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Related to Uceris: budesonide
budesonide (oral)(byoo-dess-oh-nide) ,
Entocort EC(trade name),
Pregnancy Category: C
ClassificationTherapeutic: gastroinestinal anti inflammatories
Entocort EC: Treatment of mild to moderate active Crohn’s disease involving ileum and/or ascending colon.Entocort EC: Maintenance of clinical remission for up to 3 mo of mild to moderate Crohn's disease involving ileum and/or ascending colon.Uceris: Induction of remission of active, mild to moderate ulcerative colitis
Has high local anti-inflammatory activity in the lumen of the GI tract, but is rapidly inactivated following absorption. Action is primarily local. Formulation resists acid degradation in the stomach and then releases budesonide slowly throughout the GI tract.
Improvement in symptoms/sequelae of Crohn’s disease (decreased frequency of liquid stools, decreased abdominal complaints, improved sense of well-being).
Induction of remission of ulcerative colitis
Absorption: Well absorbed following oral administration (9–21% bioavailability).
Distribution: 2.2–3.9 L/kg; enters breast milk.
Protein Binding: 85–90%.
Metabolism and Excretion: Rapidly and extensively metabolized during first pass hepatic metabolism by the CYP3A4 enzyme system to inactive metabolites which are excreted in urine and feces.
Half-life: 2.0–3.6 hr.
Time/action profile (improvement in symptoms of Crohn’s disease or induction of remission of ulcerative colitis)
Contraindicated in: Known hypersensitivity; Lactation: Excreted in breast milk. Avoid use or discontinue nursing.
Use Cautiously in: History of diabetes (or family history), tuberculosis, osteoporosis, hypertension, peptic ulcer, glaucoma (or family history) or cataracts (conditions may be exacerbated) ; Stress, including surgery or infections; supplemental doses of corticosteroid may be needed; Active untreated infections; ImmunosuppressionPotential infections (may mask signs such as fever or inflammation); Moderate to severe liver disease (↓ dose may be necessary); Obstetric / Pediatric: Safety not established; Geriatric: ↑ risk of adverse reactions.
Adverse Reactions/Side Effects
Central nervous system
- headache (most frequent)
- ↑ appetite
Ear, Eye, Nose, Throat
- abnormal vision
- nausea (most frequent)
- abdominal pain
- irregular menses
- urinary frequency
- acne (most frequent)
- easy bruising (most frequent)
- adrenal suppression (life-threatening)
- weight gain
- back pain
- infection (most frequent)
- cushingoid appearance
- flu-like syndrome
Drug-Drug interactionKnown inhibitors of the CYP3A4 enzyme system including ketoconazole, itraconazole, ritonavir, indinavir , saquinavir, and erythromycin; may ↑ levels; ↓ dose may be necessary.St. John's wort may ↓ levels.Grapefruit juice significantly ↑ blood levels; concurrent use should be avoided.
Route/DosageTreatment of Active Crohn's Disease (Entocort EC)
Oral (Adults) 9 mg once daily in the morning for up to 8 wk; recurring episodes of active disease can be treated with a repeat 8–wk course of therapy.Maintenance of Remission of Crohn's Disease (Entocort EC)
Oral (Adults) Following treatment of active disease and once patient's symptoms controlled, continue treatment with 6 mg once daily for up to 3 mo. If symptom control maintained at 3 mo, dose should be tapered to complete discontinuation. Continuing treatment for > 3 mo does not produce significant clinical benefit.Induction of Remission of Ulcerative Colitis (Uceris)
Oral (Adults) 9 mg once daily in the morning for up to 8 wk.
Availability (generic available)
Capsules (Entocort EC): 3 mg
Extended-release tablets (Uceris): 9 mg
- Assess signs of Crohn’s disease and Ulcerative Colitis (diarrhea, crampy abdominal pain, fever, bleeding from rectum) during therapy. Monitor frequency and consistency of bowel movements periodically during therapy
- Lab Test Considerations: May cause leukocytosis.
Potential Nursing DiagnosesDiarrhea (Indications)
- Periods of stress, such as surgery, may require supplemental systemic corticosteroids.
- Patients with mild to moderate Crohn’s disease may be switched from oral prednisolone without adrenal insufficiency by gradually decreasing prednisolone doses and adding budesonide.
- Oral: Administer once daily in the morning. Capsules and extended-release tablets should be swallowed whole; do not open, crush, break or chew.
- Consumption of grapefruit juice should be avoided throughout therapy.
- Instruct patient to take medication as directed. Do not share medication with others, even if they have similar symptoms; may be harmful.
- May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any Rx, OTC, or herbal products.
- Instruct patient to notify health care professional immediately if exposed to chicken pox or measles.
- Instruct patient to notify health care professional if they are planning or suspect pregnancy or if breastfeeding or planning to breastfeed.
- Improvement in symptoms/sequelae of Crohn’s disease and ulcerative colitis (decreased frequency of liquid stools, decreased abdominal complaints, improved sense of well-being).
A trademark for a preparation of the drug budesonide.