Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adult Subjects
Guzzo et al.,
Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of Ivermectin in Healthy Adult Subjects,
J. Clinical Pharmacology, doi:10.1177/009127002237994
Safety study concluding that ivermectin was generally well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose. Adverse effects were similar between ivermectin and placebo and did not increase with dose. Authors also show that the plasma concentration is much higher when taken with food (geometric mean AUC 2.6 times higher).
Guzzo et al., 8 Mar 2013, peer-reviewed, 9 authors.
Abstract: See discussions, stats, and author profiles for this publication at: https://www.researchgate.net/publication/11094854
Safety, Tolerability, and Pharmacokinetics of Escalating High Doses of
Ivermectin in Healthy Adult Subjects
Article in The Journal of Clinical Pharmacology · November 2002
DOI: 10.1177/009127002401382731 · Source: PubMed
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Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects
CA Guzzo, CI Furtek, AG Porras, C Chen, R Tipping, CM Clineschmidt, DG Sciberras, JY Hsieh and KC Lasseter
J Clin Pharmacol 2002 42: 1122
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GUZZO
HIGH
PHARMACOKINETICS
DOSES
ET ALOF IVERMECTIN
AND PHARMACODYNAMICS
IN ADULTS
Safety, Tolerability, and Pharmacokinetics
of Escalating High Doses of Ivermectin
in Healthy Adult Subjects
Cynthia A. Guzzo, MD, Christine I. Furtek, BS, Arturo G. Porras, PhD,
Cong Chen, PhD, Robert Tipping, MS, Coleen M. Clineschmidt, BA,
David G. Sciberras, PhD, John Y-K. Hsieh, PhD, and Kenneth C. Lasseter, MD
Safety and pharmacokinetics (PK) of the antiparasitic drug
ivermectin, administered in higher and/or more frequent
doses than currently approved for human use, were evaluated in a double-blind, placebo-controlled, dose escalation
study. Subjects (n = 68) were assigned to one of four panels
(3:1, ivermectin/placebo): 30 or 60 mg (three times a week) or
90 or 120 mg (single dose). The 30 mg panel (range: 347-594
µg/kg) also received a single dose with food after a 1-week
washout. Safety assessments addressed both known
ivermectin CNS effects and general toxicity. The primary
safety endpoint was mydriasis, accurately quantitated by
pupillometry. Ivermectin was generally well tolerated, with
no indication of associated CNS toxicity for doses up to 10
times the highest FDA-approved dose of 200 µg/kg. All dose
regimens had a mydriatic effect similar to placebo. Adverse
experiences were similar between ivermectin and placebo
and did not increase with dose. Following single doses of 30
to 120 mg, AUC and Cmax were generally dose proportional,
with tmax ~4 hours and t1/2 ~18 hours. The geometric mean
AUC of 30 mg ivermectin was 2.6 times higher when administered with food. Geometric mean AUC ratios (day 7/day 1)
were 1.24 and 1.40 for the 30 and 60 mg doses, respectively,
indicating that the accumulation of ivermectin given every
fourth..
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