Alvesco (Ciclesonide Inhalation) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

In clinical studies, concurrent administration of ciclesonide and other drugs commonly used in the treatment of asthma (albuterol, formoterol) had no effect on pharmacokinetics of des-ciclesonide [see Clinical Pharmacology ].

In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions [see Clinical Pharmacology].

In a drug interaction study, co-administration of orally inhaled ciclesonide and oral ketoconazole, a potent inhibitor of cytochrome P450 3A4, increased the exposure (AUC) of des-ciclesonide by approximately 3.6-fold at steady state, while levels of ciclesonide remained unchanged.

OVERDOSAGE

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.

CONTRAINDICATIONS

Status Asthmaticus

ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.

Hypersensitivity

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.