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:

ReadyMeds

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 2 years of age and older. Montelukast sodium is 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 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. Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive o

Bidhaa muhtasari:

Montelukast Sodium Chewable Tablets, 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 child-resistant 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 child-resistant cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Chewable Tablets, 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 child-resistant 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 child-resistant cap, an aluminum foil induction seal, and silica gel desiccant Montelukast Sodium Tablets, 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 child-resistant 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 child-resistant 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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, FILM COATED
READYMEDS
----------
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 AND CHEWABLE TABLETS
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions
Neuropsychiatric Events (5.4) 03/2013
Eosinophilic Conditions (5.5) 06/2013
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 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):
Asthma (2.1): Once daily in the evening for patients 2 years and
older.
Acute prevention of EIB (2.2): One 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).
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 have appropriate rescue medication available (5.1).
Inhaled corticosteroid may be reduced gradually. Do