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buprenorphine

Pronunciation

Generic Name: buprenorphine transdermal (skin patch) (BUE pre NOR feen)
Brand Name: Butrans

What is buprenorphine transdermal?

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

The buprenorphine skin patch is for around-the-clock treatment of moderate to severe chronic pain that is not controlled by other medicines. This medicine is not for use on an as-needed basis for pain.

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

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

You should not use this medicine if you have severe asthma or breathing problems, or a bowel obstruction called paralytic ileus.

Buprenorphine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Buprenorphine may also 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 MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Buprenorphine may cause life-threatening withdrawal symptoms in a newborn if the mother has used this medicine during pregnancy.

Avoid sources of heat while you are wearing a buprenorphine skin patch. Heat can increase the amount of drug your skin absorbs.

What should I discuss with my health care provider before using buprenorphine transdermal?

You should not use buprenorphine if you are allergic to it, or if you have a severe breathing problem or a bowel obstruction.

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

  • a fever;

  • 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;

  • a blockage in your stomach or intestines;

  • liver or kidney disease;

  • heart disease, low potassium levels, heart rhythm problems, or a personal or family history of Long QT syndrome; or

  • problems with your gallbladder, pancreas, or thyroid.

If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Buprenorphine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using buprenorphine.

How should I use buprenorphine transdermal?

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. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine transdermal is against the law.

The transdermal skin patch contains a high concentration of buprenorphine. Your dose needs may be different if you have recently used a similar opioid (narcotic) pain medicine and your body is tolerant to it.

The skin patch is for use only on the skin. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips.

Avoid touching the sticky side of the patch. Wash your hands after applying a skin patch. Do not use a buprenorphine transdermal skin patch if it has been cut or damaged.

Apply the patch only to clean, dry skin. Use only clear water (not soap or other chemicals) to wash the skin before you apply a patch.

Apply the patch to a flat area of the chest, back, side, or outer side of your upper arm. Wear the patch around the clock for 7 days. Never wear more than 1 buprenorphine skin patch at a time unless your doctor has told you to.

Avoid sources of heat while you are wearing the patch. Tell your doctor if you have a fever. Do not use a heating pad or electric blanket, tanning bed or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

Remove and replace the patch after 7 days. Apply the new patch to a different skin area on the chest, back, side, or upper arm. After removing a skin patch: fold it in half firmly with the sticky side in, and flush the patch down the toilet or use the Patch-Disposal Unit provided with this medication. Do not place a used skin patch into a trash can. Also dispose of any unused skin patches in the same folded manner when you no longer need this medicine. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using buprenorphine.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep track of how many skin patches have been used from each new package. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep both used and unused buprenorphine skin patches out of the reach of children or pets. The amount of buprenorphine in a used skin patch could be fatal to a child or pet who accidentally sucks or chews on the patch. Seek emergency medical attention if this happens.

What happens if I miss a dose?

If you forget to change a patch on your scheduled day, remove the patch and apply a new one as soon as you remember. Do not wear extra patches to make up a 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 slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Buprenorphine transdermal can cause death in a child who gets a hold of a skin patch and places it in the mouth or on the skin.

What should I avoid while using buprenorphine transdermal?

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.

Avoid letting another person handle your skin patches. If the sticky side of a skin patch comes into contact with another person, wash the skin with clear water and seek medical care at once. Avoid wearing a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the buprenorphine skin patch is a "bandage."

Buprenorphine transdermal side effects

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

Stop using buprenorphine and call your doctor at once if you have:

  • weak or shallow breathing, deep sighs, snoring that is new or unusual;

  • chest pain, fast heart rate, seizure (convulsions);

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

  • blisters, swelling, or severe irritation where the patch was worn; or

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

Buprenorphine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

  • constipation, nausea, vomiting, dry mouth, stomach pain;

  • headache, dizziness, drowsiness, tired feeling; or

  • redness, itching, or mild skin rash where the patch was worn.

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 (over at least 2 minutes); 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 (IV) or 0.6 mg (IM)

Comments:
-Use extra caution with IV administration, especially the first dose

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/hr patches are for opioid-experienced patients only.

-As first opioid analgesic: Initiate with 5 mcg/hr patch applied transdermally 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 applied transdermally 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 applied transdermally 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 due to risk of QTc interval prolongation

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 (over at least 2 minutes) ; 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; some patients may not need to be remedicated for 6 to 8 hours

Comments:
-Fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been established.
-Use extra caution with IV administration, especially the first dose

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 transdermal?

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 transdermal with a sleeping pill, a sedative or tranquilizer, other narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

You should not use buprenorphine transdermal if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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 can provide more information about buprenorphine.
  • 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: 3.05. Revision Date: 2015-09-02, 1:03:22 PM.

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