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Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

GI: constipation, liver enzymes, abdominal distention, abdominal pain, fecal impaction, flatulence, GI OBSTRUCTION/PERFORATION, nausea, PANCREATITIS, sphincter of Oddi spasm, vomiting

Neuro: dizziness, fatigue

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions

Drug-drug:

Availability

  • Tablets: 75 mg; 100 mg

Route/Dosage

  • PO (Adults ): 100 mg twice daily; Patients who lack a gallbladder, are unable to tolerate 100 mg twice daily or are taking concurrent OATP1B1 inhibitors: 75 mg twice daily.

Hepatic Impairment

  • PO (Adults ): Mild or moderate hepatic impairment: 75 mg twice daily.

Renal Impairment

  • PO (Adults ): eGFR <60 mL/min/1.73 m2 and not on dialysis: 75 mg twice daily.

US Brand Names

Viberzi

Action

  • Acts as a agonist at mu-opioid receptors in the GI tract.
Therapeutic effects:
  • frequency and severity of abdominal pain/diarrhea associated with IBS-d.

Classifications

Therapeutic Classification: anti irritable bowel syndrome agents, mu-opioid receptor agonists

Pharmacokinetics

Absorption: Some systemic absorption follows oral administration (bioavailability unknown).

Distribution: Unknown.

Metabolism/Excretion: Mostly metabolized by the liver; <1% excreted in urine.

Half-Life: 3.7–6 hr

Contr. Subst. Schedule

Schedule IV (C-IV)

Time/Action Profile

(effect on GI tract)

ROUTEONSETPEAKDURATION
POunknownunknown12 hr

Patient/Family Teaching

  • Instruct patient to take eluxadoline as directed. If a dose is missed, omit and take next dose as scheduled; do not double doses.
  • Advise patient that eluxadoline is a drug with known abuse potential. Protect it from theft, and never give to anyone other than the individual for whom it was prescribed.
  • Advise patient to stop eluxadoline and notify health care professional if abdominal pain (acute epigastric or biliary [right upper quadrant] pain, may radiate to back or shoulder with or without nausea and vomiting), signs and symptoms of hypersensitivity reaction (swelling of face, lips, mouth or tongue; shortness of breath; wheezing; itching; rash; hives), or severe constipation occur.
  • Caution patient to avoid more that 3 alcoholic drinks/day.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially other medications causing constipation.
  • Rep: Advise female patient to notify health care professional of pregnancy is planned or suspected or if breastfeeding.

Pronunciation

el-ux-AD-oh-leen

Code

NDC Code