MONTELUKAST SODIUM- montelukast sodium tablet, coated

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

REMEDYREPACK INC.

INN (International Name):

MONTELUKAST SODIUM

Sammensætning:

MONTELUKAST 10 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Montelukast sodium tablets, chewable tablets and oral granules are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast sodium tablets and chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium tablets, chewable tablets and oral granules are indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older. - Hypersensitivity to any component of this product. Risk Summary Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see Data] . In animal reproduction studies, no adverse developmental effects were observed with oral administration of montelukast to pregnant rats and rabbits during org

Produkt oversigt:

Montelukast Sodium Oral Granules, USP 4 mg, are white granules with 500 mg net weight, packed in a child-resistant foil sachet. They are supplied as follows: NDC 27241-015-31 unit of use carton with 30 sachets. Montelukast Sodium Chewable Tablets, USP 4-mg are pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT1' engraved on one side and plain on the other side. They are supplied as follows: NDC 27241-016-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 27241-016-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister Montelukast Sodium Chewable Tablets, USP 5-mg are pink colored, slightly mottled, circular, biconvex, uncoated tablets, with code 'MT2' engraved on one side and plain on the other side. They are supplied as follows: NDC 27241-017-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 27241-017-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister Montelukast Sodium Tablets, USP 10-mg, are beige colored, film-coated tablets, circular, biconvex tablets, with code 'MO1' engraved on one side and plain on the other side. They are supplied as follows: NDC 27241-018-03 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 27241-018-09 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel canister NDC 27241-018-90 high-density polyethylene (HDPE) bottles of 1000 with a polypropylene continuous threaded cap, an aluminum foil induction seal, and silica gel canister Storage Store montelukast sodium 4-mg oral granules, 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original package.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, COATED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS,
CHEWABLE TABLETS AND ORAL GRANULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES.
MONTELUKAST SODIUM TABLETS, CHEWABLE TABLETS AND ORAL GRANULES
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events ( 5.4) 12/2018
INDICATIONS AND USAGE
Montelukast sodium tablets, chewable tablets, and oral granules are a
leukotriene receptor antagonist indicated for:
Prophylaxis and chronic treatment of asthma in patients 12 months 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 6 months of age and
older ( 1.3).
DOSAGE AND ADMINISTRATION
Administration (by indications):
Asthma ( 2.1): Once daily in the evening for patients 12 months and
older.
Acute prevention of EIB ( 2.2): One tablet at least 2 hours before
exercise for patients 6 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 6 months
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 or one sachet of 4-mg oral
granules.
6 to 23 months: one sachet of 4-mg oral granules.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening ( 2.4). For oral granules: Must
administer within 15 minutes after opening the sachet (with or without
mixing with food) ( 2.5).
DOSAGE FORMS AND STRENGTHS
Montelukast sodium 10-mg Film-Coated Tablets
Montelukast sodium 5-mg and