Treatment Options Overview: Corticosteroids

PRODUCT DETAILS / COMPANY (APPROVED BY HEALTH CANADA FOR IBD INDICATIONS)

Budesonide / A registered trademark owned by Tillotts Pharma AG, used under license by Pendopharm, division of Pharmascience Inc. (2016)

INDICATION

Controlled ileal release capsules indicated for the treatment of mild-to-moderate active Crohn’s disease involving the ileum and/or the ascending colon.

           

Logistics and Monitoring: Corticosteroids

METHOD OF ADMINISTRATION

Oral

DOSING - ADULTS

Induction: 9 mg daily for up to 8 weeks.

Maintenance: 6 mg daily for up to 3 months for maintenance of clinical remission.

DOSING - PEDIATRIC

Induction10-11: 9 mg once daily for 8 weeks, followed by 6 mg daily for 4 weeks.

Maintenance: Not recommended.

           

RCTs: randomized clinical trials, IV: intravenous, BDP: beclomethasone dipropionate

Side Effects: Corticosteroids

SIDE EFFECTS

For more detailed information regarding side effects, please refer to the appropriate product monograph.

• Hypertension
• Acne vulgaris
• Cushingoid appearance
• Nausea
• Bruising
• Headache
• Respiratory tract infection
• Dysuria
• Infection
• Mood changes
• Peptic ulcer

           

IBD: inflammatory bowel disease

Special Populations: Corticosteroids

PEDIATRICS

Safety and effectiveness in children have not been established.

No data for Health Canada to review.

ECCO Crohn’s guidelines13:

In children with mild to moderate ileo-cecal Crohn’s disease budesonide may be used as an alterative to systemic corticosteroids for induction of remission.

ELDERLY

Product monograph: no acknowledgement of the older population.

Recommendations14:

May be preferred over conventional corticosteroids in older patients with ileocolonic or right sided luminal Crohn’s disease.

PREGNANCY

Coming soon

BREASTFEEDING

Coming soon

           

IBD: inflammatory bowel disease, 5-ASA: 5-aminosalicylic acid, ECCO: European Crohn’s and Colitis Organization, EEN: enteral nutrition