FENTANYL (Transdermal-Systemic)

Some commonly used brand names are:

In the U.S.?

• Duragesic

In Canada?

• Duragesic

Category

• Analgesic

Description

Fentanyl (FEN-ta-nil) belongs to the group of medicines called narcoticanalgesics (nar-KOT-ik an-al-GEE-ziks). Narcotic analgesics are used to relieve pain. The transdermalsystem (skin patch) form of fentanyl is used to treat chronic pain (pain thatcontinues for a long time).

Fentanyl acts in the central nervous system (CNS) to relieve pain. Someof its side effects are also caused by actions in the CNS.

When a narcotic is used for a long time, it may become habit-forming (causingmental or physical dependence). However, people who havecontinuing pain should not let the fear of dependence keep them from usingnarcotics to relieve their pain. Mental dependence (addiction) is notlikely to occur when narcotics are used for this purpose. Physical dependencemay lead to withdrawal side effects if treatment is stopped suddenly. However,severe withdrawal side effects can usually be prevented by reducing the dosegradually over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription. Prescriptionsfor transdermal fentanyl cannot be refilled. You will need to obtain a newprescription from your doctor each time you need the medicine. This medicineis available in the following dosage form:

Transdermal
• Transdermal system (stick-on skin patch) (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your health care professional will make. For fentanyl,the following should be considered:

Allergies?Tell your health care professional if you have everhad any unusual or allergic reaction to fentanyl, alfentanil (e.g., Alfenta),or sufentanil (e.g., Sufenta). Also tell your health care professional ifyou are allergic to any other substances, including the adhesives that keepstick-on bandages in place.

Pregnancy?Although studies on birth defects with fentanyl havenot been done in pregnant women, it has not been reported to cause birth defects.However, using any narcotic regularly during pregnancy may cause physicaldependence in the fetus. This may lead to withdrawal side effects after birth.Also, use of this medicine near the end of pregnancy may cause drowsinessand breathing problems in newborn babies. Before taking this medicine, makesure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding?Fentanyl passes into the breast milk. Nursing babieswhose mothers are using this medicine regularly may receive enough of it tocause unwanted effects such as drowsiness, breathing problems, and physicaldependence. Similar effects may also occur with some other narcotics if theyare taken regularly in large amounts. A mother who wishes to breast-feed andwho needs treatment for continuing pain should discuss the risks and benefitsof different pain treatments with her health care professional.

Children?This medicine has been tested in children 2 yearsof age and older. In effective doses, the medicine has not been shown to causedifferent side effects or problems than it dose in adults. The child or teenager must be opioid-tolerant in order to take fentanyl. Ifyou are unsure if your child or teenager is opioid-tolerant, ask your doctor.

Older adults?Elderly people are especially sensitive to the effectsof narcotic analgesics. This may increase the chance of side effects, especiallybreathing problems, during treatment. Your health care professional will takethis into consideration when deciding on the amount of transdermal fentanylyou should receive.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your health care professionalmay want to change the dose, or other precautions may be necessary. When youare using fentanyl, it is especially important that your health care professionalknow if you are taking any of the following:

• Buprenorphine (e.g., Buprenex) or
• Dezocine (e.g., Dalgan) or
• Nalbuphine (e.g., Nubain) or
• Pentazocine (e.g., Talwin)?Like all narcotic analgesics, thesemedicines may add to the effects of fentanyl, which may increase the chanceof side effects or overdose. However, buprenorphine, dezocine, nalbuphine,and pentazocine sometimes decrease the effects of fentanyl, so that fentanylmight be less effective in relieving pain. Also, these medicines can causewithdrawal side effects if they are given to someone who is physically dependenton fentanyl

• CYP3A4 (an isoenzyme that breaks down fentanyl in the body) inducerssuch as:
  • Carbamazepine (e.g., Tegretol) or
  • Phenytoin (e.g., Dilantin) or
  • Rifampin (e.g., Rifadin)?Giving these medicines with fentanylwill decrease the pain-relieving effects of fentanyl.

