Generic name: Fentanyl transdermal (skin patch)
Pregnancy & Lactation: Risk data not available
What is Duragesic-12?
Fentanyl is an opioid pain medicine that is used to treat moderate to severe chronic pain around the clock. Fentanyl transdermal is not for treating mild or occasional pain or pain from surgery.
Fentanyl transdermal may also be used for purposes not listed in this medication guide.
Warnings
You should not use fentanyl unless you recently used opioid medicine and your body is tolerant to it (ask your doctor if you're not sure).
Tell your doctor if you have ever had:
Tell your doctor if you have been sick with a fever. Having a high temperature can increase the amount of drug you absorb through your skin.
Do not put a fentanyl skin patch on any person who does not have a personal prescription for this medicine. You should not use fentanyl if you are allergic to it, or if you have:
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Do not breastfeed while you are using fentanyl.
- severe asthma or other breathing problems; or
- a stomach or bowel obstruction (including paralytic ileus).
- breathing problems, sleep apnea;
- a head injury, brain tumor, or mental illness;
- alcoholism or drug addiction;
- urination problems;
- a seizure disorder;
- liver or kidney disease; or
- problems with your gallbladder, pancreas, or thyroid.
How should I use Duragesic-12
Use Duragesic-12 (Transdermal) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Stop using all other around-the-clock opioid medications.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.
Do not allow the skin patch to come into contact with your mouth, eyes, nose, or lips, or another person's skin.
Store each patch in its foil pouch at room temperature.
Keep both used and unused patches out of the reach of children or pets. Seek emergency medical attention if this happens. The amount of fentanyl in a used skin patch can be fatal to a child or pet who accidentally sucks or chews on the patch.
Do not keep leftover opioid medication. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, dispose of any unused skin patches in the same folded manner. Do not flush the foil pouch or patch liners; place them in a trash container out of the reach of children and pets. Just one dose can cause death in someone using this medicine accidentally or improperly.
Follow the directions on your prescription label and read all medication guides. Tell your doctor if you feel an increased urge to use more of this medicine. Never use fentanyl in larger amounts, or for longer than prescribed.Never use a skin patch if it has been cut or damaged.
Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Wear the fentanyl skin patch around the clock, removing and replacing the patch every 72 hours (3 days). Do not wear more than 1 patch at a time unless your doctor has told you to.
When placing a skin patch on a young child, choose a wearing area where the child cannot easily remove the patch unsupervised.
Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
After removing a skin patchDo not place a used skin patch into a trash can.: fold it in half with the sticky side in, and flush the patch down the toilet right away.
If you are using the skin patches on a schedule, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. wear extra patches to make up a missed dose. Do not
Duragesic-12 side effects
Get emergency medical help if you have hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. signs of an allergic reaction:
Remove the skin patch and call your doctor at once if you have:
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- slow heart rate, sighing, weak or shallow breathing (up to several days after removing the skin patch);
- breathing that stops during sleep;
- confusion, severe drowsiness, feeling like you might pass out;
- chest pain, fast or pounding heartbeats; or
- low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
- headache, dizziness, drowsiness, tiredness;
- nausea, vomiting, stomach pain, diarrhea, constipation;
- itching, redness, or rash where a patch was worn;
- sleep problems (insomnia); or
- increased sweating, or cold feeling.
What other drugs will affect Duragesic-12?
Avoid sources of heat while you are wearing the patch.Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death. Do not use a heating pad or electric blanket, a waterbed heater, tanning bed or sauna. Do not sit in hot water, sunbathe, or raise your body temperature with vigorous activity.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Grapefruit may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid wearing a skin patch on a part of your body where a child could reach or remove the patch from your skin. Avoid allowing children to watch you put on a skin patch. Never tell a child that the fentanyl skin patch is a "bandage."