Medically reviewed by Drugs.com. Last updated on May 25, 2020.
Applies to the following strengths: 12 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Gastrointestinal Surgery
FOR HOSPITAL USE ONLY:
Initial dose: 12 mg orally ONCE, administered 30 minutes to 5 hours prior to surgery
Maintenance dose: 12 mg orally 2 times a day, beginning the day after surgery
Maximum dose: Up to 15 doses
Duration of treatment: 7 days OR until discharge
-This drug is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior.
Use: To accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Frequent monitoring recommended.
End-stage renal disease (ESRD): Not recommended.
Liver Dose Adjustments
Mild to moderate liver dysfunction: Frequent monitoring recommended. Treatment should be discontinued if adverse reactions occur.
Severe liver dysfunction: Not recommended.
Japanese patients: Frequent gastrointestinal adverse event monitoring is recommended. Treatment should be discontinued if adverse reactions occur.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm
US BOXED WARNINGS:
POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY:
-There was a greater incidence of myocardial infarction (MI) in patients treated with this drug compared to those treated with placebo in a 12-month clinical trial, though a causal relationship has not established.
-In short-term trials with this drug, an increased risk of MI was not observed.
-This drug is only available through a restricted program for short-term use (15 doses) under a REMS due to the potential risk of MI with long-term use.
-Patients taking therapeutic opioid doses over 7 consecutive days prior to starting treatment
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Data not available
-Take without regard to meals.
-LIMITATION OF USE: For hospital use only.
-GASTROINTESTINAL: Signs/symptoms of adverse events
-Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: peripheral opioid receptor antagonists
Other brands: Entereg