Transcription of Proposed Prescribing Information (USPI) Singulair
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Proposed Prescribing Information (USPI) Singulair
HIGHLIGHTS OF Prescribing INFORMATIONT hese highlights do not include all the Information needed to use Singulair safely and effectively. See full Prescribing Information for (montelukastsodium) Tablets, Chewable Tablets, and Oral GranulesInitial Approval:1998--------------------------- RECENT MAJOR CHANGES---------------------------Warnin gs and Precautions, Neuropsychiatric Events ( )09/2018----------------------------INDI CATIONS AND USAGE----------------------------SINGULA IRis aleukotriene receptor antagonist indicated for: Prophylaxis and chronic treatment of asthma in patients 12months of age and older( ). Acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older ( ). 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 ( ).-----------------------DOSAGE AND ADMINISTRATION------------------------Ad ministration (by indications): Asthma ( ): Once daily in the eveningfor patients 12 months and older.
2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Asthma SINGULAIR® is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12months of age and older.
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