Duragesic is a skin patch containing fentanyl, an opioid pain medication. An opioid is sometimes called a narcotic.

Duragesic patches are a strong prescription pain medicine. The patches are used to treat moderate to severe chronic pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment.

Duragesic patches are used 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 patches are not for treating mild or occasional pain or pain from surgery. The patches are not for use to treat pain that is not around-the-clock.

Using Duragesic patches during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fentanyl can slow or stop your breathing, and may be habit-forming. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Fatal side effects can occur if you use Duragesic with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Use Duragesic patches exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Duragesic patches in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more fentanyl. Never use a skin patch if it has been cut or damaged.

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 Duragesic skin patch to come into contact with your mouth, eyes, nose, or lips, or another person's skin.

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 Duragesic 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 Duragesic suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Duragesic.

Store each patch in its foil pouch at room temperature.

Keep both used and unused patches out of the reach of children or pets. 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. Seek emergency medical attention if this happens.

After removing a Duragesic patch: fold it in half with the sticky side in, and flush the patch down the toilet right away. Do not place a used skin patch into a trash can.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Duragesic accidentally or improperly. 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.

Usual Adult Dose for Chronic Pain:

Due to the risk of respiratory depression, the transdermal patch is for use in opioid-tolerant patients only; opioid tolerant patients have been taking at least: morphine 60 mg daily, oral oxycodone 30 mg daily, oral hydromorphone 8 mg daily, or an equianalgesic dose of another opioid for 1 week or longer.
-Discontinue all other extended-release opioids when beginning therapy.

Initial doses: The initial dose should be individualized taking into account the patient's prior treatment experience. This dose may be calculated based on the dose conversion guidelines in the product package insert, local protocol, or another reliable reference; when calculating, be aware there is substantial inter-patient variability in the relative potency of different opioid drugs and products and therefore it is preferable to underestimate a 24-hour fentanyl requirement and provide rescue medication than to overestimate which could result in adverse reactions.
Dose titration:
-Initial: May increase dose after 3 days based on the daily dose of supplemental opioid analgesics required by the patient on the second or third day of the initial application.
-Further titration should occur after no less than two 3-day applications as it may take up to 6 days for fentanyl levels to reach equilibrium. Titration should be based on the daily dose of supplementary opioids required and the following ratio may be used: Increase transdermal fentanyl by 12 mcg//hr for use of supplemental oral morphine doses of 45 mg/24 hours.
Maintenance dose: Adjust dose to obtain an appropriate balance between pain management and opioid-related adverse reactions. During chronic therapy, periodically reassess the continued need for opioid analgesics.

Comments:
-Do not begin a patient on a Duragesic transdermal patch as their first opioid.
-A small number of patients may require a 48-hour dosing interval; an increase in dose should be evaluated before changing dosing intervals.

You should not use Duragesic unless you recently used opioid medicine and your body is tolerant to it (ask your doctor if you're not sure).

Do not put a Duragesic skin patch on any person who does not have a personal prescription for this medicine. You should not use Duragesic if you are allergic to fentanyl, or if you have:

• severe asthma or other breathing problems; or

• a stomach or bowel obstruction (including paralytic ileus).

To make sure Duragesic patches are safe for you, tell your doctor if you have ever had:

• 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.

Tell your doctor if you have been sick with a fever. Having a high temperature can increase the amount of fentanyl you absorb through your skin.

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 Duragesic patches.

If you are using Duragesic 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. Do NOT wear extra patches to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Avoid sources of heat while you are wearing a Duragesic patch. 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. Heat can increase the amount of drug you absorb through your skin and may cause an overdose or death.

Grapefruit may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid wearing a Duragesic 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 Duragesic skin patch is a "bandage."

Avoid driving or operating machinery until you know how using Duragesic patches will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Get emergency medical help if you have signs of an allergic reaction to Duragesic: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

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.

Remove the Duragesic patch and call your doctor at once if you have:

• 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.

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.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Common Duragesic side effects may include:

• 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.

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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.