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Entereg (Alvimopan) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.

DOSAGE AND ADMINISTRATION

Usual Dosage in Adults

For hospital use only. The recommended adult dosage of ENTEREG is 12mg administered 30minutes to 5hours prior to surgery followed by 12mg twice daily beginning the day after surgery for a maximum of 7days or until discharge. Patients should not receive more than 15 doses of ENTEREG.

Special Populations

Geriatric Use: No dosage adjustment is necessary in elderly patients [see Use in Specific Populations].

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 and Clinical Pharmacology].

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 and Clinical Pharmacology].

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 and Clinical Pharmacology]

DOSAGE FORMS AND STRENGTHS

12 mg blue, hard gelatin capsules with "ADL2698" printed on both the body and the cap of the capsule.

HOW SUPPLIED/STORAGE AND HANDLING

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 11227-010-30) for hospital use only.

Store at 25C (77F); excursions permitted to 15-30C (59-86F) [see USP Controlled Room Temperature.]

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