ZOX Tablet

INDICATION

1. Diarrhoea caused by Cryptosporidium parvum and Giardia lamblia.

2. Amebiasis and helminth infections.

DOSAGE & ADMINISTRATION

Age 1-3 years: 5ml (100mg) twice daily for 3 days

Age 4-11 years: 10ml (200mg) twice daily for 3 days

Age > 12 years: 25ml or 1 tablet (500mg) twice daily for 3 days

The suspension or tablet should be taken with food.

Known hypersensitivity to nitazoxanide or any other ingredient in the formulations.

SIDE EFFECT

Nitazoxanide is generally well tolerated. However abdominal pain, diarrhoea vomiting and headache have been reported rarely.

OVER DOSAGE

Information on Nitazoxanide over dosage is not available. Single oral doses up to 4000 mg Nitazoxanide have been administered to healthy adults without significant adverse effects.

Nitazoxanide is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering Nitazoxanide concurrently with other highly plasma-protein bound drugs.

Pregnancy category B: This drug should be used during pregnancy only if clearly needed.

Nursing mother: It is not known whether Nitazoxanide is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when Nitazoxanide is administrated to a nursing woman.

General

The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function have not been studied. Therefore, nitazoxanide must be administered with caution to patients with hepatic and biliary disease, to patients with renal disease and to patients with combined renal and hepatic disease.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies have not been conducted.

Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. Nitazoxanide was genotoxic in one tester strain (TA 100) in the Ames bacterial mutation assay.

Nitazoxanide did not adversely affect male or female fertility in the rat at 2400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area).

Pregnancy: Teratogenic Effects

Pregnancy Category B: Reproduction studies have been performed at doses up to 3200 mg/kg/day in rats (approximately 26 times the clinical adult dose adjusted for body surface area) and 100 mg/kg/day in rabbits (approximately 2 times the clinical adult dose adjusted for surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to nitazoxanide. There are, however, no adequate and well-controlled studies in pregnant women.

The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme dependent electron transfer reaction which is essential to anaerobic energy metabolism. Studies have shown that the PFOR enzyme from Giardia lamblia directly reduces nitazoxanide by transfer of electrons in the absence of ferredoxin. The DNA-derived PFOR protein sequence of Cryptosporidium parvum appears to be similar to that of Giardia lamblia. Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity.