• Colorectal disorders

Ortikos Generic Name & Formulations

General Description

Budesonide 6mg, 9mg; ext-rel caps.

Pharmacological Class


How Supplied

Ext-rel caps—30, 100, 500

Generic Availability


Ortikos Indications


Treatment of mild to moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8yrs of age and maintenance of clinical remission for up to 3months in adults.

Ortikos Dosage and Administration


Swallow whole. Take in the AM. Treatment: 9mg once daily for up to 8weeks; may repeat an 8-week course for recurring episodes. Maintenance of remission: 6mg once daily for up to 3months; taper to complete cessation if symptom control is maintained. If switching from oral prednisolone: begin tapering prednisolone concomitantly while initiating budesonide.


<8yrs: not established. Swallow whole. Take in the AM. Treatment: 8–17yrs (>25kg): 9mg once daily for up to 8weeks, followed by 6mg once daily for 2weeks.

Ortikos Contraindications

Not Applicable

Ortikos Boxed Warnings

Not Applicable

Ortikos Warnings/Precautions


Active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections, ocular herpes simplex. Supplement with systemic corticosteroids in surgery or other stress situations. Caution when transferring from steroids with high systemic availability (monitor). May unmask allergies previously controlled by systemic corticosteroids. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Moderate to severe hepatic impairment (Child-Pugh Class B and C): avoid. Elderly. Pregnancy. Nursing mothers.

Ortikos Pharmacokinetics

See Literature

Ortikos Interactions


May be potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine); avoid. Avoid grapefruit or grapefruit juice.

Ortikos Adverse Reactions

Adverse Reactions

Headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, pain; hypercorticism, adrenal suppression, immunosuppression.

Ortikos Clinical Trials

See Literature

Ortikos Note

Not Applicable

Ortikos Patient Counseling

See Literature