Colorectal disorders:
Indications for: VIBERZI
Treatment of irritable bowel syndrome with diarrhea (IBS-D).
Adult Dosage:
Take with food. 100mg twice daily. Patients with mild or moderate hepatic impairment, moderate or severe renal impairment, ESRD (not on dialysis), receiving concomitant OATP1B1 inhibitors (see Interactions), or unable to tolerate 100mg dose: 75mg twice daily.
Children Dosage:
Not established.
VIBERZI Contraindications:
Without a gallbladder. Biliary duct obstruction. Sphincter of Oddi disease or dysfunction. Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks/day. History of pancreatitis or structural disease of the pancreas (including pancreatic duct obstruction). Severe hepatic impairment. History of chronic or severe constipation or sequelae from constipation. Mechanical GI obstruction.
VIBERZI Warnings/Precautions:
Discontinue if severe constipation develops. Increased risk of sphincter of Oddi spasm and pancreatitis; monitor for new or worsening abdominal pain (eg, acute epigastric or biliary), with or without nausea/vomiting, or associated with liver or pancreatic enzyme elevations; discontinue and treat if symptoms occur; do not restart if biliary duct obstruction or sphincter of Oddi spasm develops. Assess alcohol intake prior to initiation. Mild or moderate hepatic impairment, moderate or severe renal impairment, ESRD (not on dialysis): see Adult dose. Pregnancy. Nursing mothers.
VIBERZI Classification:
Mu-opioid receptor agonist.
VIBERZI Interactions:
Avoid excessive alcohol. Potentiated by OATP1B1 inhibitors (eg, cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, saquinavir, tipranavir, rifampin, eltrombopag). May be potentiated by strong CYP inhibitors (eg, ciprofloxacin, gemfibrozil, fluconazole, clarithromycin, paroxetine, bupropion); monitor. Increased risk for constipation with alosetron, anticholinergics, opioids; avoid. May potentiate OATP1B1 and BCRP substrates (eg, rosuvastatin: use lowest effective dose of rosuvastatin) or CYP3A substrates with narrow therapeutic index (eg, alfentanil, cyclosporine, ergots, fentanyl, pimozide, quinidine, sirolimus, tacrolimus); monitor.
Adverse Reactions:
Constipation, nausea, abdominal pain; sphincter of Oddi spasm, pancreatitis, hypersensitivity reactions (discontinue if occur).
Drug Elimination:
Fecal (major), renal. Half-life: 3.7–6 hours.
Generic Drug Availability:
NO
How Supplied:
Tabs—60
