Active Ingredient: Fentanyl
Fentanyl is indicated for management of severe chronic pain that requires continuous long term opioid administration.
For this indication, competent medicine agencies globally authorize below treatments:
Transdermal
12 - 300 ug
From 12 To 300 ug once every 3 day(s)
Fentanyl 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.
The appropriate initiating dose of fentanyl should be based on the patient’s current opioid use. It is recommended that fentanyl 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 fentanyl 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 fentanyl depending on response and supplementary analgesic requirements.
Opioid-naive 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 (e.g. morphine, hydromorphone, oxycodone, tramadol, and codeine) that are to be titrated until an analgesic dosage equivalent to fentanyl with a release rate of 12 mcg/h or 25 mcg/h is attained. Patients can then switch to fentanyl.
In the circumstance in which commencing with oral opioids is not considered possible and fentanyl 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 fentanyl is used in initiating therapy in opioid-naïve patients.
The fentanyl 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 ≈ fentanyl 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 fentanyl patch may be used for doses greater than 100 micrograms/hour. 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 fentanyl dose exceeds 300 micrograms/hour.
If analgesia is insufficient during the first application only, the Matrifen 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 and the patient should be monitored closely.
If discontinuation of fentanyl is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because fentanyl concentrations fall gradually after fentanyl 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. Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Elderly patients should be observed carefully and the dose should be individualised based upon the status of the patient.
In opioid-naïve elderly patients, treatment should only be considered if the benefits outweigh the risks. In these cases, only fentanyl 12 mcg/h dosage should be considered for initial treatment.
Fentanyl should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
In young children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.
Hair at the application site (a non-hairy area is preferred) should be clipped (not shaved) prior to application. If the site of fentanyl application requires to be cleansed 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 application of the patch. Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used.
Fentanyl 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.
Fentanyl 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.
Transdermal
0.3 - 7.2 mg
From 0.3 To 7.2 mg once every day
Fentanyl 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.
The appropriate initiating dose of fentanyl should be based on the patient’s current opioid use. It is recommended that fentanyl 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 fentanyl 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 fentanyl 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 fentanyl with a release rate of 12 mcg/h or 25 mcg/h is attained. Patients can then switch to fentanyl.
In the circumstance in which commencing with oral opioids is not considered possible and fentanyl 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 fentanyl is used in initiating therapy in opioid-naïve patients.
The fentanyl 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 ≈ fentanyl 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 fentanyl patch may be used for doses greater than 100 micrograms/hour. 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 fentanyl dose exceeds 300 micrograms/hour.
If analgesia is insufficient during the first application only, the Matrifen 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 (e.g. 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 and the patient should be monitored closely.
If discontinuation of fentanyl is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because fentanyl concentrations fall gradually after fentanyl 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. Opioid withdrawal symptoms are possible in some patients after conversion or dose adjustment.
Elderly patients should be observed carefully and the dose should be individualised based upon the status of the patient.
In opioid-naïve elderly patients, treatment should only be considered if the benefits outweigh the risks. In these cases, only fentanyl 12 mcg/h dosage should be considered for initial treatment.
Fentanyl should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arms.
In young children, the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch.
Hair at the application site (a non-hairy area is preferred) should be clipped (not shaved) prior to application. If the site of fentanyl application requires to be cleansed 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 application of the patch. Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used.
Fentanyl 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.
Fentanyl 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.
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