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BUTRANS 10MCG/HR TS PATCH
Ingredient Name: BUPRENORPHINE (byoo-pre-NOR-feen)
Drug Manufacturer: PURDUE
Common Uses: This medicine is a narcotic (opioid) pain medicine used to manage moderate to severe pain when continuous (around-the-clock) treatment is needed for an extended period of time. This medicine is not for use right after surgery if you have not already been using narcotic pain medicines, if only occasional or "as-needed" pain relief is needed, or if the pain is mild or is not expected to last for an extended period of time.
Before Using This Medicine: WARNING: THIS MEDICINE IS A NARCOTIC PAIN MEDICINE that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT use more than the recommended dose, or for longer or more often than prescribed without checking with your doctor. THIS MEDICINE MAY CAUSE severe and sometimes fatal breathing problems, especially when first starting it or with any dose increase. Contact your doctor right away if you experience slow, shallow, or difficult breathing. ACCIDENTAL EXPOSURE to this medicine may be fatal, especially in children. Keep this medicine out of the reach of children. Seek emergency medical care right away if another person is exposed to this medicine. LONG-TERM USE OF THIS MEDICINE DURING PREGNANCY may cause dependence in the unborn baby. This can lead to withdrawal in newborn, which can be life-threatening. Discuss any questions or concerns with your doctor. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking certain antiarrhythmics (eg, amiodarone, dofetilide, quinidine, sotalol), sodium oxybate (GHB), or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or if you have taken an MAOI within the past 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you take antiarrhythmics, anticholinergics (eg, benztropine), benzodiazepines (eg, alprazolam), carbamazepine, HIV protease inhibitors (eg, ritonavir), methadone, naltrexone, other pain medicines (eg, oxycodone), phenobarbital, phenothiazines (eg, chlorpromazine), phenytoin, rifamycins (eg, rifampin), or medicines that may harm the liver (eg, acetaminophen). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of lung or breathing problems (eg, asthma, COPD, emphysema, bronchitis); sleep apnea; curvature of the spine (scoliosis); high blood levels of carbon dioxide (hypercapnia / hypercarbia); low blood levels of oxygen (hypoxia); thyroid, gallbladder, or kidney problems; liver problems (eg, hepatitis, abnormal liver function tests); skin reactions to adhesives; pancreas problems (eg, pancreatitis); urinary blockage or trouble urinating; stomach or bowel problems (eg, blockage, inflammation); heart problems (eg, cor pulmonale, heart failure, slow or irregular heartbeat); recent heart attack; seizures; suicidal thoughts or actions; allergies; pregnancy; or breast-feeding. TELL YOUR DOCTOR if you have a fever, low blood pressure, dehydration, low blood volume, severe drowsiness, constipation, stomach pain, low blood potassium levels, poor health, recent head injury, growths in the brain (eg, tumor, lesion), increased pressure in thebrain, or a physical dependence on narcotic pain medicines (eg, morphine) or other opiates (eg, heroin). TELL YOUR DOCTOR if you drink alcohol or have symptoms of alcohol withdrawal, are very overweight, have never taken a narcotic pain medicine before, or have recently had or will be having surgery. TELL YOUR DOCTOR if you or a family member has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma) or you are having an asthma attack; narrowing of the stomach or bowels; or known or suspected stomach or bowel blockage (eg, paralytic ileus). USE OF THIS MEDICINE IS NOT RECOMMENDED if you or a family member has a history of a certain type of irregular heartbeat (QT interval prolongation, long QT syndrome). Use of this medicine in CHILDREN younger than 18 years old is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions about taking this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. It also comes with an additional patient information leaflet with detailed instructions for use. Read them carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE IS FOR EXTERNAL USE ONLY. Apply this medicine right away after removing it from the sealed package. Do NOT use this medicine if the pouch seal is broken or if the patch is cut, damaged, or changed in any way. THIS MEDICINE IS ONLY TO BE USED on intact, clean, dry skin. Do not apply this medicine to broken, damaged, or inflamed skin. THE APPLICATION SITE SHOULD BE HAIRLESS OR NEARLY HAIRLESS. If you have no hairless areas, clip the hair at the application site; do NOT shave it. If the application site must be cleaned, clean the site with clear water only. Do NOT clean the area with soap, alcohol, lotion, oil, or other cleansers because the risk of this medicine's side effects may be increased. Allow the skin to dry before you apply the patch. APPLY THE PATCH TO THE UPPER OUTER ARM, upper chest, upper back, or the side of your chest on either side of your body. Do not apply a new patch to the same skin area for at least 21 days. Do not wear more than 1 patch at a time unless your doctor tells you otherwise. PRESS THE PATCH FIRMLY IN PLACE with the palm of your hand for about 15 seconds. Do not rub the patch. Make sure the contact is complete, especially around the edges. Wash your hands after you apply or handle a patch. IF THE PATCH DOES NOT STICK, you may tape only the edges