Composition
Zox ® tablet : Each film coated tablet contains Nitazoxanide INN 500 mg.
Zox ® 30 ml suspension : Each 5 ml suspension contains Nitazoxanide INN 100 mg.
Zox ® 60 ml suspension : Each 5 ml suspension contains Nitazoxanide INN 100 mg.
Description
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.
Indication
1. Diarrhoea caused by Cryptosporidium parvum and Giardia lamblia.
2. Amebiasis and helminth infections.
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.
Side effect
Nitazoxanide is generally well tolerated. However abdominal pain, diarrhoea
vomiting and headache have been reported rarely.
Precaution
Nitazoxanide should be administrated with caution to patients with hepatic,
renal and biliary disease.
Contraindication
Known hypersensitivity to Nitazoxanide or any other ingredient in the
formulations.
Use in 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.
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 doses
up to 4000 mg Nitazoxanide have been administered to healthy adults without
significant adverse effects.
Reconstitution for suspension
Zox ® 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.
Zox ® 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.
Pharmaceutical precaution
Store in a cool and dry place, away from light and moisture. Once
reconstituted suspension should be used within 7 days.
Description
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