MONTELUKAST SODIUM tablet, chewable

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Preferred Pharmaceuticals Inc.

INN (International Adı):

MONTELUKAST SODIUM

Kompozisyon:

MONTELUKAST 4 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

         Montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months 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 6 months of age and older. 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 (MR

Ürün özeti:

            Montelukast sodium chewable tablets, 4 mg, are pink colored, oval biconvex shaped, uncoated tablets, debossed with '1079' on one side and '4 MG' on other side. They are supplied as follows: Bottles of 10                               NDC 68788-6946-1 Bottles of 14                               NDC 68788-6946-4 Bottles of 20                               NDC 68788-6946-2 Bottles of 30                               NDC 68788-6946-3 Bottles of 60                               NDC 68788-6946-6 Bottles of 90                               NDC 68788-6946-9 Storage             Store montelukast sodium 4-mg oral granules, montelukast sodium 4-mg chewable tablets, 5-mg chewable tablets and 10-mg film-coated tablets 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.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET, CHEWABLE
PREFERRED PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 8E1CC714-00A5-4086-99DE-03616AEBA3D2
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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, FOR ORAL USE
MONTELUKAST SODIUM CHEWABLE TABLETS, FOR ORAL USE AND 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:
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DOSAGE AND ADMINISTRATION
Administration (by indications):
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Dosage (by age) ( 2):
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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
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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).
Asthma ( 2.1): Once daily in the evening for patients 12 months 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 6 months
and older.
15 years and older: one 10-mg tablet.
6 to 14 years: one 5-mg chewable tablet
2 to 5 years: