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Table 1 The safety of ivermectin at doses higher or more frequent than current approval

From: Ivermectin to reduce malaria transmission I. Pharmacokinetic and pharmacodynamic considerations regarding efficacy and safety

Reference Population Highest single dose Maximum frequency Maximum number of doses Maximum total dose (period) Adverse events
Awadzi et al. [100] 75 males with moderate to heavy Onchocerca infection 800 mcg/kg Single Single 800 mcg/kg (once) No difference with controls taking the 150 mcg/kg dose
Awadzi et al. [101] 100 adult males infected with Onchocerca 800 mcg/kg Days 1 and 4 2 1.600 mcg/kg (4 days) No difference with controls taking the 150 mcg/kg dose
Guzzo et al. [62] 68 male and female healthy, adult volunteers 2.000 mcg/kg Days 1, 4 and 7 3 3.273 mcg/kg (1 week) No difference with controls
Kamgno et al. [67] 657 adult males infected with Onchocerca 800 mcg/kg 3-monthly 13 8.950 mcg/kg (3 years) The high dose group reported a statistically higher rate of transitory mild and subjective visual side effects
(No structural explanation).
For all other AE comparable rates reported in all groups
Smit et al. [43] 141 adults with uncomplicated malaria 600 mcg/kg Days 1, 2 and 3 3 1.800 mcg/kg (3 days) Pending publication of results
  1. The maximum total dose is the cumulative dose received by a participant during a given period which is given in brackets
  2. AE adverse events