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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