buprenorphine

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

What is buprenorphine?

Buprenorphine is an opioid (narcotic) medication that is similar to morphine, codeine, and heroin.

Buprenorphine is used to treat narcotic addiction.

Buprenorphine may also be used for purposes other than those 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. Carry an ID card or wear a medical alert bracelet stating that you are using 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.

Taking buprenorphine together with other drugs that cause drowsiness can slow the functions of your breathing and central nervous system to dangerous levels. These effects could result in a fatal overdose.

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. You may have withdrawal symptoms when you stop using buprenorphine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Buprenorphine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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.

Before using buprenorphine, tell your doctor if you are allergic to any drugs, or if you have:

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

• liver or kidney disease;

• mental illness or a history of suicide attempt;

• a history of alcoholism or IV drug use; or

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

If you have any of these conditions, you may not be able to use buprenorphine, or you may need a dosage adjustment or special tests during treatment.

Buprenorphine should be used only by the person it was prescribed for. Buprenorphine should never be given to another person, especially someone who has 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 secure place where others cannot get to it. FDA pregnancy category C. This medication may be harmful to an unborn baby. It could also cause addiction or withdrawal symptoms in a newborn if the mother takes buprenorphine during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Buprenorphine passes into breast milk and may be harmful to a nursing baby. It may also decrease breast milk production. Do not use buprenorphine if you are breast-feeding a baby. Do not give this medication to a child.

How should I take 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.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

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. Carry an ID card or wear a medical alert bracelet stating that you are using 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.

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.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

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. You may have withdrawal symptoms when you stop using buprenorphine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store buprenorphine at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Buprenorphine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Throw away any unused buprenorphine tablets down the toilet after your treatment has ended.

See also: Buprenorphine dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of buprenorphine can be fatal.

Symptoms of a buprenorphine overdose may include slowed breathing, extreme weakness, cold or clammy skin, small pupils, fainting, and coma.

What should I avoid while taking buprenorphine?

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by buprenorphine.

Taking buprenorphine together with other drugs that cause drowsiness can slow the functions of your breathing and central nervous system to dangerous levels. These effects could result in a fatal overdose.

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. Buprenorphine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Buprenorphine side effects

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• slow or shallow breathing;

• feeling light-headed, fainting;

• confusion, unusual thoughts or behavior; or

• nausea, stomach pain, low fever, 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;

• increased sweating;

• weakness;

• back pain;

• anxiety, depression;

• sleep problems (insomnia); or

• runny nose.

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. You may report side effects to FDA at 1-800-FDA-1088.

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:

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

Usual Pediatric Dose for Pain:

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

What other drugs will affect buprenorphine?

Before using buprenorphine, tell your doctor if you use any of the following drugs:

• an antifungal antibiotic such as fluconazole (Diflucan), ketoconazole (Nizoral), itraconazole (Sporanox), or voriconazole (Vfend);

• an antibacterial antibiotic such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), or telithromycin (Ketek);

• HIV medication such as nevirapine (Viramune), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), ritonavir (Norvir), saquinavir (Invirase), or nelfinavir (Viracept);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

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

• seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton), and others.

If you are using any of these drugs, you may not be able to use buprenorphine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect buprenorphine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using 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.

• 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.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.08. Revision Date: 4/12/2009 4:38:26 PM.