Fentanyl Transdermal

FEN-ta-nil

Transdermal routePatch, Extended Release
  • Fentanyl transdermal system contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (fentanyl transdermal system) may be a particular target for abuse and diversion.
  • Fentanyl transdermal system is indicated for management of persistent, moderate to severe chronic pain that:
    • requires continuous, around-the-clock opioid administration for an extended period of time
    • cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids
  • Fentanyl transdermal system should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.
  • Because serious or life-threatening hypoventilation could occur, fentanyl transdermal system is contraindicated:
    • in patients who are not opioid-tolerant
    • in the management of acute pain or in patients who require opioid analgesia for a short period of time
    • in the management of post-operative pain, including use after out-patient or day surgeries (eg, tonsillectomies)
    • in the management of mild pain
    • in the management of intermittent pain (eg, use on an as needed basis (prn))
  • Since the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.
  • The concomitant use of fentanyl transdermal system with potent cytochrome P450 3A4 inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazodone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving fentanyl transdermal system and potent CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.
  • The safety of fentanyl transdermal system has not been established in children under 2 years or age. Fentanyl transdermal system should be administered to children only if they are opioid-tolerant and 2 years of age or older.
  • Fentanyl transdermal system is only for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the fentanyl transdermal system dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean elimination half-life of 17 hours of fentanyl transdermal system, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.
  • Fentanyl transdermal system can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing fentanyl transdermal system in situations where the healthcare professional is concerned about increased risk of misuse, abuse or diversion.
  • Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (eg, major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.
  • Fentanyl transdermal systems are intended for transdermal use (on intact skin) only. Do not use a fentanyl transdermal system if the patch is cut, damaged, or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal.
  • Avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death. Patients wearing fentanyl transdermal systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the fentanyl transdermal system dose should be adjusted if necessary .

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 .

Buccal mucosa routeFilm
  • Onsolis(R)
    • Importance of Proper Patient Selection and Potential for Abuse
    • Onsolis(R) contains fentanyl, an opioid agonist and a Schedule II controlled substance, with abuse liability similar to other opioid analgesics. This should be considered when prescribing or dispensing Onsolis(R) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances, which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone, have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
    • Serious adverse events, including deaths, in patients treated with other oral transmucosal fentanyl products have been reported. Deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients) and/or improper dosing. The substitution of Onsolis(R) for any other fentanyl product may result in fatal overdose.
    • Onsolis(R) is indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least: 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
    • Onsolis(R) is contraindicated for use in opioid non-tolerant patients including those using opioids intermittently, on an as needed basis.
    • Onsolis(R) is contraindicated in the management of acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients treated with other fentanyl products.
    • When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to Onsolis(R). Patients beginning treatment with Onsolis(R) must begin with titration from the 200 mcg dose.
    • When dispensing, do not substitute an Onsolis(R) prescription for any other fentanyl product. Substantial differences exist in the pharmacokinetic profile of Onsolis(R) compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Onsolis(R) for any other fentanyl product may result in fatal overdose.
    • Special care must be used when dosing Onsolis(R). If the breakthrough pain episode is not relieved, patients should wait at least 2 hours before taking another dose.
    • Onsolis(R) is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of Schedule II opioids to treat cancer pain.
    • Patients and their caregivers must be instructed that Onsolis(R) contains a medicine in an amount which can be fatal in children, in individuals for whom it is not prescribed, and in those who are not opioid tolerant. All Onsolis(R) films must be kept out of the reach of children.
    • The concomitant use of Onsolis(R) with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression.
    • Because of the risk for misuse, abuse, and overdose, Onsolis(R) is available only through a restricted distribution program, called the FOCUS Program. Under the FOCUS Program, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive Onsolis(R). To enroll in the FOCUS Program, call 1-877-466-7654 (1-877-4ONSOLIS) or visit www.OnsolisFocus.com .

Onsolis(R)is indicated in cancer patients age 18 and older who are already receiving and who are tolerant to opioid therapy. Life-threatening hypoventilation can occur at any dose in patients not taking chronic opiates. Contraindicated in the management of acute or postoperative pain, headache/migraine, dental pain, or use in the emergency room. Has an abuse liability similar to other opioid analgesics. When beginning treatment, titrate from the 200 mcg dose, do not convert at a fentanyl mcg to mcg basis to other oral transmucosal products. Prescription should not be substituted for any other fentanyl product. If breakthrough pain occurs wait two hours before giving another dose. Contains a medicine in an amount which can be fatal to a child. Use of Onsolis(R) with strong and moderate CYP3A4 inhibitors may result in potentially fatal respiratory depression. Onsolis(R) is only available through a restricted distribution program (FOCUS Program) .

