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Fentanyl skin patch

Fentanyl skin patches may cause serious or life-threatening breathing difficulties, which can cause death, especially if not used properly. Fentanyl skin patches should be used only for chronic (around the clock, long-lasting) pain that cannot be controlled by the use of other shorter-acting pain medications that are not as strong. Fentanyl skin patches should not be used to treat short-term pain or pain after an operation or medical or dental procedure. Fentanyl is not for occasional (as needed) use. Fentanyl should be used only for people who have already received narcotic (opiate) pain medication for at least a week and are narcotic tolerant. If you are unsure if you are narcotic-tolerant, ask your doctor. inform your doctor if you are breast-feeding breathing difficulties, chronic obstructive pulmonary disease (COPD), or other lung disease.

General Information and Indications:

Fentanyl skin patches are used to relieve moderate to severe pain that occurs constantly. Fentanyl skin patches contain fentanyl inside.The medication is released from the patch continuously over a period of time and is absorbed through the skin into the bloodstream. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works to treat pain by changing the way the brain and nervous system respond to pain.

Information For Users:

Fentanyl skin patches are placed on the skin. The patch usually is changed every 3 days. Change your patch at about the same time of day on the days you are supposed to change the patch. Follow the directions on your prescription label, ask your doctor or pharmacist If you have any questions. Apply fentanyl patches exactly as directed. Read the patient information that is given to you with your prescription before you start using fentanyl skin patches.

Your doctor might start you on a low dose of fentanyl skin patches and slowly increase your dose, not more often than once every 3 days after the first patch and every 6 days thereafter, based upon your level of pain control. If your pain is not controlled by this medication, call your doctor.

Fentanyl skin patches should never be placed in the mouth, chewed, or swallowed, or used in any way other than directed by your doctor or pharmacist. Do not try to open the patch or allow someone to have your patch (new or used) for this purpose. If the fentanyl gel leaks from the patch at any time, try not to touch the gel as you remove and throw away the patch according to the directions below. If you or a caregiver touch the gel, immediately wash the area with only large amounts of water. Using soap, alcohol, or other cleansers to remove the gel may actually increase the amount of medication that goes through the skin.

Accidental exposure to the medication inside the fentanyl skin patch can cause serious harm. This may occur through transfer of a patch from an adult's body to a child while hugging, accidentally sitting on a patch, accidental exposure of a caregiver's skin to the medication in the patch when applying or removing a patch, or in other ways. If the patch comes off the person for whom it was prescribed and sticks to the skin of another person, take the patch off that person right away, wash the area with water only, and seek immediate medical attention. by calling your doctor, emergency room, or the poison control center. Accidental exposure of children to fentanyl skin patches is a medical emergency. It is important to store and handle this medication carefully to prevent accidental exposure to fentanyl skin patches.

Do not apply more than one patch at a time unless your doctor tells you to, and do not apply fentanyl skin patches more often, or for a longer period of time than your doctor tells you to. Do not stop using fentanyl skin patches without informing your doctor. Your doctor will probably decrease your dose gradually when you are to stop using this medication. If you suddenly stop using fentanyl skin patches or use the patches less often than your doctor told you to, you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, tearing from your eyes, runny nose, yawning, sweating, chills, feeling that your hair stands on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, upset stomach, loss of appetite (anorexia), vomiting, diarrhea, fast heartbeat or rapid breathing.

To apply the patch, follow the directions provided by the manufacturer and these steps:

o Select a clean, dry area of skin on your chest, back, upper arm, or side above the waist. You should choose an area of your body which is flat and hairless. Avoid areas that move a lot, areas where the skin is sensitive, an area of the skin that has been exposed to radiation (X-ray treatment); or an area where you have recently applied a skin patch. If the area is hairy, clip hair as close to the skin as possible with scissors, but do not shave it.
o Clean the skin area, using only clear water. Pat the skin completely dry. Do not put anything on the skin (including soap, lotion, alcohol, or oil) before applying the patch.
o Tear open the pouch containing the fentanyl skin patch along the dotted line, starting at the slit. Remove the skin patch from the pouch and peel off the protective liner from the back of the patch exposing the adhesive (sticky) surface. Try not to touch the sticky side.
o Immediately press the adhesive side of the patch onto the skin with the palm of your hand.
o Press the patch firmly, for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
o If the patch does not stick well or comes loose after it is applied, tape the edges down to your skin with first aid tape.
o When you are finished applying the patch, wash your hands promptly with only clear water.
o Apply each new patch to a different skin area to avoid irritation. Remove the old patch before applying another one.
o Fold used patches in half with the sticky sides together and flush down a toilet. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed fentanyl skin patches.

