"An intranasal form of naloxone hydrochloride (Narcan, Adapt Pharma, Inc), a drug that stops or reverses opioid overdose, has been approved by the US Food and Drug Administration (FDA) under a fast-track approval process.
There is limited experience with overdose of VIVITROL. 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 is contraindicated in:
- 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 [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 12/22/2015
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