Nidozox 60 ml Suspension

Nidozox 60 ml Suspension

DESCRIPTION

NIDOZOX (Nitazoxanide) is a synthetic antiprotozoal agent and is well absorbed from GIT. The

Antiprotozoal activity of Nitazoxanide is believed to be due to interference with the pyruvate ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. Following oral administration in human, Nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (deacylated-Nitazoxanide), which is readily reduced by PFOR enzymes from the parasites by transfer of electrons. This reduced form of Nitazoxanide deprives parasite of their energy and eradicates them from body.

COMPOSITION

NIDOZOX 500 Tablet : Each film-coated tablet contains Nitazoxanide INN 500 mg.

NIDOZOX Powder for 30 ml Suspension : After reconstitution each 5 ml suspension contains

Nitazoxanide INN 100 mg.

INDICATIONS

 Diarrhoea caused by Giardia lamblia or Cryptosporidium parvum.

 Amebiasis

 Helminth infections

SIDE EFFECTS

Nitazoxanide is generally well tolerated but the most common side effects are abdominal pain, diarrhoea, nausea, vomiting and headache. Other reported side effects are flatulence, appetite, malaise, sweating and dizziness.

CONTRAINDICATIONS

Nitazoxanide is contraindicated in patient with known hypersensitivity to Nitazoxanide or any other

ingredient of the product.

PRECAUTIONS

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

USE IN PREGNANCY & LACTATION

Pregnancy Category B. This drug should be used during pregnancy only if clearly needed. It is not known whether Nitazoxanide is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Nitazoxanide is administered to a nursing mother.

DRUG INTERACTION

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.

OVER DOSAGE

Information on Nitazoxanide over dosage is not available. Single oral dose of up to 4000 mg Nitazoxanide have been administered to healthy adults without significant adverse effects.

DIRECTIONS FOR RECONSTITUTION OF SUSPENSION

First shake the bottle to loosen powder. Add 22.5 ml (by using supplied measuring cup) boiled and cooled water into the bottle. Shake the bottle to disperse the powder completely. Keep the bottle tightly closed.

The reconstituted suspension should be stored in a cool place and used within 7 days of preparation.

Shake the bottle well before each use.

SUPPLY

NIDOZOX 500 Tablet : Each box contains 3 x 6 tablets in Alu-Alu blister strips.

NIDOZOX Powder for 30 ml Suspension : Each carton contains required quantity of powder to prepare 30 ml suspension in glass bottle and a measuring cup.