1. Name of the medicinal product
fentanyl patch 100 mcg/h Transdermal Patch
2. Qualitative and quantitative composition
Each Durogesic DTrans 100 patch contains fentanyl 16.8 mg.
Release rate approximately 100 µg/h; active surface area 42.0 cm2.
For excipients, see 6.1
3. Pharmaceutical form
fentanyl patch 100 mcg/h is a translucent, rectangular transdermal patch with rounded corners.
Each patch is marked:
fentanyl patch 100 mcg/h
100 µg fentanyl/h
Grey printing ink
4. Clinical particulars
4.1 Therapeutic indications
fentanyl patch 100 mcg/h is indicated for management of severe chronic pain that requires continuous long term opioid administration.
Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
4.2 Posology and method of administration
fentanyl patch doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Initial dosage selection
The appropriate initiating dose of Durogesic DTrans should be based on the patient’s current opioid use. It is recommended that Durogesic DTrans be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.