GENERIC NAME: FENTANYL - TRANSDERMAL (FEN-ta-nil)
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.
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.
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USES: This medication is used to help relieve moderate to 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.
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.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. After applying the patch, wash your hands with water only.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.
SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Mild irritation, itching, or redness at the application site may also occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, slow/fast/pounding heartbeat.Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using fentanyl, tell your doctor or pharmacist if you are allergic to it; or to adhesives; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), disease of the pancreas (pancreatitis), gallbladder disease, slow/fast/irregular heartbeat.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Tell your doctor promptly if you develop a fever, since this rise in body temperature may cause overdose (see also Warning section).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and 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, use the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone).Other medications can affect the removal of fentanyl from your body, which may affect how fentanyl works. Examples include cimetidine, nefazodone, St. John's wort, azole antifungals including itraconazole/ketoconazole, calcium channel blockers such as diltiazem/verapamil, HIV drugs such as nelfinavir/ritonavir, macrolide antibiotics including clarithromycin/erythromycin, rifamycins including rifampin, certain anti-seizure medicines including carbamazepine, among others.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is used with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
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OVERDOSE: This medication patch may be harmful if chewed or swallowed. If overdose or swallowing is suspected, remove the patch if possible, and contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, loss of consciousness.
NOTES: Do not share this medication with others. It is against the law and the medication may cause harm to others.This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.
STORAGE: Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.See also Warning and How to Use sections. Properly discard this product when it is expired or no longer needed. Read the Medication Guide for details. To discard, the FDA recommends flushing this medication down the toilet. However, consult your pharmacist or local waste disposal company.
Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.