Drug Catalog - Product Detail
MONTELUKAST TAB. TB 10MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 29300-0220-13 | UNICHEM PHARMACEUTICALS | 30 | 10MG | TABLET |
PACKAGE FILES
Generic Name
MONTELUKAST SODIUM
Substance Name
MONTELUKAST SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA208621
Description
11 DESCRIPTION Montelukast sodium USP, the active ingredient in montelukast sodium tablets USP and montelukast sodium chewable tablets USP, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT 1 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 molecular formula is C 35 H 35 ClNNaO 3 S, 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 water and in methylene chloride, freely soluble to very soluble in ethanol (96%). Each 10-mg film coated montelukast sodium tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg of montelukast, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose. The film coating consists of: carnauba wax, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and titanium dioxide. Each 4-mg and 5-mg montelukast sodium chewable 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: aspartame, cherry flavor, croscarmellose sodium, ferric oxide yellow, hydroxypropyl cellulose, magnesium stearate, mannitol, and microcrystalline cellulose. Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Montelukast sodium tablets USP, 10 mg are pale yellow coloured, round shaped, film coated tablets with 'U' debossed on one side and '220' on other side. Bottles of 30 (NDC# 29300-220-13) Bottles of 90 (NDC# 29300-220-19) Bottles of 100 (NDC# 29300-220-01) Bottles of 1000 (NDC# 29300-220-10) Montelukast sodium chewable tablets USP, 5 mg are light yellow coloured, round shaped biconvex tablets, debossed with '222' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-222-13) Bottles of 90 (NDC# 29300-222-19) Bottles of 1000 (NDC# 29300-222-10) Montelukast sodium chewable tablets USP, 4 mg are light yellow coloured, round shaped biconvex tablets, debossed with '221' on one side and 'U' on other side. Bottles of 30 (NDC# 29300-221-13) Bottles of 90 (NDC# 29300-221-19) Bottles of 1000 (NDC# 29300-221-10) Storage Store montelukast sodium chewable tablets and 10-mg film-coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000 montelukast sodium chewable tablets and 10-mg film coated tablets at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light-resistant container.
Indications & Usage
1 INDICATIONS AND USAGE Montelukast sodium 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 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 6 years of age and older. 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. Because the benefits of montelukast sodium 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 is not indicated for the treatment of an acute asthma attack..
Dosage and Administration
2 DOSAGE AND 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 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) Forprevention 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) * Safety and effectiveness in patients younger than 6 years of age have not been established 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 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 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 * Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established 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 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 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.