Classes
DEA Class; Rx
Common Brand Names; Entocort EC, Uceris, Ortikos, Tarpeyo
- Corticosteroids, Gastrointestinal
budesonide inhaled (Rx)
- Classes: Corticosteroids, Inhalants
budesonide rectal (Rx)
- Classes: Corticosteroids, Rectal
budesonide intranasal (Rx, OTC)
- Classes: Corticosteroids, Intranasal
Description
Potent corticosteroid available for intranasal, inhaled, rectal, and oral administration
Respiratory inhalation used for asthma or COPD; nasal spray used for allergic rhinitis
Used rectally to treat ulcerative colitis; used orally to treat Crohn’s disease, ulcerative colitis, and primary immunoglobulin A nephropathy (IgAN)
Indications
Indicated for the induction of remission of active, mild-to-moderate ulcerative colitis
Indicated for treatment of mild-to-moderate active Crohn disease involving the ileum and/or ascending colon
Indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g
Acthma Maintenance treatment
Indicated for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge
Indicated for seasonal or perennial allergic rhinitis
Contraindications
Documented hypersensitivity
Status asthmaticus, acute bronchospasm
Adverse Effects
Headache (21%)
Acne (<5-15%)
Nausea (11%)
Respiratory infection (11%)
Back pain (7%)
Dizziness (7%)
Abdominal pain (6%)
Dyspepsia (6%)
Vomiting (6%)
Fatigue (5%)
IgAN
- Hypertension (16%)
- Peripheral edema (14%)
- Muscle spasms (13%)
- Acne (11%)
- Dermatitis (7%)
- Weight increased (7%)
- Dyspnea (6%)
- Face edema (6%)
- Dyspepsia (5%)
- Fatigue (5%)
- Hirsutism (5%)
Warnings
When used chronically, systemic effects (eg, hypercorticism, adrenal suppression) may occur; glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress; if patients are subject to surgery or other stress situations, supplement with a systemic glucocorticosteroid
Caution in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to those with lower systemic effects (eg, budesonide); monitor for symptoms of steroid withdrawal, including those of acute adrenal suppression or benign intracranial hypertension
Drugs that suppress the immune system, including budesonide, may increase risk for infection; patients who have not had certain infections (eg, chicken pox, measles) can have more serious infections, including fatalities
Reduced liver function affects the elimination of glucocorticosteroids; increased systemic availability of oral budesonide demonstrated with liver cirrhosis; consider discontinuing use in patients with moderate-to-severe liver disease
Caution with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with other conditions where glucocorticosteroids may have unwanted effects
Pregnancy and Lactation
Available data from published case series, epidemiological studies and reviews with oral budesonide use in pregnant females have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes
Breastfeeding is not expected to result in significant exposure of the infant
Maximum Dosage
Maximum dose dependent on indication and specific drug formulation administered. Doses up to 8 mg/day of the nebulizer suspension have been used off-label.
Maximum dose dependent on indication and specific drug formulation administered. Doses up to 8 mg/day of the nebulizer suspension have been used off-label.
256 mcg/day intranasally; 720 mcg/day via dry powder inhaler (DPI) is the FDA-approved maximum dosage; doses of the nebulizer suspension as high as 4 mg/day have been used off-label. Safety and efficacy of oral formulations have not been established; however, doses up to 12 mg/day (oral capsules) have been used off-label.
12 years: 256 mcg/day intranasally; 720 mcg/day via dry powder inhaler (DPI) is the FDA-approved maximum dosage; nebulizer suspension doses as high as 4 mg/day have been used off-label. Safety and efficacy of oral formulations have not been established; however, doses up to 12 mg/day of the oral capsules have been used off-label.
6 to 11 years: 128 mcg/day intranasally; 720 mcg/day via dry powder inhaler (DPI) is the FDA-approved maximum dosage; 1 mg/day of the nebulizer suspension is the FDA-approved maximum dosage (6 to 8 years); however, doses as high as 4 mg/day have been used off-label. Safety and efficacy of oral formulations have not been established; however, doses up to 12 mg/day of the oral capsules have been used off-label.
1 to 5 years: 1 mg/day of the nebulizer suspension is the FDA-approved maximum dosage; however, doses as high as 4 mg/day have been used off-label. Safety and efficacy of other formulations have not been established.
Safety and efficacy have not been established; however, doses up to 1 mg/day of the nebulizer suspension have been used off-label.
