Nitazoxanide 500 mg Tablet, 6-count — NDC 70954-934-10 (Billing 70954-0934-10)
This is a package of 6 tablets of Nitazoxanide 500 mg Tablet from ANI Pharmaceuticals, Inc., marketed since Mar 2025 and currently FDA-listed; retail pharmacies pay about $82.20 per tablet (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 70954-934-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 70954 labeler · 934 product · 10 package
- Package marketed since
- Mar 5, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 6 EA per package
- Barcode (UPC)
- 0370954934103
- Medicaid fills, this package
- 89 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 029984
- GCN: 42761
- GPI-14 (Medi-Span): 16400060000330
- HICL (First Databank): 013845
- AHFS class code: 08:30.20.00
- RxCUI (RxNorm): 427163
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Antiprotozoal class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
- It treats diarrhea caused by two parasites, Giardia lamblia and Cryptosporidium parvum. The tablets are for people 12 and older. It hasn't been shown to work for Cryptosporidium di...
- Take it by mouth with food, about every 12 hours. A typical course for the tablets is 3 days. Food helps your body absorb more of the medicine, so don't skip it.
- The most common are stomach pain, headache, nausea, and darker or discolored urine. These are usually not dangerous. Call your doctor if you get a rash, hives, trouble breathing, o...
- Tell me if you take warfarin or other drugs that bind tightly to blood proteins. They can compete with nitazoxanide, so your prescriber may want to watch for side effects.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with nitazoxanide — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $82.197 | $493.18 / 6 tablets |
| Medicaid paysCMS SDUD · 12 mo | $85.65 | $513.90 / 6 tablets |
| Medicare drug plans payPart D · Q2 2026 | $99.55 | $597.31 / 6 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 70954-0934-10 You're viewing this Main listing | 6 TABLET in 1 BOTTLE | 2025-03-05 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Nitazoxanide 500 mgthis 70954-0934-10 | ANI | 6 tablets | $82.197 | AB | Availability likely | — |
| Nitazoxanide 500 mg 13517-0135-06 | e5 | 6 tablets | — | AB | FDA listed | — |
| Nitazoxanide 500 mg 31722-0100-30 | Camber | 30 tablets | — | AB | FDA listed | — |
| Nitazoxanide 500 mg 64980-0526-03 | Rising | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 9, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 9, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Nitazoxanide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII CQ3XH3DET6
D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
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UNII 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
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UNII GYP6Z2JR6Q
FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
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UNII 1IVH67816N
Hypromellose 2910 is a plant-derived cellulose compound used as a thickener and film-former in medicines. It helps control how quickly the medication dissolves and creates protective coatings on tablets or capsules.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII H8AV0SQX4D
A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII TTV12P4NEE
Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from ANI Pharmaceuticals, Inc. labeler code 70954
- Sertraline Hydrochloride 150 mg Capsule NDC 70954-899-10
- Sertraline Hydrochloride 200 mg Capsule NDC 70954-900-10
- Lofexidine .18 mg Tablet NDC 70954-909-10
- Hydroxyzine Hydrochloride 10 mg/5mL Solution NDC 70954-912-10
- Naproxen 375 mg Tablet, Delayed Release NDC 70954-925-10
- Naproxen 500 mg Tablet, Delayed Release NDC 70954-928-10
- Bromocriptine Mesylate 5 mg Capsule NDC 70954-951-10
- Methenamine Hippurate 1 mg Tablet NDC 70954-959-10
- Sacubitril and Valsartan 24 mg; 26 mg Tablet, Film Coated NDC 70954-975-20
- Sacubitril and Valsartan 49 mg; 51 mg Tablet, Film Coated NDC 70954-976-20
- Sacubitril and Valsartan 97 mg; 103 mg Tablet, Film Coated NDC 70954-977-20
- Bromocriptine Mesylate 2.5 mg Tablet NDC 70954-978-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS & USAGE Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum . Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2)]. Nitazoxanide tablet is an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1).
Limitations of Use: Nitazoxanide tablet has not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infected or immunodeficient patients (1).