Buccal mucosa routeLozenge/Troche
  • Actiq(R)
    • Reports of serious adverse events, including deaths in patients treated with Actiq(R) have been reported. Deaths occurred as a result of improper patient selection (eg, use in opioid non-tolerant patients) and/or improper dosing. The substitution of Actiq(R) for any other fentanyl product may result in fatal overdose.
    • Actiq(R) is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
    • Actiq(R) is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.
    • Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.
    • Actiq(R) is contraindicated in the management of acute or postoperative pain including headache/migraine.
    • When prescribing, do not convert patients on a mcg per mcg basis to Actiq(R) from other fentanyl products.
    • When dispensing, do not substitute an Actiq(R) prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of Actiq(R) compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Actiq(R) for any other fentanyl product may result in fatal overdose.
    • Special care must be used when dosing Actiq(R). If the breakthrough pain episode is not relieved 15 minutes after completion of the Actiq(R) unit, patients may take only one additional dose using the same strength and then must wait at least 4 hours before taking another dose.
    • Actiq(R) contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Actiq(R) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Actiq(R) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
    • Patients and their caregivers must be instructed that Actiq(R) contains a medicine in an amount which can be fatal to a child. Death has been reported in children who have accidentally ingested Actiq(R). All units must be kept out of the reach of children and opened units properly discarded.
    • Actiq(R) is intended to be used only in the care of cancer patients and only by oncologists and pain specialists who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
    • The concomitant use of Actiq(R) with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression .

Actiq(R): Must not be used in opioid non-tolerant patients. Life-threatening respiratory depression could occur at any dose in patients not taking chronic opiates. Contraindicated in the management of acute or postoperative pain, including headache/migraines. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Contains medicine in an amount which can be fatal to a child. Keep out of reach of children and discard opened units properly. Use of Actiq(R) with strong and moderate CYP3A4 inhibitors may result in potentially fatal respiratory depression .

Buccal mucosa routeTablet
  • Fentora(R)
    • Reports of serious adverse events, including deaths in patients treated with Fentora(R) have been reported. Deaths occurred as a result of improper patient selection (eg, use in opioid non-tolerant patients) and/or improper dosing. The substitution of Fentora(R) for any other fentanyl product may result in fatal overdose.
    • Fentora(R) is indicated 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. Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine daily, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
    • Fentora(R) is not indicated for use in opioid non-tolerant patients including those with only as needed (PRN) prior exposure.
    • Fentora(R) is contraindicated in the management of acute or postoperative pain including headache/migraine. Life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients. Deaths have occurred in opioid non-tolerant patients.
    • When prescribing, do not convert patients on a mcg per mcg basis from Actiq(R) to Fentora(R). Carefully consult the Initial Dosing Recommendations table.
    • When dispensing, do not substitute a Fentora(R) prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of Fentora(R) compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Fentora(R) for any other fentanyl product may result in fatal overdose.
    • Special care must be used when dosing Fentora(R). If the breakthrough pain episode is not relieved after 30 minutes, patients may take only one additional dose using the same strength and must wait at least 4 hours before taking another dose.
    • Fentora(R) contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Fentora(R) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Fentora(R) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule II opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.
    • Patients and their caregivers must be instructed that Fentora(R) contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children.
    • Fentora(R) is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain.
    • The concomitant use of Fentora(R) with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression .

Fentora(R): Only indicated for treatment of cancer pain in patients who are already receiving and who are tolerant to opioid therapy. Life-threatening hypoventilation can occur at any dose in patients not taking chronic opiates. Contraindicated in the management of acute or postoperative pain. Has an abuse liability similar to other opioid analgesics. Contains a medicine in an amount which can be fatal to a child. Do not substitute Fentora(R) on a mcg per mcg basis when converting patients from other oral fentanyl products due to the higher bioavailability of fentanyl in Fentora(R). Use of Fentora(R) with strong and moderate CYP3A4 inhibitors may result in potentially fatal respiratory depression .

Commonly used brand name(s):

In the U.S.

  • Duragesic

Available Dosage Forms:

  • Patch, Extended Release
  • Patch, Device Assisted

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For fentanyl

Fentanyl belongs to the group of medicines called narcotic analgesics. Narcotic analgesics are used to relieve pain. The transdermal system (skin patch) form of fentanyl is used to treat chronic pain (pain that continues for a long time).

Fentanyl acts on the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS.

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 their 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.

fentanyl is available only with your doctor's prescription.

Before Using fentanyl

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 fentanyl, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fentanyl 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of transdermal fentanyl in children 2 years of age and older. However, pediatric patients must be opioid-tolerant before using transdermal fentanyl. Safety and efficacy have not been established in children less than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of transdermal fentanyl in the elderly. However, elderly patients are more likely to have age-related lung problems, which may require an adjustment in the dose for patients receiving transdermal fentanyl.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using fentanyl 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.

  • Naltrexone

Using fentanyl 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.

