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Fentanyl Powder transdermal patches are used in chronic pain management.[24] The patches work by slowly releasing fentanyl through the skin into the bloodstream over 48 to 72 hours, allowing for long-lasting pain management.

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 Dosage is based on the size of the patch, since, in general, the transdermal absorption rate is constant at constant skin temperature.[25]Rate of absorption is dependent on a number of factors.

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Body temperature, skin type, amount of body fat, and placement of the patch can have major effects. The different delivery systems used by different makers will also affect individual rates of absorption.

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Under normal circumstances, the patch will reach its full effect within 12 to 24 hours; thus, Fentanyl Powder patches are often prescribed with a fast-acting opioid (such as morphine or oxycodone) to handle breakthrough pain.

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It is unclear if fentanyl gives long-term pain relief to people with neuropathic pain.[26]

In palliative care, transdermal fentanyl has a definite, but limited, role for:

  • people already stabilized on other opioids who have persistent swallowing problems and cannot tolerate other parenteral routes such as subcutaneous administration.
  • people with moderate to severe kidney failure.
  • troublesome side effects of oral morphine, hydromorphone, or oxycodone

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Care must be taken to guard against the application of external heat sources (such as direct sunlight, heating pads, etc.) which in certain circumstances can trigger the release of too much medication and cause life-threatening complications.

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Duragesic was first approved by the College ter Beoordeling van Geneesmiddelen, the Medicines Evaluation Board in the Netherlands, on July 17, 1995, as 25, 50, 75 and 100 µg/h formulations after a set of successful clinical trials, and on October 27, 2004, the 12 µg/h (actually 12.5 µg/h) formulation was approved as well.

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On January 28, 2005, the U.S. Food and Drug Administration approved first-time generic formulations of 25, 50, 75, and 100 µg/h fentanyl transdermal systems (made by Mylan Technologies, Inc.

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brand name Duragesic, made by Janssen) through an FTC consent agreement derailing the possibility of a monopoly in the treatment of breakthrough chronic pain by Alza Corp.

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In some cases, physicians instruct people to apply more than one patch at a time, giving a much wider range of possible dosages.

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For example, a person may be prescribed a 37.5 µg dosage by applying one 12.5 µg patch and one 25 µg patch simultaneously, or contingent on the large size of the (largest) 100 μg/h patch, multiple patches are commonly prescribed for doses exceeding 100μg/h, such as two 75 μg/h patches worn to afford a 150 μg/h dosage regimen.

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Although the commonly referred to dosage rates are 12/25/50/75/100 µg/h, the “12 µg” patch actually releases 12.5 µg/h.[27] It is designed to release half the dose of the 25 µg/h dose patch.

As of July 2009, construction of the Duragesic patch had been changed from the gel pouch and membrane design to “a drug-in-adhesive matrix designed formulation”, as described in the prescribing information.[27] This construction makes illicit use of the Fentanyl Powder more difficult.

Storage and disposal

The Fentanyl Powder patch is one of a small number of medications that may be especially harmful, and in some cases fatal, with just one dose, if used by someone other than the person for whom the medication was prescribed.

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Unused Fentanyl Powder patches should be kept in a secure location that is out of children’s sight and reach, such as a locked cabinet.

When patches cannot be disposed of through a medication take-back program, flushing is recommended for fentanyl patches because it is the fastest and surest way to remove them from the home so they cannot harm children, pets and others who were not intended to use them

Adverse effects

Fentanyl’s most common side effects (more than 10% of people) include diarrhea, nausea, constipation, dry mouth, somnolence, confusion, asthenia (weakness), sweating, and less frequently (3 to 10% of people) abdominal pain, headache, fatigue, anorexia and weight loss, dizziness, nervousness, hallucinations, anxiety, depression, flu-like symptoms, dyspepsia (indigestion), shortness of breath, hypoventilation, apnoea, and urinary retention. Fentanyl use has also been associated with aphasia.

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Despite being a more potent analgesic, fentanyl tends to induce less nausea, as well as less histamine-mediated itching, than morphine.[46]

Sustained-release fentanyl preparations, such as patches, may produce unexpected delayed respiratory depression.[47][48][49] The precise reason for sudden respiratory depression is unclear, but there are several hypotheses:

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  • Saturation of the body fat compartment in people with rapid and profound body fat loss (people with cancer, cardiac or infection-induced cachexia can lose 80% of their body fat).
  • Early carbon dioxide retention causing cutaneous vasodilation (releasing more fentanyl), together with acidosis, which reduces protein binding of fentanyl, releasing yet more fentanyl.
  • Reduced sedation, losing a useful early warning sign of opioid toxicity and resulting in levels closer to respiratory-depressant levels.

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The duration of action of fentanyl has sometimes been underestimated, leading to harm in a medical context. In 2006, the U.S. Food and Drug Administration (FDA) began investigating several respiratory deaths, but doctors in the United Kingdom were not warned of the risks with fentanyl until September 2008.

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The FDA reported on April 2012 that twelve young children had died and twelve more made seriously ill from separate accidental exposures to fentanyl skin patches.

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