Jane S. Ricciuti, RPh, MS

Disclosures

September 20, 2002

In This Article

Pulmonary Agents

Singulair
(montelukast sodium) Granule

Manufacturer: Merck

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.

Singulair (montelukast sodium) Labeling

$$www$$/druginfo/Use?id=1-16911& name=SINGULAIR+ORAL&DrugType=1&MenuID=USE &ClassID=0&GeneralStatement=N

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....