Niz

Nitazoxanide
Antiamoebic & Antiprotozoal

Niz

Description

Composition:

Niz tablet: Each tablet contains Nitazoxanide INN 500 mg .

Niz Powder for Suspension: When reconstituted each 5 ml suspension contains Nitazoxanide INN 100 mg.

 

Pharmacology:

Niz Oral Suspension contains the active ingredient Nitazoxanide, a synthetic antiprotozoal agent. Nitazoxanide is well absorbed from GIT. It interferes with Pyruvate Ferredoxin Oxidoreductase (PFOR) enzyme dependent electron transfer reaction which is important for anaerobic glucose energy metabolism. This results in cell swelling, membrane damage resulting in dysfunction of the parasite. When Nitazoxanide is administered with food, the AUC in plasma is increased almost two-fold and the Cmax is increased by almost 50%.

 

Indications:

  • Diarrhea caused by Giardia lamblia or Cryptosporidium parvum
  • Amebiasis and helminth infections.

 

Dosage & Administration:

1-3 years–5 ml (100 mg) BID with food–3 days
4-11 years –10 ml (200 mg) BID with food–3 days
Above 12 years—25 ml (500 mg) BID with food –3 days.

 

Contraindication:

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

 

Warning & Precaution:

Nitazoxanide should be administered with caution to patients with hepatic, renal and biliary disease.

 

Side Effects:

Nitazoxanide is generally well tolerated. In placebo-controlled clinical trials, the incidence of side-effects did not differ significantly from those of the placebo. None of the 613 pediatric patients discontinued therapy because of side-effects. In controlled and uncontrolled clinical studies pediatric patients who received Nitazoxanide the side-effects were abdominal pain, vomiting and headache. These were typically mild and transient in nature. Side-effects occurring in less than 1% of patients are anorexia, flatulence, appetite increase, malaise, sweating and dizziness.

 

Pregnancy and Lactation:

Pregnancy Category B: This drug should be used during pregnancy only if clearly needed.
Nursing Mothers: It is not known whether Nitazoxanide is excreted in human milk. As many drugs are excreted in human milk, caution should be exercised when Nitazoxanide is administered 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 with narrow therapeutic window.

 

Packing:

Niz tablet: Box containing 3 x 6 tablets.

Niz 60 ml Powder for Suspension: Bottle containing powder to produce 60 ml suspension when reconstituted.
Niz 30 ml Powder for Suspension: Bottle containing powder to produce 30 ml suspension when reconstituted.