Posology: DUROGESIC 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, and 50 mcg/h fentanyl to the systemic circulation, which represent about 0.3, 0.6, and 1.2 mg per day respectively.
Initial dosage selection: The appropriate initiating dose of DUROGESIC should be based on the patient's current opioid use. It is recommended that DUROGESIC 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.
Adults:
Opioid-tolerant patients: To convert opioid-tolerant patients from oral or parenteral opioids to DUROGESIC refer to Equianalgesic potency conversion as follows. 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 depending on response and supplementary analgesic requirements.
Opioid-naïve patients: 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 (eg, morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to DUROGESIC with a release rate of 12 mcg/h or 25 mcg/h is attained. Patients can then switch to DUROGESIC.
In the circumstance in which commencing with oral opioids is not considered possible and DUROGESIC is considered to be the only appropriate treatment option for opioid-naïve patients, only the lowest starting dose (ie, 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 is used in initiating therapy in opioid-naïve patients (see Precautions and Overdosage).
Equianalgesic potency conversion: In patients currently taking opioid analgesics, the starting dose of DUROGESIC should be based on the daily dose of the prior opioid. To calculate the appropriate starting dose of DUROGESIC, follow the following steps.
1. Calculate the 24-hour dose (mg/day) of the opioid currently being used.
2. Convert this amount to the equianalgesic 24-hour oral morphine dose using the multiplication factors in Table 1 for the appropriate route of administration.
3. To derive the DUROGESIC dosage corresponding to the calculated 24-hour, equianalgesic morphine dosage, use dosage-conversion Table 2 or 3 as follows: a. Table 2 is for adult patients who have a need for opioid rotation or who are less clinically stable (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).
b. Table 3 is for adult patients who are on a stable, and well-tolerated, opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 100:1).
See Tables 1, 2 and 3.
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Initial evaluation of the maximum analgesic effect of DUROGESIC cannot be made before the patch is worn for 24 hours. This delay is due to the gradual increase in serum fentanyl concentration in the 24 hours following initial patch application.
Previous analgesic therapy should therefore be gradually phased out after the initial dose application until analgesic efficacy with DUROGESIC is attained.
Dose titration and maintenance therapy: The DUROGESIC patch should be replaced every 72 hours.
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. Dosage titration should normally be performed in 12 mcg/h or 25 mcg/h increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ≈ DUROGESIC 12/25 mcg/h) and pain status of the patient should be taken into account. After an increase in dose, it may take up to 6 days for the patient to reach equilibrium on the new dose level. Therefore after a dose increase, patients should wear the higher dose patch through two 72-hour applications before any further increase in dose level is made.
More than one DUROGESIC patch may be used for doses greater than 100 mcg/h. Patients may require periodic supplemental doses of a short acting analgesic for "breakthrough" pain. Some patients may require additional or alternative methods of opioid administration when the DUROGESIC dose exceeds 300 mcg/h.
If analgesia is insufficient during the first application only, the DUROGESIC patch may be replaced after 48 hours with a patch of the same dose, or the dose may be increased after 72 hours.
If the patch needs to be replaced (eg, the patch falls off ) before 72 hours, a patch of the same strength should be applied to a different skin site. This may result in increased serum concentrations (see Pharmacology: Pharmacokinetics under Actions) and the patient should be monitored closely.
Discontinuation of DUROGESIC: If discontinuation of DUROGESIC is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because fentanyl concentrations fall gradually after DUROGESIC is removed. It may take 20 hours or more for the fentanyl serum concentrations to decrease 50%. In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms (see Adverse Reactions).
Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Tables 1, 2, and 3 should only be used to convert from other opioids to DUROGESIC and not from DUROGESIC to other therapies to avoid overestimating the new analgesic dose and potentially causing overdose.
Special populations: Elderly patients: Elderly patients should be observed carefully and the dose should be individualised based upon the status of the patient (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In opioid-naïve elderly patients, treatment should only be considered if the benefits outweigh the risks. In these cases, only DUROGESIC 12 mcg/h dosage should be considered for initial treatment.
Renal and hepatic impairment: Patients with renal or hepatic impairment should be observed carefully and the dose should be individualised based upon the status of the patient (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In opioid-naïve patients with renal or hepatic impairment, treatment should only be considered if the benefits outweigh the risks. In these cases, only DUROGESIC 12 mcg/h dosage should be considered for initial treatment.
Method of administration: DUROGESIC is for transdermal use.
DUROGESIC should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
Hair at the application site (a non-hairy area is preferable) should be clipped (not shaved) prior to application. If the site of DUROGESIC application requires cleansing prior to application of the patch, this should be done with clear water. Soaps, oils, lotions, or any other agent that might irritate the skin or alter its characteristics should not be used. The skin should be completely dry before the patch is applied. Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used.
DUROGESIC should be applied immediately upon removal from the sealed package. To remove the patch from the protective sachet, locate the pre-cut notch (indicated by an arrow on the patch label) along the edge of the seal. Fold the sachet at the notch, then carefully tear the sachet material. Further open the sachet along both sides, folding the sachet open like a book. The release liner for the patch is slit. Fold the patch in the middle and remove each half of the liner separately. Avoid touching the adhesive side of the patch. Apply the patch to the skin by applying light pressure with the palm of the hand for about 30 seconds. Make certain that the edges of the patch are adhering properly. Then wash hands with clean water.
DUROGESIC may be worn continuously for 72 hours. A new patch should be applied to a different skin site after removal of the previous transdermal patch. Several days should elapse before a new patch is applied to the same area of the skin.