Fentanyl patch 100 mcg/h
1. Name of the medicinal product
fentanyl patch 100 mcg/h Transdermal Patch
2. Qualitative and quantitative composition
Each Durogesic DTrans 100 patch contains fentanyl 16.8 mg.
Release rate approximately 100 µg/h; active surface area 42.0 cm2.
For excipients, see 6.1
3. Pharmaceutical form
fentanyl patch 100 mcg/h is a translucent, rectangular transdermal patch with rounded corners, marked with the product name, strength and a border in coloured ink.
Each patch is marked:
fentanyl patch 100 mcg/h
100 µg fentanyl/h
Grey printing ink
4. Clinical particulars
4.1 Therapeutic indications
fentanyl patch 100 mcg/h is indicated for management of severe chronic pain that requires continuous long term opioid administration.
Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
4.2 Posology and method of administration
fentanyl patch doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day respectively.
Initial dosage selection
The appropriate initiating dose of Durogesic DTrans should be based on the patient’s current opioid use. It is recommended that Durogesic DTrans be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.
To convert opioid-tolerant patients from oral or parenteral opioids to Durogesic DTrans refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/h to achieve the lowest appropriate dosage of Durogesic DTrans depending on response and supplementary analgesic requirements.
Generally, the transdermal route is not recommended in opioid-naïve patients. Alternative routes of administration (oral, parenteral) should be considered. To prevent overdose it is recommended that opioid-naïve patients receive low doses of immediate-release opioids (e.g., morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to Durogesic DTrans with a release rate of 12 mcg/h or 25 mcg/h is attained. Patients can then switch to Durogesic DTrans.
In the circumstance in which commencing with oral opioids is not considered possible and Durogesic DTrans is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (i.e., 12 mcg/h) should be considered. In such circumstances, the patient must be closely monitored. The potential for serious or life-threatening hypoventilation exists even if the lowest dose of Durogesic DTrans is used in initiating therapy in opioid-naïve patients (see sections 4.4 and 4.9).