Generic Name: buprenorphine (oral) (byoo pre NOR feen)
Brand Names: Subutex

What is buprenorphine?

Buprenorphine is an opioid pain medication. An opioid is sometimes called a narcotic.

Buprenorphine is used to treat narcotic addiction.

Buprenorphine may also be used for purposes not listed in this medication guide.

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

Using buprenorphine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs. Wear a medical alert tag or carry an ID card stating that you take buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are being treated for narcotic addiction. Avoid drinking alcohol, which can increase some of the side effects of buprenorphine. Using too much of this medicine in addition to drinking alcohol can cause death. Do not stop using buprenorphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine. You may need to use less and less before you stop the medication completely. This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you.

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

Do not use this medication if you are allergic to buprenorphine or naloxone (Narcan), or if you have used another narcotic drug within the past 4 hours.

To make sure you can safely take buprenorphine, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorders;

• liver disease (especially hepatitis B or C);

• kidney disease;

• a thyroid disorder;

• stomach problems;

• enlarged prostate, urination problems;

• gallbladder disease;

• curvature of the spine;

• Addison's disease (an adrenal gland disorder);

• a history of mental illness, personality disorder, or psychotic episode;

• a history of drug or alcohol addiction; or

• a history of seizures, head injury, or brain tumor.

Buprenorphine may be habit forming and should be used only by the person it was prescribed for. Never share buprenorphine with another person, especially someone with a history of drug abuse or addiction. Buprenorphine can cause withdrawal effects in a person who is addicted to narcotics. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn baby. Buprenorphine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using buprenorphine. Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using buprenorphine. Do not give this medication to a child.

How should I take buprenorphine?

Never take buprenorphine in larger amounts, or for longer than recommended by your doctor. Using buprenorphine improperly will increase your risk of serious side effects or death. Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine. Follow all dosing instructions carefully. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Never crush a tablet or other pill to mix into a liquid for injecting the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

The buprenorphine sublingual tablet should be placed under the tongue and allowed to dissolve. Do not chew the tablet or swallow it whole. If your doctor has prescribed more than 2 tablets per dose, place the correct number of tablets under your tongue at the same time and allow them to dissolve completely.

Wear a medical alert tag or carry an ID card stating that you take buprenorphine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using buprenorphine. You may need to stop using the medicine for a short time. Do not stop using buprenorphine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using buprenorphine. You may need to use less and less before you stop the medication completely. Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Buprenorphine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.

Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, pinpoint pupils, fainting, slow heart rate, weak pulse, weak or shallow slowed breathing (breathing may stop).

What should I avoid while taking buprenorphine?

Avoid drinking alcohol, which can increase some of the side effects of buprenorphine. Using too much of this medicine in addition to drinking alcohol can cause death. This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you.

Buprenorphine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have a serious side effect such as:

• slow or shallow breathing;

• feeling light-headed, fainting;

• confusion, unusual thoughts or behavior; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may be more likely to occur, such as:

• headache;

• stomach pain, nausea, vomiting, constipation;

• warmth or tingly feeling;

• chills, increased sweating;

• weakness;

• back pain;

• anxiety, depression;

• sleep problems (insomnia); or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: buprenorphine side effects (in more detail)

Buprenorphine Dosing Information

Usual Adult Dose for Opiate Dependence:

Initial dose: 8 mg sublingually on day 1.
Maintenance dose: Rapidly titrate to the recommended target dose of 16 mg/day. In clinical trials, patients received 8 mg on day 1 and 16 mg on day 2 and thereafter. Further dose adjustments may be made in 2 mg to 4 mg increments up to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment. The usual daily range is 4 mg to 24 mg sublingually.

The tablets should be placed under the tongue at the same time and allowed to dissolve. If patients are taking more than 2 tablets per dose and cannot hold more than 2 under the tongue comfortably, they should use 2 tablets at a time, allowing them to dissolve completely before taking more tablets.

For patients taking heroin or short-acting opioids, the first dose should be administered at least 4 hours after the patient last used opioids or preferably when early withdrawal symptoms appear.

Withdrawal symptoms may occur during buprenorphine induction treatment of patients taking methadone or long-acting opioids, especially high opioid doses or when buprenorphine is administered shortly after the last opioid dose. The optimal time for the first dose has not been reported.

The optimal method of tapering to discontinuation has not been reported.

Usual Adult Dose for Pain:

IM or IV:
Initial: 0.3 mg slow IM or IV every 6 hours as needed. May repeat once 30 to 60 minutes after the initial dose. Maximum single dose: 0.6 mg (IM only)

Transdermal patches: Apply 1 patch to a hairless or nearly hairless intact skin site. There are 8 possible application sites: upper outer arm, upper chest, upper back, and side of the chest (on both sides of the body). The patch is worn for 7 days. Maximum dose: 20 mcg/hour

Usual Pediatric Dose for Pain:

Less than 2 years: Safety and effectiveness have not been established.
2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours.
13 to 18 years: 0.3 mg IM or slow IV every 6 hours; may repeat dose in 30 to 60 minutes.

What other drugs will affect buprenorphine?

Do not take buprenorphine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

• conivaptan (Vaprisol);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• nefazodone;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), rifampin (Rifadin, Rifater, Rifamate, Rimactane), or telithromycin (Ketek);

• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), or miconazole (Oravig);

• heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

• a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax) lorazepam (Ativan), clorazepate (Tranxene), triazolam (Halcion), flurazepam (Dalmane), or temazepam (Restoril).

This list is not complete and other drugs may interact with buprenorphine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist has information about buprenorphine written for health professionals that you may read.