Naltrexone is used treat dependence on opiate drugs (narcotics) or alcohol. ReVia blocks the "high" that these substances produce. Unrelieved itching in primary biliary cirrhosis may be indicating the need for liver transplantation. In primary biliary cirrhosis, opiate antagonists such as naltrexone are considered by doctors to be a last-line effort to control itching before liver transplantation. Side effects associated with the drug include anxiety, difficulty sleeping, dizziness, headache, increased tiredness, nausea, nervousness, and vomiting.
Researchers in The Netherlands evaluated the use of naltrexone in a clinical trial in 16 patients with primary biliary cirrhosis. Patients with itching and primary biliary cirrhosis were randomly selected to receive a four-week course of naltrexone daily or placebo. Researchers then evaluated the patients' fatigue, quality of life, side effects of treatment, and liver function every two weeks. Results from this study showed that changes from the start of the study were significantly different and favored the naltrexone-treated group for daytime itching and nighttime itching. In four patients treated with ReVia, side effects consistent with an opiate withdrawal syndrome were noted. Researchers concluded that oral naltrexone may be an effective and well-tolerated alternative drug for the itching associated with primary biliary cirrhosis.
ORIGINAL USES (ON-LABEL)
To reverse the effects of opiates, to treat alcohol dependence.
NEWLY DISCOVERED USES (OFF-LABEL)
Binge eating disorder, pathological gambling, primary biliary cirrhosis, pruritus, smoking cessation.
POTENTIAL SIDE EFFECTS
Nausea, headache, dizziness, nervousness, fatigue, insomnia, vomiting, anxiety, drowsiness, depression, suicidal ideation, irritability, increased energy, rash, abdominal cramps, anorexia, diarrhea, constipation, delayed ejaculation, muscle/joint pain, nasal congestion, vision changes, chills, increased thirst.
- Not for use in patients with a narcotic dependence, current use of opioid analgesics, acute opioid withdrawal, failure to pass naloxone challenge, acute or chronic liver failure.
- Use may result in liver toxicity. Discuss these risks with your doctor.
- Must be opioid free for 7–10 days prior to administration as determined by urine analysis.
- Risk of suicide may continue to be increased even with this therapy.
Thioridazine, opioid-containing products
PREGNANCY AND BREAST-FEEDING CAUTIONS
FDA Pregnancy Risk Category C. Excretion in breast milk unknown. Not recommended for use while breast-feeding.
This drug has a black box warning describing the risk of liver injury with high doses. You should wear an identification bracelet indicating that you are using this drug.
REVIA AND PATHOLOGICAL GAMBLING
Naltrexone therapy is often combined with counseling and support groups. It is generally used after an initial detoxification period. If ReVia is used while a person is still taking opiate drugs, withdrawal symptoms may occur.
Support for the use of naltrexone for pathological gambling stems from evidence of its efficacy in the treatment of alcoholism, bulimia, drug abuse, borderline personality disorder, and other psychiatric disorders in which urges are the main symptom. Since one of the primary symptoms of pathological gambling is an uncontrolled urge triggered by potential reward, researchers at the University of Minnesota Medical School in Minneapolis evaluated ReVia for the treatment of this addictive disorder. In this study, 83 subjects with pathological gambling disorders were enrolled in a 12-week study. Patients received placebo or naltrexone. Researchers evaluated data from 45 subjects in this study and found that significant improvement was seen in all gambling symptom measures. At the end of the study, 75% of subjects treated with ReVia were "much" or "very much improved" compared with 24% of subjects who received placebo. Nausea was the most common side effect seen during the first week of the study in the naltrexone group. Based on these findings, researchers concluded that naltrexone is effective in reducing symptoms of pathological gambling.
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