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NITOXIN
Nitazoxanide
Composition:
Nitoxin Tablet: Each
tablet contains Nitazoxanide
INN 500 mg.
Nitoxin Powder for
Suspension:
After reconstitution, each 5 ml Powder for Suspension contains
Nitazoxanide INN 100 mg.
Pharmacology:
The activity of
nitazoxanide is believed to be due to interference with the
pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent
electron transfer reaction which is essential for the synthesis
of DNA of the microorganism.
Indications:
Nitazoxanide is indicated for the
treatment of dysentery & diarrhoea
caused by Amoeba, Giardia and other
protozoa. It is also effective against rota virus, different
helminthes, H. pylori and anaerobic bacteria.
Dosage & Administration:
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Age
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Dosage
|
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1-3 years
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5 ml Suspension (100 mg Nitazoxanide) bid with food for 3 days
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4-11 years
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10 ml Suspension (200 mg Nitazoxanide) bid with food for 3 days
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>12 years
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1 tablet or 25 ml Suspension (500 mg Nitazoxanide) bid with food for 3
days
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Side-effects:
The most common
side effects associated with nitazoxanide are abdominal pain and
diarrhoea. Nausea and vomiting, flatulence, and increased
appetite have also been reported. Headache may occur. Other
reported side effects include fever, malaise, pruritus,
sweating, dizziness, and rhinitis.
Contraindications:
Nitazoxanide is contraindicated in
patients with a prior hypersensitivity to nitazoxanide or any
other ingredient in the formulations.
Use in pregnancy:
Pregnancy
Category B: However, there are no adequate and well-controlled
studies in pregnant women. So this drug should be used during
pregnancy only if clearly needed.
Use in nursing mothers:
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
administered to a nursing woman.
Paediatric use:
Can be used over one year of age.
Precautions:
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.
Drug Interactions:
Tizoxanide, the
active metabolite of 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 with narrow therapeutic index.
Packing:
Nitoxin
Tablet: Box containing 3×6’s
tablets in Alu-Alu blister pack.
Nitoxin Powder for Suspension:
Bottle containing dry powder for the reconstitution of
30 & 60 ml Suspension. |
