Suboxone.com - Federal Legislation

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IMPORTANT INFORMATION:

On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid-dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

There may be doctors in your area participating in a study to measure opioid dependence treatment outcomes. Patients who meet the eligibility requirements to participate in this study can receive up to $225 in compensation to complete surveys about their treatment.

NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.

Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.

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Prescribing Information -- Site Map

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Important Information

On December 8, 2006, Congress passed H.R. 6344 to reauthorize the Office of National Drug Control Policy. This bill contains language that allows you to treat up to 100 patients—a significant increase from the previous limit of 30 patients. To treat additional patients, you must send a second notification of intent to the government. For complete second notification information, go to www.buprenorphine.samhsa.gov

What this means for Patients...
Click here to conduct a search for physicians in your area who are certified to treat opioid dependence with Suboxone

What this means for Physicians...
Click here for instructions [PDF–Size: 29KB] for more information about the change and how to apply to treat more than 30 patients

What this means for Pharmacists...
Click here for more information [PDF–Size: 29KB] about how the change may impact your pharmacy

For full prescribing information click here.

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SUBOXONE^®, SUBUTEX^®, and Here to Help^® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.

Important Safety Information

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

It is extremely dangerous to self-administer non-prescribed 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 sweating (14%, placebo 10%). 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 Prescribing Information