About SUBOXONE

A number of clinical trials have established that, at appropriate doses, SUBOXONE can help patients stay in treatment and reduce the use of other opioids by:

• suppressing withdrawal symptoms
• reducing cravings

SUBOXONE and SUBUTEX were the first opioid medications approved under the Drug Addiction Act of 2000 [DATA 2000] for the treatment of opioid dependence in a private office setting.

The primary active ingredient in both SUBOXONE and SUBUTEX is buprenorphine. SUBOXONE also contains naloxone.

In order to have an effect, opioids must first attach to opioid receptors in the central nervous system. When a full opioid agonist, such as oxycodone, hydrocodone, morphine, methadone, or heroin, binds to those receptors, it produces the full opioid effect, including feelings of euphoria, or being "high." It also causes painful withdrawal symptoms once the opioid has left the receptors.

Buprenorphine—the active ingredient in SUBOXONE—works by binding strongly to those same opioid receptors. But, because buprenorphine is a partial opioid agonist, it produces less of a maximal effect than a full opioid agonist would.

Naloxone is added to discourage misuse. If SUBOXONE is crushed and then injected or snorted, the naloxone can cause withdrawal symptoms in a person dependent on full opioid agonists. If SUBOXONE is taken as directed, the naloxone will not have this effect.

SUBOXONE binds strongly to opioid receptors and blocks the binding of other opioids. When taken as prescribed, SUBOXONE can also suppress withdrawal symptoms and reduce cravings. This can help people remain in treatment and reduces or stops the misuse of other opioids.

You need to see a doctor who has been certified to prescribe SUBOXONE.

Doctors need to be certified to prescribe SUBOXONE. Doctors who are already specialists in addiction medicine or who complete specific training can become certified to treat opioid dependence with SUBOXONE in their offices. Ask your doctor if he or she is certified. If not, you may also be able to find a doctor who can treat you with SUBOXONE by calling your local hospital or mental health center and asking whether they have any doctors certified to prescribe SUBOXONE for treatment of opioid dependence. Call 866-973-HERE (4373) to find a certified doctor near you. You can also find a doctor here.

SUBUTEX contains only buprenorphine, without naloxone, and may be used to start people on treatment for opioid dependence. It works the same way as SUBOXONE, but because it does not have naloxone to minimize the misuse of buprenorphine, it is not recommended for take-home use except for patients who cannot tolerate naloxone.

It depends on which was taken first. If someone who is taking SUBOXONE as prescribed takes another opioid, then according to dose, the buprenorphine in the SUBOXONE will help block the effect of the other opioid.

If someone who is actively using other opioids takes SUBOXONE, the SUBOXONE may cause sudden and severe ("precipitated") withdrawal (more information under Induction below).

Respiratory depression and deaths have been reported when buprenorphine has been administered with benzodiazepines and with other central nervous system depressants such as alcohol or other opioids.

It is important to communicate openly and honestly with your entire healthcare team (your doctor, nurse, and counselor) to optimize the success of your treatment for opioid dependence. They have been trained to understand opioid dependence and how to best treat this medical condition.

Be specific about when you started using opioids, what you took, how much you took, and how often you took it. If you obtained prescriptions from several doctors, let your doctor know so that your care is coordinated and understood. If you changed the tablets to take them in a way that is different than intended, also let your doctor know.

If you have been using heroin as well as prescription pain medicine, or if you are also using any other illegal drugs, let your doctor know. All the chemicals put into your body will affect what treatment your doctor feels is best for you. SUBOXONE is meant only for opioid dependence; other types of substance use should not be treated with SUBOXONE, and may require alternate therapy.

Treatment begins with Induction. The goal of induction is to switch you from your current opioid (heroin, methadone, or a prescription pain medicine) as rapidly as possible to an adequate dose of SUBOXONE. You MUST arrive for your induction already experiencing at least moderate opioid withdrawal symptoms. Being in this state is vital to having SUBOXONE or SUBUTEX work well.

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, usually within the next few days. The doctor may also want to discuss counseling, since adding counseling to treatment with medication has been shown to bring better results.

This point cannot be emphasized enough. If you take SUBOXONE before you are in withdrawal, the buprenorphine may make you feel worse because it can cause withdrawal symptoms. If you have high levels of another opioid in your system, SUBOXONE will compete with the other opioid molecules and knock them off the receptors. SUBOXONE then replaces those opioid molecules on the receptors, but because SUBOXONE has less maximal opioid effects than full opioid agonists, you may go into withdrawal and feel sick. This is called precipitated withdrawal.

