Indications
Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. ( 1 )
Contraindications
Alvimopan capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan capsules [see Warnings and Precautions ( 5.3 )] . Patients who have taken therapeutic doses of opioids for more than 7 consecutive days prior to taking alvimopan capsules. ( 4 )
Warnings and precautions
- Myocardial Infarction : A higher number of myocardial infarctions was reported in patients treated with alvimopan 0.5 mg twice daily compared with placebo in a 12-month study in patients treated with opioids for chronic non-cancer pain, although a causal relationship with long-term use has not been established. ( 5.1 )
- Gastrointestinal Adverse Reactions in Opioid Tolerant Patients : Patients recently exposed to opioids may be more sensitive to the effects of alvimopan and experience gastrointestinal adverse reactions (e.g., abdominal pain, nausea and vomiting, and diarrhea). ( 5.3 )
- Patients with Severe Hepatic Impairment : Increased risk of serious adverse reactions due to higher plasma concentrations; use is not recommended. ( 5.4 , 8.6 )
- Patients with End-Stage Renal Disease : No studies have been conducted; use is not recommended. ( 5.5 , 8.7 )
- Patients with Complete Gastrointestinal Obstruction : No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction; use is not recommended. ( 5.6 )
- Patients with Pancreatic and Gastric Anastomoses : No studies have been conducted; use is not recommended. ( 5.7 )