MONTELUKAST SODIUM- montelukast sodium tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Mylan Institutional Inc.

INN (Jina la Kimataifa):

MONTELUKAST SODIUM

Tungo:

MONTELUKAST 10 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 ha

Bidhaa muhtasari:

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 51079-223-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Store in original package. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
MYLAN INSTITUTIONAL INC.
REFERENCE LABEL SET ID: 92042155-8F37-42A1-913F-D844BB6738F6
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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, 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:
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 packet of 4 mg oral
granules.
6 to 23 months: one packet 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 packet (with or without
mixing with food) ( 2.5).
DOSAGE FORMS AND STRENGTHS
Montelukast Sodium 10 mg Film-Coated Tablets
Montelukast So