Concise Prescribing Info
Prophylaxis & chronic treatment of asthma in adults & childn ≥12 mth. Relief of daytime & nighttime symptoms of seasonal allergic rhinitis in adults & childn ≥2 yr.
Dosage/Direction for Use
Asthma Dose should be taken in evening. Allergic rhinitis Individualized time of administration based on patient needs. Patient w/ both asthma & allergic rhinitis 1 tab daily in the evening. Adult ≥15 yr One 10-mg tab daily. Childn 6-14 yr One 5-mg chewable tab daily, 2-5 yr One 4-mg chewable tab daily or 1 sachet of 4-mg oral granules daily. Childn 12 mth-2 yr w/ asthma 1 sachet of 4-mg oral granules daily.
May be taken with or without food: Oral granules may be administered directly into the mouth or mixed w/ a spoonful of cold/room temp soft foods (eg, applesauce) or dissolved in 1 tsp (5 mL) of cold/room temp baby formula or breast milk. Administer immediately (w/in 15 min) after opening of packet. Drug/food mixt should not be stored for future use. Not intended to be dissolved in liqd other than baby formula or breast milk for administration.
Hypersensitivity to montelukast or aspirin. Acute asthma attacks. Not substitute for short-acting β-agonist. Phenylketonuria (chewable tab only).
Special Precautions
Not to be abruptly substituted for inhaled or oral corticosteroids. Monitor patient when reducing dose of systemic corticosteroids. Pregnancy & lactation.
Adverse Reactions
Palpitations, allergic granulomatous angiitis; angioedema, bruising, erythema nodosum, atopic dermatitis, eczema, skin &/or SC tissue infection, rash, urticaria; GI disturbances; blood coagulation disorder; increased levels of ALT/AST, cholestatic hepatitis; hypersensitivity reactions, varicella & viral infection; neurologic disorders; conjunctivitis, myopia, otalgia, otitis, otitis media; psychiatric disorders; pyuria; resp disorders; arthralgia, myalgia including muscle cramps. Fatigue, fever, influenza, malaise, traumatic injury.
Drug Interactions
Concomitant use w/ CYP3A4 enzyme inducers. Elevated plasma conc w/ concurrent use of gemfibrozil. May result to severe peripheral edema w/ concurrent use of prednisone. Increased repaglinide plasma conc.
ATC Classification
R03DC03 - montelukast ; Belongs to the class of leukotriene receptor antagonists. Used in the systemic treatment of obstructive airway diseases.
Aspira chewable tab 4 mg
Aspira tab 10 mg
Aspira chewable tab 5 mg
Aspira oral granules 4 mg
28 × 1's
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