DUROGESIC DTRANS

Posology DUROGESIC 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. 4 mg per day respectively. Initial dosage selection The appropriate initiating dose of DUROGESIC should be based on the patient’s current opioid use.

It is recommended that DUROGESIC 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.

Adults Opioid-tolerant patients To convert opioid-tolerant patients from oral or parenteral opioids to DUROGESIC 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 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. g. morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to DUROGESIC with a release rate of 12 mcg/h or 25 mcg/h is attained.

Patients can then switch to DUROGESIC. e. 12 mcg/h) should be considered. In such circumstances, the patient must be closely monitored. 9). Equianalgesic potency conversion In patients currently taking opioid analgesics, the starting dose of DUROGESIC should be based on the daily dose of the prior opioid.

To calculate the appropriate starting dose of DUROGESIC, 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 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).

The safety of Durogesic DTrans was evaluated in 1 565 adult and 289 paediatric subjects who participated in 11 clinical studies (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 open-label, uncontrolled) used for the management of chronic malignant or non-malignant pain.

These subjects received at least one dose of Durogesic DTrans and provided safety data. e. 8%). The adverse reactions reported with the use of Durogesic DTrans from these clinical studies including the above-mentioned adverse reactions, and from post-marketing experiences are listed below in Table

Patients who have experienced serious adverse events should be monitored for at least 24 hours after removal of Durogesic DTrans, or more, as clinical symptoms dictate, because serum fentanyl concentrations decline gradually and are reduced by about 50% 20 to 27 hours later.

Patients and their carers must be instructed that Durogesic DTrans contains an active substance in an amount that can be fatal, especially to a child. Therefore, they must keep all patches out of the sight and reach of children, both before and after use.

Because of the risks, including fatal outcome, associated with accidental ingestion, misuse, and abuse, patients and their carers must be advised to keep Durogesic DTrans in a safe and secure place, not accessible by others. Opioid-naïve and not opioid-tolerant states Use of Durogesic DTrans in the opioid-naïve patient has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy, especially in patients with non-cancer pain.

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, especially in elderly or patients with hepatic or renal impairment.

The tendency of tolerance development varies widely among individuals. 2). Respiratory depression Some patients may experience significant respiratory depression with Durogesic DTrans; patients must be observed for these effects. Respiratory depression may persist beyond the removal of the Durogesic DTrans patch.

9). Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxia. Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA consider decreasing the total opioid dosage.

Risk from concomitant use of central nervous system (CNS) depressants, including sedative medicines such as benzodiazepines or related drugs, alcohol and CNS depressant narcotic drugs Concomitant use of Durogesic DTrans and sedative medicines such as benzodiazepines or related drugs, alcohol, or CNS depressant narcotic drugs, may result in sedation, respiratory depression, coma and death.

1. Acute or post-operative pain because there is no opportunity for dose titration during short-term use, and because serious or life-threatening hypoventilation or persistent post-operative opioid use could result. Severe respiratory depression.