Clinical Pharmacology Details


Fentanyl


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Indications & Dose:

Chronic intractable pain not currently treated with a strong opioid analgesic BY TRANSDERMAL APPLICATION Child 16–17 years: Initially 12 micrograms/hour every 72 hours, alternatively initially 25 micrograms/hour every 72 hours, when starting, evaluation of the analgesic effect should not be made before the system has been worn for 24 hours (to allow for the gradual increase in plasma-fentanyl concentration)— previous analgesic therapy should be phased out gradually from time of first patch application, dose should be adjusted at 48–72 hour intervals in steps of 12–25 micrograms/hour if necessary, more than one patch may be used at a time (but applied at the same time to avoid confusion)—consider additional or alternative analgesic therapy if dose required exceeds 300 micrograms/hour (important:


it takes 17 hours or more for the plasma-fentanyl concentration to decrease by 50%—replacement opioid therapy should be initiated at a low dose and increased gradually) %


Adult: Initially 12 micrograms/hour every 72 hours, alternatively initially 25 micrograms/hour every 72 hours, when starting, evaluation of the analgesic effect should not be made before the system has been worn for 24 hours (to allow for the gradual increase in plasma-fentanyl concentration)—previous analgesic therapy should be phased out gradually from time of first patch application, dose should be adjusted at 48–72 hour intervals in steps of 12–25 micrograms/hour if necessary, more than one patch may be used at a


 confusion)—consider additional or alternative analgesic therapy if dose required exceeds 300 micrograms/hour (important: it takes 17 hours or more for the plasma-fentanyl concentration to decrease by 50%—replacement opioid therapy should be initiated at a low dose and increased gradually) Chronic intractable pain currently treated with a strong opioid analgesic


BY TRANSDERMAL APPLICATION Child 2–17 years: Initial dose based on previous 24-hour opioid requirement (consult product literature), for evaluating analgesic efficacy and dose increments, see under Chronic intractable pain not currently treated with a strong opioid analgesic, for conversion from long term oral morphine to transdermal fentanyl, see Pain management with opioids p. 22. Adult: Initial dose based on previous 24-hour opioid requirement (consult product literature), for evaluating analgesic efficacy and dose increments, see Chronic intractable pain not currently treated with a strong opioid analgesic, for conversion from long term oral morphine to transdermal fentanyl, Spontaneous respiration: analgesia and enhancement of anaesthesia, during operation  BY SLOW INTRAVENOUS INJECTION Adult: Initially 50–100 micrograms (max. per dose 200 micrograms),


dose maximum on specialist advice, then 25–50 micrograms as required


BY INTRAVENOUS INFUSION Adult: 3–4.8 micrograms/kg/hour, adjusted according to response Assisted ventilation: analgesia and enhancement of anaesthesia during operation BY SLOW INTRAVENOUS INJECTION Adult: Initially 300–3500 micrograms, then 100–200 micrograms as required BY INTRAVENOUS INFUSION Adult: Initially 10 micrograms/kg, dose to be given over 10 minutes, then 6 micrograms/kg/hour, adjusted according to response, may require up to 180 micrograms/kg/hour during cardiac surgery Assisted ventilation: analgesia and respiratory depression in intensive care


BY SLOW INTRAVENOUS INJECTION Adult: Initially 300–3500 micrograms, then 100–200 micrograms as required  BY INTRAVENOUS INFUSION Adult: Initially 10 micrograms/kg, dose to be given over 10 minutes, then 6 micrograms/kg/hour, adjusted according to response, may require up to 180 micrograms/kg/hour during cardiac surgery Breakthrough pain in patients receiving opioid therapy for chronic cancer pain 


BY BUCCAL ADMINISTRATION USING LOZENGES Child 16–17 years: Initially 200 micrograms, dose to be given over 15 minutes, then 200 micrograms after 15 minutes if required, no more than 2 dose units for each pain episode; if adequate pain relief not achieved with 1 dose unit for consecutive breakthrough pain episodes, increase the strength of the dose unit until adequate pain relief achieved with 4 lozenges or less daily, if more than 4 episodes of breakthrough pain each day, adjust background analgesia Adult: Initially 200 micrograms, dose to be given over 15 minutes, then


200 micrograms after 15 minutes if required, no more than 2 dose units for each pain episode; if adequate pain relief not achieved with 1 dose unit for consecutive breakthrough pain episodes, increase the strength of the dose unit until adequate pain relief achieved with 4 lozenges or less daily, if more than 4 episodes of breakthrough pain each day, adjust background analgesia  BY BUCCAL ADMINISTRATION USING BUCCAL FILMS Adult: Initially 200 micrograms, adjusted according to response, consult product literature for information on dose adjustments, maximum 1.2 mg per episode of breakthrough pain; leave at least 4 hours between treatment of episodes of breakthrough pain, if more than 4 episodes of breakthrough pain each day occur on more than 4 consecutive days, adjust background analgesia 

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