Butrans 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.
Butrans 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 Butrans patch may be fatal, especially in children. Keep Butrans patch out of the reach of children. Seek emergency medical care right away if another person is exposed Butrans patch.
Long-term use of Butrans 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.
Managing moderate to severe chronic pain in patients who need continuous, around-the-clock narcotic (opioid) pain relief for an extended period of time. Butrans 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.
Butrans patch is a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.
Some medical conditions may interact with Butrans 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 Butrans 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 Butrans patch's side effects
Carbamazepine, naltrexone, phenobarbital, phenytoin, or rifamycins (eg, rifampin) because they may decrease Butrans patch's effectiveness
Methadone because its effectiveness may be decreased by Butrans 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 Butrans 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.
Use Butrans patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Butrans 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 Butrans patch refilled.
Butrans patch is for external use only.
Apply Butrans patch right away after removing it from the sealed package. Do not use Butrans patch if the pouch seal is broken or if the patch is cut, damaged, or changed in any way.
Butrans patch is only to be used on intact, clean, dry skin. Do not apply Butrans 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 Butrans 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 Butrans patch. Contact your pharmacist if you have any questions about how to dispose of Butrans patch.
Do not suddenly stop using Butrans patch. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Butrans 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 Butrans patch.
Butrans patch may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Butrans 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 Butrans 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 Butrans 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.
Butrans 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.
Butrans 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.
Butrans 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.
Butrans 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 Butrans 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 Butrans patch before you receive any medical or dental care, emergency care, or surgery.
Lab tests, including liver function, may be performed while you use Butrans 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 Butrans patch with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, constipation, and difficult urinating.
Butrans 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 Butrans patch while you are pregnant. Long-term use of Butrans patch during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Butrans patch is found in breast milk. Do not breast-feed while taking Butrans patch.
When used for long periods of time or at high doses, Butrans 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 Butrans patch stops working well. Do not take more than prescribed.
Some people who use Butrans 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 Butrans 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.
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:
Constipation; dizziness; drowsiness; dry mouth; headache; mild itching, rash, or redness at the application site; nausea; sweating; tiredness; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
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.
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 Butrans patch:
Store Butrans 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 Butrans patch out of the reach of children and away from pets.
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice.
If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.