• CYP3A4 inhibitors such as:
  • Azole antifungal agents (itraconazole [e.g., Sporanox], ketoconazole[e.g., Nizoral]) or
  • Macrolide antibiotics (e.g., clarithromycin [e.g., Biaxin], erythromycin,troleandomycin [e.g., Tao]) or
  • Protease inhibitors (nelfinavir [e.g., Viracept], ritonavir [e.g.,Norvir])?Giving these medicines with fentanyl may cause too much fentanylin your blood.

• Central nervous system (CNS) depressants (medicines that cause drowsiness),including other narcotics, or
• Tricyclic antidepressants?These medicines may add to the effectsof fentanyl. This may increase the chance of serious side effects

• Naltrexone (e.g., Trexan)?Fentanyl will not be effective inpeople taking naltrexone

Other medical problems?The presence of other medicalproblems may affect the use of fentanyl. Make sure you tell your health careprofessional if you have any other medical problems, especially:

• Alcohol abuse, or history of, or
• Drug dependence, especially narcotic abuse or dependence, or historyof, or
• Emotional problems or
• Kidney disease or
• Liver disease or
• Mental illness (such as major depression) or
• Underactive thyroid?The chance of side effects may be increased

• Brain tumor or
• Diarrhea caused by antibiotic treatment or poisoning or
• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones or
• Intestinal problems such as colitis or Crohn's disease or
• Pancreatitis, acute?Some of the side effects of fentanyl cancause serious problems in people who have these medical problems

• Bronchial asthma, acute or severe or
• Not opioid-tolerant (if you are NOT taking a certain amount of morphine,oxycodone, hydromorphone or other opioid medicine) or
• Ongoing breathing problems?Fentanyl patchesshould NOT be used in these patients It could cause very serious breathingproblems.

• Paralytic ileus (intestinal blockage)?Fentanyl patches should NOT be used in patients with this condition.

• Slow heartbeat?Fentanyl can make this condition worse

Proper Use of This Medicine

Transdermal fentanyl comes with patient instructions. Read them carefullybefore using the product. If you do not receive any printed instructionswith the medicine, check with your pharmacist.

Fentanyl skin patches are for use in opioid-tolerantpatients ONLY. If you are uncertain whether or not you are opioid-tolerant,check with your doctor before using this medicine.

To use:

• Use this medicine exactly as directed by yourdoctor. It will work only if it has been applied correctly.
• Fentanyl skin patches are packaged in sealed pouches. Do not remove the patch from the sealed pouch until you are ready to applyit.
• When handling the skin patch, be careful notto touch the adhesive (sticky) surface with your hand. The adhesivepart of the system contains some fentanyl, which can be absorbed into yourbody too fast through the skin of your hand. If any of the medicine does geton your hand, rinse the area right away with a lot ofclear water. Do not use soap or other cleansers.
• Be careful not to tear the patch or make anyholes in it. Damage to a patch may allow fentanyl to pass into yourskin too quickly. This can cause an overdose.
• Apply the patch to a dry, flat skin area on your upper arm, chest,or back. Choose a place where the skin is not very oilyand is free of scars, cuts, burns, or any other skin irritations. Also, donot apply this medicine to areas that have received radiation (x-ray) treatment.
• The patch will stay in place better if it is applied to an area withlittle or no hair. If you need to apply the patch to a hairy area, you mayfirst clip the hair with scissors, but do not shave itoff.
• If you need to clean the area before applying the medicine, use only plain water. Do not use soaps, other cleansers, lotions,or anything that contains oils or alcohol. Be sure that the skin iscompletely dry before applying the medicine.
• Remove the liner covering the sticky side of the skin patch. Thenpress the patch firmly in place, using the palm of your hand, for a minimumof 30 seconds. Make sure that the entire adhesive surface is attached to yourskin, especially around the edges.
• If the patch becomes loose, tape the edges with first aid tape.
• If the patch falls off after applying it, throw it away and applya new patch in a different area.
• If you need to apply more than 1 patch at a time, place the patches far enough apart so that the edges do not touch or overlapeach other.
• Wash your hands with a lot of clear water after applying the medicine.Do not use soap or other cleansers.
• Remove the patch after 72 hours (3 days), or as directed by yourdoctor. Choose a different place on your skin to applythe next patch. If possible, use a place on the other side of yourbody. Wait at least 3 days before using the first areaagain.

