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.
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If your first thought is that you can go it alone, consider this: opioid cravings can occur months and even years after your last use. Their suddenness and intensity can put even the most committed people at risk for relapse.
When prescription medication is combined with counseling, the likelihood of success is increased. That's because opioid dependence is more than a physical condition. Emotions and behavior are also part of the picture—and that's where counseling can help. While SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) helps you decrease physical cravings associated with the disease to avoid illicit opioid use, counseling can help you begin to make changes in your behavior and lifestyle that will make it easier to focus on your treatment goals.
In counseling—also known as "talk therapy"—you can learn how to recognize events that can trigger the use of opioids. You can also learn practical ways to cope with events, circumstances, or social situations that you associate with your past drug use.
Getting involved in counseling is easy. Here's how it works:
Decide what kind of counseling would work best for you.
Support groups can also make a great addition to therapy with a trained professional. Many people find self-help 12-step programs with a group of peers to be especially helpful.
When Jennifer R. started treatment, she said: "Okay, I'm just going to take the pill and not have to do anything else." She soon found that didn't work. "I still needed to go to meetings," she admits, "the medication was helping me, but it couldn't fix everything."
John F. saw a therapist every two weeks and a psychiatrist every month. He said SUBOXONE helped him discontinue illicit opioid use and remain in therapy. He was able to "learn about the underlying causes of the disease and understand them."
Michael G. admitted he needed to be responsible for changing his situation. "I've got to do that myself, and that's where psychosocial counseling comes in."
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.
