"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(buprenorphine) Transdermal System
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
Important information about BUTRANS:
- Get emergency help right away if you take too much BUTRANS (overdose). When you first start taking BUTRANS, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Never give anyone else your BUTRANS. They could die from taking it. Store BUTRANS away from children and in a safe place to prevent stealing or abuse. Selling or giving away BUTRANS is against the law.
Do not use BUTRANS if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
Before applying BUTRANS, tell your healthcare provider if you have a history of:
- head injury, seizures
- liver, kidney, thyroid problems
- problems urinating
- pancreas or gallbladder problems
- heart rhythm problems (Long QT syndrome)
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you:
- have a fever
- are pregnant or planning to become pregnant. Prolonged use of BUTRANS during pregnancy can cause withdrawal symptoms in your newborn baby
- that could be life-threatening if not recognized and treated.
- are breastfeeding. BUTRANS passes into breast milk and may harm your baby.
- are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BUTRANS with certain other medicines can cause serious side effects.
While using BUTRANS:
- Do not change your dose. Apply BUTRANS exactly as prescribed by your healthcare provider.
- See the detailed Instructions for Use for information about how to apply the BUTRANS patch.
- Do not apply a BUTRANS patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
- Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
- You should wear 1 BUTRANS patch continuously for 7 days.
- Call your healthcare provider if the dose you are using does not control your pain.
- Do not stop using BUTRANS without talking to your healthcare provider.
- To properly dispose of used and unused patches, use the Patch-Disposal Unit or fold in half and flush down the toilet. See the detailed Instructions for Use.
When using BUTRANS DO NOT:
- Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps. These can cause an overdose that can lead to death.
- Drive or operate heavy machinery, until you know how BUTRANS affects you. BUTRANS can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BUTRANS may cause you to overdose and die.
The possible side effects of BUTRANS are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, itching, redness or rash where the patch is applied. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.
These are not all the possible side effects of BUTRANS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. For more information go to dailymed.nlm.nih.gov
Instructions for Use
Be sure that you read, understand, and follow these Instructions for Use before you use BUTRANS. Talk to your healthcare provider or pharmacist if you have any questions.
Before Applying BUTRANS:
- Do not use soap, alcohol, lotions, oils, or other products to remove any leftover adhesive from a patch because this may cause more BUTRANS 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:
- BUTRANS should be applied to the upper outer arm, upper chest, upper back, or the side of the chest (See Figure A). These 4 sites (located on both sides of the body) provide 8 possible BUTRANS application sites.
- Do not apply more than 1 patch at the same time unless your doctor tells you to. However, if your healthcare provider tells you to do so, you may use 2 patches as prescribed, applied at the same site (See Figure A for application sites) right next to each other (See Figure B for an example of patch position when applying 2 patches). Always apply and remove the two patches together at the same time.
- You should change the skin site where you apply BUTRANS each week, making sure that at least 3 weeks (21 days) pass before you re-use the same skin site.
- Apply BUTRANS to a hairless or nearly hairless skin site. If needed, you can clip the hair at the skin site (See Figure C). 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 a new 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 BUTRANS:
- If you are wearing a patch, remember to remove it before applying a new one.
- Each patch is sealed in its own protective pouch.
- If you are using two patches, remember to apply them at the same site right next to each other. Always apply and remove the two patches together at the same time.
- Use scissors to cut open the pouch along the dotted line (See Figure D) 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 (See Figures E and F) 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 (See Figure G), apply the sticky side of the patch to one of the 8 body locations described above (See “Where to apply BUTRANS”).
- 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 (See Figure H).
- Press the entire patch firmly into place with the palm (See Figure I) 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.
- If you are using two patches, follow the steps in this section to apply them right next to each other.
- 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 (See “Disposing of BUTRANS Patch”).
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.
Short-term exposure of the BUTRANS patch to water, such as when bathing or showering, is permitted.
If the edges of the BUTRANS 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
- Remove the backing from the transparent adhesive dressing and place it carefully and completely over the BUTRANS patch, smoothing it over the patch and your skin.
- Never cover a BUTRANS patch with any other bandage or tape. It should only be covered with a special see-through adhesive dressing. Talk to your healthcare provider 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 (See “Disposing of a BUTRANS Patch”) and apply a new patch at a different skin site. Be sure to let your healthcare provider 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 healthcare provider).
Disposing of BUTRANS Patch:
BUTRANS patches should be disposed of by using the Patch-Disposal Unit. Alternatively, the patches can be flushed down the toilet.
To dispose of BUTRANS patches in household trash using the Patch-Disposal Unit:
Remove your patch and follow the directions printed on the Patch-Disposal Unit (See Figure J) 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 (See Figure K).
2. Place the sticky side of the used or unused patch to the indicated area on the disposal unit (See Figure L).
3. Close the disposal unit by folding the sticky sides together (See Figure M). 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 (See Figure N).
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.
To flush your BUTRANS patches down the toilet:
Remove your BUTRANS patch, fold the sticky sides of a used patch together and flush it down the toilet right away (See Figure O).
When disposing of unused BUTRANS 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 BUTRANS patches in the trash without first sealing them in the Patch-Disposal Unit.
This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.
Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431. Revised: June 2014
Last reviewed on RxList: 7/20/2015
This monograph has been modified to include the generic and brand name in many instances.
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