Suboxone.com - Office-Based Treatment for Opioid Dependence

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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.

Seeking Information for myself or loved one

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Prescribing Information -- Site Map

Now Approved - SUBOXONE(R) (buprenorphine and naloxone) Sublingual Film CIII - Learn more about SUBOXONE Film

Support That Helps Patients Stay In Treatment

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Patient Stories

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Resources Just For You

Download informative tools on treating opioid dependence with SUBOXONE

Why Choose SUBOXONE?

Opioid dependence is a chronic disease that affects the brain, leaving patients vulnerable to relapse and at risk for misuse, diversion, and abuse. For these reasons, opioid dependence treatment requires the right medication; discourages against misuse, diversion, and abuse; and incorporates support systems that include counseling.

Reckitt Benckiser Pharmaceuticals Inc. supports patient-focused quality care and provides exclusive access to the Here to Help^® Program.

Patient-Focused Quality Care — Effective clinical practice models and resources
SUBOXONE — The preferred formulation for unsupervised dosing since 2003¹
Here to Help Program — The only opioid-dependence patient support program shown to increase medication adherence²

SUBOXONE plus Here to Help—including counseling—offers unmatched value to patients and physicians in achieving treatment success.

See why some of your peers prefer SUBOXONE and value Here to Help
See how patients can succeed with SUBOXONE and Here to Help

References

1.	SUBOXONE^® [package insert]. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006.
2.	Data on file, Reckitt Benckiser Pharmaceuticals Inc., Richmond, VA.

Important Safety Information

SUBOXONE^® (buprenorphine and naloxone) Sublingual Film (CIII) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

SUBOXONE Sublingual Film should not be used by patients hypersensitive to buprenorphine or naloxone.

SUBOXONE Sublingual Film can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

SUBOXONE Sublingual Film can cause serious life-threatening respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking SUBOXONE Sublingual Film. Dose reduction of CNS depressants, SUBOXONE Sublingual Film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take SUBOXONE Sublingual Film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use of SUBOXONE Sublingual Film in pregnant women or during breast-feeding should only be considered if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of SUBOXONE Sublingual Film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with SUBOXONE Sublingual Film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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.

For information about SUBOXONE Film, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) Sublingual Film (CIII)

For more about SUBOXONE Tablets, please see full US Product Information for SUBOXONE (buprenorphine and naloxone) sublingual tablets (CIII)

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