![]() ![]() The time of administration may be individualized to suit patient needs. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. Patients who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time.įor allergic rhinitis, montelukast sodium tablets should be taken once daily. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. Who miss a dose should take the next dose at their regular time and should not take 2 doses at the same time. Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established. The following doses are recommended:įor adults and adolescents 15 years of age and older: one 10 mg tablet. Montelukast sodium tablets should be taken once daily in the evening. ![]() Patients to discontinue montelukast sodium and contact a healthcare provider immediately If changes in behavior are observed, or if new NP symptoms or suicidal thoughts and/or behavior occur, advise Advise patients and/or caregivers to be alert for changes in behavior or new NP symptoms when taking montelukast sodium. In patients with asthma or exercise-induced bronchoconstriction, consider the benefits and risks before prescribing montelukast sodium.ĭiscuss the benefits and risks of montelukast sodium with patients and caregivers when prescribing montelukast sodium. Reserve use of montelukast sodium for patients with allergic rhinitis who have an inadequate response or intolerance to alternative Sodium use are currently not well understoodīecause 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. The mechanisms underlying NP events associated with montelukast 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). Serious neuropsychiatric (NP) events have been reported with the use of montelukast sodium. ![]() FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS 1 INDICATIONS AND USAGE 1.1 Asthma 1.2 Exercise-Induced Bronchoconstriction (EIB) 1.3 Allergic Rhinitis 2 DOSAGE AND ADMINISTRATION 2.1 Asthma 2.2 Exercise-Induced Bronchoconstriction (EIB) 2.3 Allergic Rhinitis 2.4 Asthma and Allergic Rhinitis 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Neuropsychiatric Events 5.2 Acute Asthma 5.3 Concomitant Corticosteroid Use 5.4 Aspirin Sensitivity 5.5 Eosinophilic Conditions 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Hepatic Insufficiency 8.7 Renal Insufficiency 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Asthma 14.2 Exercise-Induced Bronchoconstriction (EIB) 14.3 Allergic Rhinitis (Seasonal and Perennial) 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.
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