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Durogesic

NAME OF THE MEDICINAL PRODUCT

Trade Name

DUROGESIC

International Non Proprietary Name

Fentanyl

Chemical Name

N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)

propanamide

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 away.

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 water.

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 skin.

– Follow the application instructions under "Starting with DUROGESIC".

QUALITATIVE AND QUANTITATIVE COMPOSITION

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 excipients.

PHARMACEUTICAL FORM

Transdermal patch providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours.

CLINICAL PARTICULARS

Therapeutic Indications

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 administration

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.

Adults

Opioid-tolerant Patients

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.

Opioid-naive Patients

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.)

Pediatrics

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 2).

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