Fentanyl Transdermal Patch 

(fen' ta nil)

IMPORTANT WARNING:

Fentanyl skin patches should only be used to control moderate to severe chronic (around-the-clock, long-lasting) pain that cannot be controlled by the use of other pain medications in people who are tolerant (used to the effects of the medication) to narcotic pain medications because they have taken this type of medication for at least 1 week. Fentanyl skin patches should not be used to treat mild 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.

Fentanyl skin patches may cause serious or life-threatening breathing problems, especially during the first 72 hours of your treatment. Tell your doctor if you have or have ever had breathing difficulties, asthma, chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), or other lung disease. Your doctor may tell you not to use fentanyl skin patches. Also tell your doctor and pharmacist if you are taking or plan to take any of the following medications: certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); clarithromycin (Biaxin, in Prevpac); nefazodone; nelfinavir (Viracept); ritonavir (Norvir, in Kaletra) and troleandomycin (TAO) (not available in the United States). If you have any of the following symptoms, call your doctor immediately: difficulty breathing; extreme drowsiness with slow breathing; heartbeat that is slower than normal; cold clammy skin; difficulty thinking, talking, or walking normally; dizziness; confusion; extreme tiredness; fainting; or loss of consciousness.

Do not apply fentanyl skin patches to skin that is irritated, broken out, burned, cut, or damaged in any way. Do not use a fentanyl skin patch that is cut, damaged, or changed in any way. If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 3 days. This may cause serious problems, including overdose and death.

Fentanyl skin patches can be habit-forming. Tell your doctor if you or anyone in your family drink or have ever drunk large amounts of alcohol; have overused prescription medications; have used street drugs; or have or have ever had depression or mental illness.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fentanyl skin patches and each time you refill 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.

Fentanyl skin patches should not be used in children less than 2 years of age. Talk to your child's doctor about the risks of applying fentanyl skin patches to your child.

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

WHY is this medicine prescribed?

Fentanyl skin patches are used to relieve moderate to severe pain that is expected to last for some time, that does not go away, and that cannot be treated with other pain medications. Fentanyl skin patches are only used to treat people who are tolerant (used to the effects of the medication) to narcotic pain medications because they have taken this type of medication for at least 1 week. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

HOW should this medicine be used?

Transdermal fentanyl comes as a patch to apply to the skin. The patch is usually applied to the skin once every 72 hours. Change your patch at about the same time of day every time you change it. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply fentanyl patches exactly as directed.

Your doctor may start you on a low dose of fentanyl skin patches and gradually increase your dose, not more often than once every 3 days at first, and then not more often than once every 6 days.

Fentanyl skin patches are only for use on the skin. Do not place patches in your mouth or chew or swallow the patches.

The medication in fentanyl patches is contained in a gel that is sealed between layers of the patch. If this gel leaks from the patch, remove the patch right away without touching the gel. If you or a caregiver touches the gel, immediately wash the area with large amounts of clear water. Do not use soap, alcohol, or other cleansers.

Fentanyl skin patches may be habit forming. Do not apply more than one patch at a time unless your doctor tells you that you should, and do not apply fentanyl skin patches more often, or for a longer period of time than prescribed by your doctor.

Do not stop using fentanyl skin patches without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using fentanyl skin patches you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast heartbeat, or rapid breathing.

While you are wearing a fentanyl patch, protect the patch from 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.

You may bathe, swim, or shower while you are wearing a fentanyl skin patch. If the patch falls off during these activities, dry your skin completely and apply a new patch.

To apply the patch, follow these steps:

  • Choose a flat, hairless area of skin on your chest, back, upper arm, or sides of your waist. If you are applying the patch to a child or person who is unable to think clearly, choose an area on the upper back to make it more difficult for the person to remove the patch and place it in his or her mouth. Avoid areas that move a lot, that are sensitive, that have been exposed to radiation (x-ray treatment), or where you have recently applied a skin patch. If there is hair on the skin, clip the hair as close to the skin as possible with scissors, but do not shave it.
  • Clean the area with clear water and pat dry. Do not use any soaps, lotions, alcohols or oils.
  • Tear open the pouch containing the fentanyl skin patch along the dotted line, starting at the slit. Remove the skin patch from the pouch and peel off the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
  • Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
  • Press the patch firmly for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
  • If the patch does not stick well or comes loose after it is applied, tape the edges to your skin with first aid tape.
  • When you are finished applying the patch, wash your hands with only clear water right away.
  • When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
  • After you remove your patch, fold it in half with the sticky sides together and flush it down a toilet. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed fentanyl skin patches.
  • If a patch accidentally comes off or if the skin under the patch becomes irritated, remove the patch and replace it with a new one in a different area, following the steps above.

