Buprenorphine patches can be habit-forming. This may occur at recommended doses or if it is misused or abused. Do not apply more patches, apply the patches more often, or use the patches differently than prescribed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.
Buprenorphine patches may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time that your dose is increased. If you have any of the following symptoms, call your doctor immediately or get emergency medical treatment: difficulty breathing, shortness of breath, extreme drowsiness, fainting, or loss of consciousness.
Taking certain medications, drinking alcohol, or using street drugs with buprenorphine patches may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.
Buprenorphine patches may cause serious harm or death if used by other people, especially children. Store buprenorphine patches in a safe place so that no one else can use them accidentally or on purpose.
Tell your doctor if you are pregnant or plan to become pregnant. If you use buprenorphine patches regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.
You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.
Talk to your doctor about the risks of using this medication.
Why is this medicine prescribed?
Buprenorphine patches are used to relieve severe and persistent pain. It is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Transdermal buprenorphine comes as a patch to apply to the skin. Apply the patch to the skin once every 7 days. Change your patch at about the same time of day every time you change it.
Apply buprenorphine patches exactly as directed.
Your doctor may start you on a low dose buprenorphine patch and gradually increase your dose, not more often than once every 3 days. If this increase involves the use of two patches, remove your current patch and at the same time, place the two new patches next to each other at a new site. If your doctor tells you to use two patches, you should always change and apply them at the same time. Your doctor may decrease your dose if you experience side effects. Contact your doctor if the dose you are taking does not control your pain.
Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while using buprenorphine patches. Rescue medications can reverse the life-threatening effects of an opioid overdose and are available from a community-based program, over the counter, or with a prescription. Make sure that you and your family members and people usually around you know how to recognize an overdose, how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur, they should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. If your symptoms return, the person should give you another dose of the rescue medication. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
Buprenorphine skin patches are only for use on the skin. Do not place patches in your mouth or chew or swallow the patches.
Do not stop using buprenorphine patches without talking to your doctor. If you suddenly stop using buprenorphine patches you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, teary eyes, runny nose, yawning, sweating, chills, hair standing on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, diarrhea, nausea, vomiting, anxiety, pain in the joints, weakness, fast heartbeat, or rapid breathing.
Do not use a buprenorphine patch that is cut, damaged, or changed in any way. If you use cut or damaged patches, you may receive most or all of the medication at once, instead of slowly over 7 days..
If your buprenorphine patch is exposed to extreme heat, it may release too much medication into your body at once. Do not expose your patch or the skin around it to direct heat such as heating pads, electric blankets, heat lamps, saunas, hot tubs, and heated water beds. Do not take long, hot baths or sunbathe while you are wearing the patch.
You may bathe or shower while you are wearing a buprenorphine patch. If the patch falls off during these activities, dispose of it properly. Then dry your skin completely and apply a new patch. Leave the new patch in place for 7 days after you apply it.
You can apply a buprenorphine patch to your upper outer arms, upper chest, upper back, or the side of your chest. Choose an area of skin that is flat and hairless. Do not apply the patch to parts of the body that irritated, broken, cut, damaged, or changed in any way. If there is hair on the skin, use scissors to clip the hair as close to the skin as possible. Do not shave the area. Wait at least 3 weeks before applying a new patch to same site.
Tell your doctor if your pain increases or gets worse or if you have new pain or an increased sensitivity to pain, especially after applying a buprenorphine patch. Do not apply more of it or apply it more often than prescribed by your doctor.
To apply the patch, follow these steps:
- 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.
- Use scissors to cut open the pouch containing the buprenorphine patch along the dotted line. Remove the patch from the pouch and peel off the protective liner from the back of the patch. Try not to touch the sticky side of the patch.
- Immediately press the sticky side of the patch onto the chosen area of skin with the palm of your hand.
- Press the patch firmly for at least 15 seconds. Be sure that the patch sticks well to your skin, especially around the edges. Do not rub the patch.
- If the patch does not stick well or comes loose after it is applied, tape only 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 bandages or tape. Talk to your doctor or pharmacist if your patch continues to have problems sticking to your skin.
