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This page was last updated: April 6, 2006
NOTIFICATION OF NEW PRODUCT
Durogesic® DTrans® 12 (fentanyl transdermal system with matrix technology) – introduction of new patch strength to aid titration.
Dear Colleague,
Janssen-Cilag Ltd is committed to ensuring that you are updated at the earliest opportunity on any development relating to our product Durogesic DTrans.
Durogesic DTrans 12 is indicated in the management of chronic intractable pain due to cancer and for the management of chronic intractable pain1.
Feedback from healthcare professionals has led us to develop this new patch strength which is only indicated for finer dose titration between 25mcg/hr and 75mcg/hr when prescribing Durogesic DTrans. Indeed, SIGN2 and the NPC3 advise clinicians to only increase dosages in increments which have until now been impossible with Durogesic DTrans at dosages below 50mcg/hr.
The new Durogesic DTrans 12 patch delivers approximately 12.5mcg/hr of fentanyl using the same matrix technology as the other strength patches in the Durogesic DTrans range. Since Durogesic DTrans matrix technology has superseded the old Durogesic reservoir system in the UK, the new 12 patch will only be produced as a matrix patch.
To reduce the potential for medication error, this new patch is called Durogesic DTrans 12 (not 12.5). This has been agreed with the licensing authorities to avoid possible misinterpretation of handwritten prescriptions as 125 mcg/hr instead of 12.5mcg/hr. In addition, the Durogesic DTrans 12 patch is clearly marked on its upper surface in orange ink to distinguish it from the other patch strengths of Durogesic DTrans.
The price of Durogesic DTrans 12 is £19.26 for one pack of 5 patches.
Should you require additional information please contact me using the details below. Alternatively if you have specific clinical questions please contact the Durogesic DTrans Linkline on 0800 716973.
Yours faithfully,
Mike Hinchy
Product Manager
Janssen-Cilag Ltd
References: 1. Durogesic DTrans SmPC. 2. Scottish Intercollegiate Guidelines Network. Control of pain in patients with cancer 2000. 3. National Pharmaceutical Council Inc. Pain: Current Understanding of Assessment, Management, and Treatments, 2001.
PRESCRIBING INFORMATION: Durogesic® DTrans® Transdermal Patch. Please read Summary of Product Characteristics (SmPC) before prescribing. Presentation: Patch containing fentanyl. Five strengths available. Uses: Management of chronic intractable pain. Dosage: Adults. Initial: strong opioid naive; one Durogesic DTrans 25. Opioid tolerant convert from previous opioid use (see SmPC). Titration and maintenance: change 72 hourly; titrate to analgesic efficacy with 12 patch available only for finer titration between 25 – 75 mcg/h doses. Apply to different sites. Elderly: higher serum levels. Check for toxicity in elderly, cachectic or debilitated; reduce dose if necessary. Children: Not recommended. Contraindications: Acute pain. Fentanyl or adhesive hypersensitivity. Warnings and Precautions: If serious adverse events occur, monitor up to 24 hours after removal. Keep out of reach and sight of children. Do not divide, cut or damage. See SmPC for disposal instructions. Agree outcomes with patients requiring prolonged use; stop if not met. Respiratory depression may occur. Care with chronic obstructive or other pulmonary disease, raised intracranial pressure, brain tumours and bradyarrhythmias. Tolerance and dependence may occur. Observe if hepatic or renal disease for toxicity; reduce dose if necessary. If fever develops, monitor for opioid side effects. Avoid heating application site. May affect ability to drive or use machinery. Pregnancy and lactation: Safety not established in pregnancy. Do not give during lactation. Interactions: Special care required with CNS depressants including alcohol. Only concomitant ritonavir if close monitoring. Side Effects: Hypoventilation, nausea, vomiting, constipation, hypotension, bradycardia, somnolence, headache, confusion, hallucinations, euphoria, pruritus, sweating and urinary retention. Occasionally local skin reactions; usually resolve within 24 hours of patch removal. Overdosage: Most serious: respiratory depression. Remove patch; stimulate patient physically and verbally. Administer opioid antagonist such as naloxone; repeat dose or continuously infuse if required. Maintain clear airway and assist respiration if necessary. Manage severe or persistent hypotension using parenteral fluids. Pharmaceutical Precautions: No special storage precautions. Legal Category: CD (Sch 2) POM. Pack Sizes, Product Licence Numbers and Cost: All strengths supplied in packs of 5 (15 days supply). Durogesic DTrans 12 (delivers approximately 12 mcg/h of fentanyl), PL 00242/0409-0001, £19.26. Durogesic DTrans 25 (delivers approximately 25 mcg/h of fentanyl), PL/0242/0192, £27.52. Durogesic DTrans 50 (delivers approximately 50 mcg/h), PL/0242/0193, £51.40. Durogesic DTrans 75 (delivers approximately 75 mcg/h), PL/0242/0194, £71.66. Durogesic DTrans 100 (delivers approximately 100 mcg/h), PL/0242/0195, £88.32. Further information available from the Product Licence holder: Janssen-Cilag Ltd, Saunderton, High Wycombe, Bucks HP14 4HJ, UK. Date of Preparation: APIVER 081105.
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