MONTELUKAST SODIUM tablet, chewable

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd.

INN (국제 이름):

MONTELUKAST SODIUM

구성:

MONTELUKAST 4 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. Montelukast sodium chewable tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older. Montelukast sodium chewable tablets 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 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 human response, montelukast sodium should be used during pregnancy only if clearly needed. Teratogenic Effect: 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

제품 요약:

Montelukast Sodium 5-mg Chewable Tablets are pink, capsule-shaped tablets, debossed with “5” on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 60723-005-03 Bottles of 90: NDC 60723-005-09 Bottles of 500: NDC 60723-005-50 Montelukast Sodium 4-mg Chewable Tablets are pink, capsule-shaped tablets, debossed with “4” on one side and plain on the other. They are supplied as follows: Bottles of 30: NDC 60723-004-03 Bottles of 90: NDC 60723-004-09 Bottles of 500: NDC 60723-004-50 Storage Store montelukast sodium 4-mg and 5-mg chewable 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM CHEWABLE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM CHEWABLE
TABLETS.
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Montelukast Sodium Chewable Tablets are 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
( 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): 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 2 years
and older.
Dosage (by age) ( 2):
15 years and older: 10 mg
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 5-mg and 4 mg Chewable Tablets
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