MONTELUKAST SODIUM tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (الاسم الدولي):

MONTELUKAST SODIUM

تركيب:

MONTELUKAST 10 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Montelukast Sodium Tablets and 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 Tablets and Chewable Tablets are indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients 15 years of age and older. Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Montelukast Sodium Tablets and 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 stu

ملخص المنتج:

Montelukast Sodium Tablets, 10 mg (base), are light tan, round, film-coated tablets with product identification "54 157" on one side and plain on the other. They are supplied as follows: NDC 0615-7983-39 Blistercards of 30 NDC 0615-7983-05 Blistercards of 15 Montelukast Sodium Chewable Tablets, 4 mg (base), are pink speckled, oval tablets with product identification "54 144" on one side and plain on the other side. Montelukast Sodium Chewable Tablets, 5 mg (base), are pink speckled, round tablets with product identification "54 741" on one side and plain on the other side. Storage Store montelukast sodium 4 mg chewable tablets, 5 mg chewable tablets and 10 mg film‑coated tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°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 and 500 montelukast sodium chewable tablets at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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
MONTELUKAST SODIUM CHEWABLE TABLETS
INITIAL U.S. APPROVAL: 1998
INDICATIONS AND USAGE
Montelukast Sodium Tablets and Chewable Tablets are a leukotriene
receptor antagonist indicated for: (1)
•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 15 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): (2)
•Asthma (2.1): Once daily in the evening for patients 2 years and
older.
•Acute prevention of EIB (2.2): 10 mg tablet at least 2 hours before
exercise for patients 15 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). (2)
DOSAGE FORMS AND STRENGTHS
•Montelukast Sodium Tablets, 10 mg (base) (film-coated)
•Montelukast Sodium Chewable Tablets, 4 mg (base) and 5 mg (base)
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