Generic Name: buprenorphine (BUE-pre-NOR-feen)
Brand Name: Butrans
Buprenorphine patch 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, use for longer than prescribed, or use more often than prescribed without checking with your doctor.
Buprenorphine patch may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.
Accidental exposure to buprenorphine patch may be fatal, especially in children. Keep buprenorphine patch out of the reach of children. Seek emergency medical care right away if another person is exposed buprenorphine patch.
Long-term use of buprenorphine patch during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.
Buprenorphine patch is used for:
Managing moderate to severe chronic pain in patients who need continuous, around-the-clock narcotic (opioid) pain relief for an extended period of time. Buprenorphine patch 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.
Buprenorphine patch is a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.
Do NOT use buprenorphine patch if:
- you are allergic to any ingredient in buprenorphine patch
- you have slow, shallow, or difficult breathing
- you have severe lung problems (eg, severe asthma) or you are having an asthma attack
- you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
- you or a family member has a history of a certain type of irregular heartbeat (QT interval prolongation, long QT syndrome)
- you are taking certain antiarrhythmic medicines (eg, amiodarone, dofetilide, quinidine, sotalol) or sodium oxybate (GHB)
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken one within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using buprenorphine patch:
Some medical conditions may interact with buprenorphine patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances (eg, adhesives used on bandages)
- if you have a history of chronic obstructive pulmonary disease or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
- if you have a history of thyroid problems, liver problems (eg, hepatitis B or C) or abnormal liver function tests, skin reactions to adhesives, kidney problems, pancreas problems (eg, pancreatitis), urinary blockage or trouble urinating, gallbladder problems, or stomach or bowel problems (eg, blockage, inflammation)
- if you have a history of heart problems (eg, cor pulmonale, heart failure, slow or irregular heartbeat) or recent heart attack
- if you have a recent head injury, growths in the brain (eg, tumor, lesion), increased pressure in the brain, or a history of seizures (eg, epilepsy)
- if you have a fever, low blood pressure, dehydration, low blood volume, severe drowsiness, constipation, stomach pain, low blood potassium levels, or poor health
- if you or a family member has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
- if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or actions
- if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
- if you have never taken a narcotic pain medicine before
- if you are taking a benzodiazepine (eg, alprazolam)
Some MEDICINES MAY INTERACT with buprenorphine patch. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
- Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
- Anticholinergics (eg, benztropine, scopolamine) because the risk of constipation and trouble urinating may be increased
- MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, and coma, may be increased
- Antiarrhythmics (eg, amiodarone, dofetilide, quinidine, sotalol) because the risk of a certain type of irregular heartbeat (QT interval prolongation) may be increased
- HIV protease inhibitors (eg, atazanavir, ritonavir) or other narcotic pain medicines (eg, oxycodone) because they may increase the risk of buprenorphine patch's side effects
- Carbamazepine, naltrexone, phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease buprenorphine patch's effectiveness
- Methadone because its effectiveness may be decreased by buprenorphine patch and withdrawal symptoms may occur
- Muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased
- Medicines that may harm the liver (eg, acetaminophen, isoniazid, ketoconazole, certain medicines for HIV infection, methotrexate) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if buprenorphine patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use buprenorphine patch:
Use buprenorphine patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Buprenorphine patch comes with an extra patient information sheet called a Medication Guide. It also comes with an additional patient information leaflet with detailed instructions for use. Read them carefully. Read them again each time you get buprenorphine patch refilled.
- Buprenorphine patch is for external use only.
- Apply buprenorphine patch right away after removing it from the sealed package. Do not use buprenorphine patch if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.
- Buprenorphine patch is only to be used on intact, clean, dry skin. Do not apply buprenorphine patch 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 buprenorphine patch'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.
- If the patch falls off before 7 days have passed, do NOT re-apply it. Apply a new patch to a different skin site.
- A patch may be worn continuously for 1 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.
- 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 buprenorphine patch. Contact your pharmacist if you have any questions about how to dispose of buprenorphine patch.
- Do not suddenly stop using buprenorphine patch. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop buprenorphine patch, your doctor will gradually lower your dose.
- 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.
Ask your health care provider any questions you may have about how to use buprenorphine patch.
Important safety information:
- Buprenorphine patch may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use buprenorphine patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are using buprenorphine patch. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using buprenorphine patch; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
- Buprenorphine patch may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Buprenorphine patch is to be applied to the skin only. If you or another person may have taken it by mouth, contact your poison control center or emergency room right away.
- Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Do not change the patch more often than directed by your doctor.
- Buprenorphine patch may cause withdrawal symptoms if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin). Talk with your doctor if you are dependent on narcotic medicines or other opiates.
- Do not expose the patch application site or surrounding areas to direct sources of heat, such as heating pads, electric blankets, heat or tanning lamps, saunas, hot tubs, or heated waterbeds. Avoid sunbathing; long, hot baths; or 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. The heat may cause more medicine to be released into your skin.
- If the medicine in the patch comes into contact with the skin, immediately wash the affected area with large amounts of water only. If you have concerns, speak with your pharmacist or doctor for further instructions.
- If the patch comes off your skin and accidentally sticks to the skin of another person, remove the patch 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.
- Buprenorphine patch 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 buprenorphine patch, 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.
- Tell your doctor or dentist that you take buprenorphine patch before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including liver function, may be performed while you use buprenorphine patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use buprenorphine patch with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, constipation, and difficult urinating.
- Buprenorphine patch should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using buprenorphine patch while you are pregnant. Long-term use of buprenorphine patch during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Buprenorphine patch is found in breast milk. Do not breast-feed while taking buprenorphine patch.
When used for long periods of time or at high doses, buprenorphine patch may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if buprenorphine patch stops working well. Do not take more than prescribed.
Some people who use buprenorphine patch for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.
If you suddenly stop taking buprenorphine patch, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not really there; shivering or tremors; sweating; tiredness; vomiting.
Possible side effects of buprenorphine patch:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; dry mouth; headache; mild itching, rash, or redness at the application site; nausea; sweating; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); abnormal sighing; burning, numbness, or tingling; burning, swelling, oozing, or blisters at the application 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 light-headedness; 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; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms 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 light-headedness; shortness of breath; slow or irregular heartbeat.Proper storage of buprenorphine patch:
Store buprenorphine patch at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep buprenorphine patch out of the reach of children and away from pets.
- If you have any questions about buprenorphine patch, please talk with your doctor, pharmacist, or other health care provider.
- Buprenorphine patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take buprenorphine patch or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about buprenorphine patch. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to buprenorphine patch. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using buprenorphine patch.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
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