Uceris


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Related to Uceris: budesonide

budesonide (oral)

(byoo-dess-oh-nide) ,

Entocort EC

(trade name),

Uceris

(trade name)

Classification

Therapeutic: gastroinestinal anti inflammatories
Pharmacologic: corticosteroids
Pregnancy Category: C

Indications

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

Action

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.

Therapeutic effects

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

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
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Contraindications/Precautions

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)
  • agitation
  • confusion
  • dizziness
  • drowsiness
  • fatigue
  • ↑ appetite
  • insomnia
  • malaise
  • nervousness
  • vertigo

Ear, Eye, Nose, Throat

  • abnormal vision
  • conjunctivitis

Respiratory

  • bronchitis
  • dyspnea

Cardiovascular

  • edema
  • hypertension
  • palpitations
  • tachycardia

Gastrointestinal

  • nausea (most frequent)
  • abdominal pain
  • dyspepsia
  • flatulence
  • vomiting

Genitourinary

  • dysuria
  • irregular menses
  • nocturia
  • urinary frequency

Dermatologic

  • acne (most frequent)
  • easy bruising (most frequent)
  • hirsutism
  • alopecia
  • dermatitis
  • eczema
  • flushing
  • striae
  • sweating

Endocrinologic

  • adrenal suppression (life-threatening)
  • hypokalemia

Hematologic

  • leukocytosis

Metabolic

  • weight gain

Neurologic

  • hyperkinesia
  • paresthesia
  • tremor

Musculoskeletal

  • back pain
  • cramps
  • myalgia

Miscellaneous

  • infection (most frequent)
  • cushingoid appearance
  • flu-like syndrome

Interactions

Drug-Drug interaction

Known 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/Dosage

Treatment 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

Nursing implications

Nursing assessment

  • 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 Diagnoses

Diarrhea (Indications)

Implementation

  • 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.

Patient/Family Teaching

  • 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.

Evaluation/Desired Outcomes

  • Improvement in symptoms/sequelae of Crohn’s disease and ulcerative colitis (decreased frequency of liquid stools, decreased abdominal complaints, improved sense of well-being).

Uceris

(yo͞o-sĕr′ĭs)
A trademark for a preparation of the drug budesonide.
References in periodicals archive ?
Teva believes that, based on available information, it's the first applicant to file an ANDA for a Uceris generic.
UCERIS: On January 14, 2013, the FDA approved UCERIS for the induction of remission in patients with active, mild to moderate ulcerative colitis, and on February 14, 2013, Santarus announced the commercial launch of UCERIS.
Salix Pharmaceuticals, a company that provides products and medicines to treat gastroenterology problems, has received approval for UCERIS (budesonide) rectal foam from the US Food and Drug Administration, it was reported yesterday.
M2 PHARMA-October 9, 2014-Salix Pharmaceuticals wins US FDA's approval for UCERIS 2mg rectal foam for mild-to-moderate distal ulcerative colitis
In addition, Salix Pharmaceuticals, plc will acquire Cosmo s patents for rifamycin MMX in Canada, specified Latin American countries, India, China, Japan and the rest of the Far East, excluding Australia and New Zealand, and Cosmo s patents for Uceris in Japan.
Now, the company's product portfolio offers 22 marketed products, including XIFAXAN, UCERIS, GLUMETZA, APRISO, ZEGERID, MOVIPREP, RELISTOR, SOLESTA, FULYZAQ, CYCLOSET and DEFLUX.
We believe that UCERIS fills an important therapeutic gap as a new prescription option available to physicians treating patients in the active phase of mild to moderate ulcerative colitis," said Wendell Wierenga, Ph.
M2 EQUITYBITES-October 10, 2014-Salix Pharmaceuticals receives approval for UCERIS from FDA
M2 PHARMA-August 14, 2012-Santarus Inc's NDA for UCERIS awarded PDUFA target action date of 16 January 2013(C)2012 M2 COMMUNICATIONS
M2 EQUITYBITES-October 9, 2014-Salix Pharmaceuticals wins US FDA's approval for UCERIS 2mg rectal foam for mild-to-moderate distal ulcerative colitis
Santarus Inc (NASDAQ:SNTS) on Wednesday announced that the US Food and Drug Administration (FDA) has accepted for filing it's New Drug Application (NDA) for UCERIS (budesonide) tablets 9mg.
M2 PHARMA-February 13, 2012-Initiation of Phase IIIb study with UCERIS in patients with mild or moderate active ulcerative colitis announced by Santarus(C)2012 M2 COMMUNICATIONS