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Butrans (Generic Buprenorphine Transdermal Patch)

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WARNING

Patches containing buprenorphine have the potential to become a habit after repeated use. Apply buprenorphine patches precisely as instructed. Applying the patches more frequently, using them more frequently, or using them otherwise than as directed by your doctor are all prohibited. Talk to your doctor about your pain management options, the length of your treatment, and your treatment goals while wearing buprenorphine patches. Inform your doctor if you or any members of your family regularly use excessive amounts of alcohol, use illicit drugs, abuse prescription drugs, or have ever experienced depression or another mental disease. If you currently have or have ever had any of these conditions, there is a higher chance that you may abuse buprenorphine. 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 buprenorphine patches can be severe or even fatal, especially in the first 24 to 72 hours of treatment and if your dose is raised. Throughout your therapy, your doctor will keep a close eye on you. If you have or have ever had breathing problems, asthma, chronic obstructive pulmonary disease (COPD), any lung illness, or any other lung condition, let your doctor know. Your physician might advise against using buprenorphine patches.

Buprenorphine patches may raise the risk of serious or life-threatening respiratory issues, drowsiness, or coma when used with specific drugs. Inform your doctor and pharmacist if you’re taking atazanavir (Reyataz), benzodiazepines like clonazepam (Klonopin), diazepam (Diastat, Valium), flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), triazolam (Halcion), medications for mental illness and nausea, other painkillers, muscle relax also sedatives. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right away if you experience any of the following symptoms when using buprenorphine transdermal along with any of these drugs: unusual dizziness, lightheadedness, excessive drowsiness, sluggish or laboured breathing, or unresponsiveness. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

During your buprenorphine transdermal therapy, taking illicit drugs or alcohol increases your risk of developing these severe, potentially fatal adverse effects. During your therapy, refrain from drinking alcohol, using illicit substances, or taking any prescription or over-the-counter medications that include alcohol.

Do not share your medication with anybody else. Accidental exposure, particularly in children, can have serious consequences or even be fatal. Buprenorphine patches should be kept in a secure location to prevent accidental or intentional use by others. Buprenorphine 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 you are pregnant or want to become pregnant, let your doctor know. Regular usage of buprenorphine patches during pregnancy may cause life-threatening withdrawal symptoms in the unborn child. 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.

When you start using buprenorphine patches for treatment and each time your prescription is renewed, your doctor or pharmacist will give you a copy of the manufacturer’s patient information leaflet (Medication Guide). 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?

People who are unable to be treated with other medications and are anticipated to require pain medication 24 hours a day for a prolonged period of time can use buprenorphine patches to relieve severe pain. It 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?

Buprenorphine transdermally is applied to the skin as a patch. Typically, the patch is put to the skin once every seven days. 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. Buprenorphine patches should be applied as instructed.

You might begin using a low-dosage buprenorphine patch prescribed by your doctor, and over time, your dose will be gradually increased, perhaps once every three days at most. Remove your present patch and, simultaneously, insert the two new patches next to each other at a new location if this increase requires the usage of two patches. You should always replace and apply the two patches at the same time if your doctor instructs you to use two. If you encounter side effects, your doctor might reduce your dose. If the dosage you are taking does not relieve your discomfort, speak with your doctor. Discuss your feelings regarding your buprenorphine patch therapy with your doctor.

Skin patches containing buprenorphine should only be applied to skin. Avoid putting patches in your mouth, chewing them, or swallowing them.

Stop using buprenorphine patches only after consulting your doctor. Your dose will likely be gradually reduced by your doctor. You can have withdrawal symptoms if you stop using buprenorphine patches all of a sudden. If you experience any of these withdrawal symptoms, get in touch with your doctor right away: agitation, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle aches, large pupils (black circles in the centre of the eyes), irritability, diarrhoea, nausea, vomiting, anxiety, pain in the joints, weakness, rapid breathing, or fast heartbeat.

Buprenorphine patches that have been cut, damaged, or altered in any manner should not be used. You might get most—or perhaps all—of the drug at once rather than gradually over the course of seven days if you utilise cut or damaged patches. This could result in fatal overdoses and other severe issues.

Extreme heat may cause your buprenorphine patch to discharge 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.

While using a buprenorphine patch, you are permitted to bathe or take a shower. Dispose of the patch properly if it comes off during these activities. Apply a fresh patch after properly drying your skin. After applying the updated patch, keep it in place for 7 days.

A buprenorphine patch can be placed on the side of your chest, upper chest, upper back, or upper outside arms. Pick a hairless, flat piece of skin to study. Applying the patch to any areas of the body that have been inflamed, fractured, cut, damaged, or altered in any way 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. Before updating the same site’s patch, wait at least three weeks.

To apply the patch, follow these steps:

  • Use clear water to thoroughly wash and dry the area where you’ll be applying the patch. Use no oils, lotions, alcohols, or soaps.
  • Along the dotted line, cut the pouch containing the buprenorphine patch open with scissors. Peel the protective lining from the patch’s back after removing it from the bag. Don’t touch the patch’s adhesive side if at all possible.
  • With the palm of your hand, quickly apply the sticky side of the patch to the skin’s desired location.
  • For at least 15 seconds, press hard on the patch. Make sure the patch adheres to your skin firmly, paying particular attention to the edges. You shouldn’t rub the patch.
  • Only the borders of the patch should be taped to your skin using first aid tape if it does not adhere properly or becomes loose after application. You can cover the patch with transparent dressings from the Bioclusive or Tegaderm brands if it still does not adhere well. Avoid using any other kind of bandages or tape to cover the patch. If your patch doesn’t stay on your skin, speak with your doctor or pharmacist.
  • Apply a new patch to a different area of skin if a patch comes off prematurely and needs to be disposed of properly. For seven days, keep the new patch in place.
  • Applying the patch is complete; immediately wash your hands with only pure water.
  • Note the time and date the patch was applied.
  • Peel off the old patch when it’s time to replace it, then put the new one to a different area of skin.
  • When you’ve finished applying your patch, fold it in half, sticky sides facing each other, and flush it down the toilet. To safely dispose of the used patch in the garbage, you can alternatively utilise a patch disposal unit that was given to you by the manufacturer. Children, animals, and people who have not been administered buprenorphine patches may be in danger if they come into contact with used patches that still contain some drug.

