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Buprenorphine (Transdermal route)

Pronunciation:

bue-pre-NOR-feen

Brand Names:

  • Butrans

Dosage Forms:

  • Patch, Extended Release

Warnings:

Transdermal route(Patch, Extended Release)

Buprenorphine is a schedule III controlled substance with the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Chewing, swallowing, snorting, or injecting buprenorphine extracted from the patch will result in uncontrolled delivery which may lead to overdose and death. Accidental exposure to buprenorphine, especially in children, can result in fatal overdose of buprenorphine. Prolonged use of buprenorphine during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Opioid Agonist/Antagonist

Chemical—

Opioid

Uses of This Medicine:

Buprenorphine transdermal (skin patch) is used to relieve moderate to severe chronic pain when around-the-clock pain relief is needed for a long period of time.

The buprenorphine skin patch should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain. This medicine should not be used to treat pain that you only have once in a while or "as needed".

Buprenorphine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

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 their 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. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine transdermal in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine transdermal 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 transdermal.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

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.

  • Naltrexone

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.

  • Alfentanil
  • Alphaprodine
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Atazanavir
  • Baclofen
  • Bromazepam
  • Buspirone
  • Butabarbital
  • Carbamazepine
  • Carbinoxamine
  • Carisoprodol
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Cobicistat
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Delavirdine
  • Dexmedetomidine
  • Diazepam
  • Dihydrocodeine
  • Diphenhydramine
  • Diphenoxylate
  • Doxylamine
  • Eslicarbazepine Acetate
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Fentanyl
  • Fluconazole
  • Flunitrazepam
  • Flurazepam
  • Fospropofol
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Hydroxyzine
  • Idelalisib
  • Ketazolam
  • Ketobemidone
  • Levorphanol
  • Lorazepam
  • Meclizine
  • Meperidine
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methadone
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Midazolam
  • Mitotane
  • Morphine
  • Morphine Sulfate Liposome
  • Nelfinavir
  • Nitrazepam
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pentobarbital
  • Phenobarbital
  • Piperaquine
  • Prazepam
  • Primidone
  • Promethazine
  • Propofol
  • Propoxyphene
  • Quazepam
  • Ramelteon
  • Secobarbital
  • Siltuximab
  • Sodium Oxybate
  • Sufentanil
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Temazepam
  • Thiopental
  • Thioridazine
  • Tipranavir
  • Tizanidine
  • Topiramate
  • Topotecan
  • Triazolam
  • Zaleplon
  • Zolpidem
  • Zopiclone

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.

  • Darunavir
  • Etravirine
  • Fosamprenavir
  • Perampanel

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:

  • Alcohol abuse, or history of or
  • Brain tumor or
  • CNS depression, history of or
  • Drug dependence, including narcotic or illicit drug abuse or dependence, or history of or
  • Gallbladder disease or gallstones or
  • Head injuries or
  • Heart disease (eg, congestive heart failure, myocardial ischemia), unstable or
  • Heart rhythm problem (eg, atrial fibrillation, long QT syndrome, slow heartbeat), family history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypothyroidism (an underactive thyroid) or
  • Increased pressure in your head or
  • Liver disease (including hepatitis B or C) or
  • Lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypercapnia, hypoxia, sleep apnea) or
  • Mental illness, or history of or
  • Problems with passing urine or
  • Stomach or bowel problems (eg, blockage) or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Breathing or lung problems (eg, asthma), severe or
  • Paralytic ileus (intestinal blockage or narrowing) or
  • Respiratory depression (hypoventilation or slow breathing)—Should not be used in patients with these conditions.
  • 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 of This Medicine:

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.

Buprenorphine transdermal 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 (stick-on patch):
    • For relief of moderate to severe chronic pain:
      • Adults—If you have not already been using other narcotics regularly, your doctor will determine use and dose. If you have already been using other narcotics regularly, your first dose will depend on the amount of other narcotics you have been taking every day. If necessary, your doctor will change the dose after 3 days, when the first patch is replaced. The size of the new dose will depend on how well the medicine is working and on whether you had any side effects during the first 7-day application. Other changes in dose may be needed later on.
      • Children—Use and dose must be determined by your doctor.

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.

Buprenorphine can cause serious unwanted effects or 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.

To dispose of this medicine: First, fold the patch in half, with the sticky side inside. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Then flush it down the toilet right away. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can. You may also place the used patch in the patch-disposal-unit to be sealed and thrown in a trash can.

Precautions While Using This Medicine:

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.

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 serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or 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, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.

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, abdominal or 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 transdermal, or taking too much of another narcotic while using buprenorphine transdermal, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin, low blood pressure, pinpoint pupils of the eyes, and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

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 of This Medicine:

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 gain or 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
chills
cough
cough producing mucus
diarrhea
difficult or labored breathing
difficult, burning, or painful urination
difficulty with moving
dizziness
ear congestion
fall
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
tightness in the chest
trembling or shaking of the hands or feet
trouble sleeping
unusual tiredness or weakness
vomiting
Rare
Abdominal or stomach pain or tenderness
arm, back, or jaw pain
blistering, burning, crusting, dryness, or flaking of the skin
blue lips, fingernails, or skin
chest tightness or 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
sunken eyes
sweating
swelling or puffiness of the face
thirst
trouble with walking
wrinkled skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
Change in consciousness
choking
cold and clammy skin
constricted pupils (black part of the eye)
decreased awareness or responsiveness
no muscle tone or movement
pale or blue lips, fingernails, or skin
severe sleepiness
sleepiness or unusual drowsiness
snoring
unable to speak

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
lack or loss of strength
muscle spasms
neck pain
pain or tenderness around the eyes and cheekbones
rash
stomach discomfort, upset, or pain
swelling of the joints
upper abdominal or stomach pain
weight loss
Rare
Agitation
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 abdominal or 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.


Last Updated: 11/4/2014

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