<div><p>Naltrexone kit, for intramuscular administration, consisting of: 95mg/mL naltrexone.</p><p>Indications:</p><p>VIVITROL is an opioid antagonist.  Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid-free at the time of initial VIVITROL administration. </p> <p>VIVITROL should be part of a comprehensive management program that includes psychosocial support. </p> <ul><li>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 (1.1). </li><li>VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification (1.2). </li></ul></div>