"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"...
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
BUPRENORPHINE - TRANSDERMAL
COMMON BRAND NAME(S): Butrans
WARNING: Buprenorphine has a high risk for abuse and severe, possibly fatal, breathing problems. The risk for harm is higher if you use the wrong dose/strength, misuse the medication (such as chewing or swallowing the patch), or if you use it along with other drugs that might also affect breathing. Be sure you know how to use buprenorphine and what other drugs you should avoid taking with it. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get immediate medical help if you notice unusual slow/shallow breathing.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Babies born to mothers who use this drug for a long time may develop severe (possibly fatal) withdrawal symptoms. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, shaking, persistent crying, vomiting, diarrhea, poor feeding, or difficulty gaining weight.
Keep this medicine in a safe place to prevent theft, misuse, or abuse. If a child accidentally swallows or uses this drug, get medical help right away because fatal breathing problems may occur.
USES: This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Buprenorphine belongs to a class of drugs known as narcotic (opiate) analgesics. It works in the brain to change how your body feels and responds to pain.
The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of narcotic pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking narcotic medication.
Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
HOW TO USE: See also Warning section.
Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn how to properly use, store, and discard the patches. If you have any questions, ask your doctor or pharmacist.
Use this medication on a regular schedule as directed by your doctor, not as needed for sudden (breakthrough) pain. If you are already using a narcotic medication, ask your doctor or pharmacist if you should stop or change the dose of your other narcotic medication before you start using this medication. It may take 24 hours or longer before you have pain relief from buprenorphine patches. For added pain relief, your doctor may direct you to also take quick-acting narcotic or non-narcotic pain medications (such as acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions about using buprenorphine safely with other drugs.
Apply this medication to the skin as directed by your doctor. Do not apply on burns, cuts, irritated skin, or skin that has been exposed to radiation (x-ray treatment). Select a dry, non-hairy area on a flat part of your body, such as the upper chest, sides of the chest, upper back, or upper outer arms. In people unable to think clearly (such as due to dementia), apply the patch on the upper back to lessen the chance it might be removed or placed in the mouth. If there is hair on the skin, use scissors to clip the hair as close as possible to the skin. Do not shave hair since this might cause skin irritation. If needed, use water to clean the area. Do not use soap, oils, lotions, or alcohol on the application site. Dry the skin well before applying the patch.
The patch is usually changed every 7 days. To avoid irritation, apply to a different area each time and do not apply to the same site within 3 weeks. Be sure to remove the old patch before applying a new patch. The used patch should be folded in half with the sticky sides together and properly discarded. If your manufacturer has supplied a patch disposal unit, follow directions for its use.
Do not use the patch if it appears to be broken, cut, or damaged. Remove from the sealed pouch, peel off the protective liner, and apply immediately to the skin. Press firmly in place with the palm of the hand for about 15 to 30 seconds, making sure the contact is complete (especially around the edges). If your prescribed dose is for more than one patch, apply them right next to each other but make sure the edges of the patches do not touch or overlap. After applying the patch, wash your hands with water only.
You may bathe, shower, or swim while wearing the patch. If you have problems with the patch not sticking at the application site, you may tape the edges in place with certain kinds of clear tape. Ask your doctor or pharmacist about which type of tape should be used. If this problem persists, ask your doctor for advice. If the patch falls off before 7 days, a new patch may be applied to a different skin site. Be sure to let your doctor know if this happens.
If you accidentally touch the sticky layer to your skin or handle a cut or damaged patch, wash the area well with clear water. If the patch comes off and accidentally sticks to the skin of another person, immediately remove the patch, wash the area with water, and get medical help for them right away. Do not use soap, alcohol, or other products to wash the area.
The dosage is based on your medical condition and response to treatment. Do not apply more patches than directed, change them more frequently, or use them for a longer time than prescribed. Your risk for side effects will increase.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. Withdrawal can also occur if you are switching from another narcotic medication to buprenorphine. Symptoms of withdrawal include restlessness, watering eyes, runny nose, nausea, sweating, or muscle aches. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Use this medication exactly as prescribed to lessen the risk of addiction.
Tell your doctor if your pain is not relieved or if it worsens.
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