Dosing and uses of Alvesco (ciclesonide inhaled)
Adult dosage forms and strengths
MDI
- 80mcg/inhalation
- 160mcg/inhalation
Asthma, Prophylaxis
Receiving Bronchodilators or Inhaled Corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 160 mcg twice daily
Receiving Oral Corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 320 mcg twice daily
Pediatric dosage forms and strengths
MDI
- 80mcg/inhalation
- 160mcg/inhalation
Asthma Prophylaxis
<12 years
- Safety and efficacy not established
>12 years
- Receiving bronchodilators or inhaled corticosteroids: 80 mcg inhaled PO twice daily initially; may increase to 160 mcg twice daily
- Receiving Oral Corticosteroids: 80 mcg inhaled twice daily initially; may increase to 320 mcg twice daily
Alvesco (ciclesonide inhaled) adverse (side) effects
>10%
Headache (11%)
Nasopharyngitis (11%)
1-10%
Epistaxis (4.9%)
Ear pain (2.2%)
Facial edema (3%)
Urticaria (3%)
Oral candidiasis (3%)
Back pain (3%)
Extremety pain (3%)
Conjunctivitis (3%)
Upper respiratory infection (9%)
Gastroenteritis (3%)
Sinusitis (3%)
Warnings
Contraindications
Documented hypersensitivity
Treatment of acute asthma or status asthmaticus
Cautions
Caution in active serious infections
Secondary infections may occur as a result of prolonged use of corticosteroids
Avoid exposure to chickenpox or measles
Not for acute asthma treatment
When switching from oral corticosteroids
Bronchospasm may occur following inhalation (treat with fast acting bronchodilator)
High doses may cause suppression of hypothalamic-pituitary-adrenal axis, which can result in adrenal crisis
Long-term use may result in: reduced BMD; glaucoma or cataracts; increased IOp
Development of Kaposi's sarcoma associated with prolonged use of corticosteroids
Psychiatric disturbances reported with corticosteroid use
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if excreted in breast milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Alvesco (ciclesonide inhaled)
Mechanism of action
Glucocorticoid prodrug, converted to active ingredient des-ciclesonide; has immunosuppressive properties, anti-inflammatory activity, and anti-inflammatory effects.
Distribution
Bioavailability: 63% (active metabolite)
Absorption: 52%
Protein Bound: 99% (IV)
Vd: 2.9 L/kg (ciclesonide); 12.1 L/kg (des-ciclesonide) following IV administration
Metabolism
Metabolized to active des-ciclesonide by esterases, then further metabolized by liver CYP3A4 and to a lesser extent, CYP2D6
Eliminiation
Following IV administration
- Half-life: 0.71 hr (ciclesonide); 6-7 hr (des-ciclesonide)
- Clearance: 152 L/L/hr (ciclesonide); 228 L/L/hr (des-ciclesonide)
- Excretion: Feces (66%); urine (20%)
