Entereg
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Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
History
There is currently no drug history available for this drug.
Other Information
ENTEREG Capsules contain alvimopan, a peripherally-acting µ-opioid receptor (PAM-OR) antagonist. Chemically, alvimopan is the single stereoisomer [[2(S)-[[4(R)-(3-hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]acetic acid dihydrate. It has the following structural formula:
Alvimopan is a white to light beige powder with a molecular weight of 460.6, and the empirical formula is C25H32N2O4•2H2O. It has a solubility of <0.1 mg/mL in water or buffered solutions between pH 3.0 and 9.0, 1 to 5 mg/mL in buffered solutions at pH 1.2, and 10 to 25 mg/mL in aqueous 0.1 N sodium hydroxide. At physiological pH, alvimopan is zwitterionic, a property that contributes to its low solubility.
ENTEREG Capsules for oral administration contain 12 mg of alvimopan on an anhydrous basis suspended in the inactive ingredient polyethylene glycol.
Sources
Entereg Manufacturers
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Adolor Corporation
![Entereg (Alvimopan) Capsule [Adolor Corporation]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Entereg | Adolor Corporation
2.1 Usual Dosage in AdultsFor hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery for a maximum of 7 days or until discharge. Patients should not receive more than 15 doses of ENTEREG.
2.2 Special PopulationsGeriatric Use: No dosage adjustment is necessary in elderly patients [see Use in Specific Populations (8.5)].
Hepatic Impairment: No dosage adjustment is necessary in patients with mild-to-moderate hepatic impairment (Child-Pugh Class A and B). ENTEREG is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Renal Impairment: No dosage adjustment is necessary in patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. ENTEREG is not recommended for use in patients with end-stage renal disease. [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
Race: No dosage adjustment is necessary in Black, Hispanic and Japanese patients, however, due to observed 2-fold greater ENTEREG plasma concentrations in healthy male Japanese subjects, Japanese patients should be monitored for possible adverse effects. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)]
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Cubist Pharmaceuticals, Inc.
Entereg | Merck Sharp & Dohme Corp.
For hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery until discharge for a maximum of 7 days. Patients should not receive more than 15 doses of ENTEREG.
![Entereg (Alvimopan) Capsule [Cubist Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=77a67dc6-35d3-48ff-9d18-292d4d442f70&name=entereg-04.jpg)
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