MONTELUKAST SODIUM CHEWABLE - montelukast sodium tablet, chewable

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

montelukast sodium (UNII: U1O3J18SFL) (montelukast - UNII:MHM278SD3E)

Disponibil de la:

Jubilant Cadista Pharmaceuticals Inc.

INN (nume internaţional):

montelukast sodium

Compoziție:

montelukast 4 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Montelukast sodium chewable tablets are indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months 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 6 months 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, respe

Rezumat produs:

Montelukast sodium chewable tablets 4 mg are pink colored, mottled, oval shaped, uncoated, flat face beveled edge tablets with “C” debossed on one side and “B5” on the other side having a characteristic flavor.                     Bottle of 30’s (child-resistant)                                    59746-358-30 Bottle of 90’s (child-resistant)                                    59746-358-90 Bottle of 100’s (child-resistant)                                  59746-358-01 Bottle of 500’s                                                           59746-358-05 Bottle of 1000’s                                                         59746-358-10 Blister of 10’s                                                            59746-358-12 Carton of 3x10’s                                                        59746-358-32    Montelukast sodium chewable tablets 5 mg are pink colored, mottled, round, uncoated, flat face beveled edge tablets with “C” debossed on one side and “B6” on the other side having a characteristic flavor. Bottle of 30’s (child-resistant)                                    59746-359-30 Bottle of 90’s (child-resistant)                                    59746-359-90 Bottle of 100’s (child-resistant)                                  59746-359-01 Bottle of 500’s                                                           59746-359-05 Bottle of 1000’s                                                         59746-359-10 Blister of 10’s                                                            59746-359-12 Carton of 3x10’s                                                       59746-359-32 Storage Store montelukast sodium chewable tablets 4 mg and 5 mg at 20° to 25°C (68° to 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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MONTELUKAST SODIUM CHEWABLE - MONTELUKAST SODIUM TABLET, CHEWABLE
JUBILANT CADISTA PHARMACEUTICALS INC.
----------
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
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events (5.4) 12/2016
INDICATIONS AND USAGE
Montelukast sodium chewable tablets are leukotriene receptor
antagonist indicated for: (1)
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): 10 mg 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: 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 chewable tablets 4 mg and 5 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
sub