Duragesic

Duragesic is a prescription medication used to relieve severe pain in people who need pain medication around the clock for a long time and who cannot be treated with other medications.

Duragesic belongs to a group of drugs called opiate or narcotic analgesics. These work by changing the way the brain and nervous system respond to pain.

This medication is available as a patch that is applied to the skin. A new patch is usually applied every 72 hours.

Duragesic patches cannot be placed in the mouth, swallowed, or ingested in any way. Do not cut, tear, alter, or damage patches in any way.

Common side effects of Duragesic include nausea, vomiting, sleepiness, insomnia, constipation, increased sweating, fatigue, feeling cold, anorexia, headache, and diarrhea.

Duragesic can also cause blurred vision, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how Duragesic affects you.

Duragesic is a prescription medication used to relieve severe pain in people who need pain medication around the clock for a long time and who cannot be treated with other medications. Duragesic should only be used in opioid-tolerant patients. Patients considered opioid-tolerant are those who are taking, for one 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 equivalent dose of another opioid.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

Serious side effects have been reported with Duragesic. See the “Duragesic Precautions” section.

Common side effects of Duragesic include the following:

• nausea
• vomiting
• somnolence (sleepiness)
• dizziness
• insomnia
• constipation
• hyperhidrosis (increased sweating)
• fatigue
• feeling cold
• anorexia
• headache
• diarrhea

This is not a complete list of Duragesic side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amiodarone (Cordarone, Pacerone)antidepressants
• antifungals such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral)
• antihistamines (found in cough, cold, and allergy medications)
• aprepitant (Emend)buprenorphine (Zubsolv)
• butorphanol
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril)
• clarithromycin (Biaxin, in Prevpac)
• erythromycin (E-Mycin, Erythrocin)
• fosamprenavir (Lexiva)
• medications for anxiety
• diltiazem (Cardizem, Cartia, Dilacor, Dilt-CD, Diltzac, Taztia)
• medications for nausea
• muscle relaxants
• nalbuphine
• nefazodone
• nelfinavir (Viracept)
• other medications for pain
• pentazocine (Talwin)
• phenytoin (Dilantin, Phenytek)
• rifampin (Rifadin, Rimactane, in Rifamate)
• ritonavir (Norvir, in Kaletra)
• sedatives
• sleeping pills
• St. John’s wort
• tranquilizers
• verapamil (Calan, Covera, Verelan)

Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).

This is not a complete list of Duragesic drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duragesic including the following:

• Respiratory depression: Elderly, cachectic, and debilitated patients, and patients with chronic pulmonary disease are at increased risk for life-threatening respiratory depression.
• Low blood pressure. Duragesic may cause low blodd pressure. Monitor patients closely during dose initiation and titration.
• Sedation and respiratory depression. Patients with head injury or increased intracranial pressure are at risk for excessive sedation and respiratory depression. Do not use Duragesic in patients with impaired consciousness or coma.
• Low heart rate (bradycardia). Duragesic may cause decreased heart rate. Administer with caution to patients with arrhythmias.

Duragesic can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Duragesic affects you.

Duragesic may cause serious side effects. Seek medical attention right away if you experience any of the following symptoms:

• trouble breathing
• shortness of breath
• fast heartbeat
• chest pain
• swelling of your face, tongue, or throat
• extreme drowsiness
• light-headedness when changing positions
• feeling faint

Do not take Duragesic if you:

• are allergic to Duragesic or to any of its ingredients
• are not opioid tolerant
• have acute or intermittent pain, postoperative pain, or mild pain
• have respiratory compromise or acute or severe asthma
• have a condition known as paralytic ileus

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duragesic, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Duragesic, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Duragesic or to any of its ingredients
• have or have had paralytic ileus
• have or have had seizures
• have or have had slowed heartbeat
• have or have had difficulty urinating
• have or have had low blood pressure
• have or have had thyroid disease
• have or have had heart disease
• have or have had liver disease
• have or have had pancreas disease
• have or have had gallbladder disease
• have or have had kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Duragesic falls into category C. There are no well-controlled studies that have been done in pregnant women. Duragesic should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Duragesic has been detected in human breast milk. Duragesic is not recommended for use in nursing women because of the possibility of effects in their infants.

Take Duragesic exactly as prescribed.

This medication is available as a patch that is applied to the skin. A new patch is usually applied every 72 hours.

Duragesic patches cannot be placed in the mouth, swallowed, or ingested in any way. Do not cut, tear, alter, or damage patches in any way.

To apply the patch, follow these steps:

1. Clean the area where you plan to apply the patch with clear water and pat completely dry. Do not use any soaps, lotions, alcohols, or oils.
2. Tear open the pouch containing the fentanyl patch along the dotted line, starting at the slit. Remove the patch from the pouch and peel off both parts of the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
3. Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
4. Press the patch firmly for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
5. If the patch does not stick well or comes loose after it is applied, tape the edges to your skin with first aid tape. If the patch still does not stick well, you may cover it with Bioclusive or Tegaderm brand see-through dressings. Do not cover the patch with any other type of bandage or tape.
6. If a patch falls off before it is time to remove it, dispose of the patch properly and apply a new patch. Leave the new patch in place for 72 hours.
7. When you are finished applying the patch, wash your hands with water right away.
8. When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
9. After you remove your patch, fold it in half with the sticky sides together and flush it down a toilet.

While using Duragesic, DO NOT:

• take hot baths or sunbathe, use hot tubs, saunas, heating pads, electric blankets, heated waterbeds, or tanning lamps, or engage in exercise that increases your body temperature. These can cause an overdose that can lead to death.
• drive or operate heavy machinery, until you know how Duragesic affects you.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

If you miss a dose, apply the missed patch as soon as you remember. Do not apply 2 Duragesic patches at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Duragesic should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. The starting dose for each patient must be calculated individually and take into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with Duragesic. Discontinue all other around-the-clock opioid drugs when Duragesic therapy is initiated.

If you take too much Duragesic, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Duragesic is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Duragesic at room temperature.
• Store Duragesic in its original unopened pouch.
• Keep this and all medicines out of the reach of children.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and EXPOSURE TO HEAT

Addiction, Abuse, and Misuse

DURAGESIC exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing DURAGESIC, and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DURAGESIC, even when used as recommended. Monitor for respiratory depression, especially during initiation of DURAGESIC or following a dose increase. Because of the risk of respiratory depression, DURAGESIC is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain.

Accidental Exposure

Deaths due to a fatal overdose of fentanyl have occurred when children and adults were accidentally exposed to DURAGESIC. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of DURAGESIC during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Cytochrome P450 3A4 Interaction

The concomitant use of DURAGESIC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving DURAGESIC and any CYP3A4 inhibitor or inducer.

Exposure to Heat

Exposure of the DURAGESIC application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl and death. Patients wearing DURAGESIC systems who develop fever or increased core body temperature due to strenuous exertion are also at risk for increased fentanyl exposure and may require an adjustment in the dose of DURAGESIC to avoid overdose and death.