- If a patch falls off before it is time to remove it, dispose of the patch properly and apply a new patch at a different area of skin. Leave the new patch in place for 7 days.
- When you are finished applying the patch, wash your hands with only clear water right away.
- Write down the date and time that the patch is applied.
- When it is time to change your patch, peel off the old patch and apply a new patch to a different skin area.
- After you remove your patch, use the Patch Disposal Unit provided to you by the manufacturer to safely dispose of the used patch in the trash. Close the Patch Disposal Unit by folding the sticky sides together, then press firmly and smoothly over the entire Unit so that the patch is sealed within. Do not place used patches in the trash without first sealing them in the Patch Disposal Unit. Alternatively, you may also may fold the sticky sides of a used patch together and flush it down the toilet. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed buprenorphine patches.
What special precautions should I follow?
Before using buprenorphine patch,
- tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- you should know that some medications should not be taken with buprenorphine. Make sure you have discussed any medications you are currently taking or plan to take before starting buprenorphine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking buprenorphine, please get the advice of your doctor or pharmacist.
- tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine selegiline, or tranylcypromine.
- the following nonprescription or herbal products may interact with buprenorphine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medications before you start using buprenorphine. Do not start this medication while using buprenorphine without discussing it with your healthcare provider.
- tell your doctor if you have or have ever had slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems, a paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use buprenorphine patches.
- tell your doctor if you or an immediate family member have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness, or sudden death); or if you have or ever had atrial fibrillation; heart failure; seizures; a head injury, a brain tumor, a stroke or any other condition that caused high pressure inside your skull; biliary tract disease; diabetes; slowed heartbeat; low blood pressure; low blood levels of potassium; problems urinating; or pancreas, thyroid, heart, kidney, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking buprenorphine call your doctor immediately. You should not breastfeed while using buprenorphine patches.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine patches.
- you should know that this medication may make you drowsy. Do not drive a car, operate machinery, or do other possibly dangerous activities until you know how this medication affects you.
- you should know that buprenorphine 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 a buprenorphine patch. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that buprenorphine patches may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine patches.
- you should know that if you have a fever or if you get very hot after physical activity, the amount of buprenorphine that you receive from the patch may increase and possibly cause an overdosage of medication. Avoid physical activity that might cause you to get very hot. Call your doctor right away if you have a fever.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using a buprenorphine patch.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
If you forget to apply or change a buprenorphine patch, apply the patch as soon as you remember it. Be sure to remove your used patch before applying a new patch. Wear the new patch for the period of time prescribed by your doctor (usually 7 days) and then replace it. Do not wear two patches at once unless your doctor has told you that you should.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
- narrowing or widening of the pupils (black circles in the center of the eye)
- extreme sleepiness or drowsiness
- slow or shallow breathing, difficulty breathing, unusual snoring
- unable to respond or wake up
- slow heartbeat
- cold, clammy skin
- muscle weakness
What side effects can this medicine cause?
Buprenorphine patches may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- difficulty falling asleep or staying asleep
- headache
- dry mouth
- stomach pain
- skin irritation, itching, swelling, or redness in the area where you wore the patch
- decreased sexual desire, inability to get or keep an erection
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- chest pain, changes in heartbeat
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- rash, itching, hives; hoarseness, difficulty breathing or swallowing, or swelling of the face, mouth, tongue, lips, or throat
- difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
- unusual snoring or long pauses during breaths during sleep
- new pain or pain from touch or doing ordinary tasks such as combing your hair
Buprenorphine patches may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Discard any patches that are outdated or as soon as they are no longer needed. Use a Patch Disposal Unit provided to you by the manufacturer to safely dispose of the unneeded or outdated patch(s) in the trash. Do not put unneded or outdated buprenorphine patches in a garbage can without first sealing them in a Patch Disposal Unit. Alternatively, you may dispose of the patches by carefully removing the adhesive backing, folding the sticky sides of each patch together so that it sticks to itself, and flushing the patches down the toilet. Talk to your pharmacist about the proper disposal of your medication.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.orgWhat other information should I know?
Keep all appointments with your doctor and laboratory.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using buprenorphine.
Do not let anyone else use your medication. Buprenorphine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.