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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.
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An experienced doctor who is certified to treat opioid dependence will understand what you're going through. You might begin the conversation by telling your doctor how you've been feeling lately. Explain that you're concerned about your use of opioids and think you may have become dependent.
It's important that you are open and honest so your doctor can give you the best care. Be specific. Tell your doctor:
Create a list of questions to ask the doctor, and bring them along so you don't forget anything. You might be wondering:
In order to understand the exact nature of your medical condition and recommend the best treatment, your doctor will have questions. Here are some you might hear:
Feel free to speak frankly and honestly. Remember, what you tell your doctor is private and will not be shared without your explicit permission.
Remember, opioid dependence is a serious, long-term medical condition that needs care as much as any other chronic disease. That's why talking with your doctor is so important.
Still looking for the right doctor? Let us help you make your first appointment with a doctor certified to treat opioid dependence in the privacy of his or her office: call 866-973-HERE (4373).