MONTELUKAST SODIUM tablet, film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Contract Pharmacy Services-PA

INN (International Adı):

MONTELUKAST SODIUM

Kompozisyon:

MONTELUKAST 10 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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. 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 [see Nonclinical Toxicolo

Ürün özeti:

Montelukast Sodium Tablets, USP 10 mg are pale yellow colored, round, film-coated tablets with 'U' debossed on one side and '220' debossed on other side. NDC 67046-468-07 blisterpacks of 7 NDC 67046-468-14 blisterpacks of 14 NDC 67046-468-15 blisterpacks of 15 NDC 67046-468-20 blisterpacks of 20 NDC 67046-468-21 blisterpacks of 21 NDC 67046-468-28 blisterpacks of 28 NDC 67046-468-30 blisterpacks of 30 NDC 67046-468-60 blisterpacks of 60 Storage Store Montelukast Sodium Tablets at 20 0 to 25 0 C (68 0 to 77 0 F) [See USP Controlled Room Temperature]. Protect from moisture and light. Store in original package. Storage for Bulk Bottles Store bottles of 1000, Montelukast Sodium Tablets at 20 0 to 25 0 C (68 0 to 77 0 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
468 MONTELUKAST 10 MG
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM TABLETS USP
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS USP .
MONTELUKAST SODIUM TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
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.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening ( 2.4).
DOSAGE FORMS AND STRENGTHS
Montelukast Sodium Tablets, USP 10 mg ( 3).
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 known aspirin sensitivity should continue to avoid
aspirin or non-steroidal anti-inflammat