The U.S. Food and Drug Administration

(FDA) approved Butrans (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.

 

Butrans Medication Guide

 

Read the Medication Guide that comes with Butrans before you start using it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Make sure you read and understand all the instructions for using Butrans. Talk to your doctor if you have questions.

Keep Butrans in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally uses Butrans, get emergency help right away.

 

Important information about Butrans

 

• Butrans overdose can cause serious and life threatening breathing problems.
• Butrans is a skin patch that contains the strong opioid pain medicine (narcotic) buprenorphine.
• Butrans is used to treat moderate to severe chronic pain that continues around-the-clock and is expected to last for a long period of time.
• Butrans is not for pain that:
  • you only have once in while ("as needed")
  • is expected to last for only a short time or pain due to surgery
• Serious and life-threatening breathing problems can happen with Butrans, especially during the first 24 to 72 hours after you apply a new patch. This can happen because of an overdose or if the dose you are using is too high for you.
• Call your doctor right away or get emergency medical help if you:
  • have trouble breathing
  • have changes in breathing
    • unusual deep "sighing" breathing
    • slow or shallow breathing
    • new or unusual snoring
  • have a slow heartbeat
  • have severe sleepiness
  • have cold, clammy skin
  • feel faint, dizzy, confused, or cannot think, walk, or talk normally
• Do not place direct heat on Butrans. Exposure of Butrans to direct heat may cause too much of the medicine in Butrans to pass into your body. This can lead to overdose and death. Keep the Butrans system away from:
  • heating pads
  • electric blankets
  • heaters
  • tanning lamps
  • saunas
  • hot tubs
  • heated waterbeds
  • hot baths
  • sunbathing
  • 
    
• Place the Butrans patch only on clean skin. Do not use Butrans on broken, irritated and cracked skin.
• 
  
• Do not use Butrans if the seal on the protective pouch is broken or if the patch is cut, damaged or changed. Do not cut the patch.