with first-aid tape or cover the patch with a special type of clear adhesive film dressing (eg, Bioclusive, Tegaderm). Do not cover the patch with any other bandage or tape. Ask your doctor or pharmacist about the kinds of dressings that should be used. A PATCH MAY BE WORN CONTINUOUSLY FOR ONE WEEK (exactly 7 days) or as directed by your doctor. After removing the old patch, a new patch may be applied to a different skin site. IF THE PATCH FALLS OFF before 7 days have passed, do NOT re-apply it. Apply a new patch to a different skin site. AFTER REMOVING THE USED PATCH, if a patch falls off before 7 days have passed, or if unused patches remain that are no longer needed, follow the disposal instructions listed in the additional patient leaflet with instructions for use that comes with this medicine. Contact your pharmacist if you have any questions about how to dispose of this medicine. DO NOT SUDDENLY STOP USING THIS MEDICINE. You may have an increased risk of withdrawal symptoms. If you need to stop this medicine, your doctor will gradually lower your dose. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. KEEP THISMEDICINE out of the reach of children and away from pets. IF YOU FORGET TO CHANGE YOUR PATCH ON THE DAY IT IS DUE, change the patch as soon as you remember. Do NOT double your dose to catch up.
Cautions: DO NOT USE THIS MEDICINE if you have had an allergic reaction to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or use for longer than prescribed without checking with your doctor. Exceeding the recommended dose or using this medicine for a long time may be habit-forming. Do not change the patch more often than directed by your doctor. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. LAB TESTS may be performed to monitor your progress or to check for side effects. Keep all doctor and laboratory appointments while you are using this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, emergency care, or surgery, tell the doctor or dentist that you are taking this medicine. THIS MEDICINE MAY CAUSE DROWSINESS, dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of these effects. THESE EFFECTS MAY BE WORSE if you take this medicine with alcohol or certain medicines. Do not drive or perform other possibly unsafe tasks until you know how you react to it. DO NOT DRINK ALCOHOL or take medicines that contain alcohol while using this medicine. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol. CHECK WITH YOUR DOCTOR before using medicines that may cause drowsiness (eg, muscle relaxers) while using this medicine; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase these risks. DO NOT EXPOSE THE PATCH APPLICATION SITE or surrounding areas to direct sources of heat (eg, heating pads, electric blankets, heat or tanning lamps, saunas, hot tubs, heated waterbeds). Avoid sunbathing; long, hot baths; and other sources of heat to the body. Avoid activities that can increase body temperature. Tell your doctor if you develop increased body temperature (eg, due to exercise) or a fever. IF THE PATCH COMES OFF YOUR SKIN and sticks to another person's skin, remove it from their skin immediately, wash the exposed area of skin with water, and call your doctor, emergency room, or local poison control center right away. IF THE MEDICINE IN THE PATCH comes into contact with the skin, immediately wash the affected area with large amounts of water only. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY; they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Long-term use ofthis medicine during pregnancy may cause dependence in the fetus or newborn. THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.
Possible Side Effects: SIDE EFFECTS that may occur while using this medicine include dizziness; drowsiness; dry mouth; headache; mild itching, rash, or redness at the application site; nausea; sweating; tiredness; or vomiting. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE CONSTIPATION. Talk with your doctor or pharmacist about taking a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking this medicine, talk with your doctor or pharmacist. IF YOUR PAIN CONTINUES or becomes worse or if you have side effects that concern you, contact your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal sighing; burning, numbness, or tingling; burning, swelling, oozing, or blisters at the applications site; chest pain; confusion; difficult, shallow, or slow breathing; difficulty talking, thinking, or walking; difficulty urinating; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; joint or muscle pain; memory problems; mental or mood changes (eg, anxiety, depression); seizures; severe or persistent constipation, stomach pain, or vomiting; severe or persistent drowsiness, dizziness, headache, or lightheadedness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the eyes or skin); tremor; unusual weakness; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: This medicine is to be applied to the skin only. IF OVERDOSE IS SUSPECTED, or if you or another person may have taken this medicine by mouth, contact your local poison control center or emergency room immediately. Symptoms of overdose may include abnormal snoring; bluish skin or nails; cold and clammy skin; coma; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or lightheadedness; shortness of breath; or slow or irregular heartbeat.
Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
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