⏱️ Dosage and Administration ▾
2 DOSAGE & ADMINISTRATION Nitazoxanide tablets should not be administered to pediatric patient 11 years of age or younger (2.1). Dosage for treatment of diarrhea caused by G. lamblia or C. parvum (2.1): Age Dosage Duration 12 years and older One nitazoxanide tablet (500 mg nitazoxanide) every 12 hours with food 3 days
2.1Recommended Dosage and Important Administration Instructions Important Administration Instructions for Pediatric Patients 11 years of Age or Younger: Nitazoxanide tablets should not be administered to pediatric patients 11 years of age or younger because a single tablet contains a greater amount of nitazoxanide than the recommended dosing in this pediatric age group. Table 1. Recommended Dosage Age Dosage Duration 12 years and older One nitazoxanide tablet (500 mg nitazoxanide) taken orally every 12 hours with food.
3 days
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS & STRENGTHS Nitazoxanide Tablets: 500 mg (3.1)
3.1Nitazoxanide Tablets (500 mg) Round, yellow, film-coated tablets debossed with ‘ZNN’ on one side, plain on the other side, and free from physical defects. Each tablet contains 500 mg of nitazoxanide.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity (4.1)
4.1Hypersensitivity Nitazoxanide tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions in ≥2% of patients were abdominal pain, headache, chromaturia, and nausea (6.1). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of nitazoxanide was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received nitazoxanide tablets or ALINIA for Oral Suspension at the recommended dose for at least three days. In pooled controlled clinical trials involving 536 HIV-uninfected subjects treated with nitazoxanide tablets or ALINIA for Oral Suspension, the most common adverse reactions were abdominal pain, headache, chromaturia and nausea (≥2%).
Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving nitazoxanide at the recommended dose for at least three days in 5 placebo-controlled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. There were no differences between the adverse reactions reported for nitazoxanide-treated subjects based upon age.
6.2Postmarketing Experience The following adverse reactions have been identified during post approval use of nitazoxanide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following is a list of adverse reactions spontaneously reported with nitazoxanide tablets which were not included in clinical trial listings: Gastrointestinal disorders : diarrhea, gastroesophageal reflux disease Nervous System disorders: dizziness Respiratory, thoracic and mediastinal disorders : dyspnea Skin and subcutaneous tissue disorders: rash, urticaria
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Competition for binding sites may occur when administered concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices. Monitor for adverse reactions (7).
7.1Highly Protein Bound Drugs with Narrow Therapeutic Indices Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Therefore, monitor for adverse reactions 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).
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Patients: Safety and efficacy of ALINIA ® for Oral Suspension in pediatric patients less than one year of age has not been studied (8.4).
8.1Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20.
Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.
8.2Lactation Risk Summary No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for nitazoxanide and any potential adverse effects on the breastfed infant from nitazoxanide or from the underlying maternal condition.
8.4Pediatric Use The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL [see Clinical Studies (14.1)] .
The safety and efficacy of nitazoxanide tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with nitazoxanide tablets 500 mg. A single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [see Dosage and Administration (2.1)]. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.
8.5Geriatric Use Clinical studies of nitazoxanide tablets and ALINIA for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets and ALINIA for Oral Suspension.
8.6Renal and Hepatic Impairment The pharmacokinetics of nitazoxanide in patients with compromised renal or hepatic function has not been studied.
8.7HIV-Infected or Immunodeficient Patients Nitazoxanide tablets and ALINIA for Oral Suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. Nitazoxanide tablets and ALINIA for Oral Suspension have not been shown to be su… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no data with nitazoxanide in pregnant women to inform a drug-associated risk. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Nitazoxanide produced no evidence of systemic maternal toxicity when administered once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. In rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20.
Oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL [see Clinical Studies (14.1)] .
The safety and efficacy of nitazoxanide tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with nitazoxanide tablets 500 mg. A single nitazoxanide tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [see Dosage and Administration (2.1)]. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of nitazoxanide tablets and ALINIA for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing nitazoxanide tablets and ALINIA for Oral Suspension.
