Statement of Fair Balance
SUBOXONE(R) (buprenorphine/naloxone sublingual tablets) is indicated for the treatment of opioid dependence.
Buprenorphine, usually by the intravenous route, in combination with benzodiazepines or other CNS depressants has been associated with significant respiratory depression and death.
SUBOXONE has potential for abuse and produces dependence of the opioid type with a milder withdrawal syndrome than full agonists.
Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.
There are no adequate and well controlled studies of SUBOXONE (a Category C medication) in pregnancy.
Caution should be exercised when driving cars or operating machinery.
Always store buprenorphine containing medications safely and out of the reach of children and destroy any unused medication appropriately.
The most commonly reported adverse events with SUBOXONE include headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), nausea (15%, placebo 11%), insomnia (14%, placebo 16%), and sweating (14%, placebo 10%). Please see full prescribing information for a complete list.
Suboxone and Subutex are registered tr
|SOURCE Reckitt Benckiser Pharmaceuticals Inc.|
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