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Important Safety Information
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.
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Some essential questions are answered below.
The goal of all treatments for opioid dependence is to enable individuals to manage their disease and gain control of their dependence. Each person's case is different, and the doctor who treats your dependence should work with you to create a treatment plan that is right for you.
According to the National Institute on Drug Abuse and the Center for Substance Abuse Treatment, substance dependence treatment is typically more effective when:
According to the National Institute on Drug Abuse and the Center for Substance Abuse Treatment, substance dependence treatment is typically less effective when:
Treatment of chronic diseases involves changing deeply imbedded behaviors, and relapse does not mean treatment failure. The chronic nature of the disease means that relapsing to drug use can occur. Relapse indicates the need for treatment to be reinstated or adjusted to a more intensive level of care until the person is again stable and drug-free.
Science has taught us that stress, cues linked to the drug experience (eg, people, places, things, mood), and exposure to drugs, are the most common triggers for relapse, so strategies need to be developed to help minimize or avoid these triggers. Counseling and group therapy or self-help groups are strongly recommended to help develop these strategies.
Counseling or psychosocial therapy can be very helpful to almost anyone who is dependent on opioids. There are many types of counseling, including private therapy with a psychologist or psychiatrist and group counseling sessions.
Yes. For many, 12-step programs can be beneficial. They are very popular and most are modeled on Alcoholics Anonymous®. The idea is that people who suffer from a similar problem understand and can help one another. By coming together to share experiences at regular meetings, people who are in recovery can try and help guide others out of addiction through a structured 12-step program. Many people have used 12-step programs to achieve drug-free lives.
Two helpful websites are Narcotics Anonymous at na.org
(818-773-9999) and Alcoholic Anonymous at aa.org.
Deciding whether to tell someone else about your disease and treatment is an individual decision. Sometimes, talking to other people can be helpful, since people who know about your treatment may be able to provide support when you need it. If you decide to tell someone about your efforts to gain control over your dependence, here are some tips: