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Eohilia
budesonide
Adult Dosing .
Dosage forms: SUSPENSION: 2 mg per 10 mL
eosinophilic esophagitis
- [2 mg PO bid x12wk]
- Info: avoid food/drink during administration and for at least 30min after each dose
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: avoid use; Info: caution advised if Child-Pugh Class B
Peds Dosing .
- Dosage forms: SUSPENSION: 2 mg per 10 mL
eosinophilic esophagitis
- [11 yo and older]
- Dose: 2 mg PO bid x12wk; Info: avoid food/drink during administration and for at least 30min after each dose
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: avoid use; Info: caution advised if Child-Pugh Class B
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment, Child-Pugh Class C
- systemic fungal infection
- Strongyloides infection
- cerebral malaria
- amebiasis, active
- amebiasis, latent
- ocular HSV infection
- abrupt withdrawal (long-term use)
- caution: hypersensitivity to corticosteroids
- caution: long-term systemic corticosteroid use, recent
- caution: peds patients
- caution: adolescent patients
- caution: hepatic impairment, Child-Pugh Class B
- caution: renal impairment
- caution: immunosuppressed patients
- caution: infection, active
- caution: infection risk
- caution: measles exposure (non-immune patients)
- caution: varicella exposure (non-immune patients)
- caution: HTN
- caution: pheochromocytoma risk
- caution: CHF
- caution: MI, recent
- caution: diabetes mellitus
- caution: diabetes mellitus family history
- caution: ulcerative colitis
- caution: PUD
- caution: diverticulitis
- caution: intestinal anastomosis, recent
- caution: GI perforation risk
- caution: seizure disorder
- caution: myasthenia gravis
- caution: psychiatric disorder
- caution: thyroid disorder
- caution: osteoporosis
- caution: osteoporosis risk
- caution: cataract
- caution: glaucoma
- caution: glaucoma risk
Drug Interactions .
Overview
budesonide
corticosteroid
- CYP3A4 substrate
- affects growth hormone diagnostic test results
- binds to anion exchange resin/polymer
- corticosteroid
- hyperammonemia
- hyperglycemic effects
- hypernatremia
- hypertensive effects
- hypokalemia
- immunomodulatory effects
- interferes w/ ACTH analog test
Contraindicated
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- anaphylaxis
- intracranial HTN
- HTN
- infection
- GI obstruction
- diabetes mellitus
- adrenal insufficiency
- Cushing syndrome (long-term use)
- immunosuppression (long-term use)
- Kaposi sarcoma (long-term use)
- glaucoma (long-term use)
- cataracts (long-term use)
- osteoporosis (long-term use)
- withdrawal symptoms if abrupt D/C (long-term use)
- growth suppression (long-term use in peds patients)
Common Reactions
- URI
- candidiasis, oral
- candidiasis, esophageal
- headache
- gastroenteritis
- throat irritation
- adrenal suppression
- erosive esophagitis
Safety/Monitoring .
Monitoring Parameters
TB, HBV screening at baseline; electrolytes; 2h postprandial glucose; BP; weight; height (peds); consider BMD, chest x-ray, endoscopic evaluation, ophthalmic exam; consider upper GI x-ray if PUD history or significant dyspepsia
Look/Sound-Alike Drug Names
budesonide confused with: bumetanide
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, especially in 1st trimester or if long-term use; inadequate human data available, though possible risk of orofacial cleft, low birth wt, and premature birth based on conflicting human data with other systemic corticosteroids; possible risk of fetal harm, including teratogenicity and fetal death, based on animal data with SC route at 0.03-1.2x recommended human dose; possible risk of fetal adrenal suppression based on drug's mechanism of action
Lactation
Clinical Summary
weigh risk/benefit if prolonged high-dose use, otherwise may use while breastfeeding; inadequate human data available, though risk of infant harm not expected based on limited drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for budesonide: liver extensively; CYP450: 3A4 substrate
Excretion: for budesonide: urine 60% (none unchanged), feces; Half-life: 3.3h
Subclass: Corticosteroids, Systemic
Mechanism of Action
for budesonide: exact mechanism of anti-inflammatory action unknown; inhibits multiple inflammatory cytokines; produces multiple glucocorticoid and mineralocorticoid effects
Formulary .
No Formulary Selected
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