Fentanyl has the potential to cause opioid addiction, abuse, or misuse, which may lead to overdose and death. Assess risk prior to initiation and monitor for signs of misuse, abuse, and addiction during treatment. Serious or fatal respiratory depression may occur; the highest risk for respiratory depression is at therapy initiation and dose increases. Monitor for signs of respiratory depression during treatment. Accidental exposure to transdermal fentanyl, especially in children, can result in fatal overdose of fentanyl. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged use is required in a pregnant woman, advise the patient of the risk to fetus and ensure that appropriate treatment is available. Concomitant use with CYP3A4 inhibitors or discontinuation of concomitant CYP3A4 inducers can increase fentanyl plasma concentrations and result in fatalities. Exposure of the transdermal application site and surrounding area to direct external heat sources may result in fatal overdose of fentanyl and death. Patients using transdermal fentanyl who develop fever or increased core body temperature due to strenuous exertion are at risk for increased fentanyl exposure and may require an adjustment in the dose .Transdermal route(Patch, Device Assisted)
Use of fentanyl iontophoretic transdermal system may result in potentially life-threatening respiratory depression and death; therefore, only the patient should activate dosing. Accidental exposure to an intact fentanyl iontophoretic transdermal system or to the hydrogel component, especially by children, through contact with skin or mucous membranes, can result in a fatal overdose of fentanyl. The fentanyl iontophoretic transdermal system is for use only in patients in the hospital; discontinue treatment before patients leave the hospital. Because of potentially life-threatening respiratory depression resulting from accidental exposure, the fentanyl iontophoretic transdermal system is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the IONSYS REMS Program. Transdermal fentanyl exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death; assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. The initiation of CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of fentanyl .
The fentanyl skin patch (transdermal) is used to treat severe pain. It may be applied in a hospital setting after surgery or at home for severe chronic pain when around-the-clock pain relief is needed for a long period of time. Fentanyl is a narcotic analgesic (pain medicine). It acts on the central nervous system (CNS) to relieve pain.
The Duragesic® skin patch should not be used if you need pain medicine for just a short time, such as after dental surgery or tonsil surgery. Do not use the patch for mild pain or pain that occurs only once in a while.
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 if needed. 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, but the adverse effects can usually be prevented by gradually reducing the dose.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the Duragesic® patch in children 2 years and older. However, pediatric patients must be opioid-tolerant before using a fentanyl patch. Safety and efficacy have not been established in children younger than 2 years.
Appropriate studies have not been performed on the relationship of age to the effects of the Ionsys® patch in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fentanyl transdermal in the elderly. However, elderly patients are more likely to have drowsiness and age-related lung problems, which may require caution and an adjustment in the dose for patients receiving fentanyl transdermal.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
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.
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.
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:
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
The fentanyl skin patch is only used for opioid-tolerant patients. A patient is opioid-tolerant if oral narcotics have already been used for severe pain. Check with your doctor if you have questions about this.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You will receive the Ionsys® patch while you are in a hospital. A nurse or other trained health professional will give you this medicine after surgery. You will be taught how to use this medicine in the hospital, but you will not use it at home. Do not leave the hospital with the patch on your skin.
To use the Duragesic® patch:
In young children or persons with decreased mental alertness, the Duragesic® patch should be put on the upper back to decrease the chance that the patch will be removed and placed in the mouth.
After a Duragesic® 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 fentanyl transdermal 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 fentanyl transdermal treatment. You may also need another narcotic while your dose of fentanyl is being adjusted, and to relieve any "breakthrough" pain that occurs later on. Be sure you do not take more of the other narcotic, and do not take it more often than directed. Taking 2 narcotics together can increase the chance of serious side effects.
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.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Remove the patch 3 days (72 hours) after applying it.
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.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Fentanyl can cause serious unwanted effects or a fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
To dispose of this medicine, 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. Ask your pharmacist about the best way to dispose of patches you do not use. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
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 fentanyl transdermal or other narcotic that you are using 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, medicine for seizures or barbiturates, 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 medicines listed while you are using this medicine.
The Ionsys® patch must be removed before a procedure called a magnetic resonance imaging (MRI) scan. It may cause skin burns if left in place during the procedure.
The Ionsys® patch may cause serious skin reactions. Call you doctor right away if you have blistering, lesions, a rash, redness, or swelling of the skin, especially at the site of application.
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 direct 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, electric blanket, heat or tanning lamps, sauna, 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.
Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as when you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.
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 to lessen the chance of withdrawal side effects.
Using too much transdermal fentanyl, or taking too much of another narcotic with 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 a fentanyl patch if you have taken a monoamine oxidase (MAO) inhibitor in the previous 2 weeks. Some examples of MAO inhibitors are isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), and tranylcypromine (Parnate®). If you use the 2 medicines close together it may cause serious side effects like confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high temperature, an extremely high blood pressure, or severe convulsions.
Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
Grapefruit and grapefruit juice may increase the effects of transdermal fentanyl by increasing the amount of the medicine in your body. You should not consume grapefruit products while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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:
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.