MONTELUKAST SODIUM- montelukast sodium tablet, film coated MONTELUKAST SODIUM- montelukast sodium tablet, chewable MONTELUKA

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

MONTELUKAST SODIUM

Composition:

MONTELUKAST 10 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 12 months of age and older. Montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. 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 6 months of age and older. Hypersensitivity to any component of this product. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. No teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on AUCs [see Nonclinical Toxicology (13.2)] . During worldwide marketing experience, congenital limb defects hav

Product summary:

Montelukast Sodium Tablets are available containing 10.4 mg montelukast sodium, USP which is equivalent to 10 mg of montelukast. The 10 mg tablets are blue, film-coated, round, unscored tablets debossed with ML over 1 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5201-93 bottles of 30 tablets Montelukast Sodium Chewable Tablets are available containing 4.2 mg and 5.2 mg montelukast sodium, USP which are equivalent to 4 mg and 5 mg of montelukast, respectively. The 4 mg chewable tablets are light pink, round, unscored tablets debossed with ML over 4 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5204-93 bottles of 30 tablets The 5 mg chewable tablets are dark pink, round, unscored tablets debossed with ML over 5 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5205-93 bottles of 30 tablets Montelukast Sodium Oral Granules are available containing 4.2 mg of montelukast sodium, USP equivalent to 4 mg of montelukast. Each carton contains 30 packets containing approximately 500 mg net weight of white to off-white powder in each packet. The packets are child-resistant, tearable foil. See packet and carton for product information. They are available as follows: NDC 0378-6040-93 1 carton (30 packets per carton) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Store in original package. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
MYLAN PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 92042155-8F37-42A1-913F-D844BB6738F6
----------
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, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
MONTELUKAST SODIUM ORAL GRANULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Eosinophilic Conditions (5.5) 06/2013
INDICATIONS AND USAGE
Montelukast sodium is a leukotriene receptor antagonist indicated for:
•
•
•
DOSAGE AND ADMINISTRATION
Administration (by indications):
•
•
•
•
Dosage (by age) (2):
•
•
•
•
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 packet (with or without
mixing with food) (2.5).
DOSAGE FORMS AND STRENGTHS
•
•
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
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).
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.
15 years and older: one 10 mg tablet.
6 to 14 years: on