Budesonide Capsules

Products

Budesonide sustained-release capsules have been approved in many countries since 1998 (Entocort CIR, Budenofalk).

Structure and properties

Budesonide (C25H34O6, Mr = 430.5 g/mol) is a racemate and exists as a white, crystalline, odorless, tasteless powder that is practically insoluble in water.

Effects

Budesonide (ATC R03BA02) has anti-inflammatory, antiallergic, and immunosuppressive properties. The effects are due to binding to intracellular glucocorticoid receptors.

Indications

For the treatment of Crohn’s disease.

Dosage

According to the SmPC. Capsules are usually taken once daily before breakfast.

Contraindications

Budesonide is contraindicated in hypersensitivity, severe flares, distal colon and proximal gastrointestinal tract involvement, and extraintestinal involvement. For complete precautions, see the drug label.

Interactions

Budesonide is metabolized by CYP3A4 and has marked first-pass metabolism. Drug-drug interactions are possible with CYP inhibitors and inducers. Other interactions have been described with contraceptives, cardiac glycosides, antidiabetics, anticoagulants, NSAIDs, ion-exchange resins, and antacids.

Adverse effects

The most common potential adverse effects include the typical systemic steroid side effects.