Entereg Capsules

Indications
Dosage
How Supplied

INDICATIONS

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 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.

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]

HOW SUPPLIED

Dosage Forms And Strengths

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

ENTEREG Capsules (alvimopan capsules) , 12 mg, are blue, hard-gelatin capsules printed with “ADL2698” on both the body and the cap of the capsule. ENTEREG Capsules (alvimopan capsules) are available in unit-dose packs of 30 capsules (30 doses) (NDC 11227-010-30) for hospital use only.

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

Manufactured for Adolor Corporation Exton, PA 19341-1127. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709.

Last reviewed on RxList: 12/3/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.