VICTANYL

4). During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4). Posology Victanyl 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 Victanyl should be based on the patient’s current opioid use. It is recommended that Victanyl 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 Victanyl 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 Victanyl depending on the 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 transdermal fentanyl with a release rate of 12 mcg/h or 25 mcg/h is attained.

Patients can then switch to Victanyl. Patches with a release rate of 12 mcg/h are available and should be used for initial dosing. 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 Victanyl should be based on the daily dose of the prior opioid.

To calculate the appropriate starting dose of Victanyl, 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.

The safety of transdermal fentanyl 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 transdermal fentanyl and provided safety data. e. 8%). The adverse reactions reported with the use of transdermal fentanyl 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 VICTANYL, 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 Victanyl 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 Victanyl patches in a safe and secure place, not accessible by others. Opioid-naïve and not opioid-tolerant states Use of transdermal fentanyl 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 transdermal fentanyl 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 Victanyl; patients must be observed for these effects. Respiratory depression may persist beyond the removal of the Victanyl 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 Victanyl 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 pain because there is no opportunity for dose titration during short-term use, or postoperative pain because persistent post-operative opioid use or serious or life-threatening hypoventilation could result. Severe respiratory depression.

Contraindicated in opioid naïve patients.