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Ortikos Generic Name & Formulations
Legal Class
Rx
General Description
Budesonide 6mg, 9mg; ext-rel caps.
Pharmacological Class
Glucocorticoid.
How Supplied
Ext-rel caps—30, 100, 500
Manufacturer
Generic Availability
NO
Ortikos Indications
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
Adult
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.
Children
<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
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
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
