CORTIMENT

What it is

CORTIMENT is a medicine containing 3 mg of budesonide within enteric-coated (gastro-resistant) granules as the active ingredient. It is presented as pink opaque, oblong hard gelatin capsules.

Approved indications

— Induction of remission in patients with mild to moderately active Crohn's disease affecting the ileum and/or the ascending colon.

Dosing overview

For acute Crohn's disease (for 8 weeks), the dose is 9 mg budesonide once daily in the morning, or 3 mg budesonide 3 times daily (morning, midday and evening). Continuous treatment beyond 8 weeks is not recommended. CORTIMENT capsules may be taken whole, without chewing or crushing, about 30 minutes before meals with sufficient water. Patients with difficulty swallowing the capsules may open the capsule and administer the enteric-coated granules without chewing or crushing and with plenty of liquid. At discontinuation, the dosage should be tapered gradually. In the first week of tapering, the dosage should be reduced to two capsules daily, one in the morning, one in the evening. In the second week of tapering, only one capsule should be taken in the morning. After two weeks of gradual dose reduction, treatment can be discontinued.

Key safety warnings

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticoid treatment should be carefully considered. Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Systemic effects of glucocorticoids may occur, particularly when prescribed at high doses, for prolonged periods and for those agents which are highly absorbed systemically. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric or behavioural effects. Glucocorticoids may cause suppression of the HPA axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended. Visual disturbance may be reported with systemic and topical glucocorticoid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

CORTIMENT is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients, and in patients with hepatic cirrhosis.

Regulatory history

CORTIMENT budesonide 9 mg prolonged release tablet was first listed on the ARTG on 31 August 2015.