Fentanyl (Transdermal Route)

Narcotic analgesics are used to relieve pain. The transdermal system (skin patch) form of fentanyl is used to treat chronic pain (pain that continues for a long time).

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

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

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Patch, Extended Release


• Patch, Device Assisted

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of transdermal fentanyl in children 2 years of age and older . However, pediatric patients must be opioid-tolerant before using transdermal fentanyl. Safety and efficacy have not been established in children less than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of transdermal fentanyl in the elderly. However, elderly patients are more likely to have age-related lung problems, which may require an adjustment in the dose for patients receiving transdermal fentanyl.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Adinazolam


• Alfentanil


• Alprazolam


• Alprenolol


• Amiodarone


• Amlodipine


• Amobarbital


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Atenolol


• Bepridil


• Betaxolol


• Bevantolol


• Bisoprolol


• Bromazepam


• Brotizolam


• Bucindolol


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Carteolol


• Carvedilol


• Celiprolol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Dantrolene


• Dezocine


• Diazepam


• Diltiazem


• Erythromycin


• Esmolol


• Estazolam


• Ethchlorvynol


• Felodipine


• Fentanyl


• Fluconazole


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fosamprenavir


• Fospropofol


• Furazolidone


• Halazepam


• Hydrocodone


• Hydromorphone


• Iproniazid


• Isocarboxazid


• Isradipine


• Itraconazole


• Ketazolam


• Ketoconazole


• Labetalol


• Levobunolol


• Levorphanol


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Mepindolol


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Metipranolol


• Metoprolol


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nadolol


• Nalbuphine


• Nebivolol


• Nefazodone


• Nelfinavir


• Nialamide


• Nicardipine


• Nifedipine


• Nimodipine


• Nisoldipine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxprenolol


• Oxycodone


• Oxymorphone


• Pargyline


• Pazopanib


• Penbutolol


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Pindolol


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Propranolol


• Quazepam


• Rasagiline


• Remifentanil


• Ritonavir


• Secobarbital


• Selegiline


• Sibutramine


• Sodium Oxybate


• Sotalol


• Sufentanil


• Talinolol


• Tapentadol


• Temazepam


• Tertatolol


• Thiethylperazine


• Thiopental


• Thioridazine


• Timolol


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Troleandomycin


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Azithromycin


• Carbamazepine


• Clotrimazole


• Dirithromycin


• Econazole


• Indinavir


• Josamycin


• Lopinavir


• Mepartricin


• Miconazole


• Miokamycin


• Nevirapine


• Phenytoin


• Rifampin


• Rokitamycin


• Roxithromycin


• Saquinavir


• Spiramycin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or


• Drug dependence, especially narcotic abuse or dependence, history of or


• Emotional problems or


• Mental illness (e.g., major depression) or


• Underactive thyroida€”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


• Head injury, recent or


• Heart disease or


• Impaired consciousness (slow to respond) or


• Increased pressure in your head or


• Intestinal problems such as colitis or Crohn`s disease or


• Pancreatitis, acutea€”Some of the side effects of fentanyl can cause serious problems in people who have these medical problems .

• Breathing problems (e.g., COPD or asthma) or


• Not opioid-tolerant (if you are not already taking a certain amount of morphine, oxycodone, hydromorphone or other opioid medicine) or


• Respiratory depression (hypoventilation or slow breathing)a€”Fentanyl patches should not be used in these patients. It could cause very serious breathing problems .

• Kidney disease or


• Liver diseasea€”Effects may be increased because of slower removal from the body .

• Paralytic ileus (intestinal blockage)a€”Fentanyl patches should not be used in patients with this condition.

Proper Use

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

Transdermal fentanyl comes with patient instructions. Read them carefully before using the product . If you do not receive any printed instructions with the medicine, or do not understand the instructions, check with your nurse or doctor .

To use the transdermal fentanyl patch:

• Use this medicine exactly as directed by your doctor . It will work only if it has been applied correctly.


• This medicine should only be used on intact, non-irritated skin . Do not put the patch in your mouth, chew it, or swallow it.


• Fentanyl skin patches are packaged in sealed pouches. Do not remove the patch from the sealed pouch until you are ready to apply it.


• When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand . The adhesive part of the system contains some fentanyl, which can be absorbed into your body too fast through the skin of your hand . If any of the medicine does get on your hand, rinse the area right away with a lot of clear water . Do not use soap or other cleansers.


• Be careful not to tear the patch or make any holes in it. Damage to a patch may allow fentanyl to pass into your skin 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 oily and is free of scars, cuts, burns, or any other skin irritations. Also, do not 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 with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.


• 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 is completely dry before applying the medicine.


• Remove the liner covering the sticky side of the skin patch . Then press the patch firmly in place, using the palm of your hand, for a minimum of 30 seconds. Make sure that the entire adhesive surface is attached to your skin, 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 apply a 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 overlap each 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 your doctor . Choose a different place on your skin to apply the next patch . If possible, use a place on the other side of your body . Wait at least 3 days before using the first area again.

