Learn more about usage, cautions, and possible side effects .
Chemical Name: FENTANYL (FEN-ta-nil)
This medicine is a narcotic analgesic used to treat persistent moderate to severe chronic pain that requires around the clock administration and can not be relieved by non-steroidal analgesics (such as ibuprofen or naproxen), narcotic combinations analgesics (such as oxycodone or propoxyphene) or immediate-release opioids (such as morphine sulfate immediate release).
WARNING: This medicine should be used only for long-term or chronic pain requiring continuous, around-the-clock narcotic pain relief that is not helped by other less powerful pain medicines or less frequent dosing. DO NOT USE THIS MEDICINE if you have not already been taking other prescription narcotic pain medicines (such as morphine or codeine) on a regular schedule. DO NOT USE THIS MEDICINE for short-term pain, mild pain, pain occurring after surgery, or pain that does not require medicine on a regular schedule. Because serious, sometimes life-threatening, breathing problems can occur (especially in patients who have not been given narcotic medicines previously), seek immediate medical attention in the unlikely event that very slow, shallow breathing occurs. WHEN USED FOR LONG PERIODS OF TIME or at high doses, some people develop a need to continue taking this medicine. This is known as DEPENDENCE or "addiction". Do not use more of this medicine than prescribed by your doctor. DO NOT APPLY the patch to skin that is broken or damaged. Do not cut the patch. Using a cut or damaged patch may lead to a rapid release of medicine and serious, even fatal, side effects. 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. Tell your doctor if you develop a fever. The heat may cause more medicine to be released into your skin and could cause serious, even fatal, side effects. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT USE THIS MEDICINE if you are also taking sodium oxybate, disulfiram, sibutramine, or monoamine oxidase inhibitors (such as furazolidone, linezolid, moclobemide, phenelzine, procarbazine, selegiline, isocarboxazid, or tranylcypromine) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amiodarone, amprenavir, aprepitant, certain calcium channel blockers (such as diltiazem or verapamil), certain cephalosporin antibiotics (such as cefamandole or cefotetan), cimetidine, HIV medicines (such as fosamprenavir, ritonavir, or nelfinavir), macrolide antibiotics (such as clarithromycin, erythromycin or troleandomycin), medicines to treat fungal infections (such as fluconazole, itraconazole, or ketoconazole), medicines to treat mental or mood problems (such as chlorpromazine), metronidazole, muscle relaxants (such as metaxalone), narcotic pain medicine (such as codeine), medicines for anxiety (such as midazolam or diazepam), medicines for sleep (such as zolpidem), naltrexone, or nefazodone. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including a history of coma, increased pressure in the brain (such as from a brain tumor or head injury), breathing problems (such as asthma), stomach problems (such as inflammatory bowel disease), pancreas problems (such as pancreatitis), mood or mental problems (such as depression), addiction to alcohol or other substances, slow or irregular heartbeat, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED during an asthma attack or if you have a history of alcohol or substance abuse, severe stomach problems (such as paralytic ileus or pseudomembranous colitis), severe liver problems, severe kidney problems, or severe breathing problems (such as respiratory depression). Use of this medicine in children under age 2 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. BEFORE USING THIS MEDICINE, clip (do not shave) any hair at the application site. Clean the area with clear water and allow the skin to dry completely. Do not use soaps, oils, lotions, alcohol, or any other liquid that could irritate or otherwise affect the skin. Do not apply the patch to skin that is broken or damaged. Do not use a patch if the package is not sealed. Do not cut or damage the patch in any way before applying the patch. Remove the patch from the package, and peel off the protective strip. Immediately apply the patch to the intact skin (areas that would be the best place for the patch would be the chest, back, upper arm or on the side of the stomach). Press firmly for 30 seconds to make sure the patch stays in place. Check to see that the edges of the patch are stuck to the skin. Wash your hands after applying the 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 (such as Bioclusive or Tegaderm). Do not cover the patch with any other bandage or tape. Ask your doctor if you are unsure of what type of dressing you can use. DO NOT WEAR MORE THAN ONE PATCH AT A TIME, unless otherwise directed by your doctor. EACH PATCH MAY BE WORN for up to 72 hours. AFTER REMOVING THE PATCH, fold with sticky sides together. The patch should be properly disposed of immediately upon removal. Ask your doctor or pharmacist how to dispose of this medicine properly. APPLY A NEW PATCH TO A DIFFERENT SKIN AREA to avoid irritation. If the patch falls off before 72 hours has passed, apply a new patch to a different skin site. CHECK WITH YOUR DOCTOR BEFORE EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE while taking this medicine. The risk of this medicine's side effects may be increased. STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C), away from heat and light. 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.
DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to morphine or hydromorphone. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. DO NOT USE EXTERNAL HEAT SOURCES such as electric blankets, heating pads, saunas, hot tubs while the patch is in place, as an accidental overdose can occur. TELL YOUR DOCTOR IF YOU DEVELOP A FEVER. The increase in temperature could cause more medicine to be released into your skin and result in an accidental overdose. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. When used for an extended period of time, this medicine may not work as well and may require different dosing. Some conditions may become worse when the medicine is suddenly stopped. Your dose may need to be slowly lowered to avoid side effects. DO NOT EXCEED THE RECOMMENDED DOSE, change the patch more often than directed, or use this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. KEEP ALL DOCTOR appointments while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. SOME PATCHES MAY CAUSE burns if left on the skin during certain medical procedures (eg, magnetic resonance imaging [MRI]). You may need to remove your patch before you have such tests. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. If the patch comes off your skin and accidentally sticks to the skin of another person, remove the patch immediately from their skin, wash the exposed area of skin with water and call your doctor, emergency room, or local poison control center immediately. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine. CAUTION SHOULD BE USED IN THE ELDERLY, they may be more sensitive to the effects of this drug especially respiratory depression. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS FOUND IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.
SIDE EFFECTS that may occur while using this medicine include drowsiness, stomach pain or discomfort, fatigue, nausea, vomiting, constipation, diarrhea, dry mouth, sweating, weakness or tiredness, headache, muscle ache, fever or dizziness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience loss of appetite, mental or mood changes, unusual muscle movements, loss of memory, difficulty breathing, vision problems, seizures, or difficulty urinating. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain, coughing up blood, irregular heartbeat, fainting, unusual sensation felt through the body (such as burning, tingling, tickling or pricking), or high fever. Accidental overdose may occur in the presence of a high fever. AN ALLERGIC REACTION TO THIS MEDICINE is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If overdose is suspected, remove the patch. Contact your local poison control center or emergency room immediately. Symptoms of overdose may include slow, shallow breathing; drowsiness; deep sleep or loss of consciousness; cold, clammy skin; and slow heart rate.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain a new prescription before your supply runs out. PROPERLY DISPOSE OF ANY UNUSED PATCHES remaining from a prescription as soon as they are no longer needed. KEEP THIS MEDICINE out of the reach of children and pets.
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