Drug Catalog - Product Detail
MONTELUKAST CHEWABLE TAB. TB 4MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 33342-0110-07 | MACLEODS PHARMACEUTICALS | 30 | 4MG | NA |
PACKAGE FILES
Generic Name
MONTELUKAST SODIUM
Substance Name
MONTELUKAST
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203582
Description
11 DESCRIPTION Montelukast sodium USP, the active ingredient in montelukast sodium chewable tablet, USP is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 receptor. Montelukast sodium, USP is described chemically as [R-(E)]-1-[[[1-[3-[2-(7-chloro-2-quinolinyl) ethenyl] phenyl]-3-[2-(1-hydroxymethylethyl) phenyl] propyl] thio] methyl] cyclopropaneacetic acid, monosodium salt. The empirical formula is C 35 H 35 CINNaO 3 S, 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 freely soluble in ethanol, methanol, and water and practically insoluble in acetonitrile. Each 4 mg and 5 mg montelukast sodium chewable tablets, USP 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, croscarmellose sodium, cherry flavor, disodium edetate, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, magnesium stearate and red ferric oxide. 112
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast sodium chewable tablets USP, 4 mg, are pink colour, oval, biconvex-shaped uncoated chewable mottled tablet, debossed with CL55 on one side and plain on the other side. They are supplied as follows: Bottle of 30: NDC 33342-110-07 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 90: NDC 33342-110-10 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 500: NDC 33342-110-15 unit dose of high-density polyethylene (HDPE) bottles of 500 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Bottle of 1000: NDC 33342-110-44 unit dose of high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Unit dose Blister packs of 100: NDC 33342-110-12 Unit dose Blister packs of 90: NDC 33342-110-39. Montelukast sodium chewable tablets USP, 5 mg, are pink colour, mottled, round, biconvex-shaped uncoated chewable mottle tablet, debossed with CL 56 on one side and plain on the other side. They are supplied as follows: Bottle of 30: NDC 33342-111-07 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 90: NDC 33342-111-10 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an induction seal, and silica gel desiccant Bottle of 500: NDC 33342-111-15 unit dose of high-density polyethylene (HDPE) bottles of 500 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Bottle of 1000: NDC 33342-111-44 unit dose of high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous thread cap, an aluminium foil induction seal, and silica gel desiccant Unit dose Blister packs of 100: NDC 33342-111-12 Unit dose Blister packs of 90: NDC 3342-111-39. Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in tight containers, protected from light. Store at controlled room temperature. Store in original package.
Indications & Usage
1 INDICATIONS AND USAGE Montelukast sodium chewable tablet is a leukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 2 years of age and older ( 1.1 ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( 1.2 ). Relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 2 years of age and older. Reserve use for patients who have an inadequate response or intolerance to alternative therapies ( 1.3 ). Limitations of Use: Not indicated to treat an acute asthma attack ( 5.2 ). 1.1 Asthma Montelukast sodium chewable tablet 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 chewable tablet is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 1.3 Allergic Rhinitis Montelukast sodium chewable tablet 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. Because the benefits of montelukast sodium chewable tablets may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see Warnings and Precautions ( 5.1 )], reserve use for patients who have an inadequate response or intolerance to alternative therapies. 1.4 Limitations of Use Montelukast sodium chewable tablet is not indicated for the treatment of an acute asthma attack.
Dosage and Administration
2 DOSAGE & ADMINISTRATION Administration (by indications): Asthma: Once daily in the evening for patients 2 years and older ( 2.1 ). Acute prevention of EIB: One tablet at least 2 hours before exercise for patients 6 years of age and older ( 2.2 ). Seasonal allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ). Perennial allergic rhinitis: Once daily for patients 2 years and older ( 2.3 ). Dosage (by age): 15 years and older: one 10-mg tablet ( 2 ). 6 to 14 years: one 5-mg chewable tablet ( 2 ). 2 to 5 years: one 4-mg chewable tablet ( 2 ). Patients with both asthma and allergic rhinitis should take only one dose daily in the evening ( 2.4 ). 2.1 Asthma For asthma, administer montelukast sodium chewable tablet orally once daily in the evening, with or without food. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The following doses are recommended: Table 1: Recommended Dosage in Asthma Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. 2.2 Exercise-Induced Bronchoconstriction (EIB) For prevention of EIB, administer a single dose of montelukast sodium orally at least 2 hours, before exercise. The following doses are recommended: Table 2: Recommended Dosage in Exercise-Induced Bronchoconstriction (EIB) Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age* one 5 mg chewable tablet * Safety and effectiveness in patients younger than 6 years of age have not been established. 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. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB. 2.3 Allergic Rhinitis For allergic rhinitis, administer montelukast sodium chewable tablets orally once daily without regard to time of food ingestion. Time of administration in patients with allergic rhinitis can be individualized to suit patient needs. The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended: Table 3: Recommended Dosage in Seasonal Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet 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 : Table 4: Recommended Dosage in Perennial Allergic Rhinitis Age Dose Adult and adolescent patients 15 years of age and older one 10 mg tablet Pediatric patients 6 to 14 years of age one 5 mg chewable tablet Pediatric patients 2 to 5 years of age one 4 mg chewable tablet Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time 2.4 Asthma and Allergic Rhinitis For patients with both asthma and allergic rhinitis, administer only one montelukast sodium chewable tablet dose orally once daily in the evening. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.