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Duragesic (Generic Fentanyl Transdermal Patch)

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WARNING

Fentanyl patches have the potential to develop a habit, especially with continued use. Follow the fentanyl patch’s instructions precisely. Applying the patches more frequently, using them more frequently, or using them otherwise than as directed by your doctor are all prohibited. Discuss your pain management options, treatment duration, and pain treatment goals with your doctor while using fentanyl patches. Inform your doctor if you or any family members regularly use significant amounts of alcohol, take street drugs, abuse prescription drugs excessively, experience overdosing, or currently suffer from depression or another mental disorder. If you currently have or have ever had any of these conditions, there is a higher chance that you may misuse fentanyl patches. If you suspect that you may have an opioid addiction, speak with your doctor right away and ask for advice, or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Breathing issues from fentanyl patches can be severe or even fatal, especially in the first 24 to 72 hours of treatment and if the dose is raised. Throughout your therapy, your doctor will keep a close eye on you. Fentanyl patches should not be used to treat mild or moderate pain, short-term pain, pain after an operation or other medical or dental procedure, or pain that can be controlled by medication that is taken as needed due to this serious risk. Instead, they should only be used to treat people who have taken opioid medications for at least one week and are tolerant to their effects. If you have asthma or slow breathing, let your doctor know. Most likely, your doctor will advise against using fentanyl patches. A head injury, a brain tumour, or any condition that raises the pressure inside of your skull should also be disclosed to your doctor. Lung ailments including chronic obstructive pulmonary disease (COPD), a group of illnesses that affect the lungs and airways, should also be mentioned. The likelihood that you will experience breathing issues may be increased if you are an older adult, weak, or undernourished as a result of a sickness. Call your doctor right away or get emergency medical attention if you have any of the following symptoms: slower breathing, protracted pauses between breaths, or shortness of breath.

Using fentanyl with specific drugs may raise the danger of significant or life-threatening breathing issues, sedation, or coma. If you already take or intend to take any of the following medications, inform your doctor and pharmacist right away: aprepitant (Emend), amiodarone (Nexterone, Pacerone); benzodiazepines such flurazepam, estazolam, chlordiazepoxide, clonazepam, librium, diazepam, estazolam, and flurazepam, triazolam (Halcion), lorazepam (Ativan), oxazepam (Restoril), temazepam (Carbatrol), and carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); a few antifungal medications, such as clarithromycin (Biaxin, in Prevpac), itraconazole (Onmel, Sporanox), and ketoconazole (Nizoral), as well as fluconazole (Diflucan), drugs for mental illness, nausea, and pain; diltiazem (Cardizem, Cartia, Diltzac, and Taztia); erythromycin (E-Mycin, Erythrocin); fosamprenavir (Lexiva); sedatives, sleeping pills, tranquillizers, nefazodone, nelfinavir (Viracept), phenytoin (Dilantin, Phenytek), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), and ritonavir (Norvir, in Kaletra); verapamil and troleandomycin (TAO), which are unavailable in the United States (Calan, Covera, Verelan). Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away or go to the emergency room right away if you consume fentanyl along with any of these drugs and have any of the following symptoms: Unusual lightheadedness, dizziness, excessive tiredness, breathing difficulties, or inability to respond. Make sure your carer or family members are aware of any symptoms that could be significant so they can contact an emergency room or a doctor if you are unable to do so on your own. If you combine fentanyl with any of these drugs and experience any of the following symptoms, contact your doctor right away or seek emergency medical attention: extraordinary dizziness, lightheadedness, extreme drowsiness, slowed or laboured breathing, or inability to respond. Make sure your carer or family members are aware of any symptoms that could be significant so they can contact an emergency room or a doctor if you are unable to do so on your own.

You run a higher chance of developing these severe, sometimes fatal adverse effects while receiving treatment with fentanyl if you consume alcohol, use prescription or over-the-counter drugs that do, or use illicit substances. During your treatment, refrain from drinking alcohol, taking alcohol-containing prescription or over-the-counter medications, or using illegal substances.

Do not share your medication with anybody else. Children and adults who take fentanyl patches run the risk of damage or death. Fentanyl patches should be kept in a secure location to prevent accidental or intentional usage by others. Fentanyl patches should be kept out of children’s reach at all times. Keep track of the remaining patches so you can identify those that are missing.

