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MEDICATION GUIDE

DURAGESIC®
(Dur-ah-GEE-zik)
(Fentanyl Transdermal System)

IMPORTANT:

• Keep DURAGESIC® (fentanyl transdermal) in a safe place away from children and pets. Accidental use by a child or pet is a medical emergency and may result in death. If a child or pet accidentally uses DURAGESIC® (fentanyl transdermal) , get emergency help right away.
• Make sure you read the separate “Instructions for Applying a DURAGESIC® (fentanyl transdermal) Patch.” Always use a DURAGESIC® (fentanyl transdermal) Patch the right way. DURAGESIC® (fentanyl transdermal) can cause serious breathing problems and death, especially if it is used the wrong way.
• DURAGESIC® (fentanyl transdermal) is a federally controlled substance (C-II) because it can be abused. Keep DURAGESIC® (fentanyl transdermal) in a safe place to prevent theft. Selling or giving away DURAGESIC® (fentanyl transdermal) may harm others, and is against the law.
• Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines or street drugs.

Read the Medication Guide that comes with DURAGESIC® (fentanyl transdermal) before you start using it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Make sure you read and understand all the instructions for using DURAGESIC® (fentanyl transdermal) . Do not use DURAGESIC® (fentanyl transdermal) unless you understand everything. Talk to your healthcare provider if you have questions.

What is the most important information I should know about DURAGESIC® (fentanyl transdermal) ?

DURAGESIC® is a skin patch that contains fentanyl. Fentanyl is a very strong opioid narcotic pain medicine that can cause serious and life-threatening breathing problems. Serious and life-threatening breathing problems can happen because of an overdose or if the dose you are using is too high for you. Call your doctor right away or get emergency medical help if you:

• have trouble breathing, or have slow or shallow breathing
• have a slow heartbeat
• have severe sleepiness
• have cold, clammy skin
• feel faint, dizzy, confused, or cannot think, walk, or talk normally
• have a seizure
• have hallucinations

DURAGESIC® (fentanyl transdermal) is only for adults and children over the age of two with persistent, moderate to severe chronic pain and who:

• are already using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. This is called being opioid-tolerant.
• have pain that cannot be controlled with other medicines

Do not use DURAGESIC® (fentanyl transdermal) :

if you are not already using another opioid narcotic medicine and are not opioid tolerant

• if you need opioid pain medicines for only a short time
• for pain from surgery, medical or dental procedures
• if your pain can be taken care of by occasional use of other pain medicines
• in children who are less than 2 years of age
• if you have asthma symptoms or have severe asthma

A DURAGESIC® (fentanyl transdermal) patch must be used only on the skin of the person for whom it was prescribed. 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 get medical care for them right away.

DURAGESIC® (fentanyl transdermal) patch is not safe for everyone. Tell your doctor about all of your medical conditions.

Tell your doctor if you are planning to become pregnant, are pregnant, or breastfeeding. DURAGESIC® (fentanyl transdermal) may cause serious harm to a baby.

Tell your doctor about all the medicines you take. Some medicines may cause serious or life-threatening side effects when used with DURAGESIC® (fentanyl transdermal) . Your doctor will tell you if it is safe to take other medicines while you are using DURAGESIC® (fentanyl transdermal) .

Know the medicines you take. Keep a list of your medicines to show to your doctor and pharmacist.

How should I use DURAGESIC® (fentanyl transdermal) ?

Read the separate “Instructions for Applying a DURAGESIC® (fentanyl transdermal) Patch”.

• You must always use DURAGESIC® (fentanyl transdermal) patches the right way:
  • Do not use a DURAGESIC® (fentanyl transdermal) patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
  • Do not use heat sources such as heating pads, electric blankets, heat lamps, tanning lamps, saunas, hot tubs, or heated waterbeds while wearing a DURAGESIC® (fentanyl transdermal) patch.
  • Do not take hot baths or sunbathe while wearing a DURAGESIC® (fentanyl transdermal) patch.
• If you have problems with the DURAGESIC® (fentanyl transdermal) patch not sticking:

1. Apply first aid tape only to the edges of the patch.
2. If problems with the patch not sticking persist, cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® (fentanyl transdermal) patch with any other bandage or tape.

