Pulmonary AgentsSingulair (montelukast sodium) Granule
Drug Approval Classification: Original New Drug Application (Approval Date: 7/26/02)
Indication: This new drug application provides for the use of Singulair (montelukast sodium) Oral Granules in the treatment of asthma as the primary formulation for patients 12 months to less than 2 years of age, and as an alternate formulation for ages 2- 5 years.
Prior to this new labeling, montelukast was indicated for the management of asthma in adults and children ≥ 2 years of age.
Dosing: The dosage for pediatric patients 12- 23 months of age is 1 packet of 4-mg oral granules daily to be taken in the evening. Safety and effectiveness in pediatric patients < 12 months of age have not been established.
Medscape Pharmacists. 2002;3(2) © 2002 Medscape
Cite this: September 2002 - Medscape - Sep 01, 2002.