DrugindexOnline^{2nd edition}

Generic Name: Fentanyl Transdermal Patch (FEN-ta-nil)
Brand Name: Duragesic

Duragesic Patch should be used only for long-term or chronic pain requiring continuous narcotic pain relief that is not helped by other less powerful pain medicines or less frequent dosing. Do not use Duragesic Patch if you have not already been taking other prescription narcotic pain medicines (eg, morphine, codeine) on a regular schedule. Because serious, sometimes life-threatening, breathing problems can occur (especially in patients who have not been given narcotic medicines in the past), seek immediate medical attention in the unlikely event that very slow, shallow breathing occurs. Tell your doctor if you are also taking ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, or nefazodone because they may increase the risk of side effects of Duragesic Patch. Do not give Duragesic Patch to children younger than 2 years of age or children who have not previously received narcotic pain medicines. When used for long periods of time or at high doses, some people develop a need to continue taking Duragesic Patch. This is known as DEPENDENCE or "addiction." Do not use more of Duragesic Patch than prescribed by your doctor. Tell your doctor if you have a history of mental or mood problems (eg, depression) or addiction to alcohol or other substances. Do not cut the patch. Using a cut or damaged patch may lead to a rapid release of medicine and serious, even fatal, side effects.

Duragesic Patch is used for:

Managing chronic pain in patients who need continuous narcotic (opioid) pain relief and whose pain cannot be managed by less powerful pain medicines.

Duragesic Patch is a narcotic (opioid) analgesic. It works by binding to receptors in the brain and nervous system used by the body's natural "pain relievers."

Do NOT use Duragesic Patch if:

• you are allergic to any ingredient in Duragesic Patch or any other fentanyl-related medicine (eg, sufentanil) or adhesives like those used on bandages
• you have not already been taking other prescription narcotic pain medicines (eg, morphine, codeine) on a regular schedule
• you have mild or short-term pain, including pain from injuries and surgery, which can be managed by less powerful medicines
• you do not need to take pain medicine on a regular basis
• you have trouble breathing, asthma, or bowel problems (paralytic ileus)
• you drink alcohol, you are taking sodium oxybate (GHB) or any other sedative that causes drowsiness and decreases breathing rate
• you are taking or have taken an MAO inhibitor (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Duragesic Patch:

Some medical conditions may interact with Duragesic Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of alcohol or substance abuse or narcotic dependence or you drink more than 3 alcohol-containing drinks per day
• if you have diabetes, asthma or other breathing problems, increased pressure or a lesion on the brain, heart problems, liver or kidney disease, pancreatitis, thoughts of hurting or killing yourself (suicidal thoughts), or had recent surgery or head trauma

Some MEDICINES MAY INTERACT with Duragesic Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Naltrexone because the effectiveness of Duragesic Patch may be decreased
• Alcohol, amiodarone, azole antifungals (eg, ketoconazole), barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolides (eg, clarithromycin), MAO inhibitors (eg, phenelzine), nefazodone, or sodium oxybate (GHB) because side effects such as difficulty breathing, seizures, and disorientation may occur
• Barbiturate anesthetics (eg, thiopental), benzodiazepines (eg, alprazolam), sibutramine, orsodium oxybate (GHB) because actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Duragesic Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Duragesic Patch:

Use Duragesic Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Duragesic Patch comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Duragesic Patch refilled.
• Apply Duragesic Patch immediately after removing it from the individually sealed package. Do not alter (eg, cut) the patch in any way before applying it.
• The patch should be applied to a dry, smooth, non-irradiated section of skin on your chest or back. In young children or patients with mental impairment, place patch on their upper back to decrease the chance that they will remove the patch and put it in their mouth.
• Before applying the patch, clip (do not shave) any hair at the application site, clean the area with clear water only, and then dry the area. Do not use soaps, oils, lotions, or any other liquid that could irritate or otherwise affect the skin.
• Press the patch firmly in place with the palm of your hand for 30 seconds. Make sure the contact is complete, especially around the edges. Wash your hands after applying the patch.
• A patch may be worn continuously for 72 hours. If pain relief for more than 72 hours is needed, apply a new patch to a different skin area after removing the old patch.
• After removing the used patch, fold over with the sticky side together. The patch should be flushed down the toilet immediately upon removal. You should also dispose of any unused patches remaining from a prescription as soon as they are no longer needed. Unused patches should be removed from their pouches and flushed down the toilet.
• If you forget to change your patch on the day it is due, change the patch as soon as you remember. Do not use 2 patches at the same time.

Ask your health care provider any questions you may have about how to use Duragesic Patch.

Important safety information:

• Duragesic Patch may cause drowsiness, dizziness, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Duragesic Patch. Using Duragesic Patch alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Duragesic Patch. Duragesic Patch will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Duragesic Patch may cause dizziness or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
• Do not expose the patch on your skin to direct sources of heat, such as fevers, heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing, long hot baths, or other sources of heat to the body. The heat may cause more medicine to be released into your skin.
• The patch contains a strong narcotic pain medicine (similar to morphine, hydromorphone, methadone, oxycodone, and oxymorphone) in the form of a gel. If the gel should leak from the patch at any time, do not touch the gel. If you have unintended contact with the gel, immediately wash the affected area with large amounts of water only. If you have concerns, speak with your pharmacist or doctor for further instructions.
• If the patch comes off your skin and accidentally sticks to the skin of another person, remove the patch from their skin immediately, wash the exposed area of skin with water and call you doctor, emergency room, or local poison control center immediately.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Duragesic Patch.
• Use Duragesic Patch with caution in the ELDERLY because they may be more sensitive to its effects, especially the possibility of decreased breathing and drowsiness.
• Duragesic Patch is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Duragesic Patch. Duragesic Patch is excreted in breast milk. Do not breast-feed while taking Duragesic Patch.

When used for long periods of time or at high doses, Duragesic Patch may not work as well and may require higher doses to obtain the same effect as when first taken. This is known as TOLERANCE. Talk with your doctor if Duragesic Patch stops working well. Do not take more than is prescribed.

Additionally, when used for long periods of time or at high doses, some people develop a need to continue taking Duragesic Patch. This is known as DEPENDENCE or "addiction."

If you suddenly stop taking Duragesic Patch, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; hallucinations (seeing, hearing, or feeling things that are not really there); shivering or tremors; sweating; and trouble sleeping. Stop using Duragesic Patch gradually as instructed by your health care provider.

Possible side effects of Duragesic Patch:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; dry mouth; exaggerated sense of well-being; headache; indigestion; itching; loss of appetite; nausea; nervousness or anxiety; redness or discomfort on skin where patch is applied; sleepiness; sleeplessness; stomach pain or discomfort; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; depression; difficulty urinating; excessive dizziness; excessive drowsiness; fainting; fatigue; fever; hallucinations; interrupted or difficult breathing; itching; memory loss; muscle rigidity; seizures; shock (changes in skin color); slow heartbeat; slowed or irregular breathing; tremor; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include bluish skin; cold/clammy skin; difficult or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; loss of function in the heart and lungs; nausea and vomiting; pinpoint pupils; seizures.

Proper storage of Duragesic Patch:

Store Duragesic Patch below 77 degrees F (25 degrees C) in its original sealed pouch. Store away from heat and light. Keep Duragesic Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Duragesic Patch, please talk with your doctor, pharmacist, or other health care provider.
• Duragesic Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Duragesic Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.