Drug Information for ALVESCO (ciclesonide) Inhalation Aerosol 80 mcg, 160 mcgFor Oral Inhalation Only (Sepracor Inc.): 10 OVERDOSAGE

Chronic overdosage may result in signs/symptoms of hypercorticism [see Warnings and Precautions (5.5)]. ALVESCO was well tolerated following inhalation by healthy subjects of single doses of 2880 mcg. A single oral dose of up to 10 mg of ciclesonide in healthy subjects was well tolerated and serum cortisol levels were virtually unchanged in comparison with placebo treatment. Adverse reactions were of mild or moderate severity.

The median lethal doses in mice and rats after single oral and intraperitoneal administration were >2000 mg/kg and >200 mg/kg, respectively. These doses are >12000 and >2500 times the maximum recommended daily inhalation dose in adults on a mg/m² basis.