COMPOSITION
Proxa-A Tablet : Each tablet contains Nitazoxanide INN 500 mg.
Proxa-A Powder for Suspension : When reconstituted each 5 ml suspension contains Nitazoxanide INN 100 mg.
PHARMACOLOGY
Nitazoxanide is a synthetic antiprotozoal agent for oral administration. The antiprotozoal activity of Nitazoxanide is believed to be interference with the Pyruvate Ferredoxin Oxido Reductase (PFOR) enzyme-dependant electron transfer reaction. This reaction is essential for anaerobic energy metabolism of the protozoa. Nitazoxanide and its metabolites, tizoxanid are active in vitro in inhibiting the growth of sporozoites and oocyst of Cryptosporidium parvum and trophozoites of Giardia lamblia.
INDICATION
Diarrhea caused by Giardia lamblia or Cryptosporidium parvum.
Amebiasis and helminth infections.
DOSAGE AND 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.
Drug should be taken with food.
CONTRAINDICATION
Known hypersensitivity to Proxa-A (Nitazoxanide) or any other ingredient in the formulations.
PRECAUTION
Proxa-A (Nitazoxanide) should be administered with caution to patients with hepatic, renal and biliary disease.
SIDE-EFFECTS
Proxa-A (Nitazoxanide) is generally well tolerated. However, abdominal pain, diarrhoea, vomiting & headache have been reported rarely.
DRUG INTERACTIONS
Proxa-A (Nitazoxanide) is highly bound to plasma protein (>99.9%) Therefore, caution should be used when administering Proxa-A (Nitazoxanide) concurrently with other highly plasma protein-bound drugs with narrow therapeutic window.
USE IN PREGNANCY AND LACTATION
Pregnancy Category B: This drug should be used during pregnancy only if clearly needed. It is not known whether Proxa-A (Nitazoxanide) is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Proxa-A (Nitazoxanide) is administered to a nursing woman.
STORAGE PRECAUTIONS
Store at a cool & dry place, protect from light & moisture. Keep out of reach of children.
PACKING
Proxa-A Tablet : Box cotaining 5 x 4 tablets in Alu-Alu pack.
Proxa-A Powder for Suspension : Each bottle contains dry powder for reconstituting 30 ml suspension.
