Jane S. Ricciuti, RPh, MS


September 20, 2002

In This Article

Pulmonary Agents

(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

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