Fentanyl Transdermal Patch

Fentanyl patches may be habit forming, especially with prolonged use. Use the fentanyl patch exactly as directed. Do not apply more patches, apply the patches more often, or use the patches in a different way than prescribed by your doctor. While using fentanyl patches, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse fentanyl patches if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Fentanyl patches may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Because of this serious risk, fentanyl patches should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week and should not be used to treat mild or moderate pain, short-term pain, pain after an operation or medical or dental procedure, or pain that can be controlled by medication that is taken as needed. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to use fentanyl patches. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury, a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain medications with fentanyl may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications: amiodarone (Nexterone, Pacerone); aprepitant (Emend); benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion);carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); certain antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); diltiazem (Cardizem, Cartia, Diltzac, Taztia); erythromycin (E-Mycin, Erythrocin); fosamprenavir (Lexiva); medications for mental illness and nausea; other medications for pain; muscle relaxants; nefazodone; nelfinavir (Viracept); phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); ritonavir (Norvir, in Kaletra); sedatives; sleeping pills; tranquilizers; troleandomycin (TAO) (not available in the United States); and verapamil (Calan, Covera, Verelan). Your doctor may need to change the dosages of your medications and will monitor you carefully. If you use fentanyl with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care immediately: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own. If you use fentanyl with any of these medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

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Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with fentanyl increases the risk that you will experience these serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Do not allow anyone else to use your medication. Fentanyl patches may harm or cause death to other adults and children who use them. Store fentanyl patches in a safe place so that no one else can use them accidentally or on purpose. Be especially careful to keep fentanyl patches out of the reach of children. Keep track of how many patches are left so you will know if any are missing.

People who are not being treated with fentanyl patches may be seriously harmed or may die if the sticky side of a patch touches their skin. Be careful not to allow the sticky side of the patch to touch anyone else’s skin. If you are holding or caring for children, make sure that they do not touch your patch. If the patch accidentally comes off of your body and sticks to another person’s skin, immediately remove the patch, wash the area with clear water, and get emergency medical attention.

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Fentanyl patches that have been worn for 3 days still contain enough medication to cause serious harm or death to adults or children who are not being treated with the medication. Never throw used or unused patches in a trash can or leave them in a place where they may be found by others, especially children. Dispose of used and unwanted patches properly according to instructions. (See STORAGE and DISPOSAL.)

If your fentanyl patch is exposed to extreme heat, it may release too much medication into your body at once. This can cause serious or life-threatening symptoms. Do not expose your patch or the skin around it to direct heat such as heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds. Do not take long, hot baths or sunbathe while you are wearing the patch. Your patch may also release too much medication if you have a fever or if you get very hot after physical activity. Avoid physical activity that might cause you to get very hot. Call your doctor right away if you have a fever. Your doctor may need to adjust your dose.

Tell your doctor if you are pregnant or plan to become pregnant. If you use fentanyl patches regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

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Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with fentanyl patches and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of using this medication.