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Entereg Generic Name & Formulations
Legal Class
Rx
General Description
Alvimopan 12mg; hard-gelatin caps.
Pharmacological Class
Opioid antagonist (peripheral).
How Supplied
Caps—30
Manufacturer
Entereg Indications
Indications
To accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection surgery with primary anastomosis.
Entereg Dosage and Administration
Adult
Give 12mg 30mins to 5hrs before surgery, then 12mg twice daily starting on 1st post-op day until hospital discharge for up to 7 days; max 15 doses.
Children
Not established.
Entereg Contraindications
Contraindications
Opioid use, at therapeutic doses, for >7 consecutive days prior.
Entereg Boxed Warnings
Boxed Warning
Potential risk of MI with long-term use: for short-term hospital use only.
Entereg Warnings/Precautions
Warnings/Precautions
For short-term hospital use only. Potential risk of MI with long-term use. Severe hepatic impairment, ESRD, complete GI obstruction, pancreatic or gastric anastomosis: not recommended. Mild to severe renal impairment or mild to moderate hepatic impairment: monitor closely; discontinue if adverse reactions occur. Recent (within week prior to surgery) use of >3 doses of opioids; monitor for GI events. Japanese patients (monitor). Pregnancy. Nursing mothers.
REMS
Entereg Pharmacokinetics
See Literature
Entereg Interactions
Not Applicable
Entereg Adverse Reactions
Adverse Reactions
Dyspepsia.
Entereg Clinical Trials
See Literature
Entereg Note
Notes
Available only to hospitals that enroll in the Alvimopan REMS Program. For more information, and to enroll, call (800) 278-0340.
Entereg Patient Counseling
See Literature
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