Drugs. ;68(12) Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain. Indications, side effects, contraindications and other prescribing information for Durogesic DTrans on MIMS. Following an abbreviated submission. transdermal fentanyl (Durogesic D Trans patches) 12 mcg/hour is accepted for restricted use within NHS.

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The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.

In young children, the upper back is the preferred location to minimise the potential of the child removing the patch. Therefore, after a duratesic increase, patients should wear the higher dose patch through two hour applications before any further increase in dose level is made.

Fentanyl concentrations may increase if the skin temperature increases see section 5. However, the duration of inhibition varies and for some CYP3A4 inhibitors with a long elimination half-life, such as amiodarone, or for time-dependent inhibitors such as erythromycin, idelalisib, nicardipine and ritonavir, this period may need to be longer. Pharmacists can return Irish stock for replacement via their normal supply route. Central Nervous System conditions including d-trns intracranial pressure Durogesic DTrans should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO 2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.

The leaflet has recently been redesigned to clarify the posology for these patches and uses good navigation tools. Patients and their carers must be instructed that Durogesic DTrans contains an active substance in an amount that can be fatal, especially xuragesic a child.

Then wash hands with clean water. The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended see also section 4. Adults Durogesic DTrans d-rans indicated for management of severe chronic pain that requires continuous long term opioid administration.

A carcinogenicity study daily subcutaneous injections -dtrans fentanyl hydrochloride for two years in Sprague Dawley rats did not induce any findings indicative of oncogenic potential.


To guard against accidental ingestion by children, use caution when choosing the application site for Durogesic DTrans see sections 4. Acute or postoperative pain because there is no opportunity for dose titration during short-term use and because serious or life-threatening hypoventilation could result.

Children Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy. This may result in increased serum concentrations see section 5. Company contact details Janssen-Cilag Ltd.

In a study conducted with Durogesic DTrans, healthy elderly subjects had fentanyl pharmacokinetics which did not differ significantly from healthy young subjects although peak serum concentrations tended to be lower and mean half-life values were prolonged to approximately 34 hours.

In addition, the drug may be used to prevent or relieve tachypnea and postoperative emergence delirium. Biotransformation Fentanyl is a high clearance active substance and is rapidly and extensively metabolised primarily by CYP3A4 in the liver.

transdermal fentanyl (Durogesic D Trans 12mcg/hr)

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act A mutagenic risk for the use of therapeutic doses seems unlikely since effects appeared only at high concentrations. Back to top Janssen-Cilag Ltd contact details.

Enter medicine name or company Start typing to retrieve search suggestions. Published 11 December Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. Testing makes sure that the presentation of the information enables patients to find and understand key messages for supporting safer use of the medicine within the PIL and thereby enables them to use the medicine safely and effectively.

For commenting, please login or register as a user and agree to our Community Guidelines. Even though impairment of renal function is not expected to affect fentanyl elimination to a clinically relevant extent, caution is advised because fentanyl pharmacokinetics has not been evaluated in this patient population see section 5.


In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: Explore the topic Alerts and recalls. Examples of active substances that may increase fentanyl concentrations include: Renal and urinary disorders.

Search the site Search. To calculate the appropriate starting dose of Durogesic DTrans, follow the steps below. If the analgesic effect of Durogesic DTrans is insufficient, supplementary morphine or another short-duration opioid should be administered.

Symptoms and signs The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.

Based on pooled safety data from these 3 clinical studies in paediatric subjects, the most commonly reported i. Some patients may experience significant respiratory depression with Durogesic DTrans; patients must be observed for these effects.

In testing the leaflet was well received by patients. Hair at the d-tans site a non-hairy area is preferable should be clipped not shaved prior to application. A lag time of 12 to 24 hours after application of the first patch and after a dose increase must be taken into account. Ear and labyrinth disorders. Maybe Duragesci this page is useful No this page is not useful Is there anything wrong with this page? If serotonin syndrome is suspected, treatment with Durogesic DTrans should be discontinued.

Following Durogesic DTrans application, the skin under the system absorbs fentanyl, e-trans a depot of fentanyl concentrates in the upper skin layers.

DRUG ALERT: Durogesic DTrans 25µg/hour transdermal fentanyl patches | News | Pharmaceutical Journal

Therefore, patients with fever should be monitored for opioid undesirable effects and the Durogesic DTrans dose should be adjusted if necessary. Agitation, Disorientation, Euphoric mood.

Recommended Durogesic DTrans dosage for paediatric patients 1 based upon daily oral morphine dose 2. An optimal therapeutic concentration range d-tarns fentanyl can therefore not be established.