Reference

Preclinical toxicology of nitazoxanide - a new antiparasitic compound

Preclinical toxicology of nitazoxanide - a new antiparasitic compound. Murphy, James R.; Friedmann, Jean Charles (Hampton, NH 03842, USA). JAT, J. Appl. Toxicol., 5(2), 49-52 (English) 1985. CODEN: JJATDK. ISSN: 0260-437X. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) The acute and subchronic toxicol. effects of nitazoxanide [55981-09-4] were investigated at levels near and in excess of the therapeutic dose in rats, mice, dogs and cats. Single oral gavage doses of 0.625-10 g/kg were administered to rats and mice. Single oral doses of 1-10 g/kg were administered in capsules to dogs and cats. Acute oral LD50 values were >10 g kg-1 in rats, dogs and cats, and 1.4 g kg-1 in mice. Systemic toxicity was evaluated in a repeated dose study in rats at doses of 50, 150, and 450 mg/kg, daily for 14 wk. The highest dose group exhibited intense salivation, increased liver and spleen wt., and decreased thymus wts. Variances between control and treated organ wts. were not confirmed by histopathol. evaluation. Nitazoxanide gave neg. results when tested in the Ames Salmonella assay using 5 tester strains with and without metabolic activation at levels from 1 to 100 mg/plate. The drug was also shown to be nonirritating in a test for eye irritation potential.

Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients

All Rights Reserved. Nitazoxanide in the treatment of acquired immune deficiency syndrome-related cryptosporidiosis: results of the United States compassionate use program in 365 patients. Rossignol, J.-F. (Department of Clinical Research, The Romark Institute for Medical Research, Tampa, FL, USA). Alimentary Pharmacology and Therapeutics, 24(5), 887-894 (English) 2006 Blackwell Publishing Ltd. CODEN: APTHEN. ISSN: 0269-2813. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Background: Cryptosporidiosis in patients with acquired immune deficiency syndrome is a serious, life-threatening disease. Aim: A large compassionate use clin. trial was conducted in the USA to make nitazoxanide available to patients with acquired immune deficiency syndrome-related cryptosporidiosis and to collect data related to safety and effectiveness of the drug in this population. Methods: Patients at least 3 years of age with acquired immune deficiency syndrome, diarrhea (34 stools/day for >2 wk) and Cryptosporidium-pos. stools received 500-1500 mg of nitazoxanide twice daily. Patients were evaluated at weeks 1, 2, 4 and monthly thereafter for drug safety and effectiveness including the stool examns., review of symptoms and patient diaries. Data anal. for clin. and parasitol. response was intention-to-treat. Results: Three hundred and sixty-five patients were enrolled at 165 study centers throughout the USA. The duration of treatment ranged from 1 to 1528 days (median 62 days). Among the 357 patients included in the intent-to-treat anal., 209 (59%) achieved a sustained clin. response while on treatment. Clin. responses were closely assocd. with Cryptosporidium-neg. stools (P < 0.0001). No safety issues were identified at doses up to 3000 mg/day or for long durations of treatment. Conclusions: Nitazoxanide can be considered useful therapy for treatment of with acquired immune deficiency syndrome-related cryptosporidiosis.Except for chemicals metioned above, 55981-09-4 is also used. .