Singulair

[Montelukast sodium]

Indications & Dosage
INDICATIONS AND USAGE

SINGULAIR is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.

SINGULAIR is indicated for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.

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DOSAGE AND ADMINISTRATION

General Information

SINGULAIR should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patient needs.

Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening.

Adults and Adolescents 15 Years of Age and Older with Asthma or Seasonal Allergic Rhinitis

The dosage for adults and adolescents 15 years of age and older is one 10-mg tablet daily.

Pediatric Patients 6 to 14 Years of Age with Asthma or Seasonal Allergic Rhinitis

The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable tablet daily. No dosage adjustment within this age group is necessary.

Pediatric Patients 2 to 5 Years of Age with Asthma or Seasonal Allergic Rhinitis

The dosage for pediatric patients 2 to 5 years of age is one 4-mg chewable tablet or one packet of 4-mg oral granules daily.

Pediatric Patients 12 to 23 Months of Age with Asthma

The dosage for pediatric patients 12 to 23 months of age is one packet of 4-mg oral granules daily to be taken in the evening. Safety and effectiveness in pediatric patients younger than 12 months of age have not been established.

Administration of SINGULAIR Oral Granules

SINGULAIR 4-mg oral granules can be administered either directly in the mouth, or mixed with a spoonful of cold or room temperature soft foods; based on stability studies, only applesauce, carrots, rice or ice cream should be used. The packet should not be opened until ready to use. After opening the packet, the full dose (with or without mixing with food) must be administered within 15 minutes.

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