Endurance Clear Brisa Tropical (Aluminum Zirconium Octachlorohydrex Gly) Gel [Procter And Gamble Manufacturing Company]

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