🆘 Overdosage ▾
10 OVERDOSAGE Limited information on nitazoxanide overdosage is available. In the event of overdose, gastric lavage may be appropriate soon after oral administration. Patients should be observed and given symptomatic and supportive treatment. There is no specific antidote for overdose with nitazoxanide. Because tizoxanide is highly protein bound (>99.9%), dialysis is unlikely to significantly reduce plasma concentrations of the drug.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Nitazoxanide is an antiprotozoal [ see Microbiology (12.4) ].
12.3Pharmacokinetics Absorption Single Dosing: Following oral administration of nitazoxanide tablets or ALINIA for Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameters of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. Table 2.
Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subjects ≥12 years of age. Tizoxanide Tizoxanide Glucuronide Age C max * Tmax AUCɩ C max * Tmax AUCɩ (µg/mL) (hr) (µg•hr/mL) (µg/mL) (hr) (µg•hr/mL) 12-17 years 9.1 (6.1) 4.0 (1-4) 39.5 (24.2) 7.3 (1.9) 4.0 (2-8) 46.5 (18.2) ≥18 years 10.6 (2.0) 3.0 (2-4) 41.9 (6.0) 10.5 (1.4) 4.5 (4-6) 63.0 (12.3) * T max is given as a Mean (Range) Table 3. Mean (±SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of ALINIA for Oral Suspension with food to subjects ≥1 year of age Tizoxanide Tizoxanide Glucuronide Age Dose C max *T max AUC inf C max *T max AUC inf (µg/mL) (hr) (µg•hr/mL) (µg/mL) (hr) (µg•hr/mL) 1-3 years 100 mg 3.11 (2.0) 3.5 (2-4) 11.7 (4.46) 3.64 (1.16) 4.0 (3-4) 19.0 (5.03) 4-11 years 200 mg 3.00 (0.99) 2.0 (1-4) 13.5 (3.3) 2.84 (0.97) 4.0 (2-4) 16.9 (5.00) ≥18 years 500 mg 5.49 (2.06) 2.5 (1-5) 30.2 (12.3) 3.21 (1.05) 4.0 (2.5-6) 22.8 (6.49) * T max is given as a Mean (Range) Multiple dosing: Following oral administration of a single nitazoxanide tablet every 12 hours for 7 consecutive days, there was no significant accumulation of nitazoxanide metabolites tizoxanide or tizoxanide glucuronide detected in plasma.
Bioavailability: ALINIA for Oral Suspension is not bioequivalent to nitazoxanide tablets. The relative bioavailability of the suspension compared to the tablet was 70%. When nitazoxanide tablets are administered with food, the AUC 𝜏 of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%.
When ALINIA for Oral Suspension was administered with food, the AUC 𝜏 of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C max increased by ≤10%. Nitazoxanide tablets and ALINIA for Oral Suspension were administered with food in clinical trials and hence they are recommended to be administered with food [see Dosage and Administration (2.1)] . Distribution In plasma, more than 99% of tizoxanide is bound to proteins.
Elimination Metabolism Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. Excretion Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile.
Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Specific Populations Pediatric Patients The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of nitazoxanide tablets in pediatric patients 12-17 years of age are provided above in Table 2. Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subject ≥12 years of age.
