Treatment of asthma as add-on therapy in patients w/ mild to moderate persistent asthma inadequately controlled on inhaled corticosteroids & short-acting β-agonists. Prophylaxis for exercise-induced bronchoconstriction. Chewable tab: Alternative treatment to low-dose inhaled corticosteroids in patients w/ mild persistent asthma who do not have recent history of serious asthma attacks that required oral corticosteroid use, & who have demonstrated incapable of using inhaled corticosteroids. FC tab: Symptomatic relief of seasonal allergic rhinitis in patients ≥15 yr.
Dosage/Direction for Use
Chewable tab Childn 6-14 yr One 5-mg tab daily taken in the evening, 2-5 yr One 4-mg tab daily taken in the evening. FC tab Adult & adolescent ≥15 yr 1 tab daily taken in the evening.
Administration
May be taken with or without food: Chewable tab: Take at least 1 hr before or 2 hr after a meal.
Contraindications
Hypersensitivity.
Special Precautions
Do not use as treatment for acute asthma attacks. Should not be abruptly substituted for inhaled or oral corticosteroids. Evaluate treatment regimen in case of eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complication &/or neuropathy. Reports of serious neuropsychiatric events; drowsiness or dizziness. Pregnancy & lactation. Chewable tab: Not recommended as monotherapy in patients w/ moderate persistent asthma. Contains aspartame; may be harmful for phenylketonurics. FC tab: Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
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