    Are there OTHER USES for this medicine?

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before using fentanyl skin patches,

    • tell your doctor and pharmacist if you are allergic to fentanyl, adhesives (glues), or any other medications.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING and any of the following medications: amiodarone (Cordarone); antidepressants; antihistamines; carbamazepine (Carbatrol, Equetro, Tegretol); cimetidine (Tagamet); diltiazem; erythromycin (E-Mycin, Erythrocin); fluvoxamine; medications for anxiety; medications for cough, cold, or allergies; medications for nausea; muscle relaxants; nevirapine (Viramune); other medications for pain; phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); sedatives; sleeping pills; tranquilizers; or verapamil (Calan, Covera, Verelan). Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor what herbal products you are taking, especially St. John's wort.
    • tell your doctor if you have or have ever had paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use fentanyl skin patches.
    • tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke or any other condition that caused high pressure inside your skull; seizures;slowed heartbeat; difficulty urinating; Addison's disease (a condition in which the adrenal gland does not make enough of certain natural substances); low blood pressure; or thyroid, heart, liver, pancreas, gallbladder, or kidney disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using a fentanyl skin patch, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl skin patches.
    • you should know that this medication may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this medication affects you.
    • you should know that fentanyl skin patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl skin patches. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
    • do not drink any alcohol while using fentanyl skin patches. Alcohol increases the chance that you will experience serious side effects of the medication.
    • you should know that fentanyl skin patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using fentanyl skin patches.
    • you should know that if you have a fever, the amount of fentanyl that you receive from the skin patch may increase and possibly cause an overdosage of medication. Call your doctor right away if you have a fever higher than 102 °F (38.9 °C). Your doctor may need to adjust your dose.
    • be aware that children and adults who are not being treated with fentanyl skin patches may be harmed if the medication in the patches touches their skin. Be careful not to allow the sticky side of the patch to touch anyone else's skin. If the patch comes off of your body and sticks to another person's skin, immediately remove the patch, wash the area with clear water, and get medical attention for the person.

    What SPECIAL DIETARY instructions should I follow?

    Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

    What should I do IF I FORGET to take a dose?

    If you forget to apply or change a fentanyl skin patch, apply the patch as soon as you remember it. Be sure to remove your used patch before applying a new patch. Wear the new patch for the period of time prescribed by your doctor (usually 3 days) and then replace it. Do not wear two patches at once unless your doctor has told you that you should.

    What SIDE EFFECTS can this medicine cause?

    Fentanyl skin patches may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

    • headache
    • mood changes
    • nervousness
    • depression
    • confusion
    • memory problems
    • hallucinations (seeing things or hearing voices that do not exist)
    • weakness
    • dizziness
    • difficulty falling asleep or staying asleep
    • uncontrollable shaking of a part of the body
    • pain, burning, tingling, or numbness in the hands or feet
    • dry mouth

    • hiccups

    • stomach pain
    • indigestion

    • gas

    • diarrhea
    • constipation

    • nausea

    • vomiting
    • loss of appetite
    • back pain
    • difficulty urinating

    • itching

    • skin irritation, redness, itching, swelling, or blisters in the area where you wore the patch
    • sweating

    Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

    • heartbeat that is faster than normal
    • chest pain

    • rash

    • seizure

    • coughing up blood

    Fentanyl skin patches may cause other side effects. Call your doctor if you have any unusual problems while you are using fentanyl skin patches.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the protective pouch it came in, tightly closed, and out of reach of children and pets. Store fentanyl skin patches in a safe place so that no one can take them accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing. Store the patches at room temperature and away from excess heat and moisture (not in the bathroom). Do not store fentanyl skin patches inside your car.

    Throw away any patches that are outdated or no longer needed by carefully removing the adhesive backing, folding the sticky sides of each patch together so that it sticks to itself, and flushing the patches down the toilet. Throw away the pouches and protective liners in the trash. Wash your hands well with water after throwing away fentanyl patches. Do not put unneeded or used fentanyl skin patches in a garbage can.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

    • difficulty breathing
    • extreme sleepiness or tiredness
    • difficulty thinking, talking, or walking normally
    • small, pinpoint pupils (black circles in the center of the eye)
    • faintness
    • dizziness
    • confusion
    • coma (loss of consciousness for a period of time)

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.

    This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names
    • Duragesic®
    • Also available generically

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