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

What is Butrans?

Butrans skin patches contain buprenorphine, an opioid pain medication. An opioid is sometimes called a narcotic.

The Butrans skin patch is used to treat moderate to severe chronic pain around the clock. It is not for use on an as-needed basis for pain.

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

Important information

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

Buprenorphine may be habit-forming, and the Butrans skin patch contains a high concentration of this medicine. Use Butrans 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.

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

Buprenorphine can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Butrans in larger amounts, or for longer than prescribed.

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

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

Before using Butrans

You should not use Butrans if you are allergic to buprenorphine, or if you have:

  • a severe breathing problem such as asthma attacks; or

  • a bowel obstruction called paralytic ileus.

Buprenorphine may be habit-forming. Never share Butrans 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 Butrans patches to any other person is against the law.

To make sure Butrans 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;

  • 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.

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

FDA pregnancy category C. It is not known whether Butrans 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 Butrans during pregnancy. Tell your doctor if you are pregnant.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

Your dose needs may be different if you have recently used a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

How should I use a Butrans skin patch

Use Butrans exactly as prescribed. 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 Butrans 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. Use Butrans exactly as prescribed by your doctor. MISUSE OF NARCOTIC PAIN MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

A Butrans skin patch is for use only on the skin. Avoid touching the sticky side of a skin patch. Wash your hands after applying a skin patch. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips.

Do not use a Butrans skin patch if it has been cut or damaged.

Apply the skin patch only to clean, dry skin. Use only clear water to wash the skin before you apply a skin patch. Soaps or other chemicals could increase the amount of buprenorphine your skin absorbs.

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 Butrans 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, a waterbed heater, 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 Butrans suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Butrans.

Keep both used and unused Butrans 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.

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.

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.

Butrans 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?

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 Butrans will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Avoid letting another person handle your Butrans 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.

What are the possible side effects of Butrans

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

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

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

  • confusion, severe dizziness, feeling like you might pass out;

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

  • seizure (convulsions); or

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

Common Butrans side effects may include:

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

  • mild dizziness or drowsiness;

  • headache, 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)

What other drugs will affect Butrans

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 Butrans 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 can provide more information about Butrans.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Butrans only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 3.03. Revision Date: 2014-01-13, 5:17:51 PM.

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