Alinia (Nitazoxanide) Tablets and Alinia (Nitazoxanide) for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal agent for oral administration. Nitazoxanide is a light yellow crystalline powder. It is poorly soluble in ethanol and practically insoluble in water. Chemically, nitazoxanide is 2-acetyloxy--(5-nitro-2-thiazolyl)benzamide. The molecular formula is CHNOS and the molecular weight is 307.3. The structural formula is:

Alinia (Nitazoxanide) Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, FD&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, and FD&C Blue No. 2 Aluminum Lake.

Alinia (Nitazoxanide) for Oral Suspension, after reconstitution, contains 100 mg nitazoxanide per 5 mL and the following inactive ingredients: sodium benzoate, sucrose, xanthan gum, microcrystalline cellulose and carboxymethylcellulose sodium, anhydrous citric acid, sodium citrate dihydrate, acacia gum, sugar syrup, FD&C Red #40 and natural strawberry flavoring.

Absorption
Alinia (Nitazoxanide) for Oral Suspension is not bioequivalent to Alinia (Nitazoxanide) Tablets. The relative bioavailability of the suspension compared to the tablet was 70%.

Effect of Food:
When Alinia (Nitazoxanide) for Oral Suspension was administered with food, the AUC of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C increased by ≤10%.

Alinia (Nitazoxanide) Tablets and for Oral Suspension were administered with food in clinical trials and hence they are recommended to be administered with food (see ).

Distribution:

Metabolism
In vitro
Elimination

Alinia (Nitazoxanide) Tablets and Alinia (Nitazoxanide) for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.

General:

Alinia (Nitazoxanide) Tablets and Alinia (Nitazoxanide) for Oral Suspension should be taken with food.

Diabetic patients and caregivers should be aware that the oral suspension contains 1.48 grams of sucrose per 5 mL.

Long-term carcinogenicity studies have not been conducted.

Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. Nitazoxanide was genotoxic in one tester strain (TA 100) in the Ames bacterial mutation assay.

Nitazoxanide did not adversely affect male or female fertility in the rat at 2400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area).

A single Alinia (Nitazoxanide) Tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger. Alinia (Nitazoxanide) for Oral Suspension should be used for dosing nitazoxanide in pediatric patients (See ).

Safety and effectiveness of Alinia (Nitazoxanide) for Oral Suspension in pediatric patients less than one year of age have not been studied.

Adverse events occurring in less than 1% of the patients age 12 years and older participating in clinical trials of Alinia (Nitazoxanide) Tablets are listed below:

Body as a Whole:
Nervous System:
Digestive System:
Urogenital System:
Metabolic & Nutrition:
Hemic & Lymphatic Systems:
Skin:
Special Senses:
Respiratory System:
Cardiovascular System:
Muscular System:
Alinia (Nitazoxanide) for Oral Suspension:
Adverse events occurring in less than 1% of the pediatric patients participating in clinical trials of Alinia (Nitazoxanide) for Oral Suspension are listed below:

Digestive System:
Body as a Whole:
Metabolic & Nutrition:
Skin:
Special Senses:
Respiratory System:
Nervous System:
Urogenital System:
The adverse events seen in adult patients treated with Alinia (Nitazoxanide) for Oral Suspension were similar to those observed in adult patients treated with Alinia (Nitazoxanide) Tablets.

Information on nitazoxanide overdosage is not available. In acute studies in rodents and dogs, the oral LD was higher than 10,000 mg/kg. Single oral doses of up to 4000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be carefully observed and given symptomatic and supportive treatment.

A single Alinia (Nitazoxanide) tablet contains a greater amount of nitazoxanide than is recommended for pediatric dosing and should therefore not be used in pediatric patients 11 years or younger.

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 amount 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.

Alinia (Nitazoxanide) Tablets

Alinia (Nitazoxanide) for Oral Suspension

Storage and Stability

In a second double-blind, placebo-controlled study of nitazoxanide tablets conducted in Egypt in adults and adolescents with diarrhea caused by as the sole pathogen, clinical and parasitological response rates showed a similar trend to the first study. Clinical response rates, evaluated 2 to 6 days following the end of treatment, were 71% (15/21) in the nitazoxanide group and 42.9% (9/21) in the placebo group.

Some patients with 'well' clinical responses had oocysts in their stool samples 4 to 7 days following the end of treatment. The relevance of stool examination results in these patients is unknown. Patients should be managed based upon clinical response to treatment.

A double-blind, placebo-controlled study did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia. In this study, the pediatric patients received a three day course of nitazoxanide suspension (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) and were evaluated for response four days after the end of treatment.

ROMARK Laboratories, L.C.

Alinia (Nitazoxanide) 500 mg 30 Tablets Bottle Label

NDC 67546-111-12Alinia (Nitazoxanide) ® (nitazoxanide) tablets500 mgRx only30 TABLETS

Alinia (Nitazoxanide) 500 mg 30 Tablets Carton

NDC 67546-111-12Alinia (Nitazoxanide) ®(nitazoxanide) tablets500 mgRomark PharmaceuticalsRx Only30 TABLETS

Alinia (Nitazoxanide) 500 mg 2 Tablets Sample Blister

NDC 67546-111-37Alinia (Nitazoxanide) ® (nitazoxanide) Two (2) tablets, 500 mgRx OnlySample: NOT FOR SALEManufactured for Romark Laboratories, L.C.

Alinia (Nitazoxanide) 500 mg 2 Tablets Sample Carton

NDC 67546-111-372 TABLETSAlinia (Nitazoxanide) ® (nitazoxanide) tablets500 mgRx OnlyProfessional SampleNOT FOR SALE

Alinia (Nitazoxanide) 500 mg 2 Tablets Sample Tray

NDC 67546-111-37Alinia (Nitazoxanide) ® (nitazoxanide) tablets500 mgRx Only5 Boxes x 2 TabletsProfessional SampleNOT FOR SALE

Alinia (Nitazoxanide) 100mg/5mL Suspension Bottle Label

NDC 67546-212-21Alinia (Nitazoxanide) ® (nitazoxanide) For Oral Suspension100mg/5mLReconstitute with 48mL waterSHAKE WELL BEFORE USINGAny unused portion must be discarded7 days after mixing60mL reconstitutedRx onlyRomark Laboratories, L.C.

Alinia (Nitazoxanide) 100mg/5mL Suspension Carton

NDC 67546-212-21Alinia (Nitazoxanide) ® (nitazoxanide) For Oral Suspension100mg/5mLReconstitute with 48mL waterSHAKE WELL BEFORE USINGAny unused portion must be discarded7 days after mixing60mL reconstitutedRx onlyRomark Pharmaceuticals