Brand Name
US Brand Name
Butrans
Canadian Brand Name
BAR-Buprenorphine
Butrans 10
Butrans 15
Butrans 20
Butrans 5
Description
Buprenorphine skin patch is used to treat severe and persistent pain that requires an extended treatment period and when other pain medicines did not work well enough or cannot be tolerated. It belongs to the group of medicines called narcotic analgesics (pain medicines). Buprenorphine acts on the central nervous system (CNS) to relieve pain.
The buprenorphine skin patch should not be used if you need pain medicine for just a short time, such as after surgery. Do not use this medicine for mild pain or pain that you only have once in a while or "as needed."
When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve the pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. Severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Patch, Extended Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine skin patch in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine skin patch in the elderly. However, elderly patients are more likely to have constipation and difficult or painful urination, and have age-related heart, kidney, liver, or lung problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine skin patch to avoid serious side effects.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Isocarboxazid
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Naltrexone
- Pimozide
- Piperaquine
- Posaconazole
- Safinamide
- Samidorphan
- Saquinavir
- Sparfloxacin
- Terfenadine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alprazolam
- Amantadine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
- Belladonna
- Bemetizide
- Bendroflumethiazide
- Benperidol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (adrenal problem) or
- Alcohol abuse, or history of or
- Brain problems (including tumors, increased intracranial pressure) or
- Central nervous system (CNS) depression, history of or
- Congenital long QT syndrome (abnormal heart rhythm) or
- Congestive heart failure or
- Cor pulmonale (serious heart problem) or
- Depression, history of or
- Drug dependence, including narcotic or illicit drug abuse or dependence, or history of or
- Gallbladder disease or gallstones or
- Head injury, history of or
- Heart disease (eg, angina, congestive heart failure) or
- Heart rhythm problems (eg, atrial fibrillation, slow heartbeat, long QT syndrome) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood), severe or
- Hypothyroidism (an underactive thyroid) or
- Liver disease (eg, hepatitis B or C) or
- Lung or breathing problems (eg, COPD, hypoxia, sleep apnea) or
- Mental health problems, or history of or
- Problems with passing urine or
- Sleep apnea or
- Stomach or bowel problems (eg, blockage) or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation or swelling of the pancreas), acute or
- Seizures, history of—Use with caution. May make these conditions worse.
Proper Use
Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
This medicine comes with a Medication Guide and patient instructions. Read the instructions carefully before using the product. If you do not receive any printed instructions with the medicine, or do not understand the instructions, check with your nurse or doctor.
To use the skin patch:
- Use this medicine exactly as directed by your doctor. It will work only if it has been applied correctly.
- This medicine should only be used on intact, non-irritated skin. Do not put the patch in your mouth, chew, or swallow it.
- Buprenorphine skin patches are packaged in sealed pouches. Do not use this medicine if the pouch seal is broken, or if the patch is cut, damaged, or changed in any way. Do not remove the patch from the sealed pouch until you are ready to apply it.
- This medicine is available in 3 different strengths and patch sizes. Make sure you have the right strength patch that has been prescribed for you.
- When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand. The adhesive part of the system contains some buprenorphine, which can be absorbed into your body too fast through the skin of your hand. If any of the medicine does get on your hand, rinse the area right away with a lot of clear water. Do not use soap or other cleansers.
- Be careful not to tear the patch or make any holes in it. Damage to a patch may allow buprenorphine to pass into your skin too quickly. This can cause an overdose.
- Apply the patch to a dry, flat skin area on your upper arm, chest, back, or side of the chest. Choose a place where the skin is not very oily and is free of scars, cuts, burns, or any other skin irritations.
- The patch will stay in place better if it is applied to an area with little or no hair. If you need to apply the patch to a hairy area, you may first clip the hair with scissors, but do not shave it off.
- If you need to clean the area before applying the medicine, use only plain water. Do not use soaps, other cleansers, lotions, or anything that contains oils or alcohol. Be sure that the skin is completely dry before applying the medicine.
- Remove the liner covering the sticky side of the skin patch. Then press the patch firmly in place, using the palm of your hand, for a minimum of 15 seconds. Make sure that the entire adhesive surface is attached to your skin, especially around the edges. Do not rub the patch.
- If the patch becomes loose, tape the edges with first aid tape. Do not cover it with any other bandage or tape.
- If the patch falls off after applying it, throw it away and apply a new patch in a different area.
- Wash your hands with a lot of clear water after applying the medicine. Do not use soap or other cleansers.
