Consumer Drug Information

fentanyl transdermal

Generic Name: fentanyl transdermal (skin patch) (FEN ta nil trans DERM al)
Brand names: Duragesic, Duragesic-100, Duragesic-12, Duragesic-25, Duragesic-50, Duragesic-75, Sublimaze, Actiq, Ionsys, Fentora, Onsolis

What is fentanyl transdermal?

Fentanyl is a narcotic (opioid) pain medicine.

The fentanyl skin patch is used to treat moderate to severe chronic pain.

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 skin patch?

MISUSE OF THIS MEDICATION CAN CAUSE HARMFUL OR FATAL SIDE EFFECTS. 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. Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug you absorb through your skin and may cause harmful effects. 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. Store the medication in a secure place where others cannot get to it. Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

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.

The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

What should I discuss with my healthcare provider before using a fentanyl transdermal skin patch?

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 using fentanyl, 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
kidney disease.

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 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. Store the medication in a secure place where others cannot get to it. The fentanyl transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use fentanyl transdermal skin patches?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger or smaller amounts, or use it for longer than recommended by your doctor. MISUSE OF A FENTANYL SKIN PATCH CAN CAUSE HARMFUL OR FATAL SIDE EFFECTS.

Read all patient instructions carefully before using a fentanyl transdermal skin patch. Ask your doctor or pharmacist if you have questions.

If the skin must be washed before you apply a skin patch, use clear water only. Allow the skin to dry completely before applying the patch.

Do not use soaps, oils, lotions, alcohol, or other chemicals on the skin where you will apply a fentanyl transdermal skin patch. These substances could increase the amount of fentanyl that your skin absorbs, possibly causing harmful effects.

Apply the skin patch to a flat, dry, hairless area of the chest, back, side, or outer side of your upper arm. To remove any hair from these areas, clip the hair short but do not shave it. Press the patch firmly with the palm of your hand for 30 seconds. Make sure the patch is sticking firmly, especially around the edges. You may wear the patch for up to 72 hours. Never wear more than 1 fentanyl transdermal skin patch at a time unless your doctor has told you to.

After removing a skin patch fold it in half, sticky side in, and flush the patch down the toilet. Apply a new patch to a different skin area on the chest, back, side, or upper arm. Do not use the same skin area twice in a row.

Do not use a fentanyl transdermal skin patch if it has been cut or damaged. Doing so could expose you to too much fentanyl, which can cause a life-threatening overdose.

Store the skin patches at room temperature. Keep each patch in its foil pouch until you are ready to use it. Keep both used and unused fentanyl transdermal patches out of the reach of children or pets. The amount of fentanyl in a used skin patch could be fatal to a child or pet who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.

Keep track of how many skin patches have been used from each new package of this medicine. Fentanyl 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.

What happens if I miss a dose?

Since fentanyl transdermal is used as needed, you may not be on a dosing schedule. If you are using the skin patches regularly, apply the missed patch as soon as you remember. Continue wearing the patch for up to 72 hours and then apply a new one if needed for pain. Do not wear extra patches to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine or if anyone has accidentally swallowed it. A fentanyl overdose can be fatal. Overdose symptoms may include slow breathing, extreme weakness or dizziness, pinpoint pupils, cold and clammy skin, or fainting.

What should I avoid while using a fentanyl transdermal patch?

This medication is for use only on the skin. Avoid touching the sticky side of a skin patch with your fingers. Do not allow the medicine to come into contact with your eyes, nose, mouth, or lips. If it does, rinse with water. Do not use soap or other chemicals. Fentanyl can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol, which can increase dizziness or drowsiness. Tell your doctor if you regularly use other medicines that make you sleepy (such as cold medicine, other pain medicine, muscle relaxers, and medicine for depression or anxiety). They can add to extreme drowsiness or breathing problems caused by fentanyl. Do not expose the skin patch to heat while you are wearing it. This includes a hot tub, heating pad, sauna, or heated water bed. Heat can increase the amount of drug you absorb through your skin and may cause harmful effects.

A fentanyl transdermal skin patch side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Remove the skin patch and call your doctor at once if you have any of these serious side effects:

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 was worn; or
increased sweating, urinating less than usual.

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.

Fentanyl transdermal Dosing Information

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 Tablet
Initial 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.

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 lozenge
High dose: 15 mcg/kg lozenge
Maximum dose: 400 mcg
Lozenge 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

What other drugs will affect fentanyl transdermal?

Before using this medication, tell your doctor if you are using any of the following drugs:

carbamazepine (Tegretol, Carbatrol);
phenytoin (Dilantin);
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.

Where can I get more information?

Your pharmacist can provide more information about fentanyl transdermal.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.