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Some patients may require additional or alternative methods of opioid administration when the Durogesic DTrans dose exceeds 300 mcg/h.If analgesia is insufficient during the first application only, the Durogesic DTrans patch may be replaced after 48 hours with a patch of the same dose, or the dose may be increased after 72 hours.Oral doses are those recommended when changing from a parenteral to an oral route. Table 3: Recommended starting dosage of Durogesic DTrans based upon daily oral morphine dosage (for patients on stable and well tolerated opioid therapy: conversion ratio of oral morphine to transdermal fentanyl is approximately equal to 100:1) Initial evaluation of the maximum analgesic effect of Durogesic DTrans cannot be made before the patch is worn for 24 hours.This delay is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial patch application.If discontinuation of Durogesic DTrans is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly.This is because fentanyl concentrations fall gradually after Durogesic DTrans is removed.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).
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.It may take 20 hours or more for the fentanyl serum concentrations to decrease 50%.In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms (see section 4.8).Generally, the transdermal route is not recommended in opioid-naïve patients.Alternative routes of administration (oral, parenteral) should be considered.
Durogesic DTrans doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. 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.