is a preparation of Nitazoxanide. It 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.
COMPOSITION
500 Tablet : Each film coated tablet contains Nitazoxanide INN 500 mg.
Powder for Suspension : After reconstitution, each 5 ml suspension contains
Nitazoxanide INN 100 mg.
INDICATION
(Nitazoxanide) is indicated for the treatment of diarrhea caused by Cryptosporidium
parvum, Giardia lamblia and Entamoeba histolytica.
DOSAGE AND ADMINISTRATION
Age 1-3 years : 1 tea-spoonfull or 5 ml suspension every 12 hours for 3 days.
Age 4-11 years : 2 tea-spoonfulls or 10 ml suspension every 12 hours for 3 days.
Age 12 years or above : 5 tea-spoonfulls (25 ml) suspension or 1 tablet every 12
hours for 3 days.
It is recommended to be administered with food.
SIDE EFFECT
The most frequent side effects, reported by Nitazoxanide are abdominal pain, vomiting
and headache. These side effects are typically mild and transient in nature. Very rare
side effects include- nausea, anorexia, flatulence, increased appetite, enlarged
salivary glands, increased creatinine & SGPT level, pruritus, rhinitis, sweating,
dizziness, discolored urine etc.
PRECAUTION
Nitazoxanide must be administered with caution to patients with hepatic & biliary
disease and to patients with renal disease.
CONTRAINDICATION
It is contraindicated in patients with known hypersensitivity to Nitazoxanide or any
components of the preparation.
DRUG INTERACTION
It is highly bound to plasma protein. Therefore, caution should be exercised when
administering Nitazoxanide concurrently with other highly plasma protein-bound drugs
with narrow therapeutic index.
USE IN PREGNANCY AND LACTATION
US FDA pregnancy category of Nitazoxanide is B. There are, however, no adequate
and well-controlled studies in pregnant women. Because animal reproduction studies
are not always predictive of human response, this drug should be used during
pregnancy only if clearly needed. Nitazoxanide have been shown to be excreted in
human milk. So, caution should be exercised when Nitazoxanide is administered
during lactation.
STORAGE CONDITION
Keep in a dry place away from light and heat. Keep out of the reach of children.
HOW SUPPLIED
500 Tablet : Each box contains 30 tablets in Alu-PVC blister pack.
30 ml Powder for Suspension : Each amber glass bottle contains dry powder
to reconstitute 30 ml suspension.
60 ml Powder for Suspension : Each amber glass bottle contains dry powder
to reconstitute 60 ml suspension.
Nitazoxanide 500 mg Tablet &
100 mg/5 ml Powder for Suspension
Comilla, Bangladesh.
Manufactured by:
NIPRO JMI Pharma Ltd.
Brand: NIPRO JMI Pharma Ltd
