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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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Opioid dependence is a complex condition, and you should expect to ask for advice and guidance many times along the way. Remember, when you ask for help, you take a step toward solving the problems you need to solve—and that can make you feel stronger and more in control.
There are always places to look for help. Try this approach:
Make a list of all of your positive options. Include people who may be able to help you, such as family members and friends, along with the kinds of help they might be able to provide. (Steer clear of friends who are actively using drugs.) Be sure to include the members of your treatment team, especially your doctor and counselor. You may also want to add community organizations and support groups. Order the list by putting those you think may be most effective first.
Think carefully about your options. List any issues that need to be resolved before an individual might be willing to help. Ask yourself who can help you now, and who might help you farther down the road, once you've demonstrated your commitment to treatment and shown some success. (Don't cross anyone off—just recognize that some people may take a little more time.)
Sometimes friends or family members may have been hurt by your past behavior. These people may feel that, by offering help, they could be helping you continue your dependence. They may also be resentful or angry, or even afraid of behavior they don't understand.
Don't give up on them. Chances are, these friends and family members may turn out to be your strongest sources of support—though some may want you to demonstrate your commitment to treatment first.
Don't expect it to happen overnight. Apologizing, if you think you've been out of line, can be a good place to start. Educating loved ones about opioid dependence may help them understand: they may not know how opioids can affect the brain and change a dependent person's behavior. Friends and family members also need to believe that you've made a commitment to treatment. If issues still stand in your way, keep looking for the help you need elsewhere—but stay positive, and keep in touch with these loved ones as you continue to make progress.
Don't wait for help—you should be able to rely on your doctor, your counselor, and any support groups you wish to join right away. If there are still issues to be resolved with family members and friends, be patient. Let them know that you've made a commitment to treatment, and would like their support. Be clear about your treatment goals, and the kinds of help you need. Remember, most people like to be needed, and are often quite willing to help—just as you would be willing to help them. When the time is right, ask.
You may not always find the help you need in the first place you look. The good news is, you can ask as many people, organizations, and groups as you like, until you find the help you need. Make a commitment to yourself that you'll keep asking.
Your doctor
Your counselor
Your Care Coach
Family members and friends
Self-help, 12-step, and support groups
People who've "been there"
Your community
Here to Help™
You can rely on your doctor not only for the help you need, but as a source of information to point you toward other places to find support. If you aren't in treatment yet, call 866-973-HERE (4373) and we'll help you set up an appointment with a doctor who is certified to treat opioid dependence in the privacy of his or her office.
Whether you're in one-on-one counseling or group therapy, your counselor can help you as you move through your treatment, as well as when you feel yourself close to relapse. Like your doctor, your counselor is also a source of information who can point you toward other places to find support. And, if you're in group therapy (also available online), you can ask the other members of your group for their ideas—and even their support.
Your Care Coach can provide you with information and support that can help you make better-informed decisions about your treatment, and also help you find clinical or medical professionals. (Your Care Coach is not a substitute for professional care like counseling or therapy. Your Care Coach will NOT be able to provide you with any clinical or medical advice; just support and information.) If you're already in treatment, join the Here to Help Program for exclusive access to a personal Care Coach ready to offer guidance and encouragement. Call 866-973-HERE (4373) and we'll connect you with your own personalized Care Coach.
Family members or friends you trust and know well can be excellent sources of support. Let them know how committed you are to making the changes you need to make—and be specific about the help you'd like. Let them know that you understand that support is a two-way street, and that you'll be there to help them when they need it, too. If you're out of touch, remember that renewing old contacts can be rewarding. Chances are, friends and loved ones will be glad to hear from you.
Based on the idea that people who suffer from a similar problem will understand one another and can help, 12-step programs, such as Narcotics Anonymous, bring people together to share experiences at regular meetings. People who are in recovery can help guide others out of addiction through a structured 12-step program. Many people have used 12-step programs to achieve drug-free lives. You should know, though, that peer support groups can vary in their acceptance of medication-assisted abstinence. For this reason, if you are considering going to a 12-step meeting, you may want to talk to your doctor first to find out if that group welcomes SUBOXONE patients.
Narcotics Anonymous: na.org (818-773-9999)
Alcoholics Anonymous: aa.org (212-870-3400)
Other support groups may be available through community services, faith-based organizations, and elsewhere. There are also reputable peer support groups available online. If you are participating in an online support group that is a chat room, your doctor may want to confirm that it is reputable—some chat rooms are better than others as far as the quality of information and advice offered. Seek out an online option that monitors the information that is being shared to ensure that nothing is misrepresented.
People who are further along in treatment are often eager to share the missteps they've made—and the secrets of their success. Self-help, 12-step, and support groups are good places to meet people who have gotten their opioid dependence under control and are working to get their lives back on track.
Community groups of all kinds, including religious and civic organizations, social services, and fraternal orders, can be good sources of help. Ask your doctor and counselor for advice, or call your local or state government to see what organizations are actively offering services and support in your area. Remember, part of your treatment is lifestyle change. Anything from volunteering to paint your church basement to helping out with a local event can help you get out of yourself, away from old habits, and involved.
If you and your doctor decide treatment with SUBOXONE is right for you, join the Here to Help Program and get support through every phase of your treatment—including exclusive access to a personal Care Coach, there to offer guidance and encouragement. You'll also get online tools, counseling options, and resources to help you stay motivated as you begin to get your life back on track.
One day soon you may be in a position to help others who are on the road to treatment success. It's a good feeling—and the act of helping someone else can help to make your own commitment to treatment stronger. Ask your doctor, counselor, group, or community organization how you can help.
