BuTrans is a prescription medication used to treat moderate to severe, chronic, around-the-clock pain that will last a long period of time. BuTrans belongs to a group of drugs called opioid partial agonist-antagonists, which help to relieve pain by binding to certain opioid receptors in the body.

This medication comes in skin patch form and is usually applied for a week at a time.

Some of the common side effects of BuTrans include constipation, nausea, and headache. BuTrans can cause dizziness and drowsiness. Do not drive or operate machinery until you know how BuTrans will affect you. Do not drink alcohol while taking this medication.

BuTrans is a prescription medicine used to treat moderate to severe chronic pain. The patch is used when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Purdue Pharma LP

BuTrans can cause serious side effects that can lead to death, including:

• See “Drug Precautions”
• Serious breathing problems that can be life threatening.
  Call your doctor or get emergency medical help right away if you:
  • have trouble breathing,
  • have extreme drowsiness with slowed breathing
  • have slow shallow breathing (little chest movement with breathing)
  • feel faint, very dizzy, confused, or have any other unusual symptoms
• Allergic reactions. Rash, itching, and hives are the most common symptoms of an allergic reaction. Call your doctor if you have these symptoms. Get medical help right away if you have any of these symptoms of an allergic reaction while taking BuTrans:
  • swelling of your lips or tongue
  • breathing problems
  • wheezing
  • chest pain
• BuTrans can cause a drop in your blood pressure. Low blood pressure can make you feel dizzy if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
• Liver problems. Your skin or the white part of your eyes can turn yellow (jaundice), urine can turn dark, stools can turn light in color, you may have less of an appetite, and nausea. Your doctor may do tests before you start and while you use BuTrans.
• BuTrans can increase your chances of having a seizure if you have history of seizures. Tell your doctor if you have a seizure or convulsion while using BuTrans.
• BuTrans can cause physical dependence. Do not stop using BuTrans or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction.
• There is a chance of abuse or addiction with BuTrans. The chance is higher if you are or have been addicted to or abused other medicines, street drugs or alcohol in the past. You may have a greater risk of developing abuse or addiction again while using BuTrans.
• Severe skin reactions. BuTrans can cause skin reactions at the site where the patch is applied.

The most common side effects of BuTrans include:

• nausea
• headache
• dizziness
• constipation
• drowsiness
• vomiting
• dry mouth and
• itching, redness, or rash (patch form)

Constipation (incomplete or hard bowel movements) is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using BuTrans.

Talk to your doctor about any side effect that bother you or do not go away.

These are not all the possible side effects of BuTrans. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with BuTrans. Sometimes, the doses of certain medicines and BuTrans need to be changed if used together.

Especially tell your doctor if you take:

• other pain medicines
• antidepressant medicines
• sleeping pills
• antihistamines
• anti-anxiety medicines
• muscle relaxants
• anti-nausea medicines
• sedative or tranquilizer medicines (medicines that make you sleepy)
• a medicine for abnormal heartbeats

You should not use BuTrans if you already take a monoamine oxidase inhibitor medicine (MAOI) or within 14 days after you stop taking an MAOI medicine.

Ask your doctor if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist. Your doctor will tell you if it is safe to take other medicines while you are using BuTrans.

• BuTrans overdose can cause serious and life threatening breathing problems.
• Serious and life-threatening breathing problems can happen with BuTrans, especially during the first 24 to 72 hours after you apply a new patch. This can happen because of an overdose or if the dose you are using is too high for you.
• Call your doctor right away or get emergency medical help if you:
  • have trouble breathing
  • have changes in breathing
    • unusual deep “sighing” breathing
    • slow or shallow breathing
    • new or unusual snoring
  • have a slow heartbeat
  • have severe sleepiness
  • have cold, clammy skin
  • feel faint, dizzy, confused, or cannot think, walk, or talk normally
• Do not use BuTrans if you:
  • have trouble breathing, severe asthma or severe lung problems
  • have a bowel blockage called paralytic ileus.
  • are allergic to any of the ingredients in BuTrans.
• You should not drive, operate heavy machinery, or do other dangerous activities, until you know how you react to this medicine. BuTrans can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react. Ask your doctor when it is okay to do these activities.
• You should not drink alcohol or use prescription or non-prescription medicines that have alcohol in them while using BuTrans. Alcohol can increase your chances of having serious side effects including death.

