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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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Understanding the stages of treatment

Your treatment, step by step.

(Knowing what to expect helps!)

The steps in SUBOXONE® therapy are:

  1. Induction—Your treatment begins.
  2. Stabilization & Maintenance—The doctor sees the patient regularly to monitor progress, adjust the dose of medication if necessary, and address any issues that may affect treatment. In this step, the doctor also helps the patient begin ongoing psychosocial counseling and learn how to prevent relapse by managing cravings and triggers.
  3. Medical Withdrawal—If you and your healthcare team determine the time is right, your doctor slowly tapers down your dose.

1. Induction

Treatment begins with Induction. You will be asked to present yourself at the doctor's office in a moderate state of withdrawal. Being in this state is vital to having SUBOXONE or SUBUTEX work well.

The drug you have been misusing needs to be free from the receptors in your brain so that the medication can bind to them. Your doctor will give you your first dose of the medication, which can be adjusted if you are still not feeling well.

When you are ready to leave the office, the doctor may give you instructions and a prescription that will last until your next appointment. The doctor may also want to discuss counseling, since adding counseling to treatment with medication has been shown to bring better results.

What is SUBUTEX?
SUBUTEX contains buprenorphine but no naloxone, and is the preferred induction agent. SUBUTEX is also recommended for people who are sensitive to naloxone. SUBUTEX is not recommended for use during pregnancy. If, after an assessment of the risks and benefits to mother and fetus, the decision is made to continue buprenorphine-based treatment, SUBUTEX is the recommended treatment agent.

Please see Important Safety Information.

2. Stabilization & Maintenance

During the Stabilization & Maintenance phase, your doctor will work with you to regularly monitor your treatment progress, adjusting doses if necessary, and focusing on your progress in counseling, trigger management, and relapse prevention.

3. Medical Withdrawal

Length of therapy is up to your doctor, you, and sometimes your therapist or counselor. If you and your doctor agree that the time is right for Medical Withdrawal, your doctor will slowly taper down your dose of SUBOXONE, taking care to minimize withdrawal symptoms or cravings. If you feel at risk for relapse during a taper, you can be restabilized and continue maintenance for as long as needed. Some patients remain at Step 2, staying in the Stabilization & Maintenance phase. If necessary, patients can restart treatment with SUBOXONE.

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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.