Active Ingredient: Fentanyl
Long term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy.
For this indication, competent medicine agencies globally authorize below treatments:
Transdermal
12 - 50 ug
From 12 To 50 ug once every 3 day(s)
Follow adult dosage.
Fentanyl should be administered only to those opioid-tolerant paediatric patients (ages 2 to 16 years) who are already receiving at least 30 mg oral morphine equivalents per day.
In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one transdermal fentanyl 12 microgram/hour patch.
It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to fentanyl transdermal patches. The conversion schedule could not be used to convert from transdermal fentanyl into other opioids, as overdosing could then occur.
The analgesic effect of the first dose of fentanyl patches will not be optimal within the first 24 hours. Therefore, during the first 12 hours after switching to fentanyl, the patients should be given the previous regular dose of analgesics. In the next 12 hours, these analgesics should be provided based on clinical need. Monitoring of the patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of fentanyl therapy or up-titration of the dose. Fentanyl should not be used in children aged less than 2 years because the safety and efficacy have not been established.
The fentanyl patch should be replaced every 72 hours. The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained. Dosage must not be increased in intervals of less than 72 hours. If the analgesic effect of fentanyl is insufficient, supplementary morphine or another short-duration opioid should be administered. Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose. Dose adjustments should be done in 12 micrograms/hour steps.
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 - 1.2 mg
From 0.3 To 1.2 mg once every day
Follow adult dosage.
Fentanyl should be administered only to those opioid-tolerant paediatric patients (ages 2 to 16 years) who are already receiving at least 30 mg oral morphine equivalents per day.
In two paediatric studies, the required fentanyl transdermal patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one transdermal fentanyl 12 microgram/hour patch.
It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to fentanyl transdermal patches. The conversion schedule could not be used to convert from transdermal fentanyl into other opioids, as overdosing could then occur.
The analgesic effect of the first dose of fentanyl patches will not be optimal within the first 24 hours. Therefore, during the first 12 hours after switching to fentanyl, the patients should be given the previous regular dose of analgesics. In the next 12 hours, these analgesics should be provided based on clinical need. Monitoring of the patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of fentanyl therapy or up-titration of the dose. Fentanyl should not be used in children aged less than 2 years because the safety and efficacy have not been established.
The fentanyl patch should be replaced every 72 hours. The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained. Dosage must not be increased in intervals of less than 72 hours. If the analgesic effect of fentanyl is insufficient, supplementary morphine or another short-duration opioid should be administered. Depending on the additional analgesic needs and the pain status of the child, it may be decided to increase the dose. Dose adjustments should be done in 12 micrograms/hour steps.
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.
Liability Disclaimer : RxReasoner has utilized reasonable care in providing content and services that are accurate, complete and up to date. However, RxReasoner does not accept any responsibility or liability about it. The content and services of RxReasoner are for informational purposes only and they are not intended to be a substitute for the knowledge, expertise, skill, and judgment of physicians, pharmacists, nurses, or other healthcare professionals involved in patient care. RxReasoner offers no medical advice. Users are responsible for the use of the provided content. A shown indication or treatment should not be construed to indicate that the medication is safe, appropriate, or effective in any given patient or under any particular circumstances. The absence of an indication or treatment should not roule out the existence of other appropriate medications. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition or medicament. RxReasoner is not liable for any damages allegedly sustained arising out of the use of its content and services.