After a patch is applied, the fentanyl it contains passes into the skina little at a time. A certain amount of the medicine must build up in theskin before it is absorbed into the body. Therefore, up to a day may passbefore the first dose begins to work. Your health care professional may needto change the dose during the first several applications (each kept in placefor 3 days) before finding the amount that works best for you. Even if youfeel that the medicine is not working, do not increasethe amount of transdermal fentanyl that you apply. Instead, check withyour health care professional.

You will probably need to take a faster-acting narcotic to relieve painduring the first few days of transdermal fentanyl treatment. You may continueto need another narcotic while your dose of fentanyl is being adjusted, andalso to relieve any "breakthrough" pain that occurs later on. Be sure that you do not take more of the other narcotic, and do not take itmore often, than directed. Taking other narcotics together with fentanyl canincrease the chance of an overdose.

Dosing?The dose of transdermal fentanyl will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of this medicine. If your dose is different,do not change it unless your doctor tells you to do so.

• For transdermal dosage form (stick-onpatch):
  • For relief of severe, continuing pain:
    • Adults?If you have not already been using other narcotics regularly,your doctor will determine use and dose. If you have already been using othernarcotics regularly, your first dose will depend on the amount of other narcoticyou have been taking every day. If necessary, your health care professionalwill change the dose after 3 days, when the first patch is replaced. The sizeof the new dose will depend on how well the medicine is working and on whetheryou had any side effects during the first 3-day application. Other changesin dose may be needed later on. Some people may need to use more than onepatch at a time.
    • Children?Use and dose must be determined by the doctor.

Missed dose?If you miss a dose of this medicine, apply it assoon as possible. Remove the new patch 3 days after applying it.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not keep outdated medicine or medicine no longer needed. To disposeof this medicine, first fold the patch in half, with the sticky side inside.If the patch has not been used, take it out of the pouch and remove the linerthat covers the sticky side of the patch before folding it in half. Then flushit down the toilet right away.

Precautions While Using This Medicine

Checkwith your health care professional at regular times while using fentanyl.Be sure to report any side effects.

After you have been using this medicine for a while, "breakthrough" painmay occur more often than usual, and it may not be relieved by your regulardose of medicine. If this occurs, do not increase theamount of transdermal fentanyl or other narcotic that you are taking withoutfirst checking with your health care professional.

This medicine will add to the effects of alcohol and other CNS depressants(medicines that can make you drowsy or less alert). Some examples of CNS depressantsare antihistamines or medicine for hay fever, other allergies, or colds; sedatives,tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics;barbiturates; medicine for seizures; muscle relaxants; or anesthetics, includingsome dental anesthetics. You will probably be directed to take other painrelievers if you still have pain while using transdermal fentanyl. However, check with your health care professional before takingany of the other medicines listed above while you are using this medicine.

Fentanyl may cause some people to become drowsy, dizzy, or lightheaded,or to feel a false sense of well-being. Make sure youknow how you react to this medicine before you drive, use machines, or doanything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, whenyour body gets used to the medicine. However, check withyour health care professional if drowsiness that is severe enough to interferewith your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get upsuddenly from a lying or sitting position. Getting upslowly may help lessen this problem. Also, lying down for a while mayrelieve dizziness or lightheadedness.

Nausea or vomiting may occur, especially during the first several daysof treatment. Lying down for a while may relieve these effects. However, ifthey are especially bothersome or if they continue for more than a few days,check with your health care professional. You may be able to take anothermedicine to help prevent these problems.

Using narcotics for a long time can cause severe constipation. To preventthis, your health care professional may direct you to take laxatives, drinka lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipationcan lead to more serious problems.

Heat can cause the fentanyl in the patch to be absorbed into your bodyfaster. This may increase the chance of serious side effects or an overdose.While you are using this medicine, do not use a heatingpad, a sunlamp, or a heated water bed, and do not take sunbaths or long bathsor showers in hot water. Also, check with yourhealth care professional if you get a fever.

