Understanding the stages of treatment

Your treatment, step by step.
(Knowing what to expect helps!)

The steps in medically-assisted treatment with buprenorphine for opioid dependence are:

Induction—Your treatment with a buprenorphine-only medication begins.* Induction is generally considered the first 2-3 days of your treatment.

Maintenance—During this phase, your doctor will prescribe SUBOXONE Film. The doctor sees you regularly to monitor progress, address any issues, and help you begin ongoing counseling.

Medical Taper—If you and your healthcare team determine the time is right, your doctor slowly tapers down your dose.

You should know: SUBOXONE Film is available in 2 strengths:

2 mg buprenorphine with 0.5 mg naloxone
8 mg buprenorphine with 2 mg naloxone

* SUBOXONE Film is not indicated for induction. A buprenorphine-only medication is used instead. After induction, ask your doctor for a prescription for SUBOXONE Film. SUBOXONE Film is indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and support.

Note: If you’re currently taking SUBOXONE^® (buprenorphine and naloxone) sublingual tablets (CIII), you will NOT need to repeat your induction to switch to SUBOXONE Film.

1. Induction

Treatment begins with Induction. Induction is generally considered the first 2-3 days of your treatment.* 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 successful induction on buprenorphine. (After your induction, ask your doctor for a prescription for SUBOXONE Film.)

You should know: Be sure to let your doctor know if you are pregnant or nursing. There are no adequate and well-controlled studies of SUBOXONE Film or buprenorphine/naloxone in pregnant women. SUBOXONE Film should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Buprenorphine, the main active ingredient in SUBOXONE Film, has been found in breast milk. Do not breastfeed your baby while taking SUBOXONE Film.

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.

2. Maintenance

During the Maintenance phase, while stabilizing and then maintaining your treatment, the doctor sees you regularly to monitor your progress, adjust your dose of medication if necessary, and address any issues that may affect treatment. In this step, the doctor also helps you begin ongoing counseling and support to learn how to minimize the risk of relapse by managing cravings and triggers.

If you are currently in treatment with SUBOXONE Tablet, ask your doctor about improving your treatment experience by transitioning to SUBOXONE Film.

You should know: Common side effects of SUBOXONE Film include numbness or abnormal redness of the mouth, sore tongue, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, difficulty sleeping, pain, and swelling of the feet or legs. To report suspected side effects of SUBOXONE Film use, contact Reckitt Benckiser Pharmaceuticals Inc. at 1-877-782-6966 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

3. Medical Taper

Length of treatment 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 Taper, your doctor will slowly taper down your dose of SUBOXONE Film, 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. If necessary, patients can restart maintenance treatment with SUBOXONE Film.

SUBOXONE^® and Here to Help^® are registered trademarks of Reckitt Benckiser Healthcare (UK) Ltd.
SUBOXONE Film is manufactured for Reckitt Benckiser Pharmaceuticals Inc.,
Richmond, VA 23235 by MonoSol Rx LLC, Warren, NJ 07059.
Copyright © 2011 Reckitt Benckiser Pharmaceuticals Inc.

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

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

SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets 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 and SUBOXONE Sublingual Tablets 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 or SUBOXONE Sublingual Tablets. Dose reduction of CNS depressants, SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets, 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 or SUBOXONE Sublingual Tablets can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep SUBOXONE Sublingual Film and SUBOXONE Sublingual Tablets out of the sight and reach of children.

Intravenous misuse or taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets 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 or SUBOXONE Sublingual Tablets 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 during clinical trials and postmarketing experience for SUBOXONE Sublingual Tablets are headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, and swelling of the limbs.

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 and SUBOXONE Sublingual Tablets. Please see full Product Information for a complete list.

To report an adverse event associated with taking SUBOXONE Sublingual Film or SUBOXONE Sublingual Tablets, 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.

Understanding the stages of treatment

1. Induction

2. Maintenance

3. Medical Taper

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