MONTELUKAST SODIUM- montelukast sodium tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

REMEDYREPACK INC.

INN (الاسم الدولي):

MONTELUKAST SODIUM

تركيب:

MONTELUKAST 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years 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 2 years 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 organogenesis at doses approximately 100 and 110 times, respectively, the maximum recommended human daily oral dose (MRHDOD) ba

ملخص المنتج:

Montelukast Sodium Chewable Tablets, USP, 4-mg (montelukast), are pink, oval-shaped chewable tablets, debossed with E223 on one side and plain on the other.  They are supplied as follows: NDC 0603-4653-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-28  bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4653-32  bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Chewable Tablets, USP, 5-mg (montelukast), are pink, round-shaped chewable tablets, debossed with E224 on one side and plain on the other.  They are supplied as follows: NDC 0603-4654-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-28 bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4654-32 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Film-Coated Tablets, USP, 10 mg (montelukast) are round-shaped, beige tablets, debossed with E225 on one side and plain on the other.  They are supplied as follows: NDC 0603-4655-16 unit of use high-density polyethylene (HDPE) bottles of 30 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-02 unit of use high-density polyethylene (HDPE) bottles of 90 with a polypropylene child-resistant cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-28 bulk packaging high-density polyethylene (HDPE) bottles of 500 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-32 bulk packaging high-density polyethylene (HDPE) bottles of 1,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant NDC 0603-4655-34 bulk packaging high-density polyethylene (HDPE) bottles of 5,000 with a polypropylene cap, an aluminum foil induction seal, and silica gel desiccant Storage Store montelukast 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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM 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 AND
MONTELUKAST SODIUM CHEWABLE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS.
MONTELUKAST SODIUM TABLETS AND MONTELUKAST SODIUM CHEWABLE TABLETS,
FOR ORAL USE.
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Neuropsychiatric Events ( 5.4)
12/2018
INDICATIONS AND USAGE
Montelukast sodium tablets are a 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: one 10-mg tablet.
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 Film-Coated Tablets, 10 mg
Montelukast sodium Chewable Tablets, 4 mg and 5 mg
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