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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.

I have read and understood the Important Safety Information.

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Is it opioid dependence?

Take this quiz

Answer as honestly and accurately as you can. You can use your results to start a conversation about drug dependence with your doctor.

The quiz is strictly confidential. Your personal information will not be collected, saved, or shared with anyone under any circumstances.

Review our complete privacy policy.

These questions refer to the past 12 months:

1.
Have you used drugs other than those needed for medical reasons?
YesNo
2.
Do you misuse more than one drug at a time?
YesNo
3.
Are you always able to stop using drugs?
YesNo
4.
Have you ever had blackouts or flashbacks as a result of drug use?
YesNo
5.
Do you ever feel bad or guilty about your drug use?
YesNo
6.
Does your spouse (or your parents) ever complain about your involvement with drugs?
YesNo
7.
Have you neglected your family because of your use of drugs?
YesNo
8.
Have you engaged in illegal activities in order to obtain drugs?
YesNo
9.
Have you ever experienced withdrawal symptoms (felt sick) when you stopped taking drugs?
YesNo
10.
Have you had medical problems as a result of your drug use (such as memory loss, hepatitis, convulsions, bleeding)?
YesNo

Source: This quiz is adapted from the Drug Abuse Screening Test (DAST),1 a tool used by some physicians to assess possible substance abuse problems.

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Reference

  1. Skinner HA. The Drug Abuse Screening Test. Addictive Behavior. 1982;7:363-371.
SUBOXONE (buprenorphine HCl/naloxone HCl dihydrate) CIII sublingual tablets

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This site is sponsored by Reckitt Benckiser Pharmaceuticals Inc. and intended for residents of the United States.
SUBOXONE® and Here to Help® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
This site is provided for educational and informational purposes only and is not intended
as a substitute for direct consultation with a qualified mental health professional.
Patient quotes are hypothetical.
© 2009 Reckitt Benckiser Pharmaceuticals Inc.

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.