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Nitasol

Nitazoxanide INN

NAME STRENGTH PACK SIZE DOSAGE FORM
Nitasol 500 mg 500 mg 3X4 Tablet
Nitasol (30ml) 100 mg / 5 ml 30 ml Powder for suspension
Nitasol (60ml) 100 mg / 5 ml 60 ml Powder for suspension

Description

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.

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.

Indication: 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.

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

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

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.

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

Nitasol Tablet: Each box contains 12 tablets in Alu-Alu blister. Nitasol suspension: Each bottle containing dry powder to reconstitute 30 & 60 ml suspension.