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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All patients should be advised to avoid exposing the Durogesic DTrans application site to direct external heat sources such as heating pads, electric blankets, heated water beds, heat or tanning lamps, sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths. Oral doses are those recommended when changing from a parenteral to an oral route.

If the patch needs to be replaced e. To calculate the appropriate starting dose of Durogesic DTrans, follow the steps below. Adverse reactions in adult and paediatric patients. Fentanyl induced mutagenic effects duuragesic mammalian cells in vitrocomparable to other opioid analgesics. Durogesic DTrans should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.

Durogesic DTrans 12 mcg/hr Transdermal Patch

Durogesic DTrans may be worn continuously for 72 hours. Effects on r-trans embryo were due to maternal toxicity and not to direct effects of the substance on the developing embryo. Absorption Durogesic DTrans provides continuous systemic delivery of fentanyl during the hour application period. Maybe Yes this page is useful No this page is not useful Is there anything wrong with this page?

The major metabolite, norfentanyl, and other metabolites are inactive. Each Durogesic DTrans 12 d-rrans contains fentanyl 2. This effect could either be due to altered maternal care or a direct effect of fentanyl on the pups.

Erectile dysfunction, Sexual dysfunction. The dose should be titrated individually on the basis of average daily use of supplemental analgesics, until a balance between analgesic efficacy and tolerability is attained. 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 duragssic dose may be increased after 72 hours.

However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised see sections 4. The Medicines and Healthcare Products Regulatory Agency recommends that the UK patient information leaflet be downloaded from the electronic medicines compendium website and enclosed with dispensed packs.


Serotonin syndrome may include mental-status changes e. Patients should be advised that if accidental patch transfer occurs, the transferred patch must be removed immediately from the skin of the non-patch wearer see section 4.


Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination. Symptoms and signs The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.

Some patients may experience significant respiratory depression with Durogesic DTrans; patients must be observed for these effects.

Durogesic DTrans | MIMS online

If patients with hepatic impairment receive Durogesic DTrans, they should be observed carefully for signs of fentanyl toxicity and the dose of Durogesic DTrans reduced if necessary see section 5. Pregnancy There are no adequate data from the use of Durogesic DTrans in pregnant women. Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias. Patients and their carers must be durageskc that Durogesic DTrans contains an active substance in an amount that can be fatal, especially to a child.

Initial evaluation of the maximum analgesic effect of Durogesic DTrans cannot be made before the patch is worn for 24 hours. If elderly patients duragesjc Durogesic DTrans, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary see section 5. Fold the patch in the middle and remove each half of the liner separately.

Musculoskeletal and connective tissue disorders. Adjustment of the individual fentanyl dose must be based on the patient’s response and level of tolerance.

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

Search the site Search. Both the minimum effective concentration and the toxic concentration increase with tolerance. The release liner for the patch is slit. Duragesid Principles dudagesic Pharmacy This established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by suragesic routes to sites of action in the body.

Then wash hands with clean water. The appropriate initiating dose of Durogesic DTrans should be based on the patient’s current opioid use. Children Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.


Patients can then switch to Durogesic DTrans. The safety of Durogesic DTrans was evaluated in 1, adult and 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.

F-trans increase in skin temperature through the application of a heating pad on low setting over the Durogesic DTrans system during the first 10 hours of a single application increased the mean fentanyl AUC value by 2. The potential for serious or life-threatening hypoventilation exists regardless of the dose of Durogesic Duragesci transdermal system administered. Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic drugs see sections 4.

The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended. The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained. The concomitant use of Durogesic DTrans with cytochrome P 3A4 CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression.

Fertility There are no clinical data on the effects of fentanyl on fertility. In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms see section 4.

Durogesic DTrans

Show table of contents Hide table of contents 1. Breastfeeding should therefore be discontinued during treatment with Durogesic DTrans and for at least 72 hours after removal of the patch. The pharmacokinetics of d-tgans fentanyl do not change with repeated application. This established textbook covers every aspect of drug properties from the design of dosage forms to their delivery by all routes to sites of action in the body.

Best practice example of a patient information leaflet. Reproductive system and breast disorders.