Duragesic

What is Duragesic?

Duragesic is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

Duragesic is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Duragesic is not for use to treat pain that is not around-the-clock.

What is the most important information I should know about Duragesic?

• Get emergency help right away if you use too much Duragesic (overdose). When you first start taking Duragesic, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur.
• Taking Duragesic with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) may cause severe drowsiness, decreased awareness, breathing difficulties, with slow or shallow breathing, coma, and death.
• Never give anyone else your Duragesic. They could die from taking it. Selling or giving away Duragesic is against the law.
• Store Duragesic, securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
• If the patch accidentally sticks to a family member while in close contact, take the patch off, wash the area with water, and get emergency help right away because an accidental exposure to Duragesic can lead to death or other serious medical problems.
• Dispose of expired, unwanted, or unused Duragesic, by folding the patch so that the adhesive side of the patch adheres to itself, and immediately flushing down the toilet (if a drug take-back option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Who should not take Duragesic?

Do not use Duragesic if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

What should I tell my healthcare provider before taking Duragesic?

Tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• liver, kidney, thyroid problems
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you:

• have a fever
• are pregnant or planning to become pregnant. Prolonged use of Duragesic during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• are breastfeeding. Not recommended during treatment with Duragesic. It may harm your baby.
• are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Duragesic with certain other medicines can cause serious side effects that could lead to death.

How should I take Duragesic?

When using Duragesic:

• Do not change your dose. Apply Duragesic exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Do not apply more than 1 patch at the same time unless your healthcare provider tells you to.
• You should wear the Duragesic patch continuously for 3 days, unless advised otherwise by your healthcare provider.
• Do not cut, break, chew, crush, dissolve, snort, or inject Duragesic because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are using does not control your pain.
• Do not stop using Duragesic without talking to your healthcare provider.

While using Duragesic do not:

• Take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
• Drive or operate heavy machinery, until you know how Duragesic affects you. Duragesic can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Duragesic may cause you to overdose and die.

What are the possible side effects of Duragesic?

The possible side effects of Duragesic are:

• constipation
• nausea
• sleepiness
• vomiting
• tiredness
• headache
• dizziness
• abdominal pain
• itching, redness, or rash where the patch is applied.

Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing
• shortness of breath
• fast heartbeat, chest pain
• swelling of your face, tongue or throat
• extreme drowsiness
• light-headedness when changing positions
• feeling faint
• agitation
• high body temperature
• trouble walking
• stiff muscles
• mental changes such as confusion.

These are not all the possible side effects of Duragesic. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Instructions for Use

Be sure that you read, understand, and follow these Instructions for Use before you apply DURAGESIC® transdermal system (patch). Talk to your healthcare provider or pharmacist if you have any questions.

Important information about the DURAGESIC® transdermal system (patch) appearance:

• DURAGESIC® is a rectangular, see-through patch with rounded corners.
• DURAGESIC® comes in 6 different dosage strengths and sizes:

• The product name, "DURAGESIC®", and dosage strength are printed in green in the center of each patch.
• The 12 mcg/hour patch has a solid green border around it.
• All of the other patches have a green background with see-through diagonal stripes. These stripes change in direction and increase in number as the dosage strength increases.

Parts of the DURAGESIC® patch:

Before applying DURAGESIC®

• Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove a DURAGESIC® patch from the pouch until you are ready to use it.
• Do not use a DURAGESIC® patch if the pouch seal is broken or the patch is cut, damaged or changed in any way.
• DURAGESIC® patches are available in 6 different dosage strengths and patch sizes. Make sure you have the right dose patch or patches that have been prescribed for you.

Applying a DURAGESIC® patch

1. Skin areas where the DURAGESIC® 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 Figures A–D).

For children (and adults with mental impairment):

• Put the patch on the upper back (See FIGURE B). 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® 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 E).
• Talk to your healthcare provider if you have questions about skin application sites.

2. Prepare to apply a DURAGESIC® patch:

• Choose the time of day that is best for you to apply DURAGESIC®. Change it at about the same time of day (3 days or 72 hours after you apply the patch) or as directed by your healthcare provider.
• Do not wear more than one DURAGESIC® patch at a time unless your healthcare provider tells you to do so. Before applying a new DURAGESIC® 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 not to cut the patch

Remove the DURAGESIC® patch. Each DURAGESIC® patch is sealed in its own protective pouch. Do not remove the DURAGESIC® patch from the pouch until you are ready to use it (See FIGURE F).

4. Peel off both parts of the release liner from the patch

Each DURAGESIC® patch has a clear plastic release liner that can be peeled off in two pieces. This covers the sticky side of the patch. Carefully peel this release liner off and throw the pieces away. Touch the sticky side of the DURAGESIC® patch as little as possible (See FIGURE G).

5. Press the patch onto the chosen skin site with the palm of your hand

Hold there for at least 30 seconds (See FIGURE H). Make sure it sticks well, especially at the edges.

DURAGESIC® may not stick to all people. You need to check the patch often to make sure that it is 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 the section below called "DISPOSING OF A DURAGESIC® 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 not sticking, you may cover the patch with a transparent adhesive film dressing such as Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® patch with any other bandage or tape. Remove the backing from the Bioclusive™ or Tegaderm™ dressing and place it carefully over the DURAGESIC® patch, smoothing it over the patch and your skin.
• If your patch falls off before 3 days (72 hours) of use, dispose of (throw away) properly. See the section below "DISPOSING OF A DURAGESIC® PATCH". Apply a new DURAGESIC® patch on at a different skin site. Be sure to let your healthcare provider 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 healthcare provider).

6. Wash your hands

Make sure you have washed your hands when you have finished applying a DURAGESIC® patch.

7. Remove a DURAGESIC® patch after wearing it for 3 days (72 hours)

Dispose of the used patch right away. See the section below "DISPOSING OF A DURAGESIC® PATCH". Choose a different skin site to apply a new DURAGESIC® patch. Repeat Steps 2 through 6 above when applying a new DURAGESIC® patch. Do not apply the new patch to the same place as the last one.

Water and DURAGESIC®

You can bathe, swim or shower while you are wearing a DURAGESIC® patch. If the patch falls off before 3 days (72 hours) after application, dispose of properly. See the section below "DISPOSING OF A DURAGESIC® PATCH". Apply a new DURAGESIC® patch on at a different skin site. Be sure to let your healthcare provider 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 healthcare provider).

Disposing of a DURAGESIC® patch

Fold the used DURAGESIC® patch in half so that the sticky side sticks to itself (See FIGURE I). Flush the used DURAGESIC® patch down the toilet right away (See FIGURE J). A used DURAGESIC® patch can be very dangerous for or lead to death in babies, children, pets, and adults who have not been prescribed DURAGESIC®.

Throw away any DURAGESIC® 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 release 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 release liner down the toilet. These items can be thrown away in a trash can.