Pharmaceutical

Category profile

SUBOXONE is the first opioid medication approved under DATA 2000 for the treatment of opioid dependence in an office-based setting. SUBOXONE also can be dispensed for take-home use, just as any other medicine for other medical conditions.

The primary active ingredient in SUBOXONE is buprenorphine. Because buprenorphine is a partial opioid agonist, its opioid effects are limited compared with those produced by full opioid agonists, such as oxycodone or heroin. SUBOXONE also contains naloxone, an opioid antagonist.

The naloxone in SUBOXONE is there to discourage people from dissolving the tablet and injecting it. When SUBOXONE is placed under the tongue, as directed, very little naloxone reaches the bloodstream, so what the patient feels are the effects of the buprenorphine. However, if naloxone is injected, it can cause a person dependent on a full opioid agonist to quickly go into withdrawal.

SUBOXONE at the appropriate dose may be used to:

• Reduce illicit opioid use
• Help patients stay in treatment

by

• Suppressing symptoms of opioid withdrawal
• Decreasing cravings for opioids

More information about understanding opioid dependence can be found on the following websites:

www.suboxone.com
www.turntohelp.com

Click on the links below to view further information:

Important Safety Information | Risk Management | Media Enquiries

Important Safety Information

SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate CIII sublingual tablets) is indicated for the treatment of opioid dependence.

Buprenorphine, usually by the intravenous route, in combination with benzodiazepines or other CNS depressants (including alcohol) 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 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

To report an adverse event caused by taking SUBOXONE, please call
1-877-782-6966 or e-mail pharmacovigilanceUS@rb.com.

Risk management

Reckitt Benckiser Pharmaceuticals Inc. is committed to optimizing standards of patient care and minimizing risks of diversion and abuse through programs of education and intervention that we believe represent a benchmark for the pharmaceutical industry in the therapeutic area of addiction treatment. Our Risk Management Program includes educational efforts that emphasize the safe and effective use of buprenorphine and are directed toward physicians, pharmacists, counselors, and patients and their families. All educational materials developed by Reckitt Benckiser Pharmaceuticals Inc. focus on reinforcing the matrix of care model to provide patients and their treatment providers with information that supports best medical practices. Our comprehensive educational endeavors are intended to educate healthcare providers and patients on the proper use as well as the risks associated with Suboxone and Subutex sublingual tablets.

The risk management program includes the following components:

• FDA approved labeling including educational brochures for patients, pharmacists, and physicians
• Education and training of our Clinical Liaisons
• Monitoring and control of drug distributions
• Educational materials for physicians, pharmacists, counselors, and patients
• Field Medical Advisors to monitor and advise practicing clinicians and Clinical Liaisons on best practices and ways to minimize abuse and misuse of Suboxone and Subutex
• Active surveillance and intervention program to detect and deter misuse, abuse and diversion of Suboxone and Subutex
• Data collection and analysis of reported adverse events

Media enquiries

For media enquiries relating to Suboxone click here