Fentanyl (Absorbed through the skin)

Introduction

Fentanyl (FEN-ta-nil)

Treats severe, ongoing pain that cannot be controlled with other medicines. This medicine is a narcotic pain reliever.

Brand Name(s)

Duragesic, Novaplus Fentanyl

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to fentanyl or to silicone adhesives. You should not use this patch until after you have tried other narcotic (opioid) medicines. Do not use this medicine if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine if you only need pain medicine sometimes, such as only in the morning. You should not use this medicine if you are having trouble breathing, such as with severe asthma, or if you have a digestion problem called paralytic ileus. No one else should ever use your patch for any reason.

How to Use This Medicine

Patch

• This is a very strong medicine. Using this medicine wrong can cause trouble breathing and other serious health problems, including death. If you do not understand the directions or warnings, ask your doctor.
• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
• The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one.After you apply the patch, push down on it with the palm of your hand for 30 seconds to make sure it sticks to your skin.
• If this patch is for a person who is not responsible, such as a young child, apply the patch where it cannot be reached, such as the upper back. Check the patch occasionally to make sure it is still okay.
• Do not put the patch over burns, cuts, or irritated skin.
• Do not use soap, lotion, alcohol, or oil on your skin before applying the patch. Wash the skin only with clear water. Let your skin dry completely. Do not shave the skin where you will apply the patch. If you must get rid of some hair, cut the hair with a pair of scissors.
• Put on a new patch if the old one has fallen off and cannot be reapplied. If a patch is loose, tape it to your skin with first aid tape.
• Never put the patch in your mouth.
• If your patch has gel inside it: If any of this gel escapes from the patch and gets directly on your skin, wash it off right away with clear water. The gel is only supposed to go through the patch and onto your skin.
• Water should not affect the patch, so you can take a shower or go swimming while wearing it.
• Drink plenty of fluids to help avoid constipation.

If a dose is missed:

• If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

How to Store and Dispose of This Medicine

• Throw any used patch away so that children or pets cannot get to it. There is still enough medicine in a used patch to make a child or pet very sick. When throwing away a patch, fold it in half with the sticky sides together and flush it down the toilet, and then wash your hands thoroughly with soap and water. When you stop treatment with this medicine, take all of the leftover patches out of the packages and throw them away.
• Store the patches at room temperature in the original package, away from heat, moisture, and direct light.
• Keep all medicine away from children and never share your medicine with anyone. If a child is exposed to this medicine, call Poison Control or an emergency room right away.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using troleandomycin (Tao®), nefazodone (Serzone®), clarithromycin (Biaxin®), medicine to treat HIV/AIDS (such as nelfinavir, ritonavir, Kaletra®, Norvir®, or Viracept®), or medicine to treat a fungus infection (such as fluconazole, itraconazole, ketoconazole, Diflucan®, Nizoral®, or Sporanox®).
• Make sure your doctor knows if you are also using amiodarone (Cordarone®), amprenavir (Agenerase®), aprepitant (Emend®), erythromycin (Ery-tab®), diltiazem (Cardizem®), fosamprenavir (Lexiva®), verapamil (Isoptin®), or an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you or anyone in your family has ever had major depression or other mental or emotional problems.
• Make sure your doctor knows if you or anyone in your family has ever abused drugs or alcohol or had a drug addiction. Tell your doctor if you have low blood pressure, heart disease, slow heart rhythm problems, kidney disease, pancreas problems, or liver disease.
• Tell your doctor if you have any kind of breathing problem, such as chronic obstructive pulmonary disease (COPD), cor pulmonale, pulmonary hypertension, hypoxia or hypercapnia (low oxygen or high carbon dioxide level in your blood), or hypoventilation (breathing too slowly). Tell your doctor if you have a recent head injury, brain tumor, or other problem that could increase the pressure in your head.
• Using too much of this medicine can cause death. Symptoms of getting too much medicine include: trouble breathing, slow or shallow breathing, extreme dizziness or weakness, slow heartbeat, fainting, or extreme sleepiness.
• It is against the law and dangerous for anyone else to use your medicine. Keep your unused patches in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
• Do not let the patch get too hot. It may release too much medicine too quickly. Avoid direct sunlight, and do not use a heating pad, electric blanket, heated water bed, sauna, sun lamp, or hot tub. Call your doctor if you have a fever higher than 102 degrees.
• This medicine should not be used by a child younger than 2 years old or by a child who has not received a narcotic (opioid) medicine before.
• Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as if you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when standing up suddenly from a sitting or lying position, so get up slowly.
• Make sure any doctor or dentist who treats you knows that you are using this medicine.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• If your symptoms do not improve or if they get worse, call your doctor. Your pain will not get better right away. It may take a day or longer for the medicine to reach its full effect.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, depression, nervousness, or mood or behavior changes.
• Change in how much or how often you urinate.
• Chest pain.
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness, dizziness, or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Tremors or seizures.
• Trouble breathing, slow or shallow breathing, sighing, extreme weakness or sleepiness.

If you notice these less serious side effects, talk with your doctor:

• Headache.
• Loss of appetite.
• Mild, temporary tiredness, weakness, or confusion.
• Nausea, vomiting, constipation, diarrhea, dry mouth, or stomach pain.
• Redness, itching, or mild skin rash where the patch is stuck to your skin.
• Sweating.
• Trouble sleeping.
• Weight loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088