The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ALINIA for Oral Suspension in pediatric patients 1-11 years of age are provided above in Table 3. Mean (±SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of ALINIA for Oral suspension with food to subjects ≥1 year of age. Drug Interaction Studies In vitro studies demonstrated that tizoxanide has no significant inhibitory effe… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Nitazoxanide is an antiprotozoal [ see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1Nitazoxanide Tablets (500 mg) Nitazoxanide Tablets are round, yellow, film-coated tablets debossed with ‘ZNN’ on one side, plain on the other side, and free from physical defects. Each tablet contains 500 mg of nitazoxanide. The tablets are packaged in HDPE bottles as: Bottles of 6 tablets NDC 70954-934-10 Bottles of 12 tablets NDC 70954-934-20 Bottles of 30 tablets NDC 70954-934-30 Store the tablets at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Nitazoxanide tablets contain the active ingredient, nitazoxanide, a synthetic antiprotozoal 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- N -(5-nitro-2-thiazolyl)benzamide. The molecular formula is C 12 H 9 N 3 O 5 S and the molecular weight is 307.3. The structural formula is: Nitazoxanide tablets contain 500 mg of nitazoxanide and the following inactive ingredients: corn starch, sodium starch glycolate type A, sucrose, hydroxypropyl methylcellulose, talc, magnesium stearate, polyvinyl alcohol, titanium dioxide, D&C yellow #10 aluminum lake, lecithin (soy), xanthan gum, FD&C yellow #6 aluminum lake, FD&C blue #2 aluminum lake. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients and parents/caregivers of pediatric patients taking nitazoxanide tablets of the following information: Dosage and Administration : Nitazoxanide tablets should be taken with food. Drug-drug Interactions: Avoid concurrent warfarin use. All trademarks are the property of their respective owners.
Made in India. Neutral Code: DRUGS/AP/01/2006 Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 01/2025 LB4756-00
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Single Dosing: Following oral administration of nitazoxanide tablets or ALINIA for Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. The pharmacokinetic parameters of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. Table 2.
Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subjects ≥12 years of age. Tizoxanide Tizoxanide Glucuronide Age C max * Tmax AUCɩ C max * Tmax AUCɩ (µg/mL) (hr) (µg•hr/mL) (µg/mL) (hr) (µg•hr/mL) 12-17 years 9.1 (6.1) 4.0 (1-4) 39.5 (24.2) 7.3 (1.9) 4.0 (2-8) 46.5 (18.2) ≥18 years 10.6 (2.0) 3.0 (2-4) 41.9 (6.0) 10.5 (1.4) 4.5 (4-6) 63.0 (12.3) * T max is given as a Mean (Range) Table 3. Mean (±SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of ALINIA for Oral Suspension with food to subjects ≥1 year of age Tizoxanide Tizoxanide Glucuronide Age Dose C max *T max AUC inf C max *T max AUC inf (µg/mL) (hr) (µg•hr/mL) (µg/mL) (hr) (µg•hr/mL) 1-3 years 100 mg 3.11 (2.0) 3.5 (2-4) 11.7 (4.46) 3.64 (1.16) 4.0 (3-4) 19.0 (5.03) 4-11 years 200 mg 3.00 (0.99) 2.0 (1-4) 13.5 (3.3) 2.84 (0.97) 4.0 (2-4) 16.9 (5.00) ≥18 years 500 mg 5.49 (2.06) 2.5 (1-5) 30.2 (12.3) 3.21 (1.05) 4.0 (2.5-6) 22.8 (6.49) * T max is given as a Mean (Range) Multiple dosing: Following oral administration of a single nitazoxanide tablet every 12 hours for 7 consecutive days, there was no significant accumulation of nitazoxanide metabolites tizoxanide or tizoxanide glucuronide detected in plasma.
Bioavailability: ALINIA for Oral Suspension is not bioequivalent to nitazoxanide tablets. The relative bioavailability of the suspension compared to the tablet was 70%. When nitazoxanide tablets are administered with food, the AUC 𝜏 of tizoxanide and tizoxanide glucuronide in plasma is increased almost two-fold and the C max is increased by almost 50%.
When ALINIA for Oral Suspension was administered with food, the AUC 𝜏 of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the C max increased by ≤10%. Nitazoxanide tablets and ALINIA for Oral Suspension were administered with food in clinical trials and hence they are recommended to be administered with food [see Dosage and Administration (2.1)] . Distribution In plasma, more than 99% of tizoxanide is bound to proteins.
Elimination Metabolism Following oral administration in humans, nitazoxanide is rapidly hydrolyzed to an active metabolite, tizoxanide (desacetyl-nitazoxanide). Tizoxanide then undergoes conjugation, primarily by glucuronidation. Excretion Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile.
Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. Specific Populations Pediatric Patients The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of nitazoxanide tablets in pediatric patients 12-17 years of age are provided above in Table 2. Mean (±SD) plasma pharmacokinetic parameters of tizoxanide and tizoxanide glucuronide following administration of a single dose of one 500 mg nitazoxanide tablet with food to subject ≥12 years of age.
The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ALINIA for Oral Suspension in pediatric patients 1-11 years of age are provided above in Table 3. Mean (±SD) plasma pharmacokinetic of tizoxanide and tizoxanide glucuronide parameter values following administration of a single dose of ALINIA for Oral suspension with food to subjects ≥1 year of age. Drug Interaction Studies In vitro studies demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Diarrhea Caused by G. lamblia Diarrhea caused by G. lamblia in adults and adolescents 12 years of age or older: In a double-blind, controlled trial (Study 1) conducted in Peru and Egypt in adults and adolescents with diarrhea and with one or more enteric symptoms (e.g., abdominal pain, nausea, vomiting, fever, abdominal distention, loss of appetite, flatulence) caused by G. lamblia , a three-day course of treatment with nitazoxanide tablets administered 500 mg twice daily was compared with a placebo tablet for 3 days.
A third group of patients received open-label ALINIA for Oral Suspension administered 500 mg/25mL of suspension twice daily for 3 days. A second double-blind, controlled trial (Study 2) conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal tenderness, abdominal cramps, abdominal distention, fever, bloody stool) caused by G. lamblia compared nitazoxanide tablets administered 500 mg twice daily for 3 days to a placebo tablet. For both of these studies, clinical response was evaluated 4 to 7 days following the end of treatment.
A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained: Table 4. Adult and Adolescent Patients with Diarrhea Caused by G. lamblia Clinical Response Rates* 4 to 7 Days Post-therapy % (Number of Successes/Total) Nitazoxanide Tablets ALINIA for Oral Suspension Placebo Tablets Study 1 85% (46/54) ¶ § 83% (45/54 )¶ § 44% (12/27) Study 2 100% (8/8) - 30% (3/10) *Includes all patients randomized with G. lamblia as the sole pathogen.
Patients failing to complete the studies were treated as failures. ¶ Clinical response rates statistically significantly higher when compared to placebo. § The 95% confidence interval of the difference in response rates for the tablet and suspension is (-14%, 17%). Some patients with ‘well’ clinical responses had G. lamblia cysts 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. Diarrhea caused by G. lamblia in pediatric patients 1 through 11 years of age: In a randomized, controlled trial conducted in Peru in 110 pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, right iliac fossa tenderness) caused by G. lamblia , a three-day course of treatment with nitazoxanide (100 mg twice daily in pediatric patients ages 24-47 months, 200 mg twice daily in pediatric patients ages 4 through 11 years) was compared to a five-day course of treatment with metronidazole (125 mg twice daily in pediatric patients ages 2 through 5 years, 250 mg twice daily in pediatric patients ages 6 through 11 years).
Clinical response was evaluated 7 to 10 days following initiation of treatment with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools with no hematochezia within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained: Table 5. Clinical Response Rates in Pediatric Patients 7 to 10 Days Following Initiation of Therapy Intent-to-Treat and Per Protocol Analyses % (Number of Successes/Total), [95% Confidence Interval] Population Nitazoxanide (3 days) Metronidazole (5 days) 95% CI Diff § Intent-to-treat analysis † 85% (47/55) 80% (44/55 ) [-9%, 20%] Per protocol analysis ¶ 90% (43/48) 83% (39/47 ) [-8%, 21%] † Intent-to-treat analysis includes all patients randomized with patients not completing the study treated as failures. ¶ Per protocol analysis includes only patients who took all of their medication and completed the study.
Seven patients in each treatmen… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Long-term carcinogenicity studies have not been conducted. Mutagenesis 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.
Impairment of Fertility 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).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis & Mutagenesis & Impairment Of Fertility Carcinogenesis Long-term carcinogenicity studies have not been conducted. Mutagenesis 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.
Impairment of Fertility 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).
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nitazoxanide Tablets, 500 mg Bottles of 6 tablets NDC 70954-934-10 label