However, by being in at least the first stages of withdrawal when you take your first dose, SUBOXONE should make you feel better, not worse. It is at this point, that the opioids from prescription pain medication or heroin have begun to leave the brain's opioid receptors. As the opioids come off the receptors, buprenorphine moves onto and sticks to them. The withdrawal symptoms diminish as the receptors fill up with buprenorphine.

It is really important that you tell your physician about the last time you used an opioid (along with any other medication), what it was, and how much you had, so that he or she can make the best determination about the timing of your first dose.

At the time of induction, patients can begin to feel some relief within 20 minutes of the first dose, although the full effects take about an hour and a half (100 minutes), at which point your symptoms should be reassessed. Depending on the extent to which the first SUBOXONE dose suppressed your symptoms, your doctor may decide to give you additional doses.

Urine drug screening while patients are on SUBOXONE is considered good medical practice. Urine drug screening has been identified by the National Institute on Drug Abuse as one of the factors that helps patients be successful in treatment. Patients whose SUBOXONE dose may be too low sometimes are tempted to use other drugs to try to suppress any withdrawal symptoms and cravings; doctors look for this when evaluating whether a patient is at the right dose. The use of urine drug screens may help patients and doctors develop a strong and honest rapport, and give objective "proof" of how well the overall treatment plan is working.

During the Stabilization & Maintenance phase, your doctor will work with you to regularly monitor your treatment progress, adjusting doses if necessary, and focusing on your progress in counseling, trigger management, and relapse prevention.

Length of therapy 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 Withdrawal, your doctor will slowly taper down your dose of SUBOXONE, 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 you and your doctor decided it is needed. Some patients remain in the Stabilization & Maintenance phase.

If necessary, patients can restart treatment with SUBOXONE.

• Always take it exactly as prescribed by the physician
• It is a good idea to drink some water before to moisten your mouth
• If the dose is 1 tablet, place it under the tongue. Lean head slightly forward and let the tablet dissolve
• If the dose is 2 tablets, place both of them under your tongue, one on the right and one on the left (use a mirror to make sure they are in the right place). Lean head slightly forward and let tablets dissolve
• If you have more than 2 tablets to take, put the next tablet(s) under your tongue after the first tablets have dissolved completely
• It takes about 5-10 minutes, but sometimes more, to dissolve the tablets completely. Don't chew or swallow the tablets, because less SUBOXONE will be absorbed in the bloodstream, it will not work as well, and withdrawal symptoms could get worse
• Follow the same manner of dosing each time you use the product to ensure consistency in drug absorption
• You may want to do something that doesn't involve talking, like reading a book or watching television, while waiting for the tablets to dissolve
• Let family and friends know that you won't be able to answer them or talk on the phone

It is important to take SUBOXONE exactly as prescribed by your doctor. Taking more than prescribed is especially dangerous when taken in combination with benzodiazepines or other central nervous system depressants. Patients who feel that they need a higher dose than prescribed should talk with their doctor about their concern, and any dosing adjustments should be made with a doctor's guidance.

The goals of medication-assisted treatment with SUBOXONE are to help you remain in treatment and reduce the use of other opioids so that you can engage in comprehensive treatment that includes counseling and other services that address your medical and psychosocial needs. It is important to have frequent communication with your physician about any withdrawal symptoms or cravings you experience so that together you can determine whether you will benefit from a change in your dose or whether additional psychosocial services, such as counseling, will benefit you.

There is no clinical evidence indicating the best time of day to take SUBOXONE; however, it is recommended to take the prescribed dose at the same time every day.

Stopping SUBOXONE abruptly can cause withdrawal symptoms, so when you and your doctor decide you are ready, your doctor will gradually taper your SUBOXONE dose. At that time, you may still have withdrawal symptoms or signs of relapse. When you have completely discontinued SUBOXONE treatment, carefully discard any leftover tablets to ensure that they aren't used by anyone else.

Call your doctor and make an appointment right away. Call your counselor. Call a friend. Call your Here to Help Care Coach at 866-973-HERE (4373). Do whatever it takes to get yourself back in treatment.

The length of your SUBOXONE treatment depends on what your doctor, you, and, possibly, your counselor or therapist decide is best for your needs.

The role of SUBOXONE is to help you stay in treatment and reduce illicit opioid use. It's important to remember that opioid dependence is considered a chronic illness, just like asthma or heart disease. The decision to be on medication-assisted treatment is often based on whether someone's symptoms (in this case, cravings and compulsive drug use) are likely to return if the medication is stopped, as well as whether the person in treatment is likely to resume misusing opioids.