• If your DURAGESIC® (fentanyl transdermal) patch falls off before 3 days or 72 hours, fold the sticky side together and flush down a toilet. Put a new one on at a different skin site.
• Do not change your dose unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use DURAGESIC® (fentanyl transdermal) more often than prescribed. Call your doctor if your pain is not well controlled while using DURAGESIC® (fentanyl transdermal) .
• Do not stop using DURAGESIC® (fentanyl transdermal) suddenly. Stopping DURAGESIC® (fentanyl transdermal) suddenly can make you sick with withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering). Your body can develop a physical dependence on DURAGESIC® (fentanyl transdermal) . If your doctor decides you no longer need DURAGESIC® (fentanyl transdermal) , ask how to slowly reduce this medicine so you don't have withdrawal symptoms. Do not stop taking DURAGESIC® (fentanyl transdermal) without talking to your doctor.
• Do not wear more than one DURAGESIC® (fentanyl transdermal) patch at a time, unless your doctor tells you to do so.
• Call your doctor right away if
  • You get a fever higher than 102°F
  • Your body temperature increases from exercise

A fever or increase in body temperature may cause too much of the medicine in DURAGESIC® (fentanyl transdermal) to pass into your body.

• If you use more DURAGESIC® (fentanyl transdermal) than your doctor has prescribed, get emergency medical help right away.
• Do not drink any alcohol while using DURAGESIC® (fentanyl transdermal) . Alcohol can increase your chances of having serious side effects.
• Do not drive, operate heavy machinery, or do other possibly dangerous activities until you know how DURAGESIC® (fentanyl transdermal) affects you. DURAGESIC® (fentanyl transdermal) can make you sleepy. Ask your doctor to tell you when it is okay to do these activities.
• When you remove your DURAGESIC® (fentanyl transdermal) patch, fold the sticky sides of a used DURAGESIC® (fentanyl transdermal) patch together and flush it down the toilet. Do not put used DURAGESIC® (fentanyl transdermal) patches in a trash can.

What are the possible side effects of DURAGESIC® (fentanyl transdermal) ?

Serious side effects include:

• Life-threatening breathing problems. See “What is the most important information I should know about DURAGESIC® (fentanyl transdermal) ?”
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

The common side effects with DURAGESIC® (fentanyl transdermal) are nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, sweating, and pain and redness where the patch was applied.

Constipation is a very common side effect of all opioid medicines. Talk to your doctor about the use of laxatives and stool softeners to prevent or treat constipation while taking DURAGESIC® (fentanyl transdermal) .

Talk to your doctor about any side effect that concerns you.

These are not all the possible side effects of DURAGESIC® (fentanyl transdermal) . For a complete list, ask your doctor or pharmacist.

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

How should I store DURAGESIC® (fentanyl transdermal) ?

• Store in original unopened pouch at room temperature.
• Keep a DURAGESIC® (fentanyl transdermal) patch in its protective pouch until you are ready to use it.
• Keep DURAGESIC® (fentanyl transdermal) in a safe place out of the reach of children and pets.
• Dispose of DURAGESIC® (fentanyl transdermal) patches you no longer need. Open the unused packages, fold the sticky sides of the patches together, and flush them down the toilet.

General information about the safe and effective use of DURAGESIC® (fentanyl transdermal)

• Do not use DURAGESIC® (fentanyl transdermal) for a condition for which it was not prescribed.
• Do not give DURAGESIC® (fentanyl transdermal) to other people, even if they have the same symptoms you have. DURAGESIC® (fentanyl transdermal) can harm other people and even cause death. Sharing DURAGESIC® (fentanyl transdermal) is against the law.

This Medication Guide summarizes the most important information about DURAGESIC® (fentanyl transdermal) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DURAGESIC® (fentanyl transdermal) that is written for doctors.

For questions about DURAGESIC® (fentanyl transdermal) , call the Ortho-McNeil Janssen Scientific Affairs Customer Communications Center at 1-800526-7736. If this is a medical emergency, please call 911.

What are the ingredients of DURAGESIC®?

Active Ingredient: fentanyl

Inactive ingredients: polyester/ethyl vinyl acetate film backing, polyacrylate adhesive.

This Medication Guide has been approved by the United States Food and Drug Administration.

DURAGESIC®
(Dur-ah-GEE-zik)
(fentanyl transdermal system)

Instructions for Applying a DURAGESIC® (fentanyl transdermal) patch

Before Applying DURAGESIC® (fentanyl transdermal)

• Each DURAGESIC® (fentanyl transdermal) patch is sealed in its own protective pouch. Do not remove a DURAGESIC® (fentanyl transdermal) patch from the pouch until you are ready to use it.
• Do not use a DURAGESIC® (fentanyl transdermal) patch if the pouch seal is broken or the patch is cut, damaged or changed in any way.
• DURAGESIC® (fentanyl transdermal) patches are available in 5 different doses and patch sizes. Make sure you have the right dose patch or patches that have been prescribed for you.

Applying a DURAGESIC® (fentanyl transdermal) Patch

1. Skin Areas Where the DURAGESIC® (fentanyl transdermal) Patch May Be Applied:

For adults:

• Put the patch on the chest, back, flank (sides of the waist), or upper arm in a place where there is no hair (see Figures1-4).

