Applies to the following strength(s): 12 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Gastrointestinal Surgery
Accelerate the time to upper and lower gastrointestinal recovery following partial large or small resection surgery with primary anastomosis:
Initial dose: 12 mg orally once, administered 30 minutes to 5 hours prior to surgery
Maintenance dose: 12 mg orally twice daily beginning the day after surgery for a maximum of 7 days or until discharge
Maximum dose: Not to exceed 15 doses
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild-to-moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Not recommended
No dosage adjustment is necessary in Black, Hispanic and Japanese patients. However, the exposure of alvimopan in Japanese male healthy volunteers was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or "metabolite" levels, and alvimopan should be discontinued if adverse events occur.
Alvimopan is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan therapy.
Myocardial infarctions have been reported in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions were observed between 1 and 4 months after initiation of therapy. This imbalance has not been reported in other studies of alvimopan, including studies in patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been determined.
Patients recently exposed to opioids are expected to be more sensitive to the effects of mu-opioid receptor antagonists. Since alvimopan acts peripherally, clinical signs and symptoms of increased sensitivity would likely be limited to the gastrointestinal tract (e.g., abdominal pain, nausea, vomiting, and diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical studies; therefore, alvimopan 12 mg capsules should be administered with caution to these patients.
There is a potential for 10-fold higher plasma levels of drug in patients with severe hepatic impairment. There are no studies of alvimopan in patients with severe hepatic impairment undergoing bowel resection. Because of the limited data available, alvimopan therapy is not recommended for use in patients with severe hepatic impairment.
Since there were no studies conducted in patients with end-stage renal disease, alvimopan is not recommended for use in these patients.
Use of alvimopan in patients undergoing surgery for correction of complete bowel obstruction is not advised.
Safety and effectiveness in pediatric patients have not been determined.
Alvimopan is not recommended in patients with end-stage renal disease.
Alvimopan is available only for short-term (15 doses) administration in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the alvimopan Access Support and Education (E.A.S.E.) program may administer alvimopan. To enroll in the E.A.S.E. program, the hospital must acknowledge that: hospital staff who prescribe, dispense, or administer alvimopan have been provided the educational materials on the need to limit use of alvimopan to short-term, inpatient use; patients will not receive more than 15 doses of alvimopan; and alvimopan will not be dispensed to patients after they have been discharged from the hospital. The E.A.S.E. program may be contacted at 1-866-4 ADOLOR (1-866-423-6567).
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- Drug class: peripheral opioid receptor antagonists
Other brands: Entereg