After a patch is applied, fentanyl passes into the skin a little at a time. A certain amount of the medicine must build up in the skin before it is absorbed into the body . Up to a full day (24 hours) may pass before the first dose begins to work. Your doctor may need to adjust the dose during the first few weeks before finding the amount that works best for you. Even if you feel that the medicine is not working, do not increase the amount of transdermal fentanyl that you apply. Instead, check first with your doctor .

You will probably need to take a faster-acting narcotic by mouth to relieve pain during the first few days of transdermal fentanyl treatment . You may continue to need another narcotic while your dose of fentanyl is being adjusted, and also 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 it more often, than directed . Taking other narcotics together with fentanyl can increase the chance of serious side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (stick-on patch):
  
  
  
  • For relief of severe, continuing pain:
    
    
    
    • Adultsa€”If you have not already been using other narcotics regularly, your doctor will determine use and dose . If you have already been using other narcotics regularly, your first dose will depend on the amount of other narcotic you have been taking every day. If necessary, your doctor will change the dose after 3 days, when the first patch is replaced. The size of the new dose will depend on how well the medicine is working and on whether you had any side effects during the first 3-day application. Other changes in dose may be needed later on. Some people may need to use more than one patch at a time.
    
    
    • Childrena€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Remove the new patch 3 days after applying it.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

To dispose of 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 liner that covers the sticky side of the patch before folding it in half . Then flush it down the toilet right away. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.

Precautions

Do not touch the sticky side of the patch or the gel. Fentanyl can be quickly absorbed through the eyes and mouth and can be extremely dangerous . If you do touch the sticky side of the patch or gel, let your nurse or doctor know right away and rinse the area with large amounts of water . Do not use soaps or other cleansers.

Check with your doctor at regular times while using fentanyl. Be sure to report any side effects.

After you have been using this medicine for awhile, "breakthrough" pain may occur more often than usual, and it may not be relieved by your regular dose of medicine. If this occurs, do not increase the amount of transdermal fentanyl or other narcotic that you are taking without first checking with your doctor .

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 depressants are 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, including some dental anesthetics. You will probably be directed to take other pain relievers if you still have pain while using transdermal fentanyl. Check with your doctor before taking any 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 you know how you react to this medicine before you drive, use machines, or do anything 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, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position . Getting up slowly may help lessen this problem . Also, lying down for a while may relieve dizziness or lightheadedness.

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

Using narcotics for a long time may cause severe constipation. To prevent this, your doctor may tell you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems .

Heat can cause the fentanyl in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water . Also, check with your doctor if you get a fever.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist-in-charge that you are using this medicine. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that 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 cause the patch to get loose or come off. If this does occur, throw away the patch and apply a new one in a different place . Make sure the area is completely dry 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 checking with your doctor . You may be directed to gradually reduce the amount you are using before stopping treatment completely, or to take another narcotic for a while, to lessen the chance of withdrawal side effects.

In young children or persons with decreased mental alertness, the patch should be put on the upper back to decrease the chance that the patch will be 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 area with water . The exposed person should then seek medical attention .

Using too much transdermal fentanyl, or taking too much of another narcotic while using transdermal fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin; low blood pressure; pinpoint pupils of eyes; and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

Do not use transdermal fentanyl if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan], phenelzine [Nardil], selegiline [Eldepryl], or tranylcypromine [Parnate]) in the past 2 weeks. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high temperature, an extremely high blood pressure, or severe convulsions.

Grapefruits and grapefruit juice may increase the effects of transdermal fentanyl by increasing the amount of this medicine in your body . You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Side Effects

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 may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Decrease in the amount of urine or in the frequency of urination


• Hallucinations (seeing, hearing, or feeling things that are not there)

Less common

• Chest pain


• Difficulty with speaking


• Fainting


• Mood or mental changes


• Problems with walking


• Redness, swelling, itching, or bumps on the skin at place of application


• Spitting blood

Incidence not known

• Bloating or swelling of the face, hands, lower legs, or feet


• Fast or pounding heartbeat or pulse


• Rapid weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Cold, clammy skin


• Convulsions (seizures)


• Drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened


• Low blood pressure


• Pinpoint pupils of the eyes


• Slow heartbeat


• Very slow (fewer than 8 breaths a minute) or troubled breathing

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

• Feeling anxious and restless at the same time


• Feeling of crawling, tingling, or burning of the skin


• Memory loss


• Unusual dreams

Incidence not known

• Change or problem with discharge of semen


• Decreased interest in sexual intercourse


• Inability to have or keep an erection


• Loss in sexual ability, desire, drive, or performance


• Not able to have an orgasm


• Weight loss

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• Body aches


• Fast heartbeat


• Fever, runny nose, or sneezing


• Gooseflesh


• Increased sweating


• Increased yawning


• Nervousness, restlessness, or irritability


• Shivering or trembling


• Stomach cramps


• Trouble with sleeping


• Unusually large pupils in the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.