DUROGESIC DTRANS PDF
Transdermal fentanyl matrix patches Matrifen and Durogesic DTrans are bioequivalent. Kress HG(1), Boss H, Delvin T, Lahu G, Lophaven S. The pharmacokinetic profiles of the two commercially available transdermal fentanyl patches Matrifen® ( μg/h) and Durogesic® DTrans® ( μg/h), used to. Some recent orders of Durogesic DTrans (fentanyl; Janssen-Cilag) 25µg/hour transdermal patches, batch number 8FCSC00, may have been incorrectly filled.
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Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. Patches should be inspected prior to use.
Operations If you think that you are going to receive anaesthesia tell your doctor or dentist that you are using Durogesic DTrans.
DUROGESIC DTRANS 25 MCG/HR TRANSDERMAL PATCH |
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.
Name of the medicinal product 2. Central Nervous Durogeslc conditions including increased intracranial pressure. Paediatric population Fentanyl concentrations were measured in more than children aged 2 to 17 years who were applied fentanyl patches in the dose range of Drugs in Use Optimise drug therapy for your patients.
Durogesic DTrans may have more severe adverse effects in patients with chronic obstructive or other pulmonary disease. Follow the advice above and keep the person who was wearing the patch moving and talking as much as possible. Durogesic DTrans should be used with caution in patients with brain tumours. The patches come in individually wrapped heat-sealed acrylonitrile film pouches, and usually come in cartons containing five patches, but your doctor will have prescribed the number and strength of patches which is best for you.
The treatment of cancer pain. Fentanyl citrate is used parenterally to provide preoperative anxiolysis and sedation and as a supplement to anesthesia. 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.
Monitoring of the patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of Durogesic DTrans therapy or up-titration of the dose see section 4. The extent of the interactions of CYP3A4 inhibitors with long-term transdermal fentanyl administration is not known, but may be greater than with short-term intravenous administration.
The adverse reactions are presented by System Organ Class and in order of decreasing seriousness within each frequency category. When prescribing this medicine, patients should be told: American Society of Health-System Pharmacists; Cases of serotonin syndrome have been reported when fentanyl was administered concomitantly with highly serotonergic drugs see sections 4.
Severe and unpredictable interactions with Durkgesic, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported. Biotransformation Fentanyl is a high clearance active substance and is rapidly and extensively metabolised primarily by CYP3A4 in the liver.
If serotonin syndrome is suspected, treatment with Durogesic DTrans should be discontinued. To derive the Durogesic DTrans dosage corresponding to the calculated hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows:.
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 the dose may be increased after 72 hours.
Durogesic DTrans | MIMS online
Do not drink alcohol while using Durogesic DTrans unless you have talked to your doctor first. The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended. Show table of contents Hide table of contents 1. These subjects received at least one dose of Durogesic DTrans and provided safety data. How quickly will the patches work? Hypersensitivity to the active substance or to any of the excipients listed in section dtrns.
Latest Drug Information Updates. In the next 12 hours, these analgesics should be provided based on clinical need. Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children’s medication.
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.
Durogesic DTrans 12 mcg/hr Transdermal Patch
Children Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy. Elderly patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary see section 4. Other medicines and Durogesic DTrans Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If the site of Durogesic DTrans application requires cleansing prior dtgans application of the patch, dtgans should be done surogesic clear water. It belongs to a group of strong painkillers called opioids. Each patch is packed in a heat-sealed pouch made of polyethylene terephthalate PETlow density polyethylene LDPEaluminium foil, adhesive and acrylonitrile film. Skip to main content Skip to navigation.
After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level.
Tolerance, physical dependence, and psychological dependence can develop on durogrsic use of Durogesic DTrans see section 4. Accidental exposure by patch transfer Accidental transfer of a fentanyl patch to the skin of a non-patch wearer particularly a childwhile sharing a bed or being in close physical contact with a patch wearer, may result in an opioid overdose for the non-patch wearer.
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If discontinuation of Durogesic DTrans is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly. The lowest effective dose should be used. Patients can then switch to Durogesic DTrans. The incidence of respiratory depression increases as the Durogesic DTrans dose is increased see section 4.
Central Nervous System conditions including increased 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.
An 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.
Some studies in rats have revealed reduced fertility and enhanced embryo mortality at maternally toxic doses see section 5.