Buprenorphine (Absorbed through the skin)
Relieves moderate to severe chronic pain when around-the-clock pain relief is needed for a long period of time.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to buprenorphine or to adhesives. Do not use this medicine if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. Do not use this medicine if you only need pain medicine sometimes, such as only in the morning. You should not use this medicine if you are having trouble with breathing, such as with severe asthma, or if you have a digestion problem called paralytic ileus. No one else should ever use your patch for any reason.
How to Use This Medicine
- This is a very strong medicine. Using this medicine wrong can cause trouble breathing and other serious health problems, including death. If you do not understand the directions or warnings, ask your doctor.
- Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to.
- Wash your hands with soap and water before and after applying a patch.
- Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident.
- The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. After you apply the patch, push down on it with the palm of your hand for 15 seconds to make sure it sticks to your skin.
- Do not put the patch over burns, cuts, or irritated skin.
- Do not use soap, lotion, alcohol, or oil on your skin before applying the patch. Wash the skin only with clear water. Let your skin dry completely. Do not shave the skin where you will apply the patch. If you must get rid of some hair, cut the hair with a pair of scissors.
- Put on a new patch if the old one has fallen off and cannot be reapplied. If a patch is loose, tape it to your skin with first aid tape.
- Never put the patch in your mouth.
- If your patch has gel inside it: If any of this gel escapes from the patch and gets directly on your skin, wash it off right away with clear water. The gel is only supposed to go through the patch and onto your skin.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
If a dose is missed:
- If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
How to Store and Dispose of This Medicine
- Throw any used patch away so that children or pets cannot get to it. There is still enough medicine in a used patch to make a child or pet very sick. When throwing away a patch, fold it in half with the sticky sides together and flush it down the toilet, and then wash your hands thoroughly with soap and water. You may also place the used patch in the patch-disposal-unit to be thrown in a trash can. When you stop treatment with this medicine, take all of the leftover patches out of the packages and throw them away.
- Store the patches at room temperature in the original package, away from heat, moisture, and direct light.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.
- Make sure your doctor knows if you are also using carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), medicines to treat heart rhythm problems (such as amiodarone, disopyramide, dofetilide, quinidine, procainamide, sotalol, Betapace®, Cardioquin®, Cordarone®, Norpace®, Quinaglute®, Procanbid®, or Tikosyn®), or medicines to treat HIV/AIDS (such as atazanavir, Kaletra®, Reyataz®). Tell your doctor if you are also using medicine for nerves or sleeping (such as alprazolam, diazepam, Valium®, or Xanax®), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), or muscle relaxants (such as carisoprodol, tubocurarine, or Soma®).
- Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
- Do not drink alcohol while you are using this medicine.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you or anyone in your family has ever had major depression or other mental problems.
- Make sure your doctor knows if you or anyone in your family has ever abused drugs or alcohol or had a drug addiction. Tell your doctor if you have kidney disease, liver disease, adrenal problems, enlarged prostate, gallbladder problems, low blood pressure, heart disease, heart rhythm problems, low potassium in the blood, pancreas problems, thyroid problems, or a history of epilepsy or seizures.
- Tell your doctor if you have any kind of breathing problem, such as chronic obstructive pulmonary disease (COPD), cor pulmonale, pulmonary hypertension, hypoxia or hypercapnia (low oxygen or high carbon dioxide level in your blood), or hypoventilation (breathing too slowly). Tell your doctor if you have a recent head injury, brain tumor, or other problem that could increase the pressure in your head.
Using too much of this medicine can cause death. Symptoms of getting too much medicine include: trouble breathing, slow or shallow breathing, extreme dizziness or weakness, slow heartbeat, fainting, or extreme sleepiness.
- It is against the law and dangerous for anyone else to use your medicine. Keep your unused patches in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
- If you develop swelling, burn, or blisters at the application site, stop using this medicine and tell your doctor right away.
- This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
- Do not let the patch get too hot. It may release too much medicine too quickly. Avoid direct sunlight, and do not use a heating pad, electric blanket, heated water bed, sauna, sun lamp, or hot tub. Call your doctor if you have a fever higher than 102 degrees.
- Be careful about letting other people come in contact with your patch. The patch could stick to someone else, such as if you hug them or if someone helps you put the patch on. If any medicine gets on another person, wash it off right away with clear water.
- This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
- This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when standing up suddenly from a sitting or lying position, so get up slowly.
- This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.
- Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
- If your symptoms do not improve or if they get worse, call your doctor. Your pain will not get better right away. It may take a day or longer for the medicine to reach its full effect.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
- Change in how much or how often you urinate, difficult or painful urination.
- Chest pain.
- Fast, slow, or uneven heartbeat.
- Fever, chills, cough, sore throat, and body aches.
- Lightheadedness, dizziness, or fainting.
- Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
- Problems with vision, speech, or walking.
- Swelling, burn, or blisters where the patch is stuck to your skin.
- Swelling in your hands, ankles, or feet.
- Tremors or seizures.
Trouble breathing, slow or shallow breathing, sighing, extreme weakness or sleepiness.
- Unusual tiredness or weakness.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Back pain.
- Joint or muscle pain.
- Loss of appetite.
- Nausea, vomiting, constipation, diarrhea, dry mouth, or stomach pain.
- Rash or itching skin.
- Redness, itching, or mild skin rash where the patch is stuck to your skin.
- Trouble sleeping.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
Review Date: 2011-02-04
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