MONTELUKAST SODIUM tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)

Available from:

Bryant Ranch Prepack

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Hypersensitivity to any component of this product. Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of h

Product summary:

Montelukast Sodium Chewable Tablets, 4 mg, are pink, oval, biconvex-shaped chewable tablets, engraved with "APO" on one side and "M4" on the other side. They are supplied as follows: NDC 60505-3573-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3573-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3573-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant. Montelukast Sodium Chewable Tablets, 5 mg, are pink, round, biconvex-shaped chewable tablets, engraved with "APO" on one side and "M5" on the other side. They are supplied as follows: NDC 60505-3574-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3574-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3574-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000, with a non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant. Montelukast Sodium Film-Coated Tablets, 10 mg, are beige, rounded square-shaped, biconvex film-coated tablets, engraved with "APO" on one side and "M10" on the other side. They are supplied as follows:  NDC 60505-3562-3 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3562-9 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap with a triseal liner, a lift and peel induction seal, and silica gel desiccant NDC 60505-3562-8 bulk packaging high-density polyethylene (HDPE) bottles of 1,000, non-child-resistant polypropylene cap with a triseal liner, a lift and peel induction seal and silica gel desiccant. Storage Store montelukast 4 mg chewable tablets, 5 mg chewable tablets and 10 mg film-coated tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1,000 montelukast 4 mg chewable tablets, 5 mg chewable tablets and 10 mg film-coated tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MONTELUKAST SODIUM.
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS
INITIAL U.S. APPROVAL:1998
INDICATIONS AND USAGE
Montelukast sodium tablets are 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 15 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
(1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma (2.1): Once daily in the evening for patients 2 years and
older.
Acute prevention of EIB (2.2): 10 mg tablet at least 2 hours before
exercise for patients 15 years of age and older.
Seasonal allergic rhinitis (2.3): Once daily for patients 2 years and
older.
Perennial allergic rhinitis (2.3): Once daily for patients 2 years and
older.
Dosage (by age) (2):
15 years and older: one 10 mg tablet.
6 to 14 years: one 5 mg chewable tablet.
2 to 5 years: one 4 mg chewable tablet.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4).
DOSAGE FORMS AND STRENGTHS
Montelukast Sodium Film-Coated Tablets, 10 mg
Montelukast Sodium Chewable Tablets, 5 mg and 4 mg
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4).
WARNINGS AND PRECAUTIONS
Do not prescribe montelukast sodium to treat an acute asthma attack
(5.1).
Advise patients to have appropriate rescue medication available (5.1).
Inhaled corticosteroid may be reduced gradually. Do not abruptly
substitute montelukast sodium for inhaled or oral
corticosteroids (5.2).
Patients with