MONTELUKAST SODIUM tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Proficient Rx LP

INN (Nome Internazionale):

MONTELUKAST SODIUM

Composizione:

MONTELUKAST 10 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

            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.

Dettagli prodotto:

            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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MONTELUKAST SODIUM- MONTELUKAST SODIUM TABLET
PROFICIENT RX LP
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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)
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DOSAGE AND ADMINISTRATION
ADMINISTRATION (BY INDICATIONS): (2)
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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