Other uses for this medicine

It is not recommended to use buprenorphine to treat mild to moderate pain, temporary discomfort, or pain that may be managed with as-needed medicine.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using buprenorphine patch,

  • If you have an allergy to buprenorphine, any other drugs, or any of the components in a buprenorphine patch, let your doctor and pharmacist know right once. 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, dietary supplements, and herbal products you are now using or intend to use. Mention the drugs listed in the IMPORTANT WARNING as well as any of the following ones: cyclobenzaprine (Amrix); dextromethorphan (found in many cough medicines; in Nuedexta); anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine); a few drugs for irregular heartbeat, such as amiodarone (Cordarone, Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid), quinidine (in Nuedexta), and sotalol (Betapace, Betapace AF, Sorine, Sotylize, and other drugs); lithium (Lithobid); drugs for migraines, such (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); mirtazapine (Remeron); certain seizure medications, including carbamazepine (Tegretol, Teril, and others), phenobarbit; 5HT3 serotonin blockers such alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin-reuptake inhibitors like citalopram (Celexa), escitalopram; and rifampin (Rifadin, Rimactane, in (Lexapro), sertraline (Zoloft), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and fluoxetine (Prozac, Sarafem, in Symbyax); serotonin and norepinephrine reuptake inhibitors like duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran  (Savella), and venlafaxine (Effexor); trazodone; or tricyclic antidepressants (often known as “mood elevators”) such amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). Additionally, let your doctor or pharmacist know if you’re receiving any of the following monoamine oxidase (MAO) inhibitors or if you’ve recently stopped taking them: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Buprenorphine may also interact with many other drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list. Your physician 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 doctor if you have or have ever had a paralytic ileus or any of the disorders listed in the IMPORTANT WARNING section (condition in which digested food does not move through the intestines). Your physician might advise against using buprenorphine patches.
  • Inform your physician if you or a member of your immediate family has or has ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may result in loss of consciousness or sudden death); or if you have or have ever had atrial fibrillation; heart failure; seizures; a head injury, brain tumour, stroke, or any other condition that caused high pressure inside your skull; biliary tract disease; slowed heartbeat; low blood pressure; or low bloood pressure
  • If you are breastfeeding, let your doctor know.
  • You should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine patches.
  • Inform the surgeon or dentist that you are wearing a buprenorphine patch 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 if you stand up suddenly from a laying position while wearing buprenorphine patches, you could have dizziness, lightheadedness, and fainting. When you first start taking a buprenorphine patch, this is more typical. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • Buprenorphine patches may cause constipation, so you should be aware of it. While using buprenorphine patches, discuss with your doctor whether you should alter your diet or take additional drugs to prevent or cure constipation.
  • You should be aware that the quantity of buprenorphine you receive from the patch may rise and could result in an overdose of medication if you develop a fever or become extremely heated after physical activity. 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.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you are using a buprenorphine patch and forget to put it on or replace it, put it on as soon as you recall. Before using a new patch, be sure to delete the old one. Replace the new patch after the time period recommended by your doctor (often seven days). Unless your doctor advises you to, avoid wearing two patches at once.

What side effects can this medication cause?

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

  • Having trouble falling or staying asleep
  • Headache
  • Mouth ache
  • Abdominal pain
  • When wearing the patch, you may have skin irritation, itching, swelling, or redness in that location

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Breathing or swallowing challenges
  • Breathing difficulty
  • Alterations in heartbeat
  • Hallucinations (seeing or hearing objects or voices that aren’t there), agitation, sweating excessively, confusion, rapid heartbeat, shivering, extremely rigid or twitching muscles, loss of coordination, nausea, vomiting, or diarrhoea
  • Nausea, vomiting, appetite loss, exhaustion, or lightheadedness
  • Failure to achieve or maintain erection
  • Abnormal menstruation
  • Reduced sexual arousal
  • Chest pain
  • Your face, tongue, or throat swelling
  • Rash
  • Hives
  • Itching

Other negative effects from buprenorphine patches are possible. If you experience any strange issues while taking this drug, call 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?

Keep children away from this medication. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

By gently removing the adhesive backing, folding the sticky sides of each patch together so that it attaches to itself, then flushing the patches down the toilet, you may get rid of any used, obsolete, or unnecessary patches. Buprenorphine patches should not be discarded after being used or no longer needed. Consult your pharmacist for advice on how to properly dispose of your medications.

As 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

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

If you use buprenorphine patches, your doctor might advise you to keep naloxone, a life-saving drug, on hand at all times (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. If you overdose on opiates, you probably won’t be able to heal yourself. Make sure your family, carers, or those who spend 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 someone notices that you are exhibiting overdose symptoms, they should provide your initial dose of naloxone, dial 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:

  • Tiny, focused pupils (black circles in the centre of the eye)
  • Excessive tiredness or sleepiness
  • Sluggish or challenging breathing
  • Coma (loss of consciousness for a period of time)

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to buprenorphine, your doctor will request specific lab tests.

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

Do not share your medication with anybody else. Buprenorphine is an illegal drug. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

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

  • Butrans®
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