Toza® powder for suspension: Each 5 ml reconstituted suspension contains nitazoxanide INN 100 mg.
Toza® 500 tablet: Each film-coated tablet contains nitazoxanide INN 500 mg.
Toza is a preparation of nitazoxanide, a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate: ferredoxin oxidoreductase (PFOR) enzyme - dependant electron transfer reaction that 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. Nitazoxanide and its metabolites, tizoxanide are active in vitro in inhibiting the growth of sporozoites and oocysts of Cryptosporidium parvum and trophozoites of Giardia lamblia.
Toza®is recommended to be administered with food. Age 12-47 months: One teaspoonful (5 mL) oral suspension (100 mg nitazoxanide) every 12 hours for 3 days. Age 4-11 yéars: Two teaspoonful (10 mL) oral suspension (200 mg nitazoxanide) every 12 hours for 3 days. Age 12 years or above: 500 mg tablet or five teaspoonful (25 mL).
oral suspension every 12 hours for 3 days.
Tizoxanide is highly bound to plasma protein. Therefore, caution should be taken when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur. Patients using nitazoxanide have reported no interactions with other medicinal products. However, no clinical studies have been conducted to specifically exclude the possibility of interactions between nitazoxanide and other medicinal products.
Nitazoxanide is used in pregnancy category-B. There are no adequate studies for the use of nitazoxanide in pregnancy or lactating mothers. Therefore use of nitazoxanide is indicated only in absolute indication.
Nitazoxanide must be administered with caution to patients with hepatic and biliary disease, with renal disease and with combined renal and hepatic disease.
Unsuspended powder and the reconstituted oral suspension. Do not store above 25°C. Keep away from light and wet place. The container should be kept tightly closed and the suspension should be shaken well before each administration. The suspension may be stored for 7 days, after which any unused portion must be discarded. Tablet: Do not store above 30°C, keep away from light and wet place. Keep out of reach of children.