Ciclesonide

ALVESCO, OMNARIS

What it isInhaled glucocorticoid prodrug activated in the lung; maintenance treatment of asthma.

Why this onePulmonary activation and low oropharyngeal activity reduce thrush compared with many inhaled steroids.

What limits itIt still requires mouth rinsing and is a controller, not a rescue inhaler.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Asthma maintenance — prior bronchodilators alone	≥12 yr	80 mcg BID	80 mcg BID	160 mcg BID
Asthma maintenance — prior inhaled corticosteroids	≥12 yr	80 mcg BID	80–320 mcg BID	320 mcg BID
Asthma maintenance — prior oral corticosteroids	≥12 yr	320 mcg BID	320 mcg BID	320 mcg BID

Renal Undefined

Hepatic Undefined

Oral inhalation only
Prime before first use or when not used for >10 days (actuate 3 times)
Rinse mouth with water and spit out after each use (reduce oropharyngeal candidiasis)
When transferring from oral steroids: reduce prednisone gradually, no faster than 2.5 mg/day weekly, beginning after ≥1 week of Alvesco

Primary treatment of status asthmaticus or acute asthma episodes requiring intensive measures

Oropharyngeal candidiasis — rinse mouth after use
Risk of impaired adrenal function when transferring from oral steroids; HPA suppression at high doses
Immunosuppression — more serious/fatal course of chickenpox/measles; worsening infections
Growth suppression in children; glaucoma, increased IOP, cataracts
Reduction in bone mineral density

Pregnancy No human data; low systemic exposure at recommended dose — maintain asthma control

Lactation No human data; low systemic exposure — consider benefits vs. risks

NO BOXED WARNINGS

Principal riskOral candidiasis, less than other inhaled steroids

Cost, est. cash$300–$2,500/month

Generic entry2028 est.

Therapeutic safety burden0 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.