Generic Name: fentanyl transdermal (device) (FEN ta nil trans DERM al)Brand Names: Ionsys
Fentanyl is a narcotic (opioid) pain medicine.
The fentanyl transdermal device is used only in a hospital to treat acute pain after surgery.
Fentanyl transdermal may be used for other purposes not listed in this medication guide.What is the most important information I should know about a fentanyl transdermal device?The fentanyl transdermal device is used only while you are in a hospital. You will not be allowed to use the device at home. Do not leave the hospital with a device on your skin. Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. Fentanyl may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction.
Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl.What should I discuss with my healthcare provider before using a fentanyl transdermal device?Do not use this medication unless you are already being treated with a similar opioid (narcotic) pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant. Before you receive this medication, tell your doctor if you are allergic to fentanyl or any other medications, or if you have:
a breathing disorder such as chronic obstructive pulmonary disease (COPD);
a history of head injury or brain tumor;
a heart rhythm disorder;
liver disease; or
If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Fentanyl may also cause addiction and withdrawal symptoms in a nursing infant. Do not use fentanyl transdermal without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine. Fentanyl transdermal may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction.
If the skin must be washed before fentanyl transdermal is applied, use clear water only. Allow the skin to dry completely before applying the medicine.Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will apply fentanyl transdermal. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.
The device will be applied where you can reach it, such as your chest or the outer side of your upper arm. The device is worn for 24 hours or until the device has delivered 80 doses of fentanyl.
To release the medicine from the device, press the dosing button twice. The device will sound a beep when the dose starts, and a red light will come on for 10 minutes while the dose is delivered. The light will also flash between doses to let your caregivers know how many doses are left in the device. Tell your care provider if the patch comes loose or falls off.The device will allow you to give yourself up to 6 doses per hour. Do not allow others to press the dosing button for you.
Since a fentanyl transdermal device is applied by a healthcare professional in a hospital setting, it is not likely that you will miss a dose.
weak, shallow breathing;
severe weakness, feeling light-headed or fainting;
cold, clammy skin; or
pale skin, easy bruising or bleeding.
Less serious side effects may include:
nausea, vomiting, stomach pain, constipation, gas;
dizziness, drowsiness, anxiety, sleep problems (insomnia);
muscle stiffness, back pain;
itching, blistering, redness, or swelling where the patch or device was worn; or
increased sweating, urinating less than usual.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Anesthesia:
Premedication for Anesthesia:50 to 100 mcg IM, 30 to 60 minutes prior to surgery.Lozenge: 5 mcg/kg (400 mcg is the maximum dose).Lower doses should be used for vulnerable patients.General Anesthesia:Total Low dose: 2 mcg/kg (minor procedures).Maintenance low dose: Infrequently needed.Total Moderate dose: 2 to 20 mcg/kg.Maintenance moderate dose: 25 to 100 mcg IV/IM.Total high dose: 20 to 50 mcg/kg (prolonged surgeries).Maintenance high dose: 25 mcg to half of the initial dose.Adjunct to Regional Anesthesia:50 to 100 mcg IM or slow IV over 3 to 5 minutes as required.Postoperative :50 to 100 mcg IM. May repeat dose in 1 to 2 hours as needed.
Usual Adult Dose for Pain:
Transdermal patch - Initial dose: 25 mcg/hour patch (unless opioid tolerance) every 72 hours.Transmucosal - Initial dose: 200 mcg, place in mouth (in-between cheek and lower gum) and suck over 15 minutes (do not chew or swallow).Fentanyl iontophoretic transdermal system - Patients should be titrated to comfort before initiating the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system should be applied to intact, non-irritated, non-irradiated skin on the chest or upper outer arm.Patients must have access to supplemental analgesia during treatment with the fentanyl iontophoretic transdermal system. Fentanyl iontophoretic transdermal system provides a 40 mcg dose of fentanyl per activation on-demand. It is important to instruct patients how to operate fentanyl iontophoretic transdermal system to self-administer doses of fentanyl as needed to manage their acute, short-term, postoperative pain. Only the patient should administer doses from fentanyl iontophoretic transdermal system. Each on-demand dose is delivered over a 10-minute period. To initiate administration of a fentanyl dose, the patient must press the button firmly twice within 3 seconds. An audible tone (beep) indicates the start of delivery of each dose; the red light remains on throughout the 10 minute dosing period.Patients on chronic opioid therapy or with a history of opioid abuse may require higher analgesic doses in the postoperative period than are available from fentanyl iontophoretic transdermal system. Therefore, these patients should be evaluated frequently to ensure they are receiving adequate analgesia.A maximum of six 40 mcg doses per hour can be administered by fentanyl iontophoretic transdermal system. The maximum amount of fentanyl that can be administered from a single fentanyl iontophoretic transdermal system over 24 hours is 3.2 mg (eighty 40 mcg doses). Each fentanyl iontophoretic transdermal system operates for 24 hours or until eighty doses have been administered, whichever occurs first. Up to three consecutive fentanyl iontophoretic transdermal systems may be used sequentially, each applied to a different skin site for a maximum of 72 hours of therapy for acute, short-term, postoperative pain.Buccal TabletInitial Dose: 100 mcg. Dose Titration: Patients should be titrated to a dose of fentanyl buccal tablet that provides adequate analgesia with tolerable side effects. For patients switching from oral transmucosal fentanyl citrate to fentanyl buccal tablet, the starting dose of fentanyl buccal tablet should be as follows. An oral