Erika Prouty, PharmD, is a professional community pharmacist who aids patients in medication management and pharmacy services in North Adams, Massachusetts.
Butrans (buprenorphine) comes with risks of addiction, abuse, and misuse, which may lead to overdose and death.
Due to these risks, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for this product. Under the requirements of the REMS, the manufacturers of Butrans must create education programs for healthcare providers. These providers are encouraged to complete these education programs and counsel their patients accordingly.
Serious, life-threatening respiratory depression may occur when using this medication, especially when starting or following a dose increase.
Prolonged use of this medication during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Avoid using this medicine with central nervous system (CNS) depressants, including alcohol or other drugs that cause drowsiness or affect your breathing, like benzodiazepines. Serious side effects include sedation, slowed breathing, coma, and death.
Accidental exposure to even one dose of buprenorphine, especially by children, can result in a fatal overdose of buprenorphine
Butrans (buprenorphine ) skin patches are a prescription opioid pain medicine used to manage severe around-the-clock pain. It is not used to treat acute pain.
Butrans works by binding to various opioid receptors in the body to relieve pain. It works as a partial agonist on the mu-opioid receptors. It also works as an antagonist on the kappa-opioid receptors, an agonist at the delta-opioid receptors, and as a partial agonist at the opioid receptor-like (ORL-1) receptors. Agonists are drugs that bind to receptors to produce a similar response to the receptor and antagonists bind to receptors to block their response.
As an opioid, Butrans increases the risk of substance use disorder in people taking the medication. Because of this, buprenorphine is considered a controlled substance.
Butrans is available via prescription as a transdermal skin patch, which means that the drug is slowly absorbed into the body through the skin.
The FDA approved transdermal buprenorphine as a long-term treatment for managing severe, chronic pain when other pain treatments (e.g., non-opioid analgesics or immediate-release opioids) are ineffective or cannot be tolerated.
Use this medicine exactly as directed by your healthcare provider. Don’t use more than you are prescribed. When using Butrans, apply the patches to the upper outer arm, upper chest, upper back, or the side of the chest every seven days.
The following are general tips for using Butrans patches:
Follow the instructions on the medication guide for when and how to apply Butrans patches.
Do not stop taking this medication without talking to your healthcare provider. Discuss any questions about using this medication with your healthcare provider or pharmacist.
Store Butrans patches at room temperature (around 77 degrees Fahrenheit). Store securely, out of sight and reach of children and pets. Keep it in a location not accessible by others, including visitors to the home. Place the patch in the Patch-Disposal Unit before disposing of it in the trash. You may also dispose of used patches by folding them in half and flushing them down the toilet.
Healthcare providers may prescribe buprenorphine for off-label uses, meaning for conditions not specifically indicated by the FDA.
Buprenorphine is sometimes used as a bridge therapy to prevent withdrawal symptoms when converting from high-dose opioids to high-dose sublingual buprenorphine for pain management.
This is not an FDA-approved use, and there is no evidence that buprenorphine effectively treats this condition. Using this medication without the advice of a healthcare provider can result in severe or life-threatening side effects.
Butrans is absorbed through the skin and starts working within hours. Each patch delivers buprenorphine for seven days.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
The most common side effects of Butrans are:
Call your healthcare provider immediately if you have serious side effects. Call 911 immediately if your symptoms feel life-threatening or if you think you or someone else is having a medical emergency. Serious side effects can include the following:
In severe cases, opioids can lead to life-threatening or fatal respiratory depression. Be especially careful when starting therapy or if your dosage is increased.
Butrans may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Due to the possible harmful effects of this medication, there may be changes to how it is used.
Using this medication during pregnancy may cause life-threatening withdrawal symptoms in the newborn. This condition is called neonatal opioid withdrawal syndrome.
Breastfeeding is not recommended during treatment with Butrans. It may put a breastfed infant at risk for severe adverse reactions, including excess sedation and respiratory depression.
Butrans has not been studied in infants and children. Please do not use it in this population.
Butrans is primarily eliminated by the liver. As Butrans is released over seven days, alternative pain medication is recommended in people with severe liver disease.
If you miss a dose of this medication, remove the patch and apply a new one as soon as you remember. Continue wearing the patch for up to seven days. Apply a new one if needed for pain. Do not use extra patches or double up to make up for a missed dose. Call your healthcare provider or pharmacist if unsure what to do.
If you believe you or someone else has used more Butrans than prescribed, remove the Butrans patch(es) immediately and seek medical attention. You may be treated with opioid antagonists, such as naloxone or doxapram hydrochloride (a respiratory stimulant), and monitored for at least 24 hours.
Symptoms of a Butrans overdose could be severe and even lead to death. Signs of an overdose include:
If you think you or someone else may have overdosed on Butrans, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn't breathing after taking Butrans, call 911 immediately.
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
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.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
This medicine will add to the effects of alcohol and other central nervous system (CNS) depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, benzodiazepines, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. These may be symptoms of adrenal gland problems.
Check with your doctor right away if you have dark urine, general tiredness and weakness, light-colored stools, nausea and vomiting, upper right stomach pain, and yellow eyes and skin. These may be symptoms of liver problems.
This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
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.
Heat can cause the buprenorphine in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, a sunlamp, or a heated water bed, and do not sunbathe, or take long baths or showers in hot water. Also, check with your doctor if you get a fever.
If you have been using this medicine regularly for several days, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects (eg, stomach cramps, fever, runny nose, anxiety, or restlessness).
If the patch comes off and accidentally sticks to the skin of another person, they should take the patch off immediately and wash the exposed area with water. The exposed person should then seek medical attention.
