Source: FDA, National Drug Code (US) Revision Year: 2020
ENTEREG capsules contain alvimopan, an opioid 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.
| Dosage Forms and Strengths |
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12 mg blue, hard-gelatin capsules with “ADL2698” printed on both the body and the cap of the capsule. |
| How Supplied |
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ENTEREG capsules, 12 mg, are blue, hard-gelatin capsules printed with “ADL2698” on both the body and the cap of the capsule. ENTEREG capsules are available in unit-dose packs of 30 capsules (30 doses) (NDC 67919-020-10) for hospital use only. |
| Drug | Countries | |
|---|---|---|
| ENTEREG | United States |
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