Durogesic doses should be individualized based upon the status of the patient and should be assessed at regular intervals after application.
Initial Dose Selection: The size of the initial Durogesic dose should be based on the patient's 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 (see Table 1) and recommended Durogesic daily dose based upon daily oral morphine dose (see Table 2). The dosage may be subsequently be titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/hr to achieve the lowest appropriate dose of Durogesic depending on response and supplementary analgesic requirements.
Clinical experience with Durogesic is limited in opioid-naive patients. In the circumstance in which therapy with Durogesic is considered appropriate in opioid-naive patients, it is recommended that these patients be titrated with low doses of opioids to attain equianalgesic dose to Durogesic 25 mcg/hr. Patients can then be converted to Durogesic 25 mcg/hr. The dosage may subsequently by titrated upwards or downwards, if required, in increments of either 12 or 25 mcg/hr to achieve the lowest appropriate dose of Durogesic depending on response and supplementary analgesic requirements. (See Tables 1 and 2.) (See Precautions: Opioid-naive and Not Opioid-tolerant States.)
Durogesic should be administered only to opioid-tolerant pediatric patients (2-16 years) who are already receiving at least 30 mg oral morphine equivalents per day. To convert pediatric patients from oral or parenteral opioids to Durogesic refer to Equianalgesic potency conversion (see Table 1) and Recommended Durogesic dose based upon daily oral morphine dose (see Table 2).
Clinical experience with Durogesic is limited in opioid-naive patients. In the circumstance in which therapy with Durogesic is considered appropriate in opioid-naive patients, it is recommended that these patients be titrated with low doses of opioids to attain equianalgesic dose to Durogesic dose, 25 mcg/hr.
Equianalgesic Potency Conversion: 1. Calculate the previous 24-hr analgesic requirement.
2. Convert this amount to the equianalgesic oral morphine dose using Table 1. All IM and oral doses in this chart are considered equivalent to 10 mg of IM morphine in analgesic effect.
Click on icon to see table/diagram/image
3. Table 2 displays the range of 24-hr oral morphine doses that are recommended for conversion to each Durogesic dose. Use this table to derive from the calculated 24-hr morphine dose the corresponding Durogesic dose.
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 hrs. This delay is due to the gradual increase in serum fentanyl concentration in the 24 hrs 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: A 12 mcg/hr strength is available for dose titration. The Durogesic patch should be replaced every 72 hrs. The dose should be titrated individually until analgesic efficacy is attained. If analgesia is insufficient after the initial application the dose may be increased after 3 days. Thereafter, dose adjustment can take place every 3 days. Dosage titration should normally be performed in 12 mcg/hr or 25 mcg/hr increments, although the supplementary analgesic requirements (oral morphine 45/90 mg/day ~ Durogesic 12/25 mcg/hr) and pain status of the patient should be taken into account. More than one Durogesic patch may be used for doses greater than 100 mcg/hr. 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/hr.
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 levels fall gradually after Durogesic is removed, it takes ≥17 hrs for the fentanyl serum concentration to decrease 50%. In general, the discontinuation of opioid analgesia should be gradual in order to prevent withdrawal symptoms.
Opioid withdrawal symptoms (see Adverse Reactions) are possible in some patients after conversion or dose adjustment.
Starting with Durogesic: Find an intact and hairless spot of skin on the upper part of the trunk or on the upper arm. There should be no tiny wounds nor may the skin be red, burnt or irradiated. Cut off any remaining hairs with a pair of scissors (do not shave them off since this will affect the skin). If the site of Durogesic application requires to be cleansed prior to application of the system, this should be done with clean water (no soap). The skin should be completely dry before the system is applied.
Open the package just before the application of Durogesic. Cut the pouch at the arrow from the side to the notch. Gently tear open the pouch along the side. Further open the pouch along both sides, folding the pouch open like a book.
Remove the patch.
Loosen the larger plastic cover by one of the corners and remove it entirely. Avoid touching the adhesive side of the patch.
Apply the patch to the skin and press it tightly with the palm of the hand for about 30 sec. Make sure the entire patch is in contact with the skin and especially that the corners are stuck tight.
Then wash the hands with clean water (no soap).
Durogesic may be worn continuously for 3 days (72 hrs). A new system should be applied to a different skin after removal of the previous transdermal system. Several days should elapse before a new patch is applied to the same area of the skin. The patient may have a bath, a shower or a swim.
Always note down on the packet the date when the patch is applied.
There is a space provided on the box. It will help on the correct use of Durogesic and to remember when the 3 days are over.
Changing a Patch of Durogesic: After 3 days, remove the patch by tearing it loose.
Immediately fold a used patch in half with the adhesive side facing inward and throw it away.
Apply a new patch right away, but never at the same place as the previous one. Pick another spot of intact skin.
Follow the instructions under Starting with Durogesic.