If the adhesive side of a patch comes into contact with the skin of someone who is not receiving fentanyl treatment, they could suffer catastrophic injuries or perhaps pass away. Be careful not to let anyone else’s skin come into contact with the patch’s adhesive side. Make careful that youngsters do not touch your patch while you are holding them or otherwise tending to them. Remove the patch right away, wash the affected area with clear water, and get emergency medical help if it unintentionally attaches to someone else’s skin.

Three days after being used, fentanyl patches still contain enough of the drug to kill or seriously damage adults or kids who are not receiving treatment with it. Never place worn or unneeded patches in a garbage can or leave them somewhere where anybody, particularly youngsters, can find them. In accordance with the instructions, properly dispose of worn and unwanted patches. (See DISPOSAL and STORAGE.)

Extreme heat may cause your fentanyl patch to deliver an excessive amount of medication all at once. This may result in symptoms that are severe or even fatal. Avoid using direct heat sources like heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds on your patch or the skin around it. Avoid taking long, hot baths or tanning while sporting the patch. If you have a fever or get really hot after exercising, your patch may also release too much medication. Avoid engaging in physical activity that could make you very overheated. If you have a fever, contact your physician immediately. Your dose might need to be changed by your doctor.

If you are pregnant or want to become pregnant, let your doctor know. Regular usage of fentanyl patches during pregnancy increases the risk that your unborn child could develop potentially fatal withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.

The manufacturer’s patient information sheet (Medication Guide) will be sent to you by your doctor or pharmacist when you start using fentanyl patches and each time you fill a prescription for them. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Discuss the dangers of using this drug with your doctor.

Why is this medication prescribed?

Those who are expected to require pain medication 24 hours a day for a considerable amount of time and who are unable to be treated with other medications can use fentanyl patches to relieve severe pain. Fentanyl belongs to the group of drugs known as opiate (narcotic) analgesics. It functions by altering how the nerve system and brain react to pain.

How should this medicine be used?

Fentanyl transdermal comes as a patch to put on the skin. Typically, the patch is placed on the skin once every 72 hours. Every time you change your patch, do so around the same time of day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. As directed, apply fentanyl patches.

Your doctor might start you on a low-dose fentanyl patch and progressively raise the dosage, initially no more frequently than once every three days and then no more frequently than once every six days. If you encounter side effects, your doctor might reduce your dose. Discuss your feelings as they relate to your use of fentanyl patches with your doctor.

Just the skin may be used for fentanyl patches. Avoid putting patches in your mouth, chewing them, or swallowing them.

Stop using fentanyl patches only after consulting your physician. Your dose will likely be gradually reduced by your doctor. There may be withdrawal symptoms if you stop using fentanyl patches all of a sudden. Call your doctor right away if you notice any of the following withdrawal symptoms: agitation, teary eyes, runny nose, yawning, sweating, chills, muscle pain, large pupils (black circles in the centre of the eyes), irritability, anxiety, backache, joint pain, weakness, stomach cramps, trouble falling or staying asleep, nausea, loss of appetite, vomiting, diarrhoea, rapid breathing, or a fast heartbeat.

Use caution if a fentanyl patch has been altered, damaged, or sliced in any way. You might obtain the majority or all of the drug at once rather than gradually over three days if you utilise cut or damaged patches. This could result in fatal overdoses and other severe issues.

While using a fentanyl patch, you are allowed to shower, swim, and take a bath. Dispose of the patch properly if it comes off during these activities. Apply a fresh patch after properly drying your skin. After applying the new patch, keep it in place for 72 hours.

A fentanyl patch can be applied to your waist, upper arms, back, or chest. Apply the patch on the top back of a youngster or someone who is unable to think properly if you want to make it more difficult for them to take it off and put it in their mouth. Choose a hairless, flat piece of skin to study. Using the patch to moving body parts, radiation-exposed skin, sensitive skin, oily skin, skin that has broken out, skin that is irritated, fractured, cut, or skin that is injured is not advised. If there is hair on the skin, cut it as near to the skin as you can using scissors. Avoid shaving the region.

