Nitoxin Tablet: Each tablet contains Nitazoxanide INN 500 mg.
Nitoxin Powder for Suspension: After reconstitution, each 5 ml Powder for Suspension contains Nitazoxanide INN 100 mg.
The activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential for the synthesis of DNA of the microorganism.
Nitazoxanide is indicated for the treatment of dysentery & diarrhoea caused by Amoeba, Giardia and other protozoa. It is also effective against rota virus, different helminthes, H. pylori and anaerobic bacteria.
Take with food for 3 days:
Tizoxanide, the active metabolite of 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 with narrow therapeutic index.
Nitazoxanide is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
The most common side effects associated with nitazoxanide are abdominal pain and diarrhoea. Nausea and vomiting, flatulence, and increased appetite have also been reported. Headache may occur. Other reported side effects include fever, malaise, pruritus, sweating, dizziness, and rhinitis.
Use in neonates: Safety and efficacy for use in infants and children have not been established.
Use in children: Safety and efficacy for use in children has not been established.
Use in lactation: Safety and efficacy for use in nursing mother has not been established.
Use in pregnancy: Safety for use during pregnancy has not been established. Use only when clearly needed and when the potential benefits outweigh the unknown potential hazards to the foetus.
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.
Store the tablets, powder for suspension and the reconstituted oral suspension in below 30 C, keep in dry place & protect from light. The container should be kept tightly closed and the suspension should be shaken well before each use. The suspension may be stored for 7 days, after which any unused protion must be discarded.