SINGULAIR TABLET 10 mg

II. INDICATIONS

SINGULAIR is indicated in adult and pediatric patients 1 year of age and older for the prophylaxis and chronic treatment of asthma, including the prevention of day- and nighttime symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction.

SINGULAIR is indicated for the relief of daytime and nighttime symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis in adults and pediatric patients 1 year of age and older). Because the benefits of SINGULAIR may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis, reserve use for patients who have an inadequate response or intolerance to alternative therapies.

V. CONTRAINDICATIONS

• Hypersensitivity to any component of this product

III. DOSAGE AND ADMINISTRATION

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

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

Adults 15 Years of Age and Older with Asthma and/or Allergic rhinitis

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

Pediatric Patients 6 to 14 Years of Age with Asthma and/or Allergic rhinitis

The dosage for pediatric patients 6 to 14 years of age is one 5-mg chewable tablet daily.

Pediatric Patients 2 to 5 Years of Age with Asthma and/or Allergic rhinitis

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

Pediatric Patients 1 to 2 Years of Age with Asthma

The dosage for pediatric patients 1 to 2 years of age is one packet of 4-mg oral granules daily to be taken in the evening.

Pediatric Patients 1 Year to 2 Years of Age with Perennial Allergic Rhinitis

The dosage for pediatric patients 1 year to 2 years of age is one packet of 4-mg oral granules daily.

Administration of oral granules:

SINGULAIR oral granules can be administered either directly in the mouth, dissolved in 1 teaspoonful (5 mL) of cold or room temperature baby formula or breast milk, 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 of SINGULAIR oral granules must be administered immediately (within 15 minutes). If mixed with food, or dissolved in baby formula or breast milk, SINGULAIR oral granules must not be stored for future use. SINGULAIR oral granules are not intended to be dissolved in any liquid other than baby formula or breast milk for administration. However, liquids may be taken subsequent to administration.

General Recommendations

The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one day. SINGULAIR tablets, chewable tablets, and oral granules can be taken with or without food. Patients should be advised to continue taking SINGULAIR while their asthma is controlled, as well as during periods of worsening asthma.

No dosage adjustment is necessary for pediatric patients, the elderly, for patients with renal insufficiency, or mild-to-moderate hepatic impairment, or for patients of either gender.

Therapy with SINGULAIR in Relation to Other Treatments for Asthma

SINGULAIR can be added to a patient’s existing treatment regimen.

Reduction in Concomitant Therapy:

Bronchodilator Treatments: SINGULAIR can be added to the treatment regimen of patients who are not adequately controlled on bronchodilator alone. When a clinical response is evident (usually after the first dose), the patient’s bronchodilator therapy can be reduced as tolerated.

Inhaled Corticosteroids: Treatment with SINGULAIR provides additional clinical benefit to patients treated with inhaled corticosteroids. A reduction in the corticosteroid dose can be made as tolerated. The dose should be reduced gradually with medical supervision. In some patients, the dose of inhaled corticosteroids can be tapered off completely. SINGULAIR should not be abruptly substituted for inhaled corticosteroids.