Butrans

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.

This product is available in the following dosage forms: Patch disposal units releasing 5/10/15/20 mcg/hr.

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 population

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.

Geriatric population

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 and Lactation:Category C

Animal 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. 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.

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.

• 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:

• Acepromazine, Alfentanil, Alphaprodine, Alprazolam, Alvimopan, Amisulpride, Amobarbital, Anileridine, Aripiprazole, Asenapine, Atazanavir
• Baclofen, Benperidol, Bromazepam, Buspirone, Butabarbital, Butorphanol
• Carbinoxamine, Carisoprodol, Carphenazine, Chloral Hydrate, Chlordiazepoxide, Chlorpromazine, Chlorzoxazone, Clobazam, Clonazepam, Clorazepate, Clozapine, Codeine, Cyclobenzaprine
• Dexmedetomidine, Dezocine, Diacetylmorphine, Diazepam, Dichloralphenazone, Difenoxin, Dihydrocodeine, Diphenhydramine, Diphenoxylate, Donepezil, Doxylamine, Droperidol
• Enflurane, Estazolam, Eszopiclone, Ethchlorvynol, Ethopropazine, Ethylmorphine
• Fentanyl, Flibanserin, Flunitrazepam, Fluphenazine, Flurazepam, Fluspirilene, Fospropofol
• Halazepam, Haloperidol, Halothane, Hexobarbital, Hydrocodone, Hydromorphone, Hydroxyzine
• Isoflurane
• Ketamine, Ketazolam, Ketobemidone
• Levorphanol, Lorazepam
• Meclizine, Melperone, Meperidine, Mephobarbital, Meprobamate, Meptazinol, Mesoridazine, Metaxalone, Methadone, Methdilazine, Methocarbamol, Methohexital, Methotrimeprazine, Methylene Blue, Methylnaltrexone, Midazolam, Molindone, Moricizine, Morphine, Morphine Sulfate Liposome
• Nalbuphine, Nalmefene, Nalorphine, Naloxone, Nicomorphine, Nitrazepam, Nitrous Oxide
• Olanzapine, Opium, Opium Alkaloids, Orphenadrine, Oxazepam, Oxycodone, Oxymorphone
• Papaveretum, Paregoric, Pentazocine, Pentobarbital, Perampanel, Perazine, Periciazine, Perphenazine, Phenobarbital, Pimozide, Piperacetazine, Pipotiazine, Piritramide, Prazepam, Primidone, Prochlorperazine, Promazine, Promethazine, Propofol, Propoxyphene
• Quazepam, Quetiapine
• Ramelteon, Remifentanil, Remoxipride
• Samidorphan, Secobarbital, Sertindole, Sodium Oxybate, Sufentanil, Sulpiride, Suvorexant
• Tapentadol, Temazepam, Thiethylperazine, Thiopental, Thiopropazate, Thioridazine, Tilidine, Tizanidine, Tolonium Chloride, Topiramate, Tramadol, Triazolam, Trifluoperazine, Trifluperidol, Triflupromazine, Trimeprazine
• Zaleplon, Zolpidem, Zopiclone, Zotepine

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.

Should not be used in patients with these conditions:

• Breathing or lung problems (eg, asthma),
• Severe or Paralytic ileus (intestinal blockage or narrowing)
• Respiratory depression (hypoventilation or slow breathing).
• Hypotension (low blood pressure)
• Pancreatitis (inflammation or swelling of the pancreas),Acute
• History of Seizures

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.

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.

General Precautions

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.

Pregnancy

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.

Other Medicines

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.

Driving and Work

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.

Anaphylaxis

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

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.

Continued Therapy

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.

Overdose

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 non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 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 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
• Stomach feeling full
• 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.