Buprenorphine Transdermal Patch 

(byoo pre nor' feen)


Buprenorphine skin patches can be habit-forming. Tell your doctor if you or your family drink or have ever drunk large amounts of alcohol; have overused prescription medications; have used street drugs; or have or have ever had depression or mental illness.

Buprenorphine skin patches may cause serious or life-threatening breathing problems, especially during the first 72 hours of your treatment and any time that your dose is increased. Tell your doctor if you have or have ever had breathing difficulties, asthma, chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), or other lung disease. Your doctor may tell you not to use buprenorphine skin patches. Tell your doctor and pharmacist if you are taking atazanavir (Reyataz); benzodiazepines such as such as alprazolam (Niravam, Xanax), chlordiazepoxide (Librium, in Limbitrol), clonazepam (Klonopin), diazepam (Diastat, Valium), estazolam, flurazepam (Dalmane), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), temazepam (Restoril), triazolam (Halcion); medications for mental illness and nausea; other medications for pain; muscle relaxants; sedatives; sleeping pills; and tranquilizers. If you have any of the following symptoms, call your doctor immediately: difficulty breathing; extreme drowsiness with slow breathing; heartbeat that is slower than normal; cold clammy skin; difficulty thinking, talking, or walking normally; dizziness; confusion; extreme tiredness; fainting; or loss of consciousness.

Serious harm or death my result if other people, especially children, are accidently exposed to the medication in the patches. Be careful not to allow the sticky side of the patch to touch anyone else's skin. If the patch comes off of your body and sticks to another person's skin get medical attention for the person right away.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with buprenorphine skin patches and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using this medication.

WHY is this medicine prescribed?

Buprenorphine skin patches are used to treat moderate to severe pain that is expected to last for some time. 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.

HOW should this medicine be used?

Buprenorphine comes as a patch to apply to the skin. The patch is usually applied to the skin once every 7 days. Your doctor will probably start you on a low buprenorphine patch dose and gradually increase your dose, not more often than once every 3 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use buprenorphine patches exactly as directed. Do not apply more patches or apply the patches more often than prescribed by your doctor. Contact your doctor if the dose you are taking does not control your pain.

Apply the patch to clean, dry, hairless skin that is not irritated, scarred, burned, broken, or calloused. Choose a different area every 7 days. Wait at least 3 weeks before applying a new patch to the same site.

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 use a buprenorphine skin 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. This may cause serious problems, including overdose.

Do not stop using buprenorphine skin patches without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop using buprenorphine skin 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.

While you are wearing a buprenorphine skin patch, protect the patch from 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.

To use the patch, follow these steps:

  • Choose a flat, hairless area of skin on your upper outer arm, upper chest, upper back or the side of the chest to place the patch. If there is hair on the skin, clip the hair as close to the skin as possible with scissors, but do not shave it.
  • Clean the area with clear water and pat dry. Do not use any soaps, lotions, alcohols or oils.
  • Tear open the pouch containing the buprenorphine skin patch along the line. Remove the skin 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. Do not cover the entire patch with bandages or tape. Talk to your doctor or pharmacist if your patch continues to have problems sticking to your skin.
  • 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, fold it in half with the sticky sides together and flush it down a toilet. You may also use a Patch Disposal Unit provided to you by the manufacturer to safely dispose of the used patch in the trash. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed buprenorphine 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.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before using buprenorphine skin patch,

    • tell your doctor and pharmacist if you are allergic to buprenorphine any other medications, adhesives (glues), or any of the ingredients in a buprenorphine skin patch.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take or use. Be sure to mention: anticholinergics (atropine, belladonna, benztropine, dicyclomine, diphenhydramine, isopropamide, procyclidine, and scopolamine); certain medications for irregular heartbeat including amiodarone (Cordarone), disopyramide (Norpace), procainamide (Procanbid), quinidine (Quinaglute, Quinidex) and sotalol (Betapace, Betapace AF, Sorine); medications for seizures such as carbamazepine (Tegretol), phenobarbital (Luminal, Solfoton), phenytoin (Dilantin); and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have or have ever had conditions mentioned in the IMPORTANT WARNING section or a paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use buprenorphine skin patches.
    • tell your doctor if you or an immediate family member have or have ever had long QT syndrome; 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; slowed heartbeat; low blood pressure; low blood levels of potassium; problems urinating; or thyroid, heart, kidney, or liver disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using a buprenorphine skin patch, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using a buprenorphine skin patch.
    • 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.
    • do not drink any alcohol while using buprenorphine skin patches. Alcohol increases the chance that you will experience serious side effects of the medication.
    • you should know that buprenorphine skin 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 skin patches.
    • you should know that if you have a fever, the amount of buprenorphine that you receive from the skin patch may increase and possibly cause an overdosage of medication. Call your doctor right away if you have a fever higher than 102 °F (38.9 °C). Your doctor may need to adjust your dose.
    • you should know that buprenorphine 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 a buprenorphine skin patch. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

    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 skin 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 SIDE EFFECTS can this medicine cause?

    Buprenorphine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

    • nausea

    • diarrhea
    • difficulty falling asleep or staying asleep
    • headache
    • dizziness
    • constipation
    • vomiting
    • dry mouth
    • stomach pain
    • application site itching, rash, or redness

    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:

    • trouble breathing
    • shortness of breath
    • fast heartbeat
    • chest pain
    • swelling of your face, tongue or throat

    • rash

    • hives

    • itching

    • extreme drowsiness

    Buprenorphine skin 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 [at http://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). Throw away any medication that is outdated or no longer needed. Throw away any patches that are outdated or no longer needed 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. You may also use a Patch Disposal Unit provided to you by the manufacturer to safely dispose of the unwanted patch in the trash. Wash your hands well with water after throwing away buprenorphine patches. Do not put unneeded or used by buprenorphine skin patches in a garbage can. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

    • pinpoint pupils
    • extreme drowsiness
    • slowed breathing
    • coma (loss of consciousness for a period of time)

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory.

    Before having any laboratory test, 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.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names
    • Butrans®

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