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DRUG INTERACTIONS Drug-Drug Interactions
Clinical drug interaction studies with VIVITROL have not been performed.
Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics (see PRECAUTIONS ).
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OVERDOSAGE:
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.
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CONTRAINDICATIONS:
VIVITROL is contraindicated in:
- Patients receiving opioid analgesics (see PRECAUTIONS ).
- Patients with current physiologic opioid dependence (see WARNINGS ).
- Patients in acute opiate withdrawal (see WARNINGS ).
- Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids.
- Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.
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Pregnancy, Puerperium, and Perinatal Conditions – abortion missed
Hepatobiliary Disorders – cholelithiasis, aspartate aminotransferase increased, alanine aminotransferase increased, cholecystitis acute
DRUG ABUSE AND DEPENDENCE :
Controlled Substance Class
VIVITROL is not a controlled substance.
Physical and Psychological Dependence
Naltrexone, the active ingredient in VIVITROL, is a pure opioid antagonist that does not lead to physical or psychological dependence. Tolerance to the opioid antagonist effect is not known to occur.
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