NIZ® – Nitazoxanide INN

Chemical Name:
[2-[(5-Nitro-1,3-thiazol-2-yl)carbamoyl]phenyl]ethanoate

Description:
NIZ® belongs to the class of drugs known as thiazolides. NIZ® is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to viruses. NIZ® is effective in the treatment of gastrointestinal infections including Cryptosporidium parvum or Giardia lamblia in healthy subjects. NIZ® is generally well tolerated. Nitazoxanide is a first-line, standard treatment for illness caused by C. parvum or G. lamblia infection in healthy (not immunosuppressed) adults and children and may also be considered in the treatment of illnesses caused by other protozoa or helminths. Recently, this drug has been studied as a broad-spectrum antiviral agent due to its ability to inhibit the replication of several RNA and DNA viruses.

— 60 ml Bottle

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NIZ® – Nitazoxanide INN

COMPOSITION

Available in two dosage forms:

Niz Tablet: Each tablet contains Nitazoxanide INN 500 mg.

Niz Suspension: After reconstitution, each 5 ml suspension contains Nitazoxanide INN 100 mg.

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.

INDICATION

Diarrhoea caused by Cryptosporidium parvum and Giardia lambila. 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 administered with caution to patients with hepatic, renal and biliary disease.

CONTRAINDICATION

Known hypersensitivity to Nitazoxanide of any other ingredient in the formulations.

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.

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 mother.

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

Niz 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 60 ml suspension.

STORAGE

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

PACKAGING

Niz tablet: Box contains 3 x6 tablets in Alu-Alu blister.

Niz 30 ml suspension: Bottle containing dry powder to reconstitute 30 ml suspension. Niz 60 ml suspension: Bottle containing dry powder to reconstitute 60 ml suspension.