Generic Name: fentanyl citrate (oral transmucosal) (FEN ta nil SIT rayt)Brand Names: Actiq
Fentanyl citrate is a narcotic pain medicine.
Fentanyl citrate treats "breakthrough" cancer pain that is not controlled by other medicines. This medication is not for short-term pain relief.
Fentanyl citrate may also be used for other purposes not listed in this medication guide.
You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.
Keep both the used and the unused Actiq units out of the reach of children. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit.Seek emergency medical attention if you think you have used too much of this medicine or if anyone else has accidentally swallowed it. An overdose of this medicine can be fatal. Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops. Fentanyl citrate may be habit-forming and should be used only by the person it was prescribed for. Fentanyl citrate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Keep track of how many Actiq units have been used from each new supply of this medicine. Fentanyl citrate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use more than four Actiq units per day.What should I discuss with my health care provider before taking fentanyl citrate?
You should not use this medication unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), oxymorphone (Numorphan, Opana), and others. Talk with your doctor if you are not sure you are opioid-tolerant.Do not use fentanyl citrate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you use fentanyl before the MAO inhibitor has cleared from your body.
You should not use fentanyl citrate if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
a breathing disorder such as asthma or chronic obstructive pulmonary disease (COPD);
a seizure disorder;
a history of head injury or brain tumor;
liver or kidney disease;
low blood pressure, heart disease;
a history of depression or other mental illness; or
a history of drug or alcohol addiction.
If you are diabetic, you should know that each fentanyl citrate lozenge contains 2 grams (one-half teaspoon) of sugar.
You will also receive instructions for using the medicine. Follow these instructions carefully. Do not use the medication in larger amounts or for longer than prescribed by your doctor. Your doctor may occasionally change your dose to make sure you get the best results.
The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.
Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.
Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit.Do not use more than four Actiq units per day.
If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms. Do not stop using any other pain medicines your doctor has prescribed for you. Call your doctor if fentanyl citrate does not relieve your pain. Fentanyl may be habit-forming and should be used only by the person it was prescribed for. Never share fentanyl with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Keep track of the amount of medicine used from each new bottle. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. Do not stop using fentanyl citrate suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fentanyl citrate. Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.
Pay special attention to your dental hygiene. Fentanyl citrate can cause dry mouth leading to tooth decay.
Since fentanyl citrate is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.Do not use more than four (4) Actiq units per day.
Overdose symptoms may include weak pulse, fainting, shallow breathing, or breathing that stops.
Grapefruit and grapefruit juice may interact with fentanyl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
shallow breathing, slow heart rate;
extreme sleepiness; or
feeling light-headed, fainting.
Less serious side effects may include:
headache, dizziness, weakness, anxiety; or
nausea, vomiting, or constipation.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 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
diltiazem (Cardizem, Cartia, Dilacor, Tiazac);
verapamil (Calan, Covera, Isoptin, Verelan);
an antibiotic such as clarithromycin (Biaxin) or erythromycin (E-Mycin, Ery-Tab, E.E.S.);
an antifungal medication such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox); or
HIV medicines such as indinavir (Crixivan), fosamprenavir (Lexiva), nelfinavir (Viracept), or ritonavir (Norvir).
This list is not complete and other drugs may interact with fentanyl citrate. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.