Important Safety Information (ISI)
SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.
It is extremely dangerous to take benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.
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.
Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking 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 and sight of children. 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%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list.
To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full US Prescribing Information for SUBOXONE.
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