Do not place direct heat on BuTrans patch. Exposure of BuTrans patch to direct heat may cause too much of the medicine to pass into your body. This can lead to overdose and death. Keep the BuTrans patch away from:

• heating pads
• electric blankets
• heaters
• tanning lamps
• saunas
• hot tubs
• heated waterbeds
• hot baths
• sunbathing
• Place the BuTrans patch only on clean skin. Do not use on broken, irritated and cracked skin.
• Do not use BuTrans patch if the seal on the protective pouch is broken or if the patch is cut, damaged or changed. Do not cut the patch.
• BuTrans is not for occasional or “as needed” use

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of BuTrans, grapefruit and grapefruit juice may interact with BuTrans and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using BuTrans, tell your doctor about all of your medical conditions including if you have:

• breathing or lung problems
• history of a heart problem called Long QT syndrome (or if a family member has this condition)
• head injury or brain problems
• low blood pressure
• liver problems
• kidney problems
• hepatitis B or hepatitis C
• had convulsions or seizures
• severe scoliosis
• thyroid problems
• prostate problems or trouble urinating
• Addison’s disease
• alcoholism, or a family history of this problem
• depression or hallucinations (seeing or hearing things that are not there)
• drug abuse or addiction problem, or a past problem, or a family history of this problem
• have any other medical conditions

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. The medication in BuTrans patch passes into your breast milk. You and your doctor should decide if you will use BuTrans or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you use BuTrans.

