Sunday, 11 March 2012

Fentanyl Patch



Pronunciation: FEN-ta-nil
Generic Name: Fentanyl
Brand Name: Duragesic

Fentanyl Patch should be used only for long-term or chronic pain requiring continuous, around-the-clock narcotic pain relief that is not helped by other less powerful pain medicines or less frequent dosing. Do not use Fentanyl Patch if you have not already been taking other prescription narcotic pain medicines (eg, morphine, codeine) on a regular schedule. Do not use Fentanyl Patch for short-term pain, mild pain, pain that occurs after surgery, or pain that does not require medicine 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, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, or verapamil. Tell your doctor if you eat grapefruit or drink grapefruit juice. The risk of Fentanyl Patch's side effects may be increased.


Do not give Fentanyl Patch to children younger than 2 years old 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 Fentanyl Patch. This is known as DEPENDENCE or addiction. Do not use more of Fentanyl Patch than prescribed by your doctor. Tell your doctor if you or a family member has a history of mental or mood problems (eg, depression) or addiction to alcohol or other substances.


Do not apply the patch to skin that is broken or damaged. 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. Do not expose the patch to direct sources of heat, such as 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. Tell your doctor if you develop a fever. The heat may cause more medicine to be released into your skin and could cause serious, even fatal, side effects.





Fentanyl Patch is used for:

Managing moderate to severe chronic pain in patients who need continuous, around-the-clock narcotic (opioid) pain relief and whose pain cannot be managed by less powerful pain medicines.


Fentanyl Patch is a narcotic (opioid) analgesic. It works in the brain to decrease pain.


Do NOT use Fentanyl Patch if:


  • you are allergic to any ingredient in Fentanyl Patch, to any other fentanyl-related medicine (eg, sufentanil)

  • 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 or surgery

  • you do not need to take pain medicine on a regular basis

  • you have trouble breathing, asthma, or a certain bowel problem (paralytic ileus)

  • you are taking sibutramine or sodium oxybate (GHB)

  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (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 Fentanyl Patch:


Some medical conditions may interact with Fentanyl 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 (eg, adhesives used on bandages)

  • if you have a history of mental or mood problems (eg, depression), hallucinations, or suicidal thoughts or actions

  • if you have severe drowsiness; lesions, growths, or increased pressure in the brain; or a recent head injury

  • if you have lung or breathing problems (eg, asthma, slow or difficult breathing, chronic obstructive pulmonary disease [COPD]), urinary blockage, heart problems (eg, slow or irregular heartbeat, ventricle problems), liver or kidney disease, gallbladder problems, pancreas inflammation (pancreatitis), an enlarged prostate or benign prostatic hypertrophy (BPH), stomach or bowel problems (eg, constipation, inflammatory bowel disease, pseudomembranous colitis, stomach pain), an underactive thyroid, low blood pressure, or seizures

  • if you or a family member has a history of alcohol, narcotic, or other substance abuse or dependence

  • if you have been very ill, have a fever, have poor health or nutrition, or have had a recent surgery (eg, stomach or bowel surgery)

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


  • Amiodarone, aprepitant, azole antifungals (eg, ketoconazole, voriconazole), benzodiazepines (eg, alprazolam), calcium channel blockers (eg, diltiazem, verapamil), cimetidine, HIV protease inhibitors (eg, ritonavir), macrolide antibiotics (eg, erythromycin, clarithromycin), MAOIs (eg, phenelzine), nefazodone, other opioid medicines (eg, oxycodone), phenothiazines (eg, chlorpromazine), skeletal muscle relaxants (eg, cyclobenzaprine), sleep medicines (eg, zolpidem), sodium oxybate (GHB), telithromycin, or troleandomycin because they may increase the risk of Fentanyl Patch's side effects, including serious breathing problems, severe light-headedness or dizziness, or severe drowsiness

  • Serotonin reuptake inhibitors (eg, fluoxetine) or sibutramine because a severe reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, or coma may occur

  • Mixed agonist/antagonist analgesics (eg, buprenorphine, pentazocine, butorphanol), nalmefene, naloxone, or naltrexone because they may decrease Fentanyl Patch's effectiveness and withdrawal symptoms may occur

  • Barbiturates (eg, phenobarbital), carbamazepine, corticosteroids (eg, prednisone), efavirenz, modafinil, nevirapine, oxcarbazepine, phenytoin, pioglitazone, rifamycins (eg, rifampin), St. John's wort, or troglitazone because they may decrease Fentanyl Patch's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fentanyl 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 Fentanyl Patch:


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


  • Fentanyl Patch comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fentanyl Patch refilled.

