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Durogesic DTrans is indicated for the management of severe chronic pain that requires continuous long-term opioid administration.

Children

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

Posology

Durogesic DTrans doses should be individualized 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 the degree of opioid tolerance.

Adults

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.

2. Convert this amount to the equianalgesic 24-hour oral morphine dose using the multiplication factors in Table 1 for the appropriate route of administration.

3. To derive the Durogesic DTrans dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows:

a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).

b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).

Table 1: Conversion Table – Multiplication Factors for Converting the Daily Dose of Prior Opioids to the Equianalgesic 24-hour Oral Morphine Dose

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