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Drug Information

Drug Information for ALVESCO (ciclesonide) Inhalation Aerosol 80 mcg, 160 mcgFor Oral Inhalation Only (Sepracor Inc.): 2 DOSAGE AND ADMINISTRATION

ALVESCO should be administered by the orally inhaled route. Prime ALVESCO Inhalation Aerosol before using for the first time by actuating 3 times prior to using the first dose from a new canister or when the inhaler has not been used for more than 10 days. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for four weeks or longer after initiation. After asthma stability has been achieved, it is desirable to titrate to the lowest effective dosage to reduce the possibility of side effects. For patients who do not respond adequately to the starting dose after 4 weeks of therapy, higher doses may provide additional asthma control. The safety and efficacy of ALVESCO when administered in excess of the highest recommended doses has not been established.

Recommended Dosages

The recommended starting dose and the highest recommended dose of ALVESCO Inhalation Aerosol are listed in the following table.

¹Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.1)].
PreviousTherapy	RecommendedStarting Dose	HighestRecommended Dose
Patients = 12 years who received bronchodilators alone	80 mcg twice daily	160 mcg twice daily
Patients = 12 years who receivedinhaled corticosteroids	80 mcg twice daily	320 mcg twice daily
Patients = 12 years who receivedoral corticosteroids¹	320 mcg twice daily	320 mcg twice daily

Drug Information Provided by National Library of Medicine (NLM).

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