buprenorphine

Pronunciation

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

What is buprenorphine?

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

Buprenorphine is used to treat narcotic addiction. Buprenorphine is not for use as a pain medication.

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

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

Buprenorphine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Buprenorphine may cause life-threatening addiction and withdrawal symptoms in a newborn.

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

You should not use this medication if you are allergic to buprenorphine, or if you have used another narcotic drug within the past 4 hours.

To make sure buprenorphine is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • curvature of the spine that affects breathing;

  • liver disease (especially hepatitis B or C);

  • enlarged prostate, urination problems;

  • problems with your gallbladder, adrenal gland, or thyroid;

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

  • a history of drug abuse, alcohol addiction, or mental illness.

FDA pregnancy category C. It is not known whether buprenorphine will harm an unborn baby. Buprenorphine may cause breathing problems, behavior changes, or life-threatening addiction and withdrawal symptoms in your newborn if you use the medication during pregnancy. Tell your doctor if you are pregnant.

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?

Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing. Never use buprenorphine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Buprenorphine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine is against the law.

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.

While using buprenorphine, you may need frequent blood tests to check your liver function.

If you need surgery, tell the surgeon ahead of time that you are using buprenorphine. You may need to stop using the medicine for a short time.

Wear a medical alert tag or carry an ID card stating that you take buprenorphine. Any 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.

Do not stop using buprenorphine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using buprenorphine.

Never crush or break a buprenorphine pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of buprenorphine and similar prescription drugs.

Store at room temperature away from moisture and heat. After you have stopped using this medicine, flush any unused pills down the toilet.

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.

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. A buprenorphine overdose can be fatal, especially in a child or other person using the medicine without a prescription.

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?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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:

  • weak or shallow breathing;

  • a light-headed feeling, like you might pass out;

  • 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).

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

  • constipation, nausea, vomiting;

  • headache;

  • increased sweating;

  • sleep problems (insomnia); or

  • pain anywhere in your body.

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: Side effects (in more detail)

Buprenorphine dosing information

Usual Adult Dose for Opiate Dependence:

Induction dose:
-Day 1: 8 mg sublingually once a day
-Day 2: 16 mg sublingually once a day
Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear.
-Following induction, combination buprenorphine/naloxone is preferred; use of buprenorphine alone should be limited to those patients who cannot tolerate naloxone.

Use: For the treatment of opioid dependence, preferably induction only. This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.

Usual Adult Dose for Pain:

Parenteral:
Initial dose: 0.3 mg deep IM or slow IV; may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.6 mg (IM only)

Comments:
-Use extra caution with IV administration, especially the first dose
-IV administration of maximum doses are not recommended

Use: For the relief of moderate to severe pain

Usual Adult Dose for Chronic Pain:

Individualize dosing taking into account prior analgesic treatment; 7.5 mcg, 10 mcg, 15 mcg, and 20 mcg patches are for opioid-experienced patients only.

-As first opioid analgesic: Initiate with 5 mcg/hr patch every 7 days

Conversion from Other Opioids to Buprenorphine:
-Discontinue all other around-the-clock opioid drugs when initiating therapy
For patients whose prior total opioid dose is less than 30 mg/day of oral morphine equivalents:
-Initiate with 5 mcg/hr patch every 7 days at next dosing interval
For patients whose prior total opioid dose is between 30 and 80 mg/day of oral morphine equivalents:
-Taper around-the-clock opioids for up to 7 days to no more than 30 mg/day of oral morphine equivalents, then initiate with 10 mcg/hr patch every 7 days starting at the next dosing interval; may use short-acting analgesics as needed until analgesic efficacy is attained.
For patients whose prior total opioid dose is greater than 80 mg/day of oral morphine equivalents:
-Consider use of an alternate analgesic as 20 mcg/hr patch may not provide adequate analgesia

Conversion from Methadone:
-The ratio between methadone and other opioid agonists may vary widely due to its long half-life and accumulation in the plasma; close monitoring is of particular importance.

Titration: Individually titrate to a dose that provides adequate analgesia and minimizes adverse reactions; minimal titration interval is 72 hours
Maximum dose: 20 mcg/hr

Comments:
-Monitor patients closely for respiratory depression, especially within 24 to 72 hours after initiating therapy.
-If pain level increases after dose stabilization, attempt to identify source of increased pain before increasing buprenorphine dose
-Do not abruptly discontinue; use a gradual downward titration every 7 days, may consider introduction of an immediate-release opioid.

Use: For the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Usual Pediatric Dose for Pain:

Parenteral:
13 years or older:
Initial dose: 0.3 mg deep IM or slow IV; may repeat initial dose once after 30 to 60 minutes if required
Maintenance dose: 0.3 mg deep IM or slow IV at up to 6-hour intervals as needed
Maximum dose: 0.3 mg

2 to 12 years: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours

Comments:
-Fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established: some patients may not need to be re-medicated for 6 to 8 hours.
-Use extra caution with IV administration, especially the first dose
-IV administration of maximum doses are not recommended

Use: For the relief of moderate to severe pain

Usual Pediatric Dose for Opiate Dependence:

Aged 16 years or older:
Induction dose:
-Day 1: 8 mg sublingually once a day
-Day 2: 16 mg sublingually once a day
Maintenance dose: 4 to 24 mg/day; dose adjustments may be made in increments/decrements of 2 or 4 mg to a level that suppresses opioid withdrawal symptoms and holds the patient in treatment.

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear.
-Following induction, combination buprenorphine/naloxone is preferred; use of buprenorphine alone should be limited to those patients who cannot tolerate naloxone.

Use: For the treatment of opioid dependence, preferably induction only. This drug should be used as part of a complete treatment plan to include counseling and psychosocial support.

What other drugs will affect buprenorphine?

Using this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using buprenorphine with a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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.
  • Disclaimer: 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 1996-2012 Cerner Multum, Inc. Version: 4.04. Revision Date: 2014-05-01, 10:13:17 AM.

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