For children (and adults with mental impairment):

• Put the patch on the upper back (see Figure 2). This will lower the chances that the child will remove the patch and put it in their mouth.

For adults and children

• Do not put a DURAGESIC® (fentanyl transdermal) patch on skin that is very oily, burned, broken out, cut, irritated, or damaged in any way.
• Avoid sensitive areas or those that move around a lot. If there is hair, do not shave (shaving irritates the skin). Instead, clip hair as close to the skin as possible (see Figure 5).

• Talk to your doctor if you have questions about skin application sites.

2. Prepare to Apply a DURAGESIC® (fentanyl transdermal) Patch:

• Choose the time of day that is best for you to apply DURAGESIC® (fentanyl transdermal) . Change it at about the same time of day (3 days or 72 hours after you apply the patch) or as directed by your doctor.
• Do not wear more than one DURAGESIC® (fentanyl transdermal) patch at a time unless your doctor tells you to do so. Before putting on a new DURAGESIC® (fentanyl transdermal) patch, remove the patch you have been wearing.
• Clean the skin area with clear water only. Pat skin completely dry. Do not use anything on the skin such as soaps, lotions, oils, or alcohol before the patch is applied.

3. Open the Pouch: Fold and tear at slit, or cut at slit taking care so as not to cut the patch, and remove the DURAGESIC® (fentanyl transdermal) patch. Each DURAGESIC® (fentanyl transdermal) patch is sealed in its own protective pouch. Do not remove the DURAGESIC® (fentanyl transdermal) patch from the pouch until you are ready to use it (see Figure 6).

4. Peel: Peel off both parts of the protective liner from the patch. Each DURAGESIC® (fentanyl transdermal) patch has a clear plastic backing that can be peeled off in two pieces. This covers the sticky side of the patch. Carefully peel this backing off. Throw the clear plastic backing away. Touch the sticky side of the DURAGESIC® (fentanyl transdermal) patch as little as possible (see Figure 7).

5. Press: Press the patch onto the chosen skin site with the palm of your hand and hold there for at least 30 seconds (see Figure 8). Make sure it sticks well, especially at the edges.

• DURAGESIC® (fentanyl transdermal) may not stick to all patients. You need to check the patches often to make sure that they are sticking well to the skin.
• If the patch falls off right away after applying, throw it away and put a new one on at a different skin site (see Disposing a DURAGESIC® (fentanyl transdermal) Patch).
• If you have a problem with the patch not sticking
  • Apply first aid tape only to the edges of the patch.
  • If you continue to have problems with the patch sticking, you may cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® (fentanyl transdermal) patch with any other bandage or tape. Remove the backing from the Bioclusive™ or Tegaderm™ dressing and place it carefully over the DURAGESIC® (fentanyl transdermal) patch, smoothing it over the patch and your skin.
• If your patch falls off later, but before 3 days (72 hours) of use, discard it properly (see Disposing a DURAGESIC® (fentanyl transdermal) patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

6. Wash your hands when you have finished applying a DURAGESIC® (fentanyl transdermal) patch.

7. Remove a DURAGESIC® (fentanyl transdermal) patch after wearing it for 3 days (72 hours) (see “Disposing a DURAGESIC® (fentanyl transdermal) Patch”). Choose a different place on the skin to apply a new DURAGESIC® (fentanyl transdermal) patch and repeat Steps 2 through 6.

Do not apply the new patch to the same place as the last one.

Water and DURAGESIC® (fentanyl transdermal)

8. You can bathe, swim or shower while you are wearing a DURAGESIC® (fentanyl transdermal) patch. If the patch falls off before 3 days (72 hours) after application, discard it properly (see Disposing a DURAGESIC® (fentanyl transdermal) Patch) and put a new one on at a different skin site. Be sure to let your doctor know that this has happened, and do not replace the new patch until 3 days (72 hours) after you put it on (or as directed by your doctor).

Disposing a DURAGESIC® (fentanyl transdermal) Patch

• Fold the used DURAGESIC® (fentanyl transdermal) patch in half so that the sticky side sticks to itself (Figure 9). Flush the used DURAGESIC® (fentanyl transdermal) down the toilet right away (Figure 10). A used DURAGESIC® (fentanyl transdermal) patch CAN be VERY dangerous for or even lead to death in babies, children, pets, and adults who have not been prescribed DURAGESIC® (fentanyl transdermal) .
• Throw away any DURAGESIC® (fentanyl transdermal) patches that are left over from your prescription as soon as they are no longer needed. Remove the leftover patches from their protective pouch and remove the protective liner. Fold the patches in half with the sticky sides together, and flush the patches down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in a trashcan.

Last reviewed on RxList: 10/7/2010
This monograph has been modified to include the generic and brand name in many instances.