Buprenorphine (bue-pre-NOR-feen)

Treats severe pain. This medicine is a narcotic pain reliever.

Brand Name(s):

Butrans

When This Medicine Should Not Be Used:

How to Use This Medicine:

Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose.
• Wash your hands with soap and water before and after applying a patch.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident. Do not use this medicine if the pouch seal is broken or if the patch is damaged in any way. If any medicine leaks out of the patch and gets directly on your skin, wash it off right away with water.
• Do not use soap, lotion, alcohol, or oil on your skin before you apply the patch. Wash your skin only with water and let it dry completely. Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors.
• The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. After you apply the patch, push down on it with the palm of your hand for 15 seconds to make sure it sticks to your skin.
• Do not put the patch over burns, cuts, or irritated skin.
• Put on a new patch if the old one has fallen off and cannot be reapplied. If a patch is loose, tape it to your skin with first aid tape.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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.
• Store the patches at room temperature in the original package, away from heat, moisture, and direct light.
• Disposal:
  • Follow the instructions you receive with the patch disposal unit. You will need to seal each patch in a disposal unit, even if it is a patch you did not use. Make sure children and pets cannot come in contact with used or leftover patches. Wash your hands thoroughly with soap and water after you handle the patch. If you must dispose of a patch without the patch disposal unit, be sure you fold it in half with the sticky sides together so no one comes in contact with the medicine.
  • 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

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how buprenorphine works. Tell your doctor if you are using any of the following:
  • Carbamazepine, erythromycin, ketoconazole, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, trazodone
  • Diuretic (water pill)
  • Medicine to treat anxiety, depression, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat heart rhythm problem (including amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol)
  • Phenothiazine medicine
  • Triptan or medicine to treat migraine headaches
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using butorphanol, nalbuphine, pentazocine, a benzodiazepine, or a muscle relaxer (including cyclobenzaprine, metaxalone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung disease or breathing problems (including COPD, sleep apnea), heart disease, heart rhythm problems, adrenal problems, gallbladder problems, low blood pressure, pancreas problems, or stomach or bowel problems. Tell your doctor if you have heart disease, congestive heart failure, a slow heartbeat, or a history of heart rhythm problems (including long QT syndrome). Tell your doctor if you have a history of head injury, brain tumor, seizures, depression, or alcohol or drug abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • Adrenal gland problems
  • Low blood pressure
  • Heart rhythm problems, including QT prolongation
  • Liver problems
  • Serotonin syndrome, when used with certain medicines
• Do not let the patch get too hot. Avoid direct sunlight, and do not use a heating pad, electric blanket, heated waterbed, sauna, sun lamp, or hot tub. Call your doctor if you have a fever higher than 102 degrees F.
• Be careful about letting other people come in contact with your patch. If any medicine gets on another person, wash it off right away with water.
• This medicine may make you lightheaded, dizzy, or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness or weakness, shallow breathing, sweating, seizures, cold or clammy skin
• Fast, slow, or uneven heartbeat
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation
• Swelling, burns, or blisters where the patch is placed
• Slow or trouble breathing
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Headache
• Mild constipation, nausea, or vomiting
• Mild sleepiness or tiredness
• Redness, itching, or mild skin rash where the patch is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088