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Budesonide 6mg, 9mg ER Capsule

Brand and Other Names: Ortikos
Mechanism of Action:
Budesonide is an anti-inflammatory corticosteroid and has a high glucocorticoid effect and a weak mineralocorticoid effect, and the affinity of budesonide to glucocorticoid receptors, which reflects the intrinsic potency of the drug, is about 200-fold that of cortisol and 15-fold that of prednisolone.
Indications:

ORTIKOS is a corticosteroid indicated for:
• Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older.
• Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.

Route: Oral
Dose:

Mild to moderate active Crohn’s disease (2.2):
• Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment courses recurring episodes of active disease.
• Pediatric patients 8 to 17 years who weigh more than 25 kg: 9 mg once daily for up to 8 weeks, followed by 6 mg once daily in the morning for 2 weeks. See package insert for complete information.

Adverse Reactions:
Most common adverse reactions (≥ 5%) in adults are: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain.
Contraindication:
Hypersensitivity to budesonide or any of the ingredients in ORTIKOS.
Warnings and Precautions:

Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids and paediatrics and patients with hepatic impairment may be at increased risk.
• Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids: Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema).
• Increased Risk of Infection, including Serious and Fatal Chicken Pox and Measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
• Other Corticosteroid Effects: Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g. hypertension, diabetes mellitus).

See package insert for full prescribing information.