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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Patient duraegsic leaflets PILs are improving in quality as a result of new legal obligations on manufacturers to test the documents with potential patients. 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.

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

D-trahs evaluation of d-trnas maximum analgesic effect of Durogesic DTrans cannot be made before the patch is worn for 24 hours. The latest example in the series is the leaflet for Durogesic D Trans Transdermal Patch, which contains fentanyl—a potent opioid analgesic used in the management of chronic intractable pain.

DRUG ALERT: Durogesic DTrans 25µg/hour transdermal fentanyl patches

However, as the influence of renal impairment on the pharmacokinetics of fentanyl has not been evaluated, caution is advised see sections 4. To remove the patch from the protective sachet, locate the pre-cut notch indicated by an arrow on the durragesic label along the edge of the seal. Fentanyl crosses the blood-brain barrier easily. No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with Durogesic DTrans use in children as young as 2 years old when used as directed.

D-tans population The safety of Durogesic D-trabs was evaluated in 3 open-label studies in paediatric subjects with chronic pain, aged 2 to 17 years, inclusive.

Hyperhidrosis, Pruritus, Rash, Erythema. If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube, and oxygen should be administered and respiration assisted or controlled, as appropriate. Patients and their carers must be instructed that Durogesic DTrans contains an active substance in an amount that can d-trwns fatal, especially to a child. Moreover, because fentanyl passes through the placenta, the use of Durogesic DTrans during childbirth might result in respiratory depression in the newborn infant.


Optimise drug therapy for your patients. Therefore, patients with fever should be monitored for opioid undesirable effects and the Durogesic DTrans dose should be adjusted if necessary. The duratesic fentanyl concentrations attained are proportional to the Durogesic DTrans patch size.

transdermal fentanyl (Durogesic D Trans 12mcg/hr)

This information is intended for use by health professionals. Adapted from 1 Foley KM. Patients with myasthenia gravis Non-epileptic myo clonic reactions can occur. Last updated on eMC: There are no adequate data from the use dd-trans Durogesic DTrans in pregnant women.

The concomitant use of transdermal fentanyl with CYP3A4 inducers may result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect. Fentanyl then becomes available to the systemic circulation.

Patches should be inspected prior to use. The effects of the inducer decline gradually and may result in increased fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotisation after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary.

Respiratory depression may persist beyond the removal of the Durogesic DTrans patch. Tolerance, physical dependence, and psychological dependence can develop on repeated use of Durogesic DTrans see section 4. For management of respiratory depression, immediate countermeasures include removing the Durogesic DTrans patch and physically or verbally stimulating the patient.

Durogesic DTrans 12 mcg/hr Transdermal Patch – Summary of Product Characteristics (SmPC) – (eMC)

In a study on pre- and postnatal development the survival rate of offspring was significantly reduced at doses which slightly reduced maternal weight.

Convert this amount to the equianalgesic hour oral morphine dose using the multiplication factors in Table 1 for the appropriate route of administration. Introduction to opioid conversion calculations.


Explore the topic Alerts and recalls. Effects on somatic development and behaviour of the offspring were not observed. Absorption Durogesic DTrans provides continuous systemic delivery of fentanyl during the hour application period. Some studies with female rats revealed reduced fertility and enhanced embryo mortality. Fentanyl concentrations were measured in more than children aged 2 to 17 years who were applied fentanyl patches in the dose range of Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist.

Durogesic DTrans has not been studied in children under 2 years of age. Based on pooled safety data from these clinical studies, the most commonly reported i. Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination.

This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act The potential for serious or life-threatening hypoventilation exists regardless of the dose of Durogesic DTrans transdermal system administered.

Make certain that the edges of the patch are adhering properly.

It will take only 2 minutes to fill in. Skin does not appear to metabolise fentanyl delivered transdermally. Caution is advised when Durogesic DTrans is co-administered with medicinal products that affect the serotonergic neurotransmitter systems.

Mutagenicity testing in bacteria and in rodents yielded negative results. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of Durogesic DTrans during pregnancy.

Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines. Fentanyl citrate is used parenterally to provide preoperative anxiolysis and sedation and as a supplement to d-tans. Skip to main content Skip to navigation. Examples of active substance that may decrease fentanyl plasma concentrations include: Recommended Durogesic DTrans dosage for paediatric patients 1 based upon daily oral morphine dose 2.