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Fentanyl Transdermal System 75mcg/h


Fentanyl Transdermal System 75mcg/h

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Fentanyl Transdermal System 75mcg/h
Durogesic DTrans is a translucent, rectangular transdermal patch with rounded corners. Each patch is marked in coloured printing ink as follows:

Each patch is 31.5 cm2, and is marked with a border and “DUROGESIC 75 µg fentanyl/h” in blue printing ink.

4. Clinical particulars
4.1 Therapeutic indications

Durogesic DTrans 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

Durogesic DTrans 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.


Opioid-tolerant patients

To convert opioid-tolerant patients from oral or parenteral opioids to Durogesic DTrans refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/h to achieve the lowest appropriate dosage of Durogesic DTrans depending on response and supplementary analgesic requirements.

Opioid-naïve patients

Generally, the transdermal route is not recommended in opioid-naïve patients. Alternative routes of administration (oral, parenteral) should be considered. To prevent overdose it is recommended that opioid-naïve patients receive low doses of immediate-release opioids (e.g., morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to Durogesic DTrans with a release rate of 12 mcg/h or 25 mcg/h is attained. Patients can then switch to Durogesic DTrans.

In the circumstance in which commencing with oral opioids is not considered possible and Durogesic DTrans is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (i.e., 12 mcg/h) should be considered. In such circumstances, the patient must be closely monitored. The potential for serious or life-threatening hypoventilation exists even if the lowest dose of Durogesic DTrans is used in initiating therapy in opioid-naïve patients (see sections 4.4 and 4.9).

Equianalgesic potency conversion

In patients currently taking opioid analgesics, the starting dose of Durogesic DTrans should be based on the daily dose of the prior opioid. To calculate the appropriate starting dose of Durogesic DTrans, follow the steps below.

1. Calculate the 24-hour dose (mg/day) of the opioid currently being used.

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2 cartons, 4 cartons