Alinix ® Nitazoxanide INN Composition Alinix® tablet: Each film coated tablet contains Nitazoxanide INN 500mg. Alinix® powder for suspension: When reconstituted, each 5 ml suspension contains Nitazoxanide INN 100mg. Description Nitazoxanide is a synthetic antiprotozoal agent for oral administration. Nitazoxanide and its metabolite, tizoxanide may exhibit antiprotozoal activity in various pathway. The most important way is interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzymedependent electron transfer reaction which is essential to anaerobic energy metabolism. Indications and Usage w Diarrhea caused by Giardia lamblia or Cryptosporidium parvum. w Amebiasis and Trichomoniasis w Helminth infections. Dosage & Administration Age 1-3 years Dose 4-11 years 2 teaspoon full (10 ml ) 12 hourly with food >12 years Duration 1 teaspoon full (5 ml) 12 hourly with food 3 days 1 tablet (500 mg) 12 hourly with food Contraindications Hypersensitivity to nitazoxanide, Precautions General: 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. Information for Patients Alinix® Tablets and Alinix® for Oral Suspension should be taken with food. Direction for reconstitution of suspension See the instruction for reconstitution on carton Drug Interactions 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. (e.g.,warfarin) Pregnancy Pregnancy Category B. Animal studies have revealed no evidence of impaired fertility or harm to the fetus due to nitazoxanide. There are, however, no adequate and wellcontrolled studies in pregnant women. Nursing Mothers It is not known whether nitazoxanide is excreted in breast milk. Caution should be exercised when nitazoxanide is administered to a nursing woman. Adverse Reactions The most common adverse events reported regardless of casualty assessment were: abdominal pain (6.6%), diarrhea (4.2%), headache (3.1%) and nausea (3.0%). How Supplied Alinix® for oral tablet: 5X6 tablets in Alu-Alu blister. Alinix® powder for Oral Suspension: Alinix® for Bottles of 60 ml & 30 ml Storage Store the tablets, unsuspended powder, and the reconstituted oral suspension below 25°C. Medicine: Keep out of reach of children Manufactured by Healthcare Pharmaceuticals Ltd. Rajendrapur, Gazipur, Bangladesh HP 52139
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