Clinical Pharmacology Details


Buprenorphine


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Indications & Dose:

Moderate to severe pain


 BY SUBLINGUAL ADMINISTRATION Child


(body-weight 16–25 kg): 100 micrograms every 6–8 hours Child (body-weight 25–37.5 kg): 100–200 micrograms every 6–8 hours Child (body-weight 37.5–50 kg): 200–300 micrograms every 6–8 hours Child (body-weight 50 kg and above): 200–400 micrograms every 6–8 hours Adult: 200–400 micrograms every 6–8 hours


BY INTRAMUSCULAR INJECTION


, OR BY SLOW INTRAVENOUS INJECTION Child 6 months–11 years: 3–6 micrograms/kg every 6–8 hours (max. per dose 9 micrograms/kg) Child 12–17 years: 300–600 micrograms every 6–8 hours Adult: 300–600 micrograms every 6–8 hours Premedication


  BY SUBLINGUAL ADMINISTRATION


Adult: 400 micrograms


  BY INTRAMUSCULAR INJECTION Adult: 300 micrograms Intra-operative analgesia


 BY SLOW INTRAVENOUS INJECTION Adult: 300–450 micrograms Adjunct in the treatment of opioid dependence


 BY SUBLINGUAL ADMINISTRATION Adult: Initially 0.8–4 mg for 1 dose on the first day, adjusted in steps of 2–4 mg daily if required; usual dose 12–24 mg daily; maximum 32 mg per day


  BY TRANSDERMAL APPLICATION USING PATCHES Adult: Initially 5 micrograms/hour up to every 7 days, dose adjustments—when starting, analgesic effect should not be evaluated until the system has been worn for 72 hours (to allow for gradual increase in plasma-buprenorphine concentration)—if necessary, dose should be adjusted at intervals of at least 3 days using a patch of the next strength or a combination of 2 patches applied in different places (applied at same time to avoid confusion). Maximum 2 patches can be used at any one time


BY TRANSDERMAL APPLICATION USING PATCHES Adult: Initially 35 micrograms/hour up to every 72 hours, dose adjustment—when starting, analgesic effect should not be evaluated until the system has been worn for 24 hours (to allow for gradual increase in plasma-buprenorphine concentration)—if necessary, dose should be adjusted at intervals of no longer than 72 hours using a patch of the next strength or using 2 patches of the same strength (applied at same time to avoid confusion). Maximum 2 patches can be used at any one time, for breakthrough pain, consider 200–400 micrograms buprenorphine sublingually Moderate to severe chronic cancer pain in patients who have previously received strong opioid analgesic Severe pain unresponsive to non-opioid analgesics in patients who have previously received strong opioid analgesic


 BY TRANSDERMAL APPLICATION USING PATCHES Adult: The initial dose should be based on previous 24-hour opioid requirement, consult product literature, dose adjustment—when starting, analgesic effect should not be evaluated until the system has been worn for 24 hours (to allow for gradual increase in plasma-buprenorphine concentration)—if necessary, dose should be adjusted at intervals of no longer than 72 hours using a patch of the next strength or using 2 patches of the same strength (applied at same time to avoid confusion). Maximum 2 patches can be used at any one time, for breakthrough pain, consider 200–400 micrograms buprenorphine sublingually


BY TRANSDERMAL APPLICATION USING PATCHES Adult: Initially 35 micrograms/hour up to every


96 hours, dose adjustment—when starting, analgesic effect should not be evaluated until the system has been worn for 24 hours (to allow for gradual increase in plasma-buprenorphine concentration)—if necessary, dose should be adjusted at intervals of no longer than 96 hours using a patch of the next strength or using 2 patches of the same strength (applied at same time to avoid confusion). Maximum 2 patches can be used at any one time, for breakthrough pain, consider 200–400 micrograms buprenorphine sublingually Moderate to severe chronic cancer pain in patients who have previously received strong opioid analgesic Severe pain unresponsive to non-opioid analgesics in patients who have previously received strong opioid analgesic


  BY TRANSDERMAL APPLICATION USING PATCHES Adult: The initial dose should be based on previous 24-hour opioid requirement, consult product literature, dose adjustment—when starting, analgesic effect should not be evaluated until the system has been worn for 24 hours (to allow for gradual increase in plasma-buprenorphine concentration)—if necessary, dose should be adjusted at intervals of no longer than 96 hours using a patch of the next strength or using 2 patches of the same strength (applied at same time to avoid confusion). Maximum 2 patches can be used at any one time, for breakthrough pain, consider 200–400 micrograms buprenorphine sublingually


 

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