Friday, October 14, 2016

Buprenorphine Patch



Pronunciation: BUE-pre-NOR-feen
Generic Name: Buprenorphine
Brand Name: Butrans

Buprenorphine Patch is a narcotic analgesic used to manage moderate to severe chronic pain in patients who need continuous, around-the-clock narcotic pain relief for an extended period of time. It should not be used to treat occasional pain.


Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may increase your risk of irregular heartbeat.


Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or other sources of heat to the body. The heat may cause more medicine to be released into your skin and could cause serious, even fatal, side effects.





Buprenorphine Patch is used for:

Managing moderate to severe chronic pain in patients who need continuous, around-the-clock narcotic (opioid) pain relief for an extended period of time.


Buprenorphine Patch is a narcotic (opioid) analgesic. It works by binding to receptors in the brain and nervous system to decrease pain.


Do NOT use Buprenorphine Patch if:


  • you are allergic to any ingredient in Buprenorphine Patch

  • you have very slow or difficult breathing, severe asthma, or severe lung problems

  • you have known or suspected bowel blockage (eg, paralytic ileus) or severe or persistent diarrhea caused by antibiotics

  • you have mild or short-term pain or pain that occurs after surgery

  • you do not need to take pain medicine on a regular basis

  • you are taking sodium oxybate (GHB) or you have taken a monoamine oxidase inhibitor (MAOI) (eg, furazolidone, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Buprenorphine Patch:


Some medical conditions may interact with Buprenorphine Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription, especially narcotic pain medicines (eg, oxycodone, morphine), or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of blood electrolyte problems (eg, low blood potassium levels); breathing or lung problems (eg, chronic obstructive pulmonary disease [COPD], asthma, sleep apnea); obesity; thyroid problems (eg, myxedema, an underactive thyroid); curvature of the spine; adrenal gland problems (eg, Addison disease); liver problems (eg, hepatitis B or C); skin reactions to adhesives; seizures; kidney problems; pancreas problems; prostate problems (eg, enlarged prostate gland); trouble urinating; a blockage of your bladder, bowel, stomach, or urethra; gallbladder problems; bowel problems (eg, constipation, inflammatory bowel disease); stomach problems; or recent bladder, bowel, or stomach surgery

  • if you have a history of heart problems (eg, cor pulmonale, heart failure), heart rhythm problems (eg, atrial fibrillation, slow heartbeat), a recent heart attack, or if you or a family member has a history of long QT syndrome

  • if you have a history of a recent head injury, growths in the brain (eg, tumor, lesion), increased pressure in the brain, or muscle problems (eg, myasthenia gravis)

  • if you have a fever, low blood pressure, low blood volume, severe drowsiness, or slow or shallow breathing

  • if you have a history of mental or mood problems (eg, depression, hallucinations), narcotic dependence, are in alcohol withdrawal, or if you or a family member has a history of alcohol or substance abuse

  • if you are taking an antiarrhythmic medicine (eg, quinidine, sotalol, amiodarone)

Some MEDICINES MAY INTERACT with Buprenorphine Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Antiarrhythmics (eg, amiodarone, quinidine, sotalol), azole antifungals (eg, ketoconazole, voriconazole), HIV protease inhibitors (eg, atazanavir, ritonavir), or phenothiazines (eg, chlorpromazine) because they may increase the risk of Buprenorphine Patch's side effects

  • Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), or sodium oxybate ( GHB) because the risk of severe drowsiness, severe breathing problems, and seizures may be increased

  • Carbamazepine, naltrexone, phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease Buprenorphine Patch's effectiveness

  • MAOIs (eg, phenelzine) because the risk of their side effects may be increased by Buprenorphine Patch

  • Methadone because its effectiveness may be decreased by Buprenorphine Patch

  • Medicines that may harm the liver (eg, acetaminophen, isoniazid, ketoconazole, certain medicines for HIV infection, methotrexate) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

This may not be a complete list of all interactions that may occur. Ask your health care provider if Buprenorphine Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Buprenorphine Patch:


Use Buprenorphine Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Buprenorphine Patch comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Buprenorphine Patch refilled.

  • Do not use Buprenorphine Patch if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.

  • Keep Buprenorphine Patch in its original package until you are ready to use it. Apply the patch as soon as you remove it from the sealed pouch.

  • Buprenorphine Patch is only to be used on intact, clean, dry skin. Do not apply Buprenorphine Patch to broken, damaged, or inflamed skin.

  • The application site should be hairless or nearly hairless. If you have no hairless areas, clip the hair; do NOT shave it. If the application site must be cleaned, clean the site with clear water only. Do NOT clean the area with soap, alcohol, lotion, oil, or other cleansers because the risk of Buprenorphine Patch's side effects may be increased. Allow the skin to dry before you apply the patch.

