Presentation

Nitazox tablet: Each tablet contains Nitazoxanide INN 500 mg .

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

Description

Nitazox 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

(1) Diarrhea caused by Giardia lamblia or Cryptosporidium parvum

(2) 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.

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.

Precautions

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

Use in Pregnancy & 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.

Over Dose

Information on Nitazoxanide overdosage is not available. Single oral doses of up to 4000 mg Nitazoxanide have been administered to healthy adult volunteers without significant adverse effects.

Directions for reconstitution of suspension

Shake the bottle until all powder flows freely. Add approximately one-half of the total amounts of boiled and cool water required for reconstitution and shake vigorously to suspend powder. Add remainder of water and again shake vigorously until all the powder is in suspension.

Note: Shake the bottle vigorously before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place and used within 7 days after reconstitution.

Commercial Pack

Nitazox tablet: Box containing 10 blister strips of 3 tablets. Nitazox 60 ml Powder for Suspension: Bottle containing powder to produce 60 ml suspension when reconstituted.

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

Others

Shake the bottle until all powder flows freely. Add approximately one-half of the total amounts of boiled and cool water required for reconstitution and shake vigorously to suspend powder. Add remainder of water and again shake vigorously until all the powder is in suspension.

Note: Shake the bottle vigorously before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place and used within 7 days after reconstitution.

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