  • Acebutolol
  • Adinazolam
  • Alfentanil
  • Alprazolam
  • Alprenolol
  • Amiodarone
  • Amlodipine
  • Amobarbital
  • Amprenavir
  • Anileridine
  • Aprepitant
  • Aprobarbital
  • Atenolol
  • Bepridil
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bromazepam
  • Brotizolam
  • Bucindolol
  • Buprenorphine
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carisoprodol
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clorgyline
  • Codeine
  • Dantrolene
  • Dezocine
  • Diazepam
  • Diltiazem
  • Erythromycin
  • Esmolol
  • Estazolam
  • Ethchlorvynol
  • Felodipine
  • Fentanyl
  • Fluconazole
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fosamprenavir
  • Fospropofol
  • Furazolidone
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Iproniazid
  • Isocarboxazid
  • Isradipine
  • Itraconazole
  • Ketazolam
  • Ketoconazole
  • Labetalol
  • Levobunolol
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Mepindolol
  • Meprobamate
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Metipranolol
  • Metoprolol
  • Midazolam
  • Moclobemide
  • Morphine
  • Morphine Sulfate Liposome
  • Nadolol
  • Nalbuphine
  • Nebivolol
  • Nefazodone
  • Nelfinavir
  • Nialamide
  • Nicardipine
  • Nifedipine
  • Nimodipine
  • Nisoldipine
  • Nitrazepam
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxprenolol
  • Oxycodone
  • Oxymorphone
  • Pargyline
  • Pazopanib
  • Penbutolol
  • Pentazocine
  • Pentobarbital
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Pindolol
  • Prazepam
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propoxyphene
  • Propranolol
  • Quazepam
  • Rasagiline
  • Remifentanil
  • Ritonavir
  • Secobarbital
  • Selegiline
  • Sibutramine
  • Sodium Oxybate
  • Sotalol
  • Sufentanil
  • Talinolol
  • Tapentadol
  • Temazepam
  • Tertatolol
  • Thiethylperazine
  • Thiopental
  • Thioridazine
  • Timolol
  • Toloxatone
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Troleandomycin
  • Verapamil

Using fentanyl 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.

  • Atazanavir
  • Azithromycin
  • Carbamazepine
  • Clotrimazole
  • Dirithromycin
  • Econazole
  • Indinavir
  • Josamycin
  • Lopinavir
  • Mepartricin
  • Miconazole
  • Miokamycin
  • Nevirapine
  • Phenytoin
  • Rifampin
  • Rokitamycin
  • Roxithromycin
  • Saquinavir
  • Spiramycin

Interactions with Food/Tobacco/Alcohol

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 fentanyl 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 fentanyl, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of fentanyl. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol abuse, or history of or
  • Drug dependence, especially narcotic abuse or dependence, history of or
  • Emotional problems or
  • Mental illness (e.g., major depression) or
  • Underactive thyroid—The chance of side effects may be increased.
  • Brain tumor or
  • Diarrhea caused by antibiotic treatment or poisoning or
  • Enlarged prostate or problems with urination or
  • Gallbladder disease or gallstones or
  • Head injury, recent or
  • Heart disease or
  • Impaired consciousness (slow to respond) or
  • Increased pressure in your head or
  • Intestinal problems such as colitis or Crohn's disease or
  • Pancreatitis, acute—Some of the side effects of fentanyl can cause serious problems in people who have these medical problems.
  • Breathing problems (e.g., COPD or asthma) or
  • Not opioid-tolerant (if you are not already taking a certain amount of morphine, oxycodone, hydromorphone or other opioid medicine) or
  • Respiratory depression (hypoventilation or slow breathing)—Fentanyl patches should not be used in these patients. It could cause very serious breathing problems.
  • Kidney disease or
  • Liver disease—Effects may be increased because of slower removal from the body.
  • Paralytic ileus (intestinal blockage)—Fentanyl patches should not be used in patients with this condition.

Proper Use of fentanyl

Fentanyl skin patches are for use in opioid-tolerant patients only. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using fentanyl.

Transdermal fentanyl comes with patient instructions. Read them carefully before using the product. If you do not receive any printed instructions with the medicine, or do not understand the instructions, check with your nurse or doctor.