Before having any kind of surgery (including dentalsurgery) or emergency treatment, tell the medical doctor or dentist in chargethat you are using this medicine. Serious side effects can occur ifyour medical doctor or dentist gives you certain other medicines without knowingthat you are using fentanyl.

You may bathe, shower, or swim while wearing a fentanyl skin patch. However,be careful to wash and dry the area around the patch gently. Rubbing may causethe patch to get loose or come off. If this does occur, throw away the patchand apply a new one in a different place. Make sure the area is completelydry before applying the new patch.

If you have been using this medicine regularly for several weeks or more, do not suddenly stop using it without first checkingwith your health care professional. You may be directed to reduce graduallythe amount you are using before stopping treatment completely, or to takeanother narcotic for a while, to lessen the chance of withdrawal side effects.

In young children or persons with decreased mental alertness, the patchshould be put on the upper back to decrease the chances that the patch willbe removed and placed in the mouth.

If the patch comes off and accidentally sticks to the skin of another person,they should take the patch off immediately and wash the exposed areawith water. The exposed person should then seek medical attention.

Using too much transdermal fentanyl, or taking toomuch of another narcotic while using transdermal fentanyl, may cause an overdose.If this occurs, get emergency help right away. An overdose can causesevere breathing problems (breathing may even stop), unconsciousness, anddeath. Serious signs of an overdose include very slow breathing (fewer than8 breaths a minute) and drowsiness that is so severe that you are not ableto answer when spoken to or, if asleep, cannot be awakened. Other signs ofan overdose may include cold, clammy skin; low blood pressure; pinpoint pupilsof eyes; and slow heartbeat. It may be best to have afamily member or a friend check on you several times a day when you startusing a narcotic regularly, and whenever your dose is increased, sothat he or she can get help for you if you cannot do so yourself.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects.Although not all of these side effects may occur, if they do occur they mayneed medical attention.

Get emergency help immediatelyif the following signs of overdose occur:

Cold, clammy skin; convulsions (seizures); drowsiness that is so severe that you are not ableto answer when spoken to or, if asleep, cannot be awakened; low blood pressure; pinpoint pupils of eyes; slow heartbeat; very slow (fewer than8 breaths a minute) or troubled breathing

Also, check with your doctor as soon as possibleif any of the following side effects occur:

More common

Decrease in amount of urine or in the frequency of urination; hallucinations (seeing, hearing, or feeling thingsthat are not there)

Less common

Chest pain; difficulty in speaking; fainting; irregular heartbeat; mood or mental changes; problems withwalking; redness, swelling, itching, or bumps onthe skin at place of application; spitting blood

Rare

Any change in vision; bladder pain; difficulty in speaking; fever with orwithout chills; fluid-filled blisters on skin; frequent urge to urinate; noisy breathing,shortness of breath, tightness in chest, or wheezing; red, thickened, or scaly skin; swelling of abdomenor stomach area; swollen and/or painful glands; unusual bruising

Incidence not known

Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome:

More common

Abdominal or stomach pain that was not present before treatment; confusion; constipation; diarrhea; dizziness, drowsiness,or lightheadedness; false sense of well-being; feeling anxious; headache; indigestion; loss of appetite; nausea or vomiting; nervousness; sweating; weakness

Less common

Bloated feeling or gas; feeling anxiousand restless at the same time; feeling of crawling,tingling, or burning of the skin; memory loss; unusual dreams

Incidence not known

After you stop using this medicine, your body may need time to adjust.The length of time this takes depends on the amount of medicine you were usingand how long you used it. During this period of time check with your doctorif you notice any of the following side effects:

Anxiety; body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; increased sweating; increased yawning; loss of appetite; nauseaor vomiting; nervousness, restlessness, or irritability; shivering or trembling; stomach cramps; trouble in sleeping; unusually large pupils of eyes; weakness

Other side effects not listed above mayalso occur in some patients. If you notice any other effects, check with yourdoctor.