Label: MONTELUKAST SODIUM tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 14, 2022

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

    Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. The types of events reported were highly variable, and included, but were not limited to, agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior (including suicide). The mechanisms underlying NP events associated with montelukast sodium use are currently not well understood [see Warnings and Precautions (5.1)] .

    Because of the risk of NP events, the benefits of montelukast sodium may not outweigh the risks in some patients, particularly when the symptoms of disease may be mild and adequately treated with alternative therapies. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative therapies [see Indications and Usage (1.3)] . In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.

    Discuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise patients to discontinue montelukast sodium and contact a healthcare provider immediately [see Warnings and Precautions (5.1)] .

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  • 1 INDICATIONS AND USAGE
    1.1 Asthma - Montelukast sodium tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 15 years of age and older. 1.2 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Asthma - Montelukast sodium tablets should be taken once daily in the evening. The following doses are recommended:Montelukast sodium tablets should be taken once daily in the evening. The ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Montelukast sodium tablets, USP 10 mg are beige coloured, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on the other side.
  • 4 CONTRAINDICATIONS
    Hypersensitivity to any component of this product.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Neuropsychiatric Events - Serious neuropsychiatric (NP) events have been reported with use of montelukast sodium. These postmarketing reports have been highly variable and included, but were ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    No dose adjustment is needed when montelukast sodium is co-administered with theophylline, prednisone, prednisolone, oral contraceptives, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a ...
  • 10 OVERDOSAGE
    No specific information is available on the treatment of overdosage with montelukast sodium. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove ...
  • 11 DESCRIPTION
    Montelukast sodium, the active ingredient in montelukast sodium tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The cysteinyl leukotrienes (LTC - 4, LTD - 4, LTE ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No evidence of tumorigenicity was seen in carcinogenicity studies of either 2 years in Sprague-Dawley rats or 92 weeks in mice at oral ...
  • 14 CLINICAL STUDIES
    14.1 Asthma - Adults and Adolescents 15 Years of Age and Older with Asthma - Clinical trials in adults and adolescents 15 years of age and older demonstrated there is no additional clinical ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    NDC: 71335-1599-1: 30 Tablets in a BOTTLE - NDC: 71335-1599-2: 4 Tablets in a BOTTLE - NDC: 71335-1599-3: 7 Tablets in a BOTTLE - NDC: 71335-1599-4: 60 Tablets in a ...
  • 17 PATIENT COUNSELING INFORMATION
    For the tablets, advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide). Advise patients about the potential risk for serious neuropsychiatric ...
  • MEDICATION GUIDE
    Dispense with Medication Guide available at www.accordhealthcare.us/medication-guides - MEDICATION GUIDE - Montelukast Sodium Tablets ...
  • PRINCIPAL DISPLAY PANEL
    Montelukast Sodium 10mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information