Butrans Skin Patch

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

What is Butrans?

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

The Butrans 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.

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.

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, and may be habit-forming. Use only your prescribed dose. Never share Butrans patches with another person.

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

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

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 Butrans skin patch. Heat can increase the amount of drug your skin absorbs.

Before using this medicine

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

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;

problems with your gallbladder, pancreas, or thyroid; or

if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with buprenorphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use Butrans 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 Butrans.

How should I use Butrans?

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. 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 Butrans is against the law.

The Butrans 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 Butrans 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 skin patch if it has been cut or damaged.

Apply the Butrans 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 Butrans 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 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 Butrans 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 Butrans 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 Butrans.

Store Butrans 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 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.

See also: Dosage Information (in more detail)

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

What should I avoid while using Butrans?

Do not drink alcohol. Dangerous side effects or death could occur.

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 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 Butrans skin patch is a "bandage."

Butrans side effects

Get emergency medical help if you have signs of an allergic reaction to Butrans: 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.

Stop using Butrans 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;

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

low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Butrans 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)

What other drugs will affect Butrans?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

other narcotic medications - opioid pain medicine or prescription cough medicine;

drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.