Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)
Proficient Rx LP
MONTELUKAST SODIUM
MONTELUKAST 10 mg
ORAL
PRESCRIPTION DRUG
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 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 6 months of age and older. Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women.
Montelukast sodium tablets, 10 mg, are light brown colored, round, biconvex film coated tablets debossed with "1081" on one side and "10MG" on other side. They are supplied as follows: Bottles of 30 NDC 63187-430-30 Bottles of 60 NDC 63187-430-60 Bottles of 90 NDC 63187-430-90 Storage Store Montelukast sodium 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 container.
Abbreviated New Drug Application
MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET PROFICIENT RX LP ---------- 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 INITIAL U.S. APPROVAL: 1998 INDICATIONS AND USAGE MONTELUKAST SODIUM TABLETS ARE A LEUKOTRIENE RECEPTOR ANTAGONIST INDICATED FOR: (1) • • • DOSAGE AND ADMINISTRATION ADMINISTRATION (BY INDICATIONS): (2) • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥5% and greater than placebo listed in descending order of frequency): upper respiratory infection, fever, headache, pharyngitis, cough, abdominal pain, diarrhea, otitis media, influenza, rhinorrhea, sinusitis, otitis (6.1). (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TORRENT PHARMA INC. AT 1-269-544-2299 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) _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. _(6) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 11/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1. INDICATIONS AND USAGE 1.1 Asthma 1.2 Exercise-Induced Bronchoconstriction 1.3 Allergic Rhinitis 2. DOSAGE AND ADMINISTRATION 2.1 Asthma 2.2 Exercise-Induced Bronchoconstriction (EIB) in Patients 15 Years of Age and Older 2.3 Allergic Rhinitis 2.4 Asthma and Allergic Rhinitis 2.5 Instructions for Administration of Oral Granules 3. DOSAGE FORMS AND STRENGTHS PROPHYLAXISAND CHRONIC TREATMENT OF ASTHMA INPATIENTS 12 MONTHS OF AGE AND OLDER(1.1 ). ACUTEPREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION(EIB) IN PATIENTS 15 YEARS O Belgenin tamamını okuyun