Monograph Details
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Gastrointestinal Tract
> Colorectal disorders
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ENTOCORT EC |
| Manufacturer |
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AstraZeneca Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Steroid. |
| Generic Name |
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Budesonide (micronized) 3 mg; e-c granules in caps. |
| Indications |
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Mild to moderate Crohn's disease of the ileum and/or ascending colon: to treat and to maintain clinical remission for up to 3 months. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole. Treatment: 9 mg once daily in the AM for up to 8 weeks; may repeat an 8-week course. Maintenance of remission: 6mg once daily for up to 3 months. Taper other systemic steroids when transferring to budesonide. |
| Precautions |
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Systemic fungal, viral, or mycobacterial infections. Live vaccines. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Supplement with more steroids in physiologic stress. Caution when transferring from steroids with high systemic availability. Monitor for hypercorticism in moderate to severe liver disease; consider reducing dose. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended. |
| Interactions |
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Avoid grapefruit juice. Systemic effects may be potentiated by CYP3A4 inhibitors (eg, ketoconazole, ritonavir, erythromycin); consider reducing budesonide dose. Drug release characteristics may be affected by drugs that affect gastrointestinal pH. |
| Adverse Reactions |
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Headache, infection, sinusitis, nausea, arthralgia, hypercorticism (eg, acne, bruising, face edema, hirsutism). |
| How Supplied |
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Caps—100 |
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