September 30, 2014
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BuTrans

(buprenorphine (patch))

DIN (Drug Identification Number)

02341174 BUTRANS 5 G/ HOUR PATCH
02341212 BUTRANS 10 G/ HOUR PATCH
02341220 BUTRANS 20 G/ HOUR PATCH

How does BuTrans work? What will it do for me?

Buprenorphine belongs to the class of medications called opioid analgesics (pain relievers). Buprenorphine sustained release is only intended to treat persistent severe chronic (long-term) pain, where pain relief is needed around the clock. For acute pain or "breakthrough" pain, the doctor will prescribe another pain medication such as acetaminophen, ibuprofen, or a narcotic-containing medication.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use BuTrans?

The usual dose of buprenorphine patch varies according to the needs of the individual. The most common starting dose of buprenorphine sustained release patch is 5 µg per hour and it may be slowly increased as required. The maximum daily dose of buprenorphine patch is 20 µg per hour. Each patch should be worn for 7 days.

The patch may be applied to any convenient skin area - recommended sites include the upper outer arm, upper chest, upper back, or the side of the chest. Change the skin site where you apply the patch each week, making sure that at least 3 weeks (21 days) pass before you reuse the same skin site. Apply this medication to a hairless or nearly hairless skin site. If the application site must be cleaned, clean the site with water only and avoid using soaps, alcohol, oils, lotions, or abrasive devices. Allow the skin to dry before applying the patch.

Do not apply the patch to broken skin or to areas where there may be irritation (rashes, swelling, redness, or other skin problems). When handling the patch do not touch the sticky side of the patch with your fingers, and instead use the protective liner as a handle. Press the entire patch firmly into place with the palm of your hand over the patch for about 30 seconds - do not rub the patch. Wash your hands thoroughly after the application. Following use, discard the patch in a manner that prevents accidental application or ingestion by curious pets or children.

This medication may be habit-forming if taken for long periods of time. You may experience withdrawal effects if you stop using this medication suddenly after extended use. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If the patch falls off, do not reapply the patch. Discard the medication safely and apply a new patch to a different site. If the edges of the patch start to loosen, apply first aid tape or special see-through adhesive dressings only to the edges of the patch. If you leave the patch on for more than 7 days, remove the patch and apply a new patch. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.





What form(s) does BuTrans come in?

5 µg/hour
Each rectangular or square, beige coloured patch consisting of a protective liner, functional layers, and an active surface area of 6.25 cm2 delivers 5 µg/hour buprenorphine. Nonmedicinal ingredients: beige coloured backing layer of polyethylene terephthalate; an adhesive matrix rim without buprenorphine; a separating foil over the adhesive matrix; the buprenorphine-containing adhesive matrix with inactive ingredients including aluminum acetylacetonate, levulinic acid, oleyl oleate, polyacrylate (dry solids), and povidone; and a release liner (before use, the release liner covering the adhesive layer is removed and discarded).

10 µg/hour
Each rectangular or square, beige coloured patch consisting of a protective liner, functional layers, and an active surface area of 12.5 cm2 delivers 10 µg/hour buprenorphine. Nonmedicinal ingredients: beige coloured backing layer of polyethylene terephthalate; an adhesive matrix rim without buprenorphine; a separating foil over the adhesive matrix; the buprenorphine-containing adhesive matrix with inactive ingredients including aluminum acetylacetonate, levulinic acid, oleyl oleate, polyacrylate (dry solids), and povidone; and a release liner (before use, the release liner covering the adhesive layer is removed and discarded).

20 µg/hour
Each rectangular or square, beige coloured patch consisting of a protective liner, functional layers, and an active surface area of 25 cm2 delivers 20 µg/hour buprenorphine. Nonmedicinal ingredients: beige coloured backing layer of polyethylene terephthalate; an adhesive matrix rim without buprenorphine; a separating foil over the adhesive matrix; the buprenorphine-containing adhesive matrix with inactive ingredients including aluminum acetylacetonate, levulinic acid, oleyl oleate, polyacrylate (dry solids), and povidone; and a release liner (before use, the release liner covering the adhesive layer is removed and discarded).

Who should NOT take BuTrans?

Do not use this medication if you:

  • are allergic to buprenorphine or any ingredients of this medication
  • are dependent on opioids or experiencing narcotic withdrawal symptoms
  • are pregnant, planning to become pregnant, in labor, or breast-feeding
  • are under 18 years of age
  • had a head injury
  • have acute or severe asthma or another airway disease
  • have ileus (narrowing of intestines or a blockage in intestines)
  • have mild, irregular, or temporary pain
  • have myasthenia gravis
  • have severe drowsiness or severe breathing difficulties
  • have severe liver disease
  • have taken MAO inhibitors (e.g., phenelzine, tranylcypromine, moclobemide or selegiline) within 14 days
  • may require abdominal surgery (e.g. people with inflamed pancreas or appendix)
  • require pain relief before or after surgery
  • suffer from alcohol addiction or dependence, or have convulsions

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