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VIVITROL (naltrexone for extended-release injectable suspension) VIVITROL: A Treatment Option For The Daily Struggle Against Alcohol Dependence. One dose all month long.
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National Clearinghouse for Alcohol and Drug Informatio logo National Clearinghouse for Alcohol and Drug Information (NCADI)/Substance Abuse and Mental Health Services Administration (SAMHSA)
www.ncadi.samhsa.gov
The US Department of Health and Human Services has created the NCADI to collect and organize information for schools, institutions, libraries, and the public. The vision of SAMHSA is to "build resilience and facilitate recovery for those with or at risk of substance abuse or mental illness."

National Institute on Alcohol Abuse and Alcoholism logo National Institute on Alcohol Abuse and Alcoholism (NIAAA)
www.niaaa.nih.gov
The NIAAA is the arm of the National Institutes of Health that focuses on supporting scientific research into the many aspects of alcoholism and its treatment.

 
Important Safety Information
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.