Follow these steps to apply the patch:

  1. Using clear water and a towel, thoroughly dry the area where you intend to apply the patch. Use no oils, soaps, lotions, or alcohols.
  2. Start at the slit and tear the fentanyl patch pouch open along the dotted line. Peel off both pieces of the protecting liner from the back of the patch after removing it from the pouch. Try to avoid touching the patch’s sticky side.
  3. Using the palm of your hand, quickly press the patch’s sticky side onto the skin’s desired location.
  4. For at least 30 seconds, apply firm pressure on the patch. Make sure the patch adheres effectively to your skin, paying specific attention to the edges.
  5. Use first aid tape to secure the patch’s edges to your skin if it does not adhere to your skin well or falls off after application. You can cover the patch with transparent dressings from the Bioclusive or Tegaderm brands if it still does not adhere well. Never use another form of bandage or tape to cover the patch.
  6. Apply a fresh patch if a patch comes off prematurely and should be properly disposed of. During 72 hours, keep the new patch in place.
  7. Wash your hands with water as soon as you are done applying the patch.
  8. Peel off the old patch when it’s time to replace it, then put the new one to a different area of skin.
  9. When you’ve finished applying your patch, fold it in half, sticky sides facing each other, and flush it down the toilet.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you’re interested in using this drug for any other conditions.

What special precautions should I follow?

Before using fentanyl patches,

  • If you have an allergy to fentanyl, any other drugs, or any of the chemicals in fentanyl patches, inform your doctor and pharmacist very away. For a list of the ingredients, ask your doctor or pharmacist or consult the Medication Guide.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Mention any of the following medications along with the ones specified in the IMPORTANT WARNING: antidepressants, antihistamines (found in drugs for colds, coughs, and allergies); butorphanol, dextromethorphan, buprenorphine (Buprenex, Subutex, Suboxone), lithium (Lithobid), and drugs for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), and rizatriptan (Maxalt), zolmitriptan (Zomig) and sumatriptan (Alsuma, Imitrex, in Treximet); sedatives, 5HT3 serotonin blockers such alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); the drug mirtazapine (Remeron); nalbuphine; pentazocine (Talwin); fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft) are examples of selective serotonin-reuptake inhibitors, drugs that block the reuptake of serotonin and norepinephrine, such as venlafaxine (Effexor), milnacipran (Savella), duloxetine (Cymbalta), and desvenlafaxine (Khedezla, Pristiq); trazodone (Oleptro); or tricyclic antidepressants (often known as “mood elevators”), such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Additionally, let your doctor or pharmacist know if you’re taking any of the following medicines, have recently stopped taking them, or have recently started taking any of the following: monoamine oxidase (MAO) inhibitors like tranylcypromine (Eldepryl), isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), and selegiline (Eldepryl, Ems (Parnate). Tell your doctor about all of the medications you are taking, including any that do not appear on this list, as many other drugs may also interact with fentanyl. Your doctor might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor about the herbal supplements you are taking, especially if you take St. John’s wort or tryptophan.
  • Inform your physician whether you now have or previously had paralytic ileus (condition in which digested food does not move through the intestines). Your physician might advise against using fentanyl patches.
  • Inform your doctor if you currently have or previously had thyroid, heart, liver, pancreas, gallbladder, or renal disease as well as slowed heartbeat, difficulties urinating, low blood pressure, or any of the aforementioned conditions.
  • If you are breastfeeding, let your doctor know.
  • You should be aware that this medicine may lower both male and female fertility. Discuss the dangers of wearing a fentanyl transdermal patch with your doctor.
  • Inform the surgeon or dentist that you are using fentanyl patches if you are having surgery, including dental surgery.
  • You should be aware that this medicine may cause you to feel sleepy. Before you know how this drug affects you, avoid operating machinery, operating a vehicle, or engaging in any other potentially hazardous activity.
  • You should be aware that fentanyl patches could make you feel faint when you stand up too rapidly from a laying posture. When utilising fentanyl patches for the first time, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • Fentanyl patches may produce constipation, so you should be aware of it. While using fentanyl patches, discuss with your doctor whether you should alter your diet or take other drugs to prevent or cure constipation.

What special dietary instructions should I follow?

