"The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.
Vivitrol is an extended-release formulation of naltrexone administ"...
- Patient Information:
Details with Side Effects
There is limited experience with overdose of VIVITROL (naltrexone xr inj) . Single doses up to 784 mg were administered to 5 healthy subjects. There were no serious or severe adverse events. The most common effects were injection site reactions, nausea, abdominal pain, somnolence, and dizziness. There were no significant increases in hepatic enzymes.
In the event of an overdose, appropriate supportive treatment should be initiated.
VIVITROL (naltrexone xr inj) is contraindicated in:
- Patients with acute hepatitis or liver failure [see WARNINGS AND PRECAUTIONS]
- Patients receiving opioid analgesics [see WARNINGS AND PRECAUTIONS].
- Patients with current physiologic opioid dependence [see WARNINGS AND PRECAUTIONS].
- Patients in acute opioid withdrawal [see WARNINGS AND PRECAUTIONS].
- Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids [see WARNINGS AND PRECAUTIONS].
- Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.
Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Vivitrol Information
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