Proxa-A Suspension100 mg/5 ml 1 Pc

Indications

Nitazoxanide is indicated in diarrhoea caused by Cryptosporidium parvum and Giardia lamblia, Amebiasis and helminth infections.

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Therapeutic Class

Anti-diarrhoeal Antiprotozoal

Pharmacology

Nitazoxanide, a synthetic antiprotozoal agent. Nitazoxanide is well absorbed from GIT. 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.

Dosage & Administration

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.

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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.

Contraindications

Known hypersensitivity to Nitazoxanide or any other ingredient in the formulations

Side Effects

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

Pregnancy & Lactation

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.

Precautions

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

Overdose Effects

Information on Nitazoxanide overdosage is not available. Single oral doses of up to 4000 mg Nitazoxanide have been administered to healthy adult volunteers without significant adverse effects.

Use in Special Population

Paediatric Use: Safety and effectiveness of Nitazoxanide for Oral Suspension in paediatric patients less than one year of age have not been studied.

Impaired renal or hepatic function: The pharmacokinetics of Nitazoxanide in patients with impaired renal or hepatic function have not been studied. Therefore, 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.

Reconstitutions

30 ml suspension: Shake the bottle well before adding water. Then add 20 ml of boiled and cooled water (with the help of provided cup) into the bottle and shake well to make 30 ml suspension.

60 ml suspension: Shake the bottle well before adding water. Then add 40 ml of boiled and cooled water (with the help of provided cup) into the bottle and shake well to make 60 ml suspension.

Storage Conditions

Store in a cool and dry place, away from light and moisture. Once reconstituted suspension should be used within 7 days.