Budesonide

What it is and how it works

Mechanism of Action Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.

Mechanism class: Corticosteroid Hormone Receptor Agonists

Indications

Budesonide delayed-release capsules are a corticosteroid indicated for: • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.

Dosage and administration (summary)

Administration Instructions : • Take once daily in the morning. • Swallow whole. Do not chew or crush. • For patients unable to swallow an intact capsule, open the capsules and empty the granules onto one tablespoonful of applesauce. Mix and consume the entire contents within 30 minutes. Do not chew or crush. Follow with 8 ounces of water. • Avoid consumption of grapefruit juice for the duration of therapy. Recommended Dosage : Mild to moderate active Crohn’s disease : • Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment courses for recurring episodes of active disease.

Contraindications

Budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred . Hypersensitivity to budesonide or any of the ingredients in budesonide delayed-release capsules.

Warnings and precautions

• Hypercorticism and Adrenal Axis Suppression : May occur with treatment; monitor for signs and symptoms; pediatrics and patients with hepatic impairment may be at increased risk. ( 2.4 , 5.1 , 8.4 , 8.6 ) • Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids : Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema).

Pregnancy

Pregnancy Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations .

Storage and supply

Budesonide 3 mg delayed-release capsules are hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with ENTOCORT EC 3 mg on the capsule and are supplied as follows: NDC 0574–9855–10 Bottles of 100 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) . Keep container tightly closed.

Source: Budesonide (Budesonide) — US FDA prescribing information, 2024-06-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.