Medizen pharmaceutical Industries for Utopia Pharmaceuticals.
Nanazoxid Suspension Composition:
Each 5ml suspension contains:
Nitazoxanide 100mg (after reconstitution).
Sucrose, pregelatlnized starch, carboxy methyt cellulose sodium, FD & C red citric acid, acacia gum, microcrystalline cellulose, xanthan gum, sodium benzoate and strawberry flavor.
Nanazoxid Suspension Description:
Nanazoxid 100mg for oral suspension contains the active ingredient nitazoxanide; a synthetic Intestinal antlprotozoal agent for oral administration.
Nanazoxid Suspension Clinical Pharmacology:
Absorption: Following oral administration of Nanazoxid 100 mg oral suspension, maximum plasma concentrations of the active metabolites tizoxanide and tizoxanide glucuronide are observed within 14 hours. The parent nitazoxanide is not detected in plasma. When Nanazoxid 100 mg for oral suspension was administered with food, the AUC. of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the Cmax increased by </=10%.
Distribution:In plasma, more than 99% of tizoxanide is bound to proteins.
Metabolism: Nitazoxanide Is rapidly hydrolyzed to an active metabolite. tizoxanide (desacetyl- nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation.
Elimination: Tizoxanide is excrated in the urine, bile and faces, and tizoxanide glucuronide is excrated in urine and bile. Approximately two-thirds of the oral dose of nitazoxanide is excrated In the faces and one-third in the urine.
Nanazoxid Suspension Mechanism of Action:
The antiprotozoal activity of nitazoxanide is believed to be due to interferance with the pyruvate ferredoxin oxiredctase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism.
Nanazoxid Suspension Indications and Usage:
Nanazoxid for Oral Suspension Is indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum.
Nanazoxid Suspension Overdosage:
Information on nitazoxanide overdosage is not available.
Nanazoxid Suspension Contraindications:
Nanazoxld 100 mg for oral suspension is contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the fonnulations.
Nanazoxid Suspension Adverse Reactions:
The most frequent adverse events reported were:
Abdomnal pain, diarrnea, vomiting and headache.
Nanazoxid Suspension Drug Interactions:
Tizoxanide Is highly bound to plasma protein (>99.9%).lherefore, caution should be used when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices as competition for binding sites may occur (e.g., warfarin).
Nanazoxid Suspension Pregnancy & lactation:
No adequate and weli-controlled studies in pregnant women.
It Is not known whether nitazoxanide is excrated in human milk. Because many drugs are excreted In human milk, caution should be exercised when nitazoxanide is administered to a nursing woman.
Nanazoxid Suspension Precautions:
– Nitazoxanide must be administered with caution to patients with hepatic and biliary diseases, to patients with renal diseases, and to patients with combined renal and hepatic disease.
– Diabetic patients should be aware that the oral suspension contains 1.2 grams of
Sucrose per 5 mL.
– Keep out of raach of children.
– Keep at a temperature not exceeding 30°C.
After reconstitution; keep for one week at a temperature not exceeding 30·C.
Information for Patients:
Nanazoxid 100 mg for oral suspension should be taken with food.
Diabetic patients should be aware that the oral suspension contains1.2 grams of
sucrose per 5 ml.
Prepare a suspension at time of dispensing as follows:
– The amount of water required for preparation of the suspension is 48 ml.
– Tap bottle until all powder flows freely.
– Add approximately one-half of the total amounts of water required for reconstitution and shake vigorously to suspend powder.
– Add remainder of water and again shake vigorously.
– The container should be kept tightly closed, and the suspension should be shaken well before each administration.
– The suspension may be stored for 7 days. after which any unused portion must be discarded.
Produced by :
Medizen Pharmaceutical Industries for utopia Pharmaceuticals.