"The US Food and Drug Administration has approved AstraZeneca's Symbicort inhalation aerosol (80/4.5 mcg) for children aged 6 to 12 years with asthma that is not well controlled with an inhaled corticosteroid, the company has announced.
Chronic overdosage may result in signs/symptoms of hypercorticism [see WARNINGS AND PRECAUTIONS]. 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.
ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
ALVESCO is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/15/2016
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