What is the most important information I should know about buprenorphine?

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Buprenorphine can cause death from overdose, especially if it is injected with a tranquilizer. Use buprenorphine exactly as directed by your doctor.

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Buprenorphine can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine is not for occasional ("as needed") use. Do not stop taking buprenorphine without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms.

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In an emergency, have family members tell emergency room staff that you are taking buprenorphine and that you are dependent on opioids.

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Use caution when driving, operating machinery, or performing other hazardous activities. Buprenorphine may cause drowsiness, dizziness, or impaired thinking. If you experience drowsiness, dizziness, or impaired thinking, avoid these activities.

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Avoid alcohol while taking buprenorphine. Alcohol may dangerously increase drowsiness and dizziness caused by the medication.

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Buprenorphine may dangerously increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other prescription or over-the-counter medicine, including herbal products, without first talking to your doctor.

What is buprenorphine?

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Buprenorphine is an opioid medication. Buprenorphine is similar to other opioids such as morphine, codeine, and heroin however, it produces less euphoric ("high") effects and therefore may be easier to stop taking.

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Buprenorphine is used as a pain reliever and to treat opiate addiction.

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Buprenorphine may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking buprenorphine?

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Do not take buprenorphine if:

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the medication was not prescribed for you; or

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you are allergic to buprenorphine or any other component of the medication.

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Before taking buprenorphine, tell your doctor if you have:

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lung problems or difficulty breathing;

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a head injury or brain problem;

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liver problems;

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kidney problems;

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gallbladder problems;

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adrenal gland problems, such as Addison's disease;

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low thyroid (hypothyroidism);

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enlarged prostate gland;

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problems urinating;

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a curve in the spine that affects breathing;

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severe mental problems or hallucinations (seeing or hearing thing that are not really there); or

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alcoholism.

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You may not be able to take buprenorphine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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Buprenorphine is in the FDA pregnancy category C. This means that it is not known whether buprenorphine will be harmful to an unborn baby. Use of buprenorphine during pregnancy may cause withdrawal symptoms in a newborn baby. Do not take buprenorphine if you are pregnant or could become pregnant during treatment.

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Buprenorphine passes into breast milk and may be harmful to a nursing baby. Do not take buprenorphine if you are breast-feeding a baby.

How should I take buprenorphine?

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Take buprenorphine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

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Your doctor, nurse, or healthcare provider will administer injectable buprenorphine for pain relief.

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The buprenorphine tablets should be placed under the tongue and allowed to dissolve. This will take 2 to 10 minutes. If more than one tablet is prescribed per dose, your doctor may tell you to put all of the tablets under your tongue at the same time, or put 2 tablets under your tongue and allow them to dissolve completely, then put the next tablet or tablets under the tongue right away.

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Do not chew or swallow the tablets. The medicine will not work this way and you may get withdrawal symptoms.

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Do not change the dose of buprenorphine or take it more often than prescribed without first talking to your doctor.

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Do not inject ("shoot-up") crushed buprenorphine tablets. Shooting-up is dangerous and may cause bad withdrawal symptoms.

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Buprenorphine may cause withdrawal symptoms if taken too soon after a dose of heroin, morphine, or methadone.

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Buprenorphine can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine is not for occasional ("as needed") use. Do not stop taking buprenorphine without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms.

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When treatment with buprenorphine is completed, flush any unused tablets down the toilet.

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Buprenorphine can cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increasing the amount of fiber in your diet can also help to alleviate constipation.

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Your doctor may want to perform blood tests or other forms of monitoring during treatment with buprenorphine.

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Store buprenorphine at room temperature away from moisture and heat. Buprenorphine may be a target for people who abuse prescription or street drugs. Therefore, keep the tablets in a safe place to protect them from theft. Never give them to anyone else. Sell or giving away this medicine is against the law.

What happens if I miss a dose?

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Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

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Seek emergency medical attention.

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Symptoms of a buprenorphine overdose may include slow breathing, seizures, dizziness, weakness, loss of consciousness, coma, confusion, tiredness, cold and clammy skin, and small pupils.

What should I avoid while taking buprenorphine?

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In an emergency, have family members tell emergency room staff that you are taking buprenorphine and that you are dependent on opioids.

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Use caution when driving, operating machinery, or performing other hazardous activities. Buprenorphine may cause drowsiness, dizziness, or impaired thinking. If you experience drowsiness, dizziness, or impaired thinking, avoid these activities.

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Dizziness may be more likely to occur when rising from a sitting or lying position. Rise slowly to minimize dizziness and prevent a fall.

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Avoid alcohol while taking buprenorphine. Alcohol may dangerously increase drowsiness and dizziness caused by the medication.

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Buprenorphine may dangerously increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other prescription or over-the-counter medicine, including herbal products, without first talking to your doctor.

What are the possible side effects of buprenorphine?

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Buprenorphine can cause drug dependence. This means that withdrawal symptoms may occur if you stop using the medicine too quickly. Withdrawal symptoms may also occur at the start of treatment due to dependence on another drug. Buprenorphine is not for occasional ("as needed") use. Do not stop taking buprenorphine without first talking to your doctor. Your doctor may want to gradually reduce the dose to avoid or minimize withdrawal symptoms.

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Seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

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an allergic reaction (difficulty breathing; closing of the throat, swelling of the lips, tongue, or face; or hives);

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slow breathing;

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dizziness or confusion; or

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liver problems such as yellowing of the skin or eyes, dark colored urine, light colored stools (bowel movements), decreased appetite for several days or longer, nausea, or lower stomach pain.

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Other less serious side effects may be more likely to occur. Continue to take buprenorphine and talk to your doctor if you experience

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headache;

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pain;

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problems sleeping;

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nausea;

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sweating;

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stomach pain; or

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constipation.

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Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect buprenorphine?

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Buprenorphine can cause death from overdose, especially if it is injected with a tranquilizer. Use buprenorphine exactly as directed by your doctor.

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Do not take buprenorphine without first talking to your doctor if you are taking:

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a benzodiazepine such as alprazolam (Xanax), diazepam (Valium), clonazepam (Klonopin), clorazepate (Tranxene), lorazepam (Ativan), chlordiazepoxide (Librium), oxazepam (Serax), triazolam (Halcion), temazepam (Restoril), estazolam (Prosom), quazepam (Doral), or flurazepam (Dalmane);

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erythromycin (Ery-Tab, E.E.S., E-Mycin, others) or clarithromycin (Biaxin);

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itraconazole (Sporanox) or ketoconazole (Nizoral);

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an HIV protease inhibitor such as indinavir (Crixivan), ritonavir (Norvir) or saquinavir (Fortovase, Invirase);

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rifampin (Rifadin, Rimactane), rifapentine (Priftin), or rifabutin (Mycobutin);

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phenytoin (Dilantin);

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carbamazepine (Tegretol);

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a barbiturate such as phenobarbital, mephobarbital (Mebaral), and others.

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You may not be able to take buprenorphine, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medications listed above.

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Buprenorphine may dangerously increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other prescription or over-the-counter medicine, including herbal products, without first talking to your doctor.

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Drugs other than those listed here may also interact with buprenorphine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

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Your pharmacist may have additional information about buprenorphine written for health professionals that you may read.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.