Drug Interaction Report

CONTRAINDICATED: Recent exposure to opioids can increase the sensitivity to mu opioid receptor antagonists.

MANAGEMENT: The use of alvimopan is contraindicated in patients who have received therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan administration. Caution is advised in patients who have received more than 3 doses of an opioid within the week prior to surgery, as these patients were not studied in the postoperative ileus clinical trials. Patients with recent exposure to opioids should be monitored for increased adverse effects such as abdominal pain, nausea and vomiting, and diarrhea.

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

Coadministration with a high-fat meal may decrease the rate and extent of alvimopan absorption. According to the product labeling, alvimopan peak plasma concentration (Cmax) and systemic exposure (AUC) were decreased by approximately 38% and 21%, respectively, and the time to reach peak plasma concentration (Tmax) was prolonged by approximately 1 hour when taken with a high-fat meal. The clinical significance is unknown. In postoperative ileus clinical trials, the preoperative dose of alvimopan was administered in a fasting state, and subsequent doses were given without regard to meals.