Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2040
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VIVITROL (Kit)
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| dailymed-instance:boxedWarn... |
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.
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| dailymed-instance:genericMe... |
naltrexone
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| dailymed-instance:fullName |
VIVITROL (Kit)
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| dailymed-instance:adverseRe... |
In all controlled and uncontrolled trials during the premarketing development of VIVITROL, more than 900 patients with alcohol and/or opioid dependence have been treated with VIVITROL. Approximately 400 patients have been treated for 6 months or more, and 230 for 1 year or longer.<br/>Adverse Events Leading to Discontinuation of Treatment: In controlled trials of 6 months or less, 9% of patients treated with VIVITROL discontinued treatment due to an adverse event, as compared to 7% of the patients treated with placebo. Adverse events in the VIVITROL 380-mg group that led to more dropouts were injection site reactions (3%), nausea (2%), pregnancy (1%), headache (1%), and suicide-related events (0.3%). In the placebo group, 1% of patients withdrew due to injection site reactions, and 0% of patients withdrew due to the other adverse events.<br/>Common Adverse Events: The table lists all adverse events, regardless of causality, occurring in���5% of patients with alcohol dependence, for which the incidence was greater in the combined VIVITROL group than in the placebo group. A majority of patients treated with VIVITROL in clinical studies had adverse events with a maximum intensity of���mild���or���moderate.���<br/>Post-marketing Reports:
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VIVITROL
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