Nitazoxanide is indicated for the treatment of diarrhea caused by Cryptosporidium parvum, Giardia lamblia, and Entamoeba histolytica.

Nitazoxanide is a synthetic antiprotozoal agent for oral administration. Its antiprotozoal activity is believed to occur through inhibition of the pyruvate ferredoxin oxidoreductase (PFOR) enzyme–dependent electron transfer reaction. This reaction is essential for anaerobic energy metabolism in protozoa. Nitazoxanide and its active metabolite, tizoxanide, show in vitro activity by inhibiting the growth of sporozoites and oocysts of Cryptosporidium parvum and trophozoites of Giardia lamblia.

Age 1-3 years: 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.

Age 4-11 years: 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.

Age 12 years or above: 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12 hours for 3 days.

It is recommended to be administered with food.

Nitazoxanide is highly bound to plasma proteins. Therefore, caution should be taken when it is used together with other highly plasma protein–bound drugs that have a narrow therapeutic index.

Nitazoxanide is contraindicated in patients with known hypersensitivity to Nitazoxanide or any component of the formulation.

The most common side effects of Nitazoxanide include abdominal pain, vomiting, and headache. These are usually mild and temporary. Rare side effects may include nausea, loss of appetite (anorexia), flatulence, increased appetite, enlargement of salivary glands, increased creatinine and SGPT levels, itching (pruritus), rhinitis, sweating, dizziness, and discolored urine.

Nitazoxanide is classified as US FDA pregnancy category B. However, adequate and well-controlled studies in pregnant women are not available. It should be used during pregnancy only if clearly needed. Nitazoxanide is excreted in human breast milk; therefore, caution is required during breastfeeding.

Nitazoxanide should be used with caution in patients with hepatic or biliary disease and in those with renal impairment.

Anti-diarrhoeal, Antiprotozoal

Store in a dry place, protected from light and heat. Keep out of reach of children.