To use the :

  • Use fentanyl exactly as directed by your doctor. It will work only if it has been applied correctly.
  • fentanyl should only be used on intact, non-irritated skin. Do not put the patch in your mouth, chew it, or swallow it.
  • Fentanyl skin patches are packaged in sealed pouches. Do not remove the patch from the sealed pouch until you are ready to apply it.
  • When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand. The adhesive part of the system contains some fentanyl, which can be absorbed into your body too fast through the skin of your hand. If any of the medicine does get on your hand, rinse the area right away with a lot of clear water. Do not use soap or other cleansers.
  • Be careful not to tear the patch or make any holes in it. Damage to a patch may allow fentanyl to pass into your skin too quickly. This can cause an overdose.
  • Apply the patch to a dry, flat skin area on your upper arm, chest, or back. Choose a place where the skin is not very oily and is free of scars, cuts, burns, or any other skin irritations. Also, do not apply fentanyl to areas that have received radiation (x-ray) treatment .
  • The patch will stay in place better if it is applied to an area with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.
  • If you need to clean the area before applying the medicine, use only plain water. Do not use soaps, other cleansers, lotions, or anything that contains oils or alcohol. Be sure that the skin is completely dry before applying the medicine.
  • Remove the liner covering the sticky side of the skin patch. Then press the patch firmly in place, using the palm of your hand, for a minimum of 30 seconds. Make sure that the entire adhesive surface is attached to your skin, especially around the edges.
  • If the patch becomes loose, tape the edges with first aid tape.
  • If the patch falls off after applying it, throw it away and apply a new patch in a different area.
  • If you need to apply more than 1 patch at a time, place the patches far enough apart so that the edges do not touch or overlap each other.
  • Wash your hands with a lot of clear water after applying the medicine. Do not use soap or other cleansers.
  • Remove the patch after 72 hours (3 days), or as directed by your doctor. Choose a different place on your skin to apply the next patch. If possible, use a place on the other side of your body. Wait at least 3 days before using the first area again.

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 transdermal fentanyl 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 transdermal fentanyl 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.

Dosing

The dose of fentanyl 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 fentanyl. 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.

  • For transdermal dosage form (stick-on patch):
    • For relief of severe, continuing pain:
      • Adults—If you have not already been using other narcotics regularly, your doctor will determine use and dose. If you have already been using other narcotics regularly, your first dose will depend on the amount of other narcotic you have been taking every day. If necessary, your doctor will change the dose after 3 days, when the first patch is replaced. The size of the new dose will depend on how well the medicine is working and on whether you had any side effects during the first 3-day application. Other changes in dose may be needed later on. Some people may need to use more than one patch at a time.
      • Children—Use and dose must be determined by the doctor.

Missed Dose

If you miss a dose of fentanyl, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Remove the new patch 3 days after applying it.

Storage

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.

To dispose of fentanyl, first 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 fentanyl

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 fentanyl 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 transdermal fentanyl or other narcotic that you are taking without first checking with your doctor.

fentanyl 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; barbiturates; medicine for seizures; 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 are using fentanyl.

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 fentanyl 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 tell 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 fentanyl, do not use a heating pad, 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.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist-in-charge that you are using fentanyl. 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 fentanyl 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.

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.

If the patch comes off and accidentally sticks to the skin of another person, they should take the patch off immediately and wash the exposed area with water. The exposed person should then seek medical attention.

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 transdermal fentanyl if you have taken a monoamine oxidase (MAO) inhibitor (isocarboxazid [Marplan], phenelzine [Nardil], selegiline [Eldepryl], or tranylcypromine [Parnate]) in the past 2 weeks. If you do, you may develop 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 fentanyl in your body. You should not eat grapefruit or drink grapefruit juice while you are using fentanyl.

fentanyl Side Effects

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:

More common
  • Decrease in the amount of urine or in the frequency of urination
  • hallucinations (seeing, hearing, or feeling things that are not there)
Less common
  • Chest pain
  • difficulty with speaking
  • fainting
  • mood or mental changes
  • problems with walking
  • redness, swelling, itching, or bumps on the skin at place of application
  • spitting blood
Incidence not known
  • Bloating or swelling of the face, hands, lower legs, or feet
  • fast or pounding heartbeat or pulse
  • rapid weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Cold, clammy skin
  • convulsions (seizures)
  • drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened
  • low blood pressure
  • pinpoint pupils of the eyes
  • slow heartbeat
  • very slow (fewer than 8 breaths a minute) or troubled breathing

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:

More common
  • Abdominal or stomach pain that was not present before treatment
  • confusion
  • constipation
  • diarrhea
  • dizziness, drowsiness, or lightheadedness
  • false sense of well-being
  • feeling anxious
  • headache
  • indigestion
  • loss of appetite
  • nausea or vomiting
  • nervousness
  • sweating
  • weakness
Less common
  • Feeling anxious and restless at the same time
  • feeling of crawling, tingling, or burning of the skin
  • memory loss
  • unusual dreams
Incidence not known
  • Change or problem with discharge of semen
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • not able to have an orgasm
  • weight loss

After you stop using fentanyl, 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:

  • Body aches
  • fast heartbeat
  • fever, runny nose, or sneezing
  • gooseflesh
  • increased sweating
  • increased yawning
  • nervousness, restlessness, or irritability
  • shivering or trembling
  • stomach cramps
  • trouble with sleeping
  • unusually large pupils in the eyes

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.

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