transmucosal fentanyl citrate dose of 200 mcg or 400 mcg converts to an initial fentanyl buccal tablet dose of 100 mcg. An oral transmucosal fentanyl citrate dose of 600 or 800 mcg converts to an initial fentanyl buccal tablet dose of 200 mcg. And, an oral transmucosal fentanyl citrate dose of 1200 mcg or 1600 mcg converts to an initial fentanyl buccal tablet dose of 400 mcg.Re-dosing Patients Within a Single Episode: Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one fentanyl buccal tablet dose. Re-dosing may occur 30 minutes after the start of administration of fentanyl buccal tablet and the same dosage strength should be used.Buccal soluble film:For use only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain:Only prescribers enrolled in the FOCUS program may prescribe buccal soluble film.The goal of dose titration is to find the individual patient's effective and tolerable dose. The dose of fentanyl buccal soluble film is not predicted from the daily maintenance dose of opioid used to manage the persistent cancer pain and must be determined by dose titration.Individually titrate fentanyl buccal soluble film to a dose that provides adequate analgesia with tolerable side effects.Initial dose: All patients must begin treatment using one 200 mcg fentanyl buccal soluble film. Due to differences in pharmacokinetic properties and individual variability, patients switching from another oral transmucosal fentanyl product must be started on no greater than 200 mcg of fentanyl buccal soluble film. When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl buccal soluble film as fentanyl buccal soluble film is not equivalent on a mcg per mcg basis with any other fentanyl product. Fentanyl buccal soluble film is not a generic version of any other oral transmucosal fentanyl product.Following the initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia. If adequate pain relief is not achieved after one 200 mcg fentanyl buccal soluble film, titrate using multiples of the 200 mcg fentanyl buccal soluble film (for doses of 400, 600, or 800 mcg). Increase the dose by 200 mcg in each subsequent episode until the patient reaches a dose that provides adequate analgesia with tolerable side effects. Do not use more than four of the 200 mcg fentanyl buccal soluble film simultaneously. When multiple 200 mcg fentanyl buccal soluble films are used, they should not be placed on top of each other and may be placed on both sides of the mouth.If adequate pain relief is not achieved after 800 mcg fentanyl buccal soluble film (i.e., four 200 mcg fentanyl buccal soluble films), and the patient has tolerated the 800 mcg dose, treat the next episode by using one 1200 mcg fentanyl buccal soluble film. Doses above 1200 mcg fentanyl buccal soluble film should not be used.The patient should then get a prescription for fentanyl buccal soluble film of the dose determined by titration (i.e., 200, 400, 600, 800, or 1200 mcg) to treat subsequent episodes.Single doses should be separated by at least 2 hours. Fentanyl buccal soluble film should only be used once per breakthrough cancer pain episode, i.e., fentanyl buccal soluble film should not be re-dosed within an episode.During any episode of breakthrough cancer pain, if adequate pain relief is not achieved from use of fentanyl buccal soluble film, the patient may use a rescue medication (after 30 minutes) as directed by their healthcare provider.During maintenance treatment, if the prescribed dose no longer adequately manages the breakthrough cancer pain episode for several consecutive episodes, increase the dose of fentanyl buccal soluble film. Once a successful dose has been found, each episode is treated with a single film. Fentanyl buccal soluble film should be limited to four or fewer doses per day. Consider increasing the dose of the around-the-clock opioid medicine used for persistent cancer pain in patients experiencing more than four breakthrough cancer pain episodes daily.The tongue should be used to wet the inside of the cheek or rinse the mouth with water to wet the area for placement of fentanyl buccal soluble film. The fentanyl buccal soluble film package should be opened immediately prior to product use. Place the entire fentanyl buccal soluble film near the tip of a dry finger with the pink side facing up and hold in place. Place the pink side of the fentanyl buccal soluble film against the inside of the cheek. Press and hold the fentanyl buccal soluble film in place for five seconds. The fentanyl buccal soluble film should stay in place on its own after this period. Liquids may be consumed after five minutes. Fentanyl buccal soluble film, if chewed and swallowed, might result in lower peak concentrations and lower bioavailability than when used as directed.The fentanyl buccal soluble film should not be cut or torn prior to use. The fentanyl buccal soluble film will dissolve within 15 to 30 minutes after application. The film should not be manipulated with the tongue or finger(s). Eating food should be avoided until the film has dissolved.
Usual Pediatric Dose for Anesthesia:
1 to 12 years:Induction and Maintenance of Anesthesia:IM,IV: 2 to 3 mcg/kg.Continuous epidural: 1 mcg/kg/hour.Low dose: 5 mcg/kg lozenge.Moderate dose: 10 mcg/kg lozengeHigh dose: 15 mcg/kg lozengeMaximum dose: 400 mcgLozenge should be sucked 20 to 40 minutes prior to desired effect.
Usual Pediatric Dose for Sedation:
Study (n=23)Mechanical Ventilation (greater than or equal to 7 days and less than 3 months): 3 mcg/kg/hr IV, slowly increase dose to desired effect.Study (n=133)Conscious sedation (greater than or equal to 2 years): <= 2 mcg/kg IV initially, then slowly titrate upwards if needed (Maximum total dose in 1 hour: 5 mcg/kg)
Usual Pediatric Dose for Pain:
Review Oncology Patients (n=58)Continuous Epidural: 1 mcg/kg/hour
Before using this medication, tell your doctor if you are using any of the following drugs:
carbamazepine (Tegretol, Carbatrol);
diltiazem (Cartia, Dilacor, Tiazac);
St. John's wort;
rifampin (Rifater, Rifamate, Rimactane);
antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin Ery-Tab, E.E.S.), itraconazole (Sporanox), ketoconazole (Nizoral), or troleandomycin (Tao); or
HIV medicines such as amprenavir (Agenerase), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept).
This list is not complete and there may be other drugs that can interact with fentanyl transdermal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.