Powder For Suspension Nitoxin 100 mg/5 ml – 30 ml

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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.

Presentation:

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.

Indication:

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.

Dosage & Administration:

AGE DOSAGE

1-3 years 5 ml Suspension (100 mg Nitazoxanide) bid with food for 3 days

4-11 years 10 ml Suspension (200 mg Nitazoxanide) bid with food for 3 days

>12 years 1 tablet or 25 ml Suspension (500 mg Nitazoxanide) bid with food for 3 days

Contrainidications:

Nitazoxanide is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

Warning & Precautions:

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.

Side effects:

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.

Drug interaction:

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.

Use in special groups:

Use in pregnancy: Pregnancy Category B: However, there are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Use in lactation: 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 administered to a nursing woman. Use in children: Can be used over one year of age.

Packing:

Nitoxin Tablet: Box containing 30’s tablets in Alu-Alu blister pack. Nitoxin Powder for Suspension: Bottle containing dry powder for the reconstitution of 30ml/60 ml Suspension.

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