If a patch accidentally comes off or if the skin under the patch becomes irritated, remove the patch and replace it with a new one in a different area, following the steps above.

Do not remove a skin patch from its protective pouch or remove the protective backing until just before applying it. Do not use a patch if the pouch or backing has been broken or damaged.

If fentanyl has been prescribed for a person who is unable to think well or for a child, the patch should be placed on his or her upper back so it is less likely that the patch could be removed and put in their mouth.

Special precautions:

o Inform your doctor or pharmacist if you have allergy to fentanyl, other opiate (narcotic) pain medications, adhesives (glues), any other medications, or any of the ingredients in fentanyl skin patches. Ask your pharmacist for a list of the ingredients.
o Inform your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the CAUTION and any of the following medications: antidepressants; antihistamines; carbamazepine (Carbatrol, Epitol, Tegretol); dexamethasone (Decadron, Dexpak); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); medications for anxiety; medications for cough, cold, or allergies; medications for upset stomach; muscle relaxants; nevirapine (Viramune); other medications for pain; phenobarbital; sedatives; sleeping pills; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); or tranquilizers. Also Inform 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 furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Carbex, Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
o Inform your doctor what herbal products you are taking, especially St. John's wort.
o inform your doctor if you are breast-feeding a head injury, a brain tumor, a stroke or any other condition that caused high pressure inside your skull; seizures; irregular heartbeat; prostate problems or any other condition that causes difficulty in urination; Addison's disease (a condition in which the adrenal gland does not make enough of certain natural substances); gallbladder disease; low blood pressure; paralytic ileus or any other problem which causes blockage of the intestines;or thyroid, heart, liver, or kidney disease.
o Inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using a fentanyl skin patch, call your doctor. Do not use fentanyl skin patches if you are breast-feeding.
o if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl skin patches.
o you should know that this drug may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this drug affects you.
o you should know that fentanyl skin patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl skin patches. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
o remember that alcohol can add to the drowsiness caused by this medication. . Do not drink any alcohol while using fentanyl skin patches.
o you should know that fentanyl skin patches may cause constipation (less frequent than usual or hard bowel movements). Talk to your doctor about the use of laxatives or stool softeners to prevent or treat constipation while you are using fentanyl skin patches.
o keep in mind that you should not expose a fentanyl skin patch to direct heat or sunlight, heating pads, electric blankets, sun lamps or tanning beds, hot tubs, saunas, heated water beds, or other heat sources. Heat may increase the amount of fentanyl you receive from the skin should know that if you have a fever the amount of fentanyl that you receive from the skin patch may increase significantly and possibly result in an overdosage of medication. the amount of fentanyl that you receive from the skin patch may increase significantly and possibly result in an overdosage of medication. Call your doctor right away if you have a fever higher than 102 °F. Your doctor may need to adjust your dose.

Possible Adverse Effects:

Fentanyl skin patches may cause adverse effects. Inform your doctor if any of these symptoms or those listed in SPECIAL PRECAUTIONS are severe or do not go away:

o headache
o mood changes
o nervousness
o depression
o difficulty falling asleep or staying asleep
o hand tremor, shaking hands
o pain, burning, tingling, or numbness in the hands or feet
o dry mouth
o hiccups
o stomach pain
o indigestion
o gas
o back pain
o difficulty in urination
o itching
o skin irritation, redness, itching, swelling, or blisters at the area where the patch is worn
o flu-like symptoms
o sore throat

If you experience any of these symptoms or those listed in the CAUTION section, call your doctor without delay:

o heartbeat that is slower or faster than normal
o chest pain
o rash
o seizure

Possible Symptoms of Overdose:

o difficulty breathing
o extreme sleepiness or tiredness
o difficulty thinking, talking, or walking normally
o small, pinpoint pupils (black circles in the center of the eye)
o faintness
o dizziness
o confusion
o coma

Brand Name(s):

o Duragesic®

 Polyethylene glycol 3350



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