Although short-term treatment may be an effective option for some, for others it may not allow enough time to address the psychological and behavioral aspects of their condition, or to reduce illicit opioid use. The chance of relapsing can be higher with short-term treatment. In general, suppressing cravings for other opioids with SUBOXONE (for as long as necessary), together with counseling and behavioral modification, offers the best likelihood for treatment success.

SUBOXONE can be dangerous to mix with drugs like benzodiazepines, alcohol, sleep aids and other tranquilizers, certain antidepressants, or other opioid medications, especially when not under the care of a doctor or in doses different from those prescribed by your doctor. Mixing these drugs can lead to drowsiness, sedation, unconsciousness, and death, especially if injected. It is important to let your doctor know about all medications and substances you are taking.

You may experience headaches, withdrawal syndrome, pain, insomnia, nausea, and constipation. You may already be experiencing some of these side effects because of your current use of opioids. If so, let your doctor know. Your doctor can effectively treat many of these symptoms.

SUBOXONE can cause blood pressure to drop, and dizziness if you get up too fast from sitting or lying down. Your doctor will determine if you need to stop taking SUBOXONE because of these side effects.

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.

Do not take SUBOXONE if you are allergic to buprenorphine or naloxone.

SUBOXONE may cause drowsiness. Caution should be exercised when driving cars or operating machinery.

See full Product Information.

Contact your doctor if:

• You feel faint, dizzy, confused, or have any other unusual symptoms, or if your breathing becomes much slower than normal. These can be signs of taking too much SUBOXONE or of other serious problems
• You experience an allergic reaction. Symptoms of a bad allergic reaction include difficulty breathing, hives, swelling of your face, asthma (wheezing), or shock (loss of blood pressure and consciousness)
• You suspect liver problems due to any of these symptoms:
• Your skin or the white part of your eyes turns yellow (jaundice)
• Your urine turns dark
• Your bowel movements (stools) turn light in color
• You don't feel like eating much food for several days or longer
• You feel sick to your stomach (nauseated)
• You have lower-stomach pain

Be aware that SUBOXONE can change the size of your pupil and cause differences in levels of consciousness. This may affect:

• A doctor's evaluation of you if you've experienced a head injury
• Safe driving

You should also note that pupil size is one method law enforcement officers use to evaluate drivers when they suspect intoxication.

All opioids can cause dependence. SUBOXONE produces dependence of the opioid type with a milder withdrawal syndrome than full agonists and may be delayed in onset.

As a Schedule III narcotic, buprenorphine has the potential for being abused and is subject to criminal diversion. Abuse of buprenorphine poses a risk of overdose and death. This risk is increased with the abuse of buprenorphine and alcohol and other substances, especially benzodiazepines.

When used as a treatment for opioid dependence, buprenorphine helps people remain in treatment and reduces the use of illicit opioids by decreasing cravings and suppressing withdrawal symptoms.

It is very important to remember that, as a Schedule III medication, it is illegal to share or transfer this medicine to anyone else because of the risks of taking it without a prescription.

If a child is exposed accidentally to SUBOXONE or SUBUTEX, seek medical attention immediately and go to the nearest emergency room right away or call the local Poison Control Center. Patients should keep SUBOXONE in a secure place, out of the sight and reach of children and other household members. Accidental or deliberate ingestion by a child may cause respiratory depression that can result in death. Medical personnel will be able to monitor the child's breathing and other symptoms, which is why it is so important to have the child assessed immediately.

Buprenorphine can cause opioid-like effects, including slowed breathing and other symptoms that need to be assessed and monitored medically, so seek medical attention immediately and go to the nearest emergency room right away or call the local Poison Control Center.

It is really important to know that combining buprenorphine with other drugs or medications that cause respiratory depression, such as benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol can be fatal to people dependent on opioids, as well as people who have not had recent experience with opioids. A complete understanding of what other substances and medications a person has taken is crucial.

Using medication-assisted treatment for opioid dependence is much like using medication for other chronic illnesses such as asthma or heart disease. It is meant to help you stay healthy. In particular, SUBOXONE helps people stay in treatment and reduce illicit use of opioids by reducing cravings and withdrawal symptoms so they can engage in comprehensive treatment that includes counseling and other services that address their medical and psychosocial needs.

Medicine can be an important component for managing both the short- and the long-term effects of opioid dependence. Typically, the changes that cause opioid dependence will not correct themselves right away, even though the misuse of opioids has stopped. In fact, these changes can trigger cravings months and even years after a patient has stopped misusing opioids. Consequently, overcoming opioid dependence is not simply a matter of eliminating misused drugs from the body.

It is really important that you and your family learn as much as you can about opioid dependence and treatment to help you understand why and how medication can be useful.