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NITASOL

NITAZOXANIDE INN


NAME STRENGTH PACK SIZE DOSAGE FORM
NITASOL 30 ML POS 100 MG/ 5 ML 30 ML POS
NITASOL 500 MG TABLET 500 MG 12 S TABLET
NITASOL 60 ML POS 100 MG/ 5 ML 60 ML POS

Nitasol Tablet: Each film coated tablet contains Nitazoxanide INN 500 mg. Nitasol 30 ml suspension: Each 5 ml reconstituted suspension contains Nitazoxanide INN 100 mg. Nitasol 60 ml suspension: Each 5 ml reconstituted suspension contains Nitazoxanide INN 100 mg.

Nitasol (Nitazoxanide), a synthetic antiprotozoal drug. It is well absorbed from gastrointestinal tract. It interferes with the Pyruvate Ferredoxin Oxidoreductase (PFOR) enzyme dependent electron transfer reaction which is essential to anaerobic glucose energy metabolism. This results in cell swelling, membrane damage resulting in dysfunction of the parasite.

1. Diarrhea caused by Cryptosporidium parvum and Giardia lamblia. 2. Amebiasis and helminth infections.

Age 1-3 years: 5 ml (100 mg) twice daily for 3 days. Age 4-11 years: 10 ml (200 mg) twice daily for 3 days. Age >12 years: 25 ml or 1 tablet (500 mg) 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.

Nitazoxanide should be administrated with caution to patients with hepatic, renal and biliary disease.

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

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.

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.

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.

Store in a cool and dry place& away from light and moisture. The reconstituted suspension should be used within 7 days of preparation.

Nitasol Tablet: Box contains 12 tablets in Alu-Alu blister. Nitasol 30 ml suspension: Bottle containing dry powder to reconstitute 30 ml suspension. Nitasol 60 ml suspension: Bottle containing dry powder to reconstitute 60 ml suspension.