Budesonide

PULMICORT

What it isInhaled or enteric corticosteroid; asthma, COPD, and — as the enteric form — Crohn disease and microscopic colitis.

Why this oneExtensive first-pass metabolism means the oral form acts largely on the gut with limited systemic exposure.

What limits itOral candidiasis when inhaled. CYP3A4-dependent, so strong inhibitors can produce systemic corticosteroid effects.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Mild to moderate active Crohn's disease	Adults	9 mg QAM	9 mg QAM up to 8 weeks	9 mg QD
Mild to moderate active Crohn's disease	Peds 8–17 yr, >25 kg	9 mg QAM ×8 weeks	then 6 mg QAM ×2 weeks	9 mg QD
Maintenance of clinical remission of Crohn's disease	Adults	6 mg QAM	6 mg QAM up to 3 months, then taper	6 mg QD

Renal Undefined

Hepatic Moderate (Child-Pugh B): consider reducing to 3 mg QD; avoid in severe (Child-Pugh C)

Take once daily in the morning
Swallow whole; do not chew or crush
If unable to swallow, open capsule onto 1 tablespoon applesauce, consume within 30 min, follow with 8 oz water
Avoid grapefruit juice for the duration of therapy
When switching from oral prednisolone, taper prednisolone concomitantly
Attempt taper to cessation after 3 months of maintenance

Hypercorticism and adrenal axis suppression (higher risk in peds and hepatic impairment)
Steroid withdrawal symptoms when transferred from systemic corticosteroids
Immunosuppression/increased infection risk (varicella, measles, TB, hepatitis B reactivation, fungal, Strongyloides, amebiasis, cerebral malaria, ocular HSV)
Kaposi's sarcoma reported with corticosteroid therapy
Caution with hypertension, diabetes, osteoporosis, glaucoma/cataracts

Pregnancy Insufficient human data; animal fetal harm. Monitor infants for hypoadrenalism

Lactation Present in human milk (inhaled data); weigh benefits against exposure

NO BOXED WARNINGS

Principal riskOral candidiasis when inhaled

Cost, est. cash$4–$300/month

Generic entry2008

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability3 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryC

Defining liabilityHyperglycemia, infection, osteoporosis and potentially severe mood, sleep or psychotic effects.