buprenorphine

Pronunciation

Generic Name: buprenorphine (injection) (byoo pre NOR feen)
Brand Name: Buprenex

What is buprenorphine injection?

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

Buprenorphine is used to treat moderate to severe pain.

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, especially when you start using this medicine or whenever your dose is changed. Never use buprenorphine in larger amounts, or for longer than prescribed.

Do not drink alcohol. Buprenorphine can increase the effects of alcohol, which could be dangerous.

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Buprenorphine may be habit-forming, even at regular doses. Use this medicine exactly as prescribed by your doctor. Never share the medicine with another person. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a 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.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine.

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

You should not use this medication if you are allergic to buprenorphine.

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

  • any type of breathing problem or lung disease;

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

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

  • urination problems;

  • liver or kidney disease;

  • curvature of the spine that affects breathing;

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

  • problems with your gallbladder, pancreas, or thyroid.

Buprenorphine may be habit-forming. Never share buprenorphine 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. Selling or giving away buprenorphine is against the law.

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. Do not breast-feed while you are using buprenorphine.

How should I use buprenorphine?

Follow all directions on your prescription label. Buprenorphine can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. 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. Take this medicine exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICATION CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Buprenorphine is injected into a muscle or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, syringes, IV tubing, and other items used to inject the medicine.

Buprenorphine is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if buprenorphine does not relieve your pain within 1 hour after an injection.

Prepare your dose in a syringe or IV only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription. Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

This medicine can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.

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.

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.

Wear a medical alert tag or carry an ID card stating that you use buprenorphine. Any medical care provider who treats you should know that you are using buprenorphine. Make sure your family members know you are using buprenorphine in case they need to speak for you during an emergency.

Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new ampule. 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?

Since buprenorphine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use 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, especially in a person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness or weakness, cold or clammy skin, slow heart rate, weak pulse, fainting, or slow breathing (breathing may stop).

What should I avoid while using buprenorphine?

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with buprenorphine.

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 injection 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.

Even if you have used other narcotic medications, you may still have serious side effects from buprenorphine.

Call your doctor at once if you have:

  • weak or shallow breathing, feeling like you might pass out;

  • blue lips or fingernails;

  • confusion, feelings of extreme happiness;

  • fast or slow heart rate; or

  • little or no urinating.

Common side effects may include:

  • dizziness, spinning sensation, weakness, tired feeling;

  • nausea, vomiting, constipation;

  • increased sweating, numbness or tingly feeling;

  • headache, depressed mood; or

  • blurred vision, double vision.

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 mg, 10 mg, 15 mg, and 20 mg 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

What other drugs will affect buprenorphine injection?

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 doctor or pharmacist can provide more information about buprenorphine injection.
  • 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: 4.03. Revision Date: 2014-01-13, 5:16:45 PM.

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