Fentanyl (Transdermal route)
Warnings:Transdermal route(Patch, Extended Release)
Fentanyl: Fentanyl transdermal system is contraindicated in patients who are not opioid-tolerant, in the management of acute or postoperative pain (including use in outpatient surgeries), and in the management of mild or intermittent pain. Should not be used in children under 2 years of age. The concomitant use of fentanyl transdermal system with any CYP3A4 inhibitor may cause potentially fatal respiratory depression. Fentanyl transdermal systems are intended for transdermal use (on intact skin) only. Using damaged or cut fentanyl transdermal systems can lead to the rapid release of the contents of the fentanyl transdermal system and absorption of a potentially fatal dose of fentanyl to the patient and/or caregiver. Fentanyl transdermal system has an abuse liability similar to other opioid analgesics . Due to potential temperature-dependent increases in fentanyl release from the system, avoid exposing the application site and surrounding areas to direct heat sources (such as electric blankets, tanning lamps, hot baths and sunbathing). Development of fever or increased core body temperature due to strenuous exercise may also result in increase release of fentanyl .Transdermal route(Patch, Extended Release)
Duragesic(R): Contains fentanyl, a Schedule II controlled substance, which is subject to misuse, abuse, addiction, and criminal diversion. Fatal respiratory depression could occur in patients who are not opioid-tolerant and in patients that are opioid-tolerant even if Duragesic(R) is not misused or abused. Accidental exposure to Duragesic(R), especially in children, can result in a fatal overdose of fentanyl. CYP3A4 inhibitors can result in a fatal overdose of fentanyl from concomitant use with Duragesic(R). Avoid exposing the Duragesic(R) application site and surrounding area to direct external heat sources. Temperature dependent increases in fentanyl release from the system may result in overdose and death .
Uses of This Medicine:
Fentanyl transdermal (skin patch) is used to relieve moderate to severe chronic pain when around-the-clock pain relief is needed for a long period of time.
The fentanyl skin patch should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. This medicine should not be used to treat pain that you only have once in a while or "as needed".
Fentanyl belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
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 the 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.
Before Using This Medicine:
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 fentanyl transdermal in children 2 years of age 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 of age.
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.
Studies in women suggest that this medication poses minimal risk to the infant when used during 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:
Proper Use of This Medicine:
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.
Fentanyl skin patch is for use in opioid-tolerant patients only. If you are not sure whether or not you are opioid-tolerant, check with your doctor before using this medicine.
This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
To use the patch:
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.
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 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 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.
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 new 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.
Fentanyl can cause serious unwanted effects or 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. 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 While Using This Medicine:
It is very important that your doctor check your or your child's 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 or your child 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 other medicines listed above while you or your child 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 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, or to take another narcotic for a while, to lessen the chance of withdrawal side effects.
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 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.
Grapefruits and grapefruit juice may increase the effects of transdermal fentanyl by increasing the amount of the medicine in your body. You should not eat grapefruit or drink grapefruit juice 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.
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 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.
Last Updated: 4/4/2014
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