  • Apply the patch to the upper outer arm, upper chest, upper back, or the side of your chest on either side of your body. Do not apply a new patch to the same skin area for at least 21 days. Do not wear more than 1 patch at a time unless your doctor tells you otherwise.

  • Press the patch firmly in place with the palm of your hand for about 15 seconds. Do not rub the patch. Make sure the contact is complete, especially around the edges. Wash your hands after you apply or handle a patch.

  • If the patch does not stick, you may tape only the edges with first-aid tape or cover the patch with a special type of clear adhesive film dressing (eg, Bioclusive, Tegaderm). Do not cover the patch with any other bandage or tape. Ask your doctor or pharmacist about the kinds of dressings that should be used.

  • If the patch falls off, do NOT re-apply it. Apply a new patch to a different skin site.

  • A patch may be worn continuously for 1 week (exactly 7 days) or as directed by your doctor. After removing the old patch, a new patch may be applied to a different skin site.

  • After removing the used patch, fold it in half with the sticky sides together. Flush the used patch down the toilet. You can also use the patch-disposal unit to seal the used patch. Never throw Buprenorphine Patch away if it is not sealed in the patch-disposal unit. Discard the patch out of the reach of children and away from pets.

  • If you forget to change your patch on the day it is due, change the patch as soon as you remember. Do NOT double your dose to catch up.

Ask your health care provider any questions you may have about how to use Buprenorphine Patch.



Important safety information:


  • Buprenorphine Patch may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Buprenorphine Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Buprenorphine Patch; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Buprenorphine Patch may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not change the patch more often than directed by your doctor.

  • Buprenorphine Patch may cause withdrawal symptoms if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin). Talk with your doctor if you are dependent on narcotic medicines or other opiates.

  • Do not expose the patch on your skin to direct sources of heat, such as heating pads, electric blankets, heat or tanning lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or other sources of heat to the body. Tell your doctor if you develop a fever. The heat may cause more medicine to be released into your skin.

  • If the patch comes off your skin and accidentally sticks to the skin of another person, remove the patch from their skin immediately, wash the exposed area of skin with water, and call your doctor, emergency room, or local poison control center right away.

  • Buprenorphine Patch may cause constipation. Talk with your doctor about taking a stool softener or fiber laxative to prevent or treat constipation.

  • Tell your doctor or dentist that you take Buprenorphine Patch before you receive any medical or dental care, emergency care, or surgery.

  • Lab tests, including liver function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Buprenorphine Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially decreased breathing and drowsiness.

  • Buprenorphine Patch should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Buprenorphine Patch, discuss with your doctor the benefits and risks of using Buprenorphine Patch during pregnancy. Buprenorphine Patch is found in breast milk. Do not breast-feed while taking Buprenorphine Patch.

When used for long periods of time or at high doses, Buprenorphine Patch may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Buprenorphine Patch stops working well. Do not take more than prescribed.


Some people who use Buprenorphine Patch for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.


Do not suddenly stop taking Buprenorphine Patch. If you do, you may experience WITHDRAWAL symptoms including anxiety; back, muscle, or joint pain; chills; diarrhea; enlarged pupils; fainting; irritability; runny nose; goose bumps and abnormal skin sensations; increased tearing; muscle or stomach cramps; nausea; pain; persistent loss of appetite; rapid heartbeat or breathing; restlessness; severe or persistent headache; sweating; trouble sleeping; vomiting; weakness; and yawning.



Possible side effects of Buprenorphine Patch:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; dry mouth; fatigue; headache; itching, rash, or redness at the application site; nausea; sweating; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal sighing or snoring; burning, swelling, oozing, or blisters at the application site; chest pain; confusion; dark urine; difficult, shallow, or slow breathing; difficulty talking, thinking, or walking; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; joint or muscle pain; loss of consciousness; mental or mood changes (eg, anxiety, depression); pale stools; seizures; severe drowsiness, dizziness, or lightheadedness; severe or persistent headache or stomach pain; shortness of breath; swelling of the hands, ankles, or feet; tremor; unusual weakness; vision changes; yellowing of the eyes or skin.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Buprenorphine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include abnormal snoring; cold and clammy skin; excessive drowsiness; fainting; irregular heartbeat; loss of consciousness; muscle weakness; severe dizziness; slow heartbeat; very slow and shallow breathing; very small pupils.


Proper storage of Buprenorphine Patch:

Store Buprenorphine Patch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Buprenorphine Patch out of the reach of children and away from pets.


General information:


  • If you have any questions about Buprenorphine Patch, please talk with your doctor, pharmacist, or other health care provider.

  • Buprenorphine Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Buprenorphine Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Buprenorphine resources


  • Buprenorphine Side Effects (in more detail)
  • Buprenorphine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Buprenorphine Drug Interactions
  • Buprenorphine Support Group
  • 84 Reviews for Buprenorphine - Add your own review/rating


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