- Remove the patch after 7 days, or as directed by your doctor. Choose a different place on your skin to apply the next patch. If possible, use a place on the other side of your body. Wait at least 3 weeks (21 days) before using the first area again.
Dosing
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.
- For transdermal dosage form (skin patch):
- For moderate to severe chronic pain:
- Adults—If you are not using other narcotics regularly, your doctor will determine the correct dose. If you are using other narcotics regularly, your dose will be based on your present daily narcotic dose. Your doctor may adjust the dose if needed. The patch is applied to the skin and left in place for 7 days.
- Children—Use and dose must be determined by your doctor.
- For moderate to severe chronic pain:
Missed Dose
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Buprenorphine can cause serious unwanted effects or a fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
Use the patch-disposal unit that was provided with your prescription to dispose of the patches. Read and follow the printed instructions on the disposal unit and use one unit for each patch. Peel off the liner of the disposal unit to reveal the sticky surface. Place the sticky side of the used patch on the disposal unit and seal the entire package. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side before placing it on the disposal unit. Throw the sealed disposal unit in a trash can. Talk to your pharmacist if you have questions about how to use the disposal unit. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. 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.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
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.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
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, which can be life-threatening and require 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.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- rapid weight gain
- swelling, burn, or blisters at the patch site
- tingling of the hands or feet
- unusual weight loss
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or tightness
- chills
- cough producing mucus
- diarrhea
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with moving
- dizziness
- ear congestion
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- increased sweating
- joint pain
- loss of appetite
- loss of voice
- lower back or side pain
- muscle aches and pains
- muscle stiffness
- nasal congestion
- nausea
- nervousness
- pain
- pain in the arms or legs
- pounding in the ears
- runny nose
- shakiness in the legs, arms, hands, or feet
- shivering
- slow or fast heartbeat
- sneezing
- sore throat
- sweating
- trembling or shaking of the hands or feet
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Rare
- Arm, back, or jaw pain
- blistering, burning, crusting, dryness, or flaking of the skin
- blue lips, fingernails, or skin
- chest heaviness
- confusion
- decreased urination
- deep or fast breathing with dizziness
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- extremely shallow or slow breathing
- fainting
- fast, irregular, pounding, or racing heartbeat or pulse
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- increase in heart rate
- irregular, fast or slow, or shallow breathing
- itching, scaling, severe redness, soreness, or swelling of the skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- loss of bladder control
- loss of consciousness
- numbness of the feet, hands, and around the mouth
- rapid breathing
- slow or irregular heartbeat
- stomach pain or tenderness
- sunken eyes
- swelling or puffiness of the face
- thirst
- trouble with walking
- wrinkled skin
Incidence not known
- Agitation
- darkening of the skin
- increased sensitivity to pain
- skin rash
- mental depression
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- restlessness
- talking or acting with excitement you cannot control
- twitching
- worsening of pain
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Blurred vision
- confusion
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- irregular, fast or slow, or shallow breathing
- pale or blue lips, fingernails, or skin
- pinpoint (small) pupils in the eyes
- relaxed and calm
- sleepiness or unusual drowsiness
- sweating
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Constipation
- itching, redness, or rash at the patch site
Less common
- Acid or sour stomach
- anxiety
- back pain
- belching
- depression
- headache, severe and throbbing
- heartburn
- indigestion
- irritation at the patch site
- itching skin or rash
- lack or loss of strength
- muscle spasms
- neck pain
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, or pain
- swelling of the joints
- upper abdominal or stomach pain
- weight loss
Rare
- Being forgetful
- blurred or loss of vision
- change in taste
- changes in patterns and rhythms of speech
- clumsiness or unsteadiness
- confusion about identity, place, and time
- cramps
- decreased interest in sexual intercourse
- decreased weight
- disturbed color perception
- double vision
- dry eyes or skin
- excess air or gas in the stomach or intestines
- feeling of constant movement of self or surroundings
- feeling of unreality
- full feeling
- general feeling of discomfort or illness
- halos around lights
- heavy bleeding
- inability to have or keep an erection
- lack of feeling or emotion
- loss in sexual ability, desire, drive, or performance
- loss of taste
- muscle weakness
- night blindness
- nightmares
- overbright appearance of lights
- passing gas
- pressure in the stomach
- relaxed and calm
- restlessness
- sensation of spinning
- sense of detachment from self or body
- sleepiness
- slurred speech
- swelling of the stomach area
- trouble with speaking
- tunnel vision
- uncaring
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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