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FDA warnings a result of inappropriate use – how to use fentanyl patches correctly

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Durogesic (Fentanyl Transdermal system) is a strong painkiller medication that is taken as a patch on the skin. Since being introduced in 1990 it has proven itself as an effect, safe and convenient method of long-term pain control. However, following several cases of patients overdosing on Durogesic the US Food and Drug Association has released several new guidelines regarding the correct use of Durogesic (Fentanyl Transdermal system).

Who is Durogesic suitable for?

Durogesic (Fentanyl Transdermal system) is designed for people with long term, constant pain that is quite strong. It is only recommended for people who already need to take strong painkiller medication (opiate medication such as morphine or oxycontin).

Durogesic (Fentanyl Transdermal system) is not recommended for:

  • People with short term, post-operative or changing pain
  • People with a history of drug or alcohol abuse 
  • Children 
  • Pregnant mothers 
  • People who have never before taken an opioid medication. 

When being given Durogesic (Fentanyl Transdermal system) it is important to tell your doctor about all the medications that you are currently taking, including over the counter medication as this may affect this medication.

What doses are available?

Durogesic (Fentanyl Transdermal system) is available in doses of 12, 25, 50 and 100 micrograms per hour. Most people will begin on a low dose (such as 12 or 25) and then this will be increased every three days as needed by the individual person. Durogesic (Fentanyl Transdermal system) has a slow onset of action and may take up to two days to begin working at full effect. 

What are the common side effects of Durogesic

The most common side effects of Durogesic (Fentanyl Transdermal system) are:

  • Feeling dizzy and nauseous. This usually only occurs in the first few days and then goes away. If this is becomes a serious discomfort then please see your doctor as there are medications available to help with this.
  • Feeling very sleepy. This usually only occurs in the first week of two after starting and then goes away.
  • Constipation. This often happens in the long term and can become a serious problem. It this becomes a problem it is important to see you doctor to get advise and possibly medication to help with the constipation.

The other more rare side effects include a skin rash, sleeplessness, anxiety, sweating or palpitations. Although rare it is important to see your doctor if you experience any of these when on Durogesic (Fentanyl Transdermal system).

How to correctly use Durogesic

Below is the correct procedure to apply the Durogesic (Fentanyl Transdermal system) Patch. Please note that for the medication to be used safely this procedure must be followed exactly. 

  1. Find an intact and hairless spot of skin, preferably on the torso, or on the upper arm. The skin must be healthy and undamaged. Do not place the patch onto skin that is red, burnt or damaged.
  2. Trim any excess hair with scissors. Do not shave the hair off since this may affect the skin.
  3.  Wash the skin with water, do not use soap, lotions or moisturisers. Then dry the skin, the skin should be completely dry before applying the patch. 
  4. To open the pouch, locate the pre-cut notch indicated by the scissors. Make a small cut and fold at the notch. Carefully tear the pouch along the edge and then fully open the pouch by folding it open like a book. 
  5. Remove the Durogesic patch from the sealed pouch. 
  6. Do not apply the patch if it looks damaged in any way. Never cut or divide the patch.  
  7. Each Durogesic patch has a clear plastic protective (release) liner that can be peeled off in two pieces. After folding the patch in the middle, peel off each part of the protective liner separately. Avoid touching the adhesive side of the patch. 
  8. Apply the patch to the skin and press with the palm of the hand for about 30 seconds. Make sure all of the patch is in contact with skin and the corners are stuck tightly. 
  9. Wash hands after applying or removing the patch. 
  10. Write the date and time that the patch was applied on the pack as a reminder as to when the patch must be replaced.

The patch can be left on the skin for three days (72 hours), after which it must be removed and disposed of. When the patch is on a person may bath, shower or swim, but it is important to avoid saunas or hot tubs as these increase body temperature and increase the amount of medication that you receive, which can lead to an overdose.

Common causes of an overdose on Durogesic

Some of the common causes of Durogesic (Fentanyl Transdermal system) overdose include:

  • use of other medicines that interact with Durogesic (Fentanyl Transdermal system). Please inform your doctor of all the medication you are taking when starting on Durogesic (Fentanyl Transdermal system).
  • drinking alcohol 
  • having an increase in body temperature or being exposed to heat. This includes having a fever, using electric blankets or hot baths.

Pease note that correct disposal of used patches is essential. If a child finds a used patch and places it onto the skin there is a chance of overdose which can result in serious injury or even death.

What are the signs of Durogesic overdose?

The signs of Durogesic (Fentanyl Transdermal system) overdose are:

  • trouble breathing or shallow breathing
  • extreme sleepiness or sedation 
  • inability to think, talk or walk normally 
  • feeling faint, dizzy or confused

It is important to seek immediate medical advice if you suspect Durogesic (Fentanyl Transdermal system) overdose.

Conclusion

Durogesic (Fentanyl Transdermal system) is a safe, effective and convenient medication for controlling very strong pain. However, when taking the medication it is important to use it only as prescribed by your doctor and to correctly apply the patch. If you have any concerns about how to correctly apply the patch then it is important to contact your doctor for advice. It is also important to see your doctor if your are experiencing any significant side effects or if the medication is not controlling your pain.

References:

  1. FDA Public Health Advisory. Safety Warnings Regarding Use of Fentanyl Transdermal (Skin) Patches. US Food and Drug Administration; 2007. Available from
  2. CMPMedica Australia. eMIMS. Version 5.01.0088. St Leonards: CMPMedica Australia; 2007
  3. Deglin JH, Vallerand AH (Ed). Davis’ drug Guide for Physicians. F.A. Davis Company; 2005
  4. Janssen Pharmaceutica Products. Patient Information DURAGESIC (Fentanyl transdermal system). Janssen; 2003. Available from < http://www.fda.gov/cder/drug/infopage/fentanyl/DuragesicPPI.pdf>
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Dates

Posted On: 12 March, 2008
Modified On: 16 January, 2014

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Created by: myVMC