• Before applying the BuTrans patch:
  • Do not use soap, alcohol, lotions, oils, or other products to remove any leftover medicine gel from a patch because this may cause more medication to pass through the skin.
  • Each patch is sealed in its own protective pouch. Do not remove a patch from the pouch until you are ready to use it.
  • Do not use a patch if the seal on the protective pouch is broken or if the patch is cut, damaged or changed in any way.
  • BuTrans patches are available in different strengths and patch sizes. Make sure you have the right strength patch that has been prescribed for you
• Where to apply BuTrans patches:
  • BuTrans patches should be applied to the upper outer arm, upper chest, upper back, or the side of the chest. These 4 sites (located on both sides of the body) provide 8 possible application sites. You should change the skin site where you apply a a patch each week, making sure that at least 3 weeks (21 days) pass before you re-use the same skin site.
  • Apply the patch to a hairless or nearly hairless skin site. If needed, you can clip the hair at the skin site. Do not shave the area. The skin site should not be irritated. Use only water to clean the application site. You should not use soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before you apply the patch.
  • The skin site should be free of cuts and irritation (rashes, swelling, redness, or other skin problems).
• When to apply the patch:
  • When you apply a new patch, write down the date and time that the patch is applied. Use this to remember when the patch should be removed.
  • Change the patch at the same time of day, one week (exactly 7 days) after you apply it.
  • After removing and disposing of the patch, write down the time it was removed and how it was disposed.
• How to apply the patch:
  • If you are wearing a patch, remember to remove it before applying a new one.
  • Each patch is sealed in its own protective pouch.
  • Use scissors to cut open the pouch along the dotted line and remove the patch. Do not remove the patch from the pouch until you are ready to use it. Do not use patches that have been cut or damaged in any way.
  • Hold the patch with the protective liner facing you.
  • Gently bend the patch along the faint line and slowly peel the larger portion of the liner, which covers the sticky surface of the patch.
  • Do not touch the sticky side of the patch with your fingers.
  • Using the smaller portion of the protective liner as a handle, apply the sticky side of the patch to one of the 8 body locations described above
  • While still holding the sticky side down, gently fold back the smaller portion of the patch. Grasp an edge of the remaining protective liner and slowly peel it off.
  • Press the entire patch firmly into place with the palm (See Figure 7) of your hand over the patch, for about 15 seconds. Do not rub the patch.
  • Make sure that the patch firmly sticks to the skin.
  • Go over the edges with your fingers to assure good contact around the patch.
  • Always wash your hands after applying or handling a patch.
  • After the patch is applied, write down the date and time that the patch is applied. Use this to remember when the patch should be removed.
• If the patch falls off right away after applying, throw it away and put a new one on at a different skin site.
• If a patch falls off, do not touch the sticky side of the patch with your fingers. A new patch should be applied to a different site. Patches that fall off should not be re-applied. They must be thrown away correctly.
• If the edges of the patch start to loosen:
  • Apply first aid tape only to the edges of the patch.
  • If problems with the patch not sticking continue, cover the patch with special see-through adhesive dressings (for example Bioclusive or Tegaderm).
    • Remove the backing from the transparent adhesive dressing and place it carefully and completely over the patch, smoothing it over the patch and your skin.
• Never cover a patch with any other bandage or tape. It should only be covered with a special see-through adhesive dressing. Talk to your doctor or pharmacist about the kinds of dressing that should be used.
• If your patch falls off later, but before 1 week (7 days) of use, throw it away properly and apply a new patch at a different skin site. Be sure to let your doctor know that this has happened. Do not replace the new patch until 1 week (7 days) after you put it on (or as directed by your doctor).
• Disposing a BuTrans patch:
  • Patches must be disposed of by flushing them down the toilet or using the Patch-Disposal Unit.
  • To flush your patch down the toilet:
    • Remove your patch, fold the sticky sides of a used patch together and flush it down the toilet right away.
  • When disposing of unused patches you no longer need, remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet.
  • Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in the trash.
  • If you prefer not to flush the used patch down the toilet, you must use the Patch-Disposal Unit provided to you to discard the patch.
  • Never put used patches in the trash without first sealing them in the Patch-Disposal Unit.
  • To dispose of patches in household trash using the Patch-Disposal Unit:
    • Remove your patch and follow the directions printed on the Patch-Disposal Unit (See Figure 9) or see complete instructions below. Use one Patch-Disposal Unit for each patch.
    1. Peel back the disposal unit liner to show the sticky surface.
    2. Place the sticky side of the used or unused patch to the indicated area on the disposal unit.
    3. Close the disposal unit by folding the sticky sides together, Press firmly and smoothly over the entire disposal unit so that the patch is sealed within.
    4. The closed disposal unit, with the patch sealed inside may be thrown away in the trash.
    • Do not put unused patches in household trash without first sealing them in the Patch-Disposal Unit.
    • Always remove the leftover patches from their protective pouch and remove the protective liner. The pouch and liner can be disposed of separately in the trash and should not be sealed in the Patch-Disposal Unit.

The BuTrans dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

If you have not been taking other opioids, the standard starting dosage is one BuTrans (buprenorphine) patch 5 mcg/hour patch applied once a week. If your pain is not adequately controlled after three days, your healthcare provider may increase your dosage. The increase will be based on the amount of short-acting pain medication you needed, or how much "breakthrough" pain you experienced, in the two to three days after starting this medication.

The maximum BuTrans (buprenorphine) patch dose is one 20-mcg/hour patch applied once a week. Higher doses increase the risk for dangerous changes in the heart rhythm (QTc interval prolongation).

If you apply too much of this medication call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep the BuTrans patch in its unopened protective pouch until you are ready to use it.
• Keep BuTrans in a safe place out of the reach of children.
• BuTrans is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs. Prevent theft, misuse and abuse. Keep BuTrans in a safe place to protect from being stolen. Never give BuTrans to anyone else, even if they have the same symptoms you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

WARNING: ADDICTION, ABUSE, and MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; and NEONATAL OPIOID WITHDRAWAL SYNDROME

• BUTRANS exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor for development of these behaviors or conditions.
• Serious, life-threatening or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients on proper administration of BUTRANS to reduce the risk. 
• Accidental exposure to BUTRANS, especially in children, can result in fatal overdose of buprenorphine. 
• Prolonged use of BUTRANS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.