"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.
FENTANYL - TRANSDERMAL
COMMON BRAND NAME(S): Duragesic
WARNING: Fentanyl has a high risk for abuse and severe, possibly fatal, breathing problems. Do not use transdermal patches unless you have been regularly taking moderate to large amounts of narcotic pain medication. Otherwise, it may cause overdose (even death). The risk for harm is higher if you use the wrong dose/strength, or if you use it along with other drugs that might also affect breathing. The risk for breathing problems might also be higher when you start this medication and after a dose increase. Get medical help right away if you notice unusual slow/shallow breathing.
Do not use this medication to relieve mild, short-term, or sudden pain (such as due to headache/migraine, dental/medical procedures), or pain after surgery (including same-day surgery when you do not need to stay in the hospital overnight). This medication is not for occasional ("as needed") use.
Since they are not used the same way, different forms of fentanyl (including lozenges, buccal tablets, patches) do not have the same effects at equal strengths and should not be substituted for each other. Tell your doctor or pharmacist of all medications that you use, especially of drugs that can affect how fentanyl works (see also Drug Interactions section). Do not start, stop, or change the dosage of any medicines you are using without your doctor's approval.
Carefully follow the manufacturer's instructions for using fentanyl transdermal patches. The patches are for use on the skin only. Raising your skin/body temperature, using cut or damaged fentanyl patches, or using the patch improperly (such as by chewing it) may cause fatal overdose. Avoid increasing your skin temperature at/near the application site by using products such as heating pads, electric blankets, hot tubs, heat lamps, or tanning lamps. Avoid taking hot baths and sunbathing. However, you may bathe, shower, or swim while wearing the patch as long as you avoid hot water.
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. This medication is not recommended for use in children younger than 2 years. Some manufacturers recommend that this product should not be used in children younger than 18 years. If a child accidentally swallows this drug, get medical help right away.
USES: This medication is used to help relieve severe ongoing pain (such as due to cancer). Fentanyl 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.
Do not use the patch form of fentanyl 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.
Before you start using this medication, ask your doctor or pharmacist if you should stop or change the dose of your other narcotic medication(s). It may take up to 24 hours before you have pain relief from fentanyl 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 fentanyl 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 chest, sides, back, or upper arms. In young children or 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 72 hours. To avoid irritation, apply to a different area each time. Be sure to remove the old patch before applying a new patch. The used patch still contains enough fentanyl to cause serious harm, even kill a child or pet, so fold it in half with the sticky sides together and discard properly. Do not let children see you apply a patch, and do not apply the patch where children can see it. Children have found patches that have fallen off or removed patches on sleeping adults and put them in their mouths or on their bodies with fatal results. (See also Warning section).
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 30 seconds, making sure the contact is complete (especially around the edges). If your prescribed dose is for more than one patch, make sure the edges of the patches do not touch or overlap. Wash your hands after applying the patch.
If you have problems with the patch not sticking at the application site, you may tape the edges in place with first aid tape. If this problem persists, ask your doctor for advice. If the patch falls off before 72 hours, 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.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. 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 persists or worsens.
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