NAME OF THE MEDICINAL PRODUCT
International Non Proprietary
How to Use DUROGESIC ?
Starting with DUROGESIC
Find an intact and hairless pot
of skin on the upper part of your trunk or on your 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 you need to wash the skin beforehand, use some
clean water (no soap!), and then make sure the skin is perfectly dry again.
1. To remove the patch from the
protective pouch, located the pre-cut notch located along the edge of the
seal (this notch is indicated by an arrow on the pouch label). Fold the
pouch at the notch, then carefully tear the pouch material. It is preferred
not to use scissors to open the pouch, as they may damage the patch. Further
open the pouch along both sides, folding the pouch open like a book.
2. To apply the patch, remove the
patch from the pouch with the S-slit backing facing up (the printed text
will be on the reverse side).
3. Peel off both parts of the
protective liner from the patch. Each DUROGESIC patch has a clear plastic
backing that can be peeled off in two pieces. This covers the sticky side of
the patch. Carefully peel this backing off. Throw the clear plastic backing
4. Try no to touch the sticky
side of the patch and put it on the skin firmly.
5. Once the patch is applied to
the skin, press it firmly in place with the palm of your hand and hold for a
minimum of 30 seconds to make it adhere well.
6. Make sure the entire patch
adheres properly to the skin. The removed liner can be discarded in the
household waste. After applying the patch, thoroughly rinse hands with
You can now leave the patch on
for 3 days (72 hours).
You may have a bath, a shower or
a swim. Always write down the date you applied a patch. There is room for
that on the box. It will help you to use DUROGESIC correctly and to remember
when the 3 days are over.
Changing a Patch of DUROGESIC
– After 3 days, remove the patch
by peeling it off.
– 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 in the same place as the previous one. Pick a new spot of intact
– Follow the application
instructions under "Starting with DUROGESIC".
QUALITATIVE AND QUANTITATIVE
The lowest dose is designated as
12 mcg/h (however, the actual dose is 12.5 mcg/h) to distinguish it from a
125 mcg/h dose that could be prescribed by using multiple patches.
For excipients, see List of
Transdermal patch providing
continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72
DUROGESIC is indicated in the
management of chronic pain and intractable pain that requires continuous
opioid administration for an extended period of time.
Posology and Method of
DUROGESIC doses should be
individualized based upon the status of the patient and should be assessed
at regular intervals after application. 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
(see QUALITATIVE AND QUANTITATIVE COMPOSITION), 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.
To convert opioid-tolerant
patients from oral or parenteral opioids to DUROGESIC 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 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 immediate release opioids (eg, morphine, hydromorphone, oxycodone,
tramadol, and codeine) to attain equianalgesic dosage relative to DUROGESIC
with a release rate of 25 mcg/h. Patients can then be converted to DUROGESIC
25 mcg/h. The dosage may subsequently by titrated upwards or downwards, if
required, in increments of either 12 or 25 mcg/h to achieve the lowest
appropriate dose of DUROGESIC depending on response and supplementary
analgesic requirements (see Equianalgesic Potency Converstion below).
(See also Special Warnings and Special Precautions for Use: Opioid-naive and
Not Opioid-tolerant States.)
DUROGESIC should be administered
only opioid-tolerant pediatric patients (ages 2 to 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 (Table 1) and
Recommended DUROGESIC Dosage Based Upon Daily Oral Morphine Dose (Table