  • Apply Fentanyl Patch right away after removing it from the sealed package. Do not use a patch if the package is not sealed. Do not apply a patch that has been cut or damaged in any way.

  • The patch should be applied to a dry, smooth, undamaged, nonirradiated section of skin on a flat surface (eg, chest, back, upper arm). In young children or patients with mental impairment, place the patch on their upper back to decrease the chance that they will remove the patch and put it in their mouths.

  • 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.

  • If the patch does not stick, you may tape only the edges with first-aid tape or cover the patch with a special type of clear adhesive film dressing (eg, Bioclusive, Tegaderm). Do not cover the patch with any other bandage or tape. Ask your doctor if you are unsure of what type of dressing you can use.

  • 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. Do not wear more than 1 patch at a time unless your doctor tells you otherwise.

  • If the patch falls off before 72 hours have passed, apply a new patch to a different skin site.

  • After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets. You should also dispose of any unused patches remaining from a prescription as soon as they are no longer needed. Ask your doctor or pharmacist how to dispose of Fentanyl Patch properly.

  • Check with your doctor before you eat grapefruit or drink grapefruit juice while you are using Fentanyl Patch.

  • If you forget to change your patch on the day it is due, change the patch as soon as you remember. Do NOT double your dose to catch up.

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



Important safety information:


  • Fentanyl Patch may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fentanyl Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol while you are using Fentanyl Patch.

  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fentanyl Patch; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Fentanyl Patch may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Fentanyl Patch is to be applied to the skin only. Fentanyl Patch may cause choking or severe and sometimes life-threatening problems if it is placed in the mouth, chewed, or swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Do NOT use more than the recommended dose or for longer than prescribed without checking with your doctor. Do not change the patch more often than directed by your doctor.

  • Do not expose the patch on your skin to direct sources of heat, such as heating pads, electric blankets, heat or tanning lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or other sources of heat to the body. Tell your doctor if you develop a fever. 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 leaks 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 right away.

  • Tell your doctor or dentist that you take Fentanyl Patch before you receive any medical or dental care, emergency care, or surgery.

  • If you will be having an MRI, tell your doctor that you use Fentanyl Patch. You may need to remove the patch before having the MRI.

  • Fentanyl Patch may cause constipation. Talk with your doctor about taking a stool softener or laxative to prevent or treat constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation.

  • Use Fentanyl Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially the possibility of decreased breathing and drowsiness.

  • Fentanyl Patch should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fentanyl Patch while you are pregnant. Fentanyl Patch is found in breast milk. Do not breast-feed while taking Fentanyl Patch.

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


Some people who use Fentanyl Patch for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Fentanyl 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 Fentanyl Patch gradually as instructed by your health care provider.



Possible side effects of Fentanyl 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; drowsiness; dry mouth; exaggerated sense of well-being; headache; indigestion; loss of appetite; mild redness, swelling, or discomfort at the skin application site; nausea; 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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; coughing up blood; difficulty urinating; difficulty talking, thinking, or walking; difficult, shallow, or slow breathing; excessive or persistent dizziness or drowsiness; fainting; fast, slow, or irregular heartbeat; fatigue; fever; flu-like symptoms (eg, headache, muscle aches, tiredness); hallucinations; mood or mental changes (eg, anxiety, agitation, depression, nervousness); memory loss; muscle rigidity; numbness or tingling; persistent sore throat; seizures; shortness of breath; tremor; vision problems; weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Fentanyl side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin; cold and clammy skin; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness; excessive sweating; nausea and vomiting; seizures.


Proper storage of Fentanyl Patch:

Store Fentanyl Patch below 77 degrees F (25 degrees C) in its original sealed pouch. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat and light. Keep Fentanyl Patch out of the reach of children and away from pets.


General information:


  • If you have any questions about Fentanyl Patch, please talk with your doctor, pharmacist, or other health care provider.

  • Fentanyl 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.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Fentanyl 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.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Fentanyl resources


  • Fentanyl Side Effects (in more detail)
  • Fentanyl Use in Pregnancy & Breastfeeding
  • Fentanyl Drug Interactions
  • Fentanyl Support Group
  • 149 Reviews for Fentanyl - Add your own review/rating


Compare Fentanyl with other medications


  • Anesthesia
  • Anesthetic Adjunct
  • Breakthrough Pain
  • Pain
  • Postoperative Pain
  • Sedation

No comments:

Post a Comment