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Citicoline exhibits very low toxicity profile in humans.
Film-coated tablet: In clinical use it has been observed to be safe at doses up to 2g/day.
Solution for injection: In a short term, placebo-controlled, cross-over study, 12 healthy adults took citicoline at daily doses of 600 and 1000 mg or placebo for consecutive five-day periods. Transient headaches occurred in four subjects on 600 mg dose, five on the 1000 mg dose, and one in placebo. No changes or abnormalities were observed in hematology, clinical biochemistry or neurological test.
The LD50 of a single intravenous dose of citicoline was 4,600 mg/kg and 4,150 mg/kg in mice and rats, respectively.
In an unpublished acute toxicity study, free-base citicoline was administered to male and female rats at a dose of 2000 mg/kg body weight for 14 days. No changes in body weight, deaths, clinical symptoms or gross pathological changes were observed.
