Butrans

Dosage Forms And Strengths

BUTRANS is a rectangular or square, beige-colored system consisting of a protective liner and functional layers. BUTRANS is available in five strengths:

• BUTRANS 5 mcg/hour Transdermal System (dimensions: 45 mm by 45 mm)
• BUTRANS 7.5 mcg/hour Transdermal System (dimensions: 58 mm by 45 mm)
• BUTRANS 10 mcg/hour Transdermal System (dimensions: 45 mm by 68 mm)
• BUTRANS 15 mcg/hour Transdermal System (dimensions: 59 mm by 72 mm)
• BUTRANS 20 mcg/hour Transdermal System (dimensions: 72 mm by 72 mm)

Storage And Handling

BUTRANS Transdermal System is supplied in cartons containing 4 individually-packaged systems and a pouch containing 4 Patch-Disposal Units.

BUTRANS (buprenorphine) 5 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 45 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 5 mcg/hr and are supplied in a 4-count carton (NDC 59011-750-04).

BUTRANS (buprenorphine) 7.5 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 58 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 7.5 mcg/hr and are supplied in a 4-count carton (NDC 59011-757-04).

BUTRANS (buprenorphine) 10 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 68 mm by 45 mm. Each system is printed in blue with the BUTRANS logo and 10 mcg/hr and are supplied in a 4-count carton (NDC 59011-751-04).

BUTRANS (buprenorphine) 15 mcg/hour Transdermal Systems are rectangular, beige-colored adhesive patches measuring 72 mm by 59 mm Each system is printed in blue with the BUTRANS logo and 15 mcg/hr and are supplied in a 4-count carton (NDC 59011-758-04).

BUTRANS (buprenorphine) 20 mcg/hour Transdermal Systems are square, beige-colored adhesive patches measuring 72 mm by 72 mm, Each system is printed in blue with the BUTRANS logo and 20mcg/hr and are supplied in a 4-count carton (NDC 59011-752-04).

Store at 25°C (77°F); excursions permitted between 15°C - 30°C (59°F - 86°F).

Distributed by: Purdue Pharma L.P., Stamford, CT 06901-3431. Manufactured by: LTS Lohmann Therapy Systems Corp., West Caldwell, NJ 07006. Revised: Jan 2017

• Purdue Pharma LP

BuTrans is part of the drug class:

• Oripavine derivatives

Tell your doctor if you are breastfeeding or plan to breastfeed. The medication in BuTrans patch passes into your breast milk. You and your doctor should decide if you will use BuTrans or breastfeed. You should not do both. Talk to your doctor about the best way to feed your baby if you use BuTrans.

The BuTrans dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

If you have not been taking other opioids, the standard starting dosage is one BuTrans (buprenorphine) patch 5 mcg/hour patch applied once a week. If your pain is not adequately controlled after three days, your healthcare provider may increase your dosage. The increase will be based on the amount of short-acting pain medication you needed, or how much "breakthrough" pain you experienced, in the two to three days after starting this medication.

The maximum BuTrans (buprenorphine) patch dose is one 20-mcg/hour patch applied once a week. Higher doses increase the risk for dangerous changes in the heart rhythm (QTc interval prolongation).

If you apply too much of this medication call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

In the U.S.

• Butrans

Available Dosage Forms:

• Patch, Extended Release

Therapeutic Class: Analgesic

Pharmacologic Class: Opioid Agonist/Antagonist

Chemical Class: Opioid

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:

• 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

• 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 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
• tightness in the chest
• trembling or shaking of the hands or feet
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• 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:

• Change in consciousness
• cold and clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pale or blue lips, fingernails, or skin
• pinpoint (small) pupils in the eyes
• sleepiness or unusual drowsiness
• slow heartbeat
• unable to speak
• very slow or troubled breathing
• weak muscle tone

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:

• Constipation
• itching, redness, or rash at the patch site

• 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

• 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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Store patches in pouch until ready for use.
• After you take off a skin patch, be sure to fold the sticky sides of the patch to each other.
• Follow the info that comes with this medicine for throwing out patches that are used or not needed. Check with your pharmacist if you have questions about how to throw out this medicine (Butrans).
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about this medicine (Butrans), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine (Butrans). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine (Butrans).

Review Date: October 4, 2017