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