Description

Oral Chronic asthma Adult: As film-coated tab: 10 mg once daily in the evening. Allergic rhinitis Adult: 10 mg once daily. Prophylaxis of exercise-induced asthma Adult: 10 mg at least 2 hr prior to exercise; do not take additional doses w/in 24 hr. Elderly: No dosage adjustment needed. Hepatic impairment: Mild to moderate: No dosage adjustment needed. ... Show more Child Dose Asthma Prophylaxis and maintenance treatment in patients aged >12 months <12 months: Safety and efficacy not established 12-24 months: 4 mg (granules) PO once daily in evening 2-6 years: 4 mg (chewable tablet or granules) PO once daily in evening 6-15 years: 5 mg (chewable tablet) PO once daily in evening >15 years: 10 mg (conventional tablet) PO once daily in evening Exercise-Induced Bronchospasm Prophylaxis 6-15 years: 5 mg (chewable tablet) PO 2 hours before exercise; do not take additional dose within 24 hours >15 years: 10 mg PO 2 hours before exercise; do not take additional dose within 24... ... Show more Renal Dose Renal impairment: No dosage adjustment needed.

Induced hepatic metabolism resulting to decreased plasma concentration w/ potent inducers of cytochrome P450 isoenzymes (e.g. phenobarbital, phenytoin, rifampicin).

>10% Headache (18.4%; similar to placebo) 1-10% >2% Abdominal pain,Eczema,Influenza,Laryngitis,Pharyngitis,Viral infection,Wheezing,Dental pain,Dizziness,Dyspepsia, Dental pain (2%),Dizziness (2%),Dyspepsia (2%)Elevated liver function tests (2%),Fever (2%),Gastroenteritis (2%),Nasal congestion (2%),Otitis (2%),Rash (2%),Urticaria (2%), >1% Bronchitis,Cough,Sinusitis,Upper respiratory tract infection <1% Allergic granulomatous angiitis (Churg-Strauss syndrome; rare),Cholestatic hepatitis (rare),Aggressive behavior, altered behavior, suicidal thoughts Potentially Fatal: Anaphylaxis, Churg-Strauss syndrome.

Not for the relief of acute bronchospasm. Not to be used as monotherapy for the prevention of exercise-induced bronchospasm. Patients in whom asthma is precipitated by aspirin or other NSAIDs should continue to avoid aspirin and NSAIDs. Do not abruptly substitute for oral or inhaled corticosteroids. Be alert for any signs of Churg-Strauss syndrome. Pregnancy and lactation. Children <6 mth. Lactation: Unknown whether agent is excreted in breast milk, use with caution