Adolor Corporation

Adolor Corporation Drugs

• Entereg
  

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  Entereg

  

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  2.1 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.

  2.2 Special Populations

  Geriatric 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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