FENTANYL (Systemic)
Some commonly used brand names are:
In the U.S.?
Category
Description
Fentanyl (FEN-ta-nil)belongs to the group of medicines called narcotic analgesics (nar-KOT-ik an-al-GEE-ziks).Narcotic analgesics are used to relieve pain. The transmucosal form of fentanylis used to treat breakthrough cancer pain. Breakthrough episodes of cancerpain are the flares of pain which ?breakthrough? the medicationused to control the persistent pain. Transmucosal fentanyl is only used inpatients who are already taking narcotic analgesics.
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 narcoticis used for a long time, it may become habit-forming (causing mental or physicaldependence). However, people who have continuing pain should not let thefear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are usedfor this purpose. Physical dependence may lead to withdrawal side effectsif treatment is stopped suddenly. However, severe withdrawal side effectscan usually be prevented by reducing the dose gradually over a period of timebefore treatment is stopped completely. Your health care professional willtake this into consideration when deciding on the amount of transmucosal fentanylyou should receive.
This medicine is available only with your doctor's prescription, in thefollowing dosage form(s):
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 doctor will make. For transmucosal fentanyl,the following should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to fentanyl, including the stick-on patch. Also tell yourhealth care professional if you are allergic to any other substances, suchas foods, preservatives, or dyes.
Pregnancy?Although studies on birth defects with fentanyl havenot been done in pregnant women, it has not been reported to cause birth defects.
Breast-feeding?Fentanyl passes into breast milk. Nursing babieswhose mothers are using this medicine regularly may receive enough of it tocause unwanted effects such as drowsiness or breathing problems. A motherwho wishes to breast-feed and who needs treatment for continuing pain shoulddiscuss the risks and benefits of different pain treatments with her healthcare professional.
Children?Studies with transmucosal fentanyl have been doneonly in adult patients, and there is no specific information comparing useof transmucosal fentanyl in children with use in other age groups. It contains a medicine in an amount which can be fatal to achild. Patients and their caregivers should keep transmucosal fentanylout of the reach of children and discard open units properly.
Older adults?Elderly people may be especially sensitive to theeffects of narcotic analgesics. This may increase the chance of side effectsduring treatment. Your health care professional will take this into considerationwhen deciding on the amount of transmucosal fentanyl you 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 doctor may want tochange the dose, or other precautions may be necessary. When you are usingtransmucosal fentanyl, it is especially important that your health care professionalknow if you are taking any other dosage form of fentanyl (e.g., injection,patch) or nonprescription (over-the-counter [OTC] medicine) or any of thefollowing:
- Alcohol or
- Central nervous system (CNS) depressants (medicines that cause drowsiness),including other narcotics or
- Erythromycin (e.g., E-Mycin) or
- Itraconazole (e.g., Diflucan) or
- Ketoconazole (e.g., Nizoral) or
- Ritonavir (e.g., Norvir)?These medicines may add to the effectsof transmucosal fentanyl. This may increase the chance of serious side effects.
- Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g.,Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline[e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Taking transmucosalfentanyl while you are taking or within 2 weeks of taking MAO inhibitors maycause an increased chance of serious side effects
Other medical problems?The presence of other medicalproblems may affect the use of transmucosal fentanyl. Make sure you tell yourdoctor if you have any other medical problems, especially:
- Alcohol abuse or history of or
- Drug dependence, especially narcotic abuse or dependence, historyof or
- Kidney disease or
- Liver disease?The chance of side effects may be increased
- Emphysema or other chronic lung disease or
- Head injuries?Some of the side effects of transmucosal fentanylcan cause serious problems in people who have these medical problems
- Slow heartbeat?Transmucosal fentanyl can make this conditionworse
Proper Use of This Medicine
Transmucosal fentanyl contains a medicine in an amount which can be fatalto a child. Patients and their caregivers should keep transmucosalfentanyl out of the reach of children and discard open units properly.
Transmucosal fentanyl comes with patient instructions. Read them carefullybefore using the product.
How to use transmucosal fentanyl:- Keep medication in sealed pouch until ready to use.
- The foil package should be opened with scissors immediately priorto product use.
- Place the medicine in mouth between the cheek and lower gum, occasionallymoving the medicine from one side to the other using the handle.
- The medicine should be sucked, not chewed.
- Suck the medicine over a 15-minute period.
Dosing?The dose of transmucosal fentanylwill be different for different patients. Follow yourdoctor's orders or the directions on the label. The following informationincludes only the average doses of transmucosal fentanyl. If your dose is different, do not change it unless your doctor tellsyou to do so.
The number of units that you use will depend on the strength of the medicine.Also, the number of doses you use each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are using transmucosal fentanyl.
- For oral transmucosal dosage form :
- For cancer pain:
- Adults?The initial dose to treat episodes of breakthrough cancerpain in patients who are already receiving and who are tolerant to opioidtherapy for their underlying persistent cancer pain is 200 micrograms.
Redosing may start 15 minutes after the previous dose has been completed(30 minutes after the start of the previous dose). Patients should not usemore than 2 units per episode of breakthrough pain. Patients should recordtheir use over several episodes of breakthrough cancer pain and review theirexperience with their physicians to determine if a dosage adjustment is warranted. - Children?Use and dose must be determined by the doctor.
Missed dose?If your medical doctor has ordered you to use thismedicine according to a regular schedule and you miss a dose, use it as soonas you remember. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
- Do not use if the foil pouch has been opened.
- A temporary storage bottle is provided as part of the Actiq [reg ] Welcome Kit. This container is to be usedby patients or their caregivers in the event that a partially consumed unitcannot be disposed of promptly. If additional assistance is required, referto 1-800-615-0187.
Precautions While Using This Medicine
Transmucosal fentanyl contains a medicine in an amount whichcan be fatal to a child. Patients and their caregivers should keeptransmucosal fentanyl out of the reach of children and discard open unitsproperly.
Check with your health care professional at regular times while using fentanyl. Be sure to report any side effects.
Transmucosal fentanyl comes with patient instructions. Read them carefullybefore using the product.
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 CNSdepressants are antihistamines or medicine for hay fever, other allergies,or colds; sedatives, tranquilizers, or sleeping medicine; other prescriptionpain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants;or anesthetics, including some dental anesthetics. Checkwith your health care professional before taking any of the other medicineslisted above while you are using this medicine.
Transmucosal fentanyl may cause some people to become drowsy, dizzy, orlightheaded, 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 alertand clearheaded. These effects usually go away after a few days oftreatment, when your body gets used to the medicine. However, check with your health care professional if drowsiness that is severe enoughto interfere with 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 up slowly may help lessenthis problem. Also, lying down for a while may relieve dizziness or lightheadedness.
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 tofollow the directions carefully, because continuing constipation can leadto more serious problems.
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 transmucosal fentanyl.
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 to lessen thechance of withdrawal side effects.
Using too much transmucosal fentanyl, or taking toomuch of another narcotic while using transmucosal 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.
Check with your dentist at regular times while using fentanyl. This medicinecontains sugar and may increase your chance for tooth decay or other troublewith your teeth or gums.
Side Effects of This Medicine
Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.
Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:
After you stop using this medicine, your bodymay need time to adjust. The length of time this takes depends on the amountof medicine you were using and how long you used it. During this period oftime check with your doctor if you notice any of the following side effects:
Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.
Developed: 06/14/1999
Revised: 11/29/2004
