Nitazoxanide Schedule (India)

Schedule H

Nitazoxanide Routes

Oral

Nitazoxanide Formulations

Tablets: 200 mg, 500 mg

Oral suspension: 100 mg/5 mL (powder for reconstitution)

Nitazoxanide Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Diarrhoea caused by Giardia lamblia (Giardiasis)

Parameter Recommendation

Starting dose 500 mg twice daily with food

Titration Not applicable

Usual maintenance dose 500 mg twice daily

Maximum dose 500 mg twice daily (1 g/day)

Duration: 3 days

Clinical Notes:

Confirm diagnosis with stool microscopy or antigen detection before initiating therapy

Administer with food to enhance absorption

Response rate >85% for Giardia infections

Diarrhoea caused by Cryptosporidium parvum (Cryptosporidiosis)

Parameter Recommendation

Starting dose 500 mg twice daily with food

Titration Not applicable

Usual maintenance dose 500 mg twice daily

Maximum dose 500 mg twice daily (1 g/day)

Duration: 3 days (may extend to 5–7 days in immunocompromised patients)

Clinical Notes:

Particularly useful in HIV patients with cryptosporidiosis (in addition to ART)

Ensure adequate hydration and electrolyte replacement

Efficacy reduced in severely immunocompromised patients

Intestinal Amoebiasis (Entamoeba histolytica)

Parameter Recommendation

Starting dose 500 mg twice daily with food

Titration Not applicable

Usual maintenance dose 500 mg twice daily

Maximum dose 500 mg twice daily

Duration: 3–5 days

Clinical Notes:

May be used as alternative to metronidazole or tinidazole

Not recommended for hepatic amoebiasis (metronidazole preferred)

Confirm diagnosis with stool examination or antigen testing

Intestinal Helminthic Infections

Used when first-line agents (albendazole, mebendazole) are contraindicated, not tolerated, or unavailable. Active against Ascaris lumbricoides, Trichuris trichiura, Ancylostoma duodenale, Enterobius vermicularis, Taenia species, Hymenolepis nana, and Fasciola hepatica.

Parameter Recommendation

Starting dose 500 mg twice daily with food

Titration Not applicable

Usual maintenance dose 500 mg twice daily

Maximum dose 500 mg twice daily

Duration: 3 days for most helminths; may extend to 5–7 days for Fasciola or mixed infections

Clinical Notes:

Not first-line for routine helminthiasis; albendazole/mebendazole preferred

Confirm parasitic infection with stool examination before treatment

May be useful in mixed protozoal and helminthic infections

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Clostridioides difficile Infection (mild-moderate, recurrent or metronidazole-refractory) 500 mg twice daily with food 10 days OFF-LABEL — Specialist only (Gastroenterology/ID). Based on RCTs showing comparable efficacy to vancomycin in mild-moderate CDI. Not first-line; consider when vancomycin or