If you plan to consume grapefruits or grapefruit juice while taking this medication, consult your doctor.

What should I do if I forget a dose?

If you are using a fentanyl patch and forget to put it on or change it, put it on as soon as you recall. When putting on a new patch, make sure to remove your old one. Replace the new patch after wearing it for the allotted amount of time (often three days) recommended by your doctor. If your doctor has not instructed you to, avoid wearing two patches at once.

What side effects can this medication cause?

Side effects from fentanyl patches could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Headache
  • Mood shifts
  • Being chilly
  • Drowsiness
  • Depression
  • Having trouble falling or staying asleep
  • Body part shaking that is uncontrollable
  • Hands or foot pain, burning, tingling, or numbness
  • Mouth ache
  • Abdominal pain
  • Indigestion
  • Back ache
  • Having trouble urinating
  • Itching
  • Skin irritation, redness, itching, or swelling where you applied the patch to your skin

Some adverse effects may be severe. Call your doctor right away if you have any of the following symptoms or any of the ones detailed in the IMPORTANT CAUTION section:

  • Alterations in heartbeat
  • Agitation, hallucinations (hearing voices or seeing things that are not there), disorientation, fever, sweating, shivering, extremely stiff or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, weight loss, anorexia, or lightheadedness
  • Failure to achieve or maintain erection
  • Irregular periods of time
  • Less sexual arousal
  • Chest ache
  • Seizure
  • Rash
  • Hives
  • Swelling of the lower legs, hands, arms, feet, ankles, or throat, as well as the eyes, face, mouth, tongue, and throat
  • Hoarseness
  • Breathing or swallowing challenges

Other adverse reactions to fentanyl patches are possible. If you experience any strange issues while using fentanyl patches, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

The fentanyl patches should be kept at room temperature, away from sources of extreme heat and moisture (not in the bathroom).

Using a drug take-back programme, you must immediately get rid of any used or unopened patches that have expired or are no longer required. If you do not have access to a take-back programme right away, carefully remove the adhesive backing from any patches you no longer need, fold the sticky sides of each patch together so that they adhere to one another, then flush the folded patches down the toilet. Put the protective liners and pouches in the garbage after use. After disposing of the fentanyl patches, thoroughly wash your hands with water. Fentanyl patches should not be thrown away if they are no longer needed.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Remove the fentanyl patch from the victim’s skin in case of overdose, then dial 911 to contact your neighborhood’s emergency services.

You should speak with your doctor about keeping naloxone, a life-saving drug, on hand while using fentanyl patches (e.g., home, office). Naloxone is used to undo an overdose’s potentially fatal consequences. To treat harmful symptoms brought on by excessive levels of opiates in the blood, it functions by inhibiting the effects of opiates. Your doctor may also give you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. Make sure you, your family, your caretakers, and anyone else who spends time with you are aware of the signs of an overdose, how to administer naloxone, and what to do until emergency assistance arrives. You and your family members will be shown how to use the medication by your doctor or pharmacist. For the directions, speak to your pharmacist or go to the manufacturer’s website. If you start to experience overdose symptoms, a friend or family member should administer the first dose of naloxone, contact 911 right away, and stay by your side while keeping a careful eye on you until emergency medical assistance comes. After receiving naloxone, your symptoms can come back a short while later. The person should administer you another dose of naloxone if your symptoms come back. If symptoms reappear before receiving medical attention, more doses may be given every 2 to 3 minutes.

Overdose signs could include the following:

  • Having trouble breathing
  • Weak or sluggish breathing
  • Excessive drowsiness or fatigue
  • Trouble with regular walking, talking, or thinking
  • Tiny, focused pupils (black circles in the centre of the eye)
  • Faintness
  • Dizziness
  • Confusion
  • Not able to speak or awaken

What other information should I know?

Keep all of your appointments with your physician and the lab. To determine how your body reacts to fentanyl, your doctor will request specific lab tests.

Inform your doctor and the lab staff that you are using fentanyl prior to any laboratory test (particularly ones involving methylene blue).

This medication cannot be renewed. If your doctor wants you to continue using fentanyl patches, make sure to schedule appointments with them frequently to avoid running out of medicine.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Duragesic®
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