Using too much buprenorphine, or taking too much of another narcotic while using buprenorphine, may cause an overdose. If this occurs, get emergency help right away. Symptoms of an overdose include: drowsiness, extreme dizziness or weakness, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, relaxed and calm, slow heartbeat or breathing, seizures, sleepiness, trouble breathing, or cold, clammy skin. Tell your doctor right away if you notice these symptoms. Your doctor may also give naloxone to treat an overdose.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
Using too much of this medicine may cause reduced infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Avoid taking Butrans if you are allergic to buprenorphine or any other components of this medication.
Do not use Butrans if you have:
Watch out for these medications when taking Butrans, as they can affect how it works in the body.
Avoid combining Butrans with benzodiazepines as the combination may increase the risk of respiratory depression. Examples include:
CYP3A4 Inhibitors and Inducers
Starting CYP3A4 inhibitors or discontinuing CYP3A4 inducers may increase Butrans concentrations.
Examples of CYP3A4 inhibitors include, but are not limited to:
CYP3A4 inducers can include, but are not limited to:
Coadministration with these agents may increase the risk of serotonin syndrome, as serotonergic drugs stimulate the serotonin receptors.
Examples of serotonergic drugs include triptans (e.g., sumatriptan), antidepressants like serotonin norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (MAOIs).
Avoid using mixed agonist/antagonist analgesics, such as naltrexone, with Butrans because they may affect how it works or trigger withdrawal symptoms.
This is not a comprehensive list of medications that may affect how Butrans works. Share a list of your current medications and supplements with your healthcare provider or a pharmacist. Some medicines can increase the risk of severe side effects from buprenorphine.
Medications similar to Butrans include:
Like Butrans, Lidoderm is approved for adults only. It works by inhibiting nerve impulses to reduce sensitivity to pain (numbing medication). Unlike Butrans, this patch may be cut to size and applied over painful areas. It is not dosed around the clock. Instead, it is applied daily to the most painful areas for 12 hours, then removed for another 12 hours. It may be used during pregnancy and breastfeeding as minimal systemic absorption is expected.
Fentanyl is an opioid pain medication used to treat moderate to severe chronic pain around the clock. It is not for treating mild or occasional pain or surgery-related pain. It works by binding various opioid receptors in the body to provide pain relief.
Due to its potential for abuse, fentanyl is also a controlled medication like Butrans. It is also dosed around the clock, removing and replacing the patch every three days. It is approved in adults and children 2 years and older, with dose adjustments required for kidney and liver disease. Like Butrans, avoid heat exposure as heat causes rapid medication absorption, resulting in toxic levels.
Aspercreme Lidocaine Patch (Lidocaine Topical Patch)
Aspercreme Lidocaine patch is a pain relief patch available over the counter (OTC) with no prescription. It works by inhibiting nerve impulses to reduce sensitivity to pain. It is applied every six to eight hours. It is approved for use in children over 12 years old.
Avoid direct heat exposure when using Butrans. Heat may cause more of the medication to be absorbed from the skin for all patches. With a drug like Butrans, this increased absorption can quickly become life-threatening. Heat sources to avoid include heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated waterbeds.
Make sure you rotate the application site of Butrans each time you reapply. Do not shave your skin right before applying Butrans, as this may irritate the skin even further. Instead, clip the hair at the application site if needed
Butrans may be covered only with Bioclusive or Tegaderm film dressings. Place Butrans on dry, non-lubricated skin to help it stick. Press down with your palm over the patch. Apply to a hairless or nearly hairless skin site. Avoid touching the sticky side of the patch while applying it. If Butrans falls off during the seven-day dosing interval, dispose properly and place a new patch at a different skin site.
To dispose in household trash using the Patch-Disposal Unit:
To dispose in the toilet:
Unused patches must be removed from their protective pouch and the protective liner removed before flushing. Throw the pouch and the protective liner in the trash.
Butrans is vital in treating around-the-clock pain that does not respond to other pain treatments like non-opioid analgesics or immediate-release opioids. Follow all directions on your prescription label and read all medication guides before using this medication.
People using Butrans are at risk for serious side effects. Do not use this medicine to treat any condition your healthcare provider is not aware of and has not prescribed it for. Misusing this medicine can lead to addiction, overdose, or death. Buprenorphine is a drug of potential abuse. Therefore, it is important to tell your healthcare provider if you feel an urge to use more of this medicine. Never use buprenorphine in larger amounts or for longer than prescribed. Store in a place where others cannot access it. Selling or giving away buprenorphine is against the law.
Remember to keep both used and unused patches out of the reach of children or pets. The amount of buprenorphine in a used skin patch could be fatal to a child or pet. Do not stop Butrans suddenly, or you could have withdrawal symptoms. Consult with your healthcare provider on how to stop using Butrans safely.
If you have trouble remembering to use this medication, consider setting alarms on your phone or calendar. As with all medications, discuss any questions or concerns about your treatment with a healthcare provider or pharmacist.
Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.
Food and Drug Administration. Butrans label.
Kornfeld H, Reetz H. Transdermal buprenorphine, opioid rotation to sublingual buprenorphine, and the avoidance of precipitated withdrawal: a review of the literature and demonstration in three chronic pain patients treated with Butrans. Am J Ther. 2015;22(3):199-205. doi:10.1097/MJT.0b013e31828bfb6e
UpToDate. Cytochrome P450 3A (including 3A4) inhibitors and inducers.
Food and Drug Administration. Lidoderm label.
Aspercreme. Aspercreme Lidocaine pain relief patch.
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