MONTELUKAST SODIUM granule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Montelukast Sodium (UNII: U1O3J18SFL) (montelukast - UNII:MHM278SD3E)

थमां उपलब्ध:

Dr.Reddy's Laboratories Limited

INN (इंटरनेशनल नाम):

Montelukast Sodium

रचना:

montelukast 4 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in pediatric patients 12 months 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. 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) based on AUCs [see Data] .   The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. A

उत्पाद समीक्षा:

Montelukast sodium oral granules, 4 mg (montelukast), are white to off white granular powder packed in aluminum foil packet. They are supplied as follows: Unit Dosage Package of 30 (1x30)                                                       NDC 55111-763-03 Storage Store montelukast sodium oral granules, 4 mg (montelukast), at 20°–25°C (68°–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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

MONTELUKAST SODIUM- MONTELUKAST SODIUM GRANULE
DR.REDDY'S LABORATORIES LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MONTELUKAST SODIUM ORAL GRANULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MONTELUKAST SODIUM ORAL GRANULES.
MONTELUKAST SODIUM ORAL GRANULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1998
RECENT MAJOR CHANGES
Warnings and Precautions, Neuropsychiatric Events (5.4) 08/2019
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).
• 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.
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):
2 to 5 years: one packet of 4 mg oral granules.
6 to 23 months: one packet of 4 mg oral granules.
Patients with both asthma and allergic rhinitis should take only one
dose daily in the evening (2.4). For oral granules: Must
administer within 15 minutes after opening the packet (with or without
mixing with food) (2.5).
DOSAGE FORMS AND STRENGTHS
• Montelukast sodium 4 mg (montelukast) oral granules (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 a