Fentanyl, Transdermal

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KEY POINTS

• This medicine is put on the skin to a patch that is put on skin to relieve chronic pain. Use it exactly as directed. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: narcotic (opioid) pain reliever

Generic and brand names: fentanyl, transdermal; Duragesic

What is this medicine used for?

This medicine is a patch that is put on skin to relieve chronic pain in people who have taken narcotic pain medicines before. The patch allows the medicine to be absorbed slowly and constantly through the skin. This medicine is only for people who have taken narcotic pain medicines before and whose pain cannot be managed with other pain medicines.

This medicine is NOT used for mild pain, pain that you have once in a while, or pain that is expected to last a short time (such as after surgery).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Diabetes
• Heart disease or irregular heartbeat
• Liver or kidney disease
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant while using this medicine. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. Do not breast-feed while using this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a new prescription.

Check the label on the medicine for directions about your specific dose. These patches come in several different strengths. Your healthcare provider will work with you to find the correct strength for you. You may need to apply more than one patch at a time. Use this medicine exactly as your healthcare provider prescribes.

Check with your healthcare provider before using this medicine in children under age 2.

Do not use a patch if the seal is broken, or if it is cut or damaged in any way. The patch is for use on the skin only.

Wash your hands before using this medicine. Clip away hair (do not shave) before applying the patch. Use only water (no soap, oil, or alcohol) to clean the area where you put the patch. Allow the skin to dry completely before putting on the patch. Put the sticky side of the patch that contain the medicine on a flat surface of the upper body.

Do not put the patch on skin that is broken or irritated. You may bathe, swim, or shower while wearing the patch, However, do not use a heating pad, electric blanket, heat lamp, tanning bed, hot tub, sauna, or other direct heat where you apply the patch. Also, avoid strenuous exercise. These may increase the amount of medicine released from the patch and could result in an overdose. Talk with your healthcare provider about this.

To dispose of a used patch, fold it so that it sticks to itself with the medicine inside. Then dispose of it safely away from children and pets, such as flushing down the toilet. Do NOT put a used patch in a trash can.

What if I miss a dose?

If you forget to change the patch, change it as soon as you remember. Do not apply extra patches to make up for a missed dose. If the patch falls off, put a new patch on clean, dry skin. If you are not sure of what to do, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: extreme drowsiness; pinpoint pupils; confusion; trouble breathing or breathing that stops, cold and clammy skin; muscle weakness; irregular or slow heartbeat; fainting; seizures; coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

If you develop a fever or skin irritation while wearing this patch, contact your healthcare provider right away.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may lessen this effect.

This medicine may make you constipated. Drinking lots of water, exercising, and taking more fiber may help. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

If the patch comes off and accidentally sticks to the skin of another person, take the patch off of that person right away, wash the area with water, and contact your healthcare provider right away. This may happen while hugging, or from applying or removing the patch for someone else.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); chest pain; fast, slow, or irregular heartbeat; severe muscle weakness; decreased or trouble urinating; severe dizziness or fainting; trembling; pinpoint pupils; blurred vision; cold, clammy skin; blue lips, fingernails, or skin; unusual mood or behavior changes; severe drowsiness, nervousness, restlessness, or weakness; problems walking or talking.

Other: Drowsiness, dizziness, nausea, vomiting, constipation, sweating, headache, dry mouth, decreased appetite, change in sexual desire or ability, trouble sleeping, skin irritation where you put the patch.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Abiraterone (Zytiga)
• Alcohol
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), nilotinib (Tasigna), and others
• Cimetidine (Tagamet)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eluxadoline (Viberzi)
• Flibanserin (Addyi)
• Heart medicines such as digoxin (Lanoxin), dronedarone (Multaq), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as gotu kola, kava, St. John's wort, valerian, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), promethazine, and others
• Pain medicines such as buprenorphine (Buprenex, Butrans), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Rasagiline (Azilect)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Tedizolid (Sivextro)

Do not drink alcohol while you are taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store patches at room temperature in a closed container. Protect them from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.