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All multiple dose artesunate studies were undertaken in Asia and regression analyses were limited to patients from this region.
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In all studies with multiple dose rectal administration with artesunate (all in Asia), a 200 mg suppository was provided sequentially at intervals over 72 hours, resulting in a mean exposure of 7.9 mg/kg over 12 hours and 14.9 mg/kg over 24 hours.
The results indicate that both artemisinin and artesunate, whether as single or multiple dose regimens, induce a superior parasitological response than parenteral quinine over the 24 hours following initiation of treatment.
The crude PRR at 12 hours with a multiple dose was 52.6% compared to a single dose of rectal artesunate at 64.1%.
multiple dose activated charcoal.
A multiple dose, parallel group study was conducted to assess for a drug-drug interaction between the pyronaridine/artesunate (PA) combination antimalarial and ritonavir.
Mean PRRs at 12 hours with single dose artemisinin and single dose artesunate suppositories were 72.3% and 64.2%, respectively.
At 24 hours, mean PRR was 83.1% for single dose artemether and 96.7% with single dose artesunate (p ≤ 0.0001).
Mean total treatment dose during the initial 24 hours with single dose artemether was 6.72 mg/kg compared with 9.4 mg/kg with single dose artesunate.
At higher dose, artesunate exhibited significant increase (P <.001) in LPO in testis of 45-day treated group (group C).
Mean PRR at 12 hours was 53.5% for single dose rectal artemether compared with 73.5% with single dose artesunate (p ≤ 0.0001).
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