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FENTANYL, 2.1mg/5.25cm2 , 12μg/h, transdermal patch

https://unicat.msf.org/cat/product/34706
NST DEXTFENT2TP

Valid Article

Former Code(s): DEXTZNL0212
2.2 - Opioid analgesics
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
N02AB03
Anatomical Therapeutic Chemical Classification according to WHOCC
PE
The order of this product needs to be justified and is only acceptable under certain conditions.
N1
Substance listed as Narcotic Drug or Psychotropic Substance, and as precursors. Other substances may be subject to restrictions according to national regulations. These substances require an import permit from the country of destination when ordering.
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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FENTANYL transdermal patch - NST

Please always consider the MSF STD before ordering a NST.

Therapeutic Action

Strong opioid analgesic

Indications

Moderate to severe pain in patients whose pain is previously controlled with morphine or another opioid.

Prolonged opioid therapy in patients with severe renal impairment or when oral administration is not possible (dysphagia or frequent vomiting).

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Instructions for use

The patches deliver 12 or 25 µg (mcg) fentanyl per hour:

  • a 12 µg/hr patch is equivalent to approx. 30-45 mg morphine in 24 hrs.
  • a 25 µg/hr patch is equivalent to approx. 60-90 mg morphine in 24 hrs.

Other patches deliver 50 or 100 µg (mcg) fentanyl per hour:

  • a 50 µg/hr patch is equivalent to approx. 120-180 mg morphine in 24 hrs.
  • a 100 µg/hr patch is equivalent to approx. 240-360 mg morphine in 24 hrs.

Dosage:

  • Patients should be on opioid regimen prior to initiate fentanyl patch with a relatively controlled level of pain.
  • The dose of fentanyl should be calculated on the basis of a 24-hour morphine equivalent.
  • In case of paroxysmal pain attacks, administer immediate release morphine PO (fentanyl PO does not exist). Calculate dose by converting fentanyl TD to oral morphine, then calculate appropriate unit dose.
  • Monitor efficacy, side effects and overdose.

Method of administration:

  • Transdermal use
  • Apply to clean, dry, intact skin on a flat surface of the torso or upper arms.
  • Choose an area where the skin is not very oily and is free of scars, cuts, burns or irritations.
  • Hair at the application site should be clipped (not shaved) prior to application (a non-hairy area is preferable).
  • Do not remove the patch from the sealed package until ready to apply it.
  • Press the patch firmly in place with the palm of the hand for at least 30 seconds. Ensure that the entire adhesive surface is adhering properly to the skin, especially the edges.
  • Wash hands.
  • Replace the patch every 72 hours (to a different skin site after removal of the previous patch).

Remark:

After removal of the patch, the effects of fentanyl remain during 12 to 18 hrs (beware of opioid toxicity). Systematically order naloxone (specific opioid antagonist) together with fentanyl.

Distribution to be controlled: narcotics register or supervision of amounts in and out, and storage under lock and key. (CF Introduction: Narcotic and psychotropic medicines under international control)

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Precautions for Use

Avoid touching the adhesive side of the patch when handling the patch.

Do not use soap, oils, lotions or any other product that might irritate the skin.

Do not administer in children under 2 years of age.

In patients with fever, fentanyl absorption may be increased due to increased skin permeability (risk of opioid overdose).

In patients in terminally ill phase with transdermal fentanyl, keep the patch in place and administer emergency doses by another route if necessary.

The TD patch should only be used when the patient's pain is controlled by morphine or another opioid. It takes 24 hours for the patch to reach therapeutic steady state, so rapid titration is not possible.

Storage

  • Below 25°C - Protect from sunlight
  • Store in the original pouch.

Description updated and validated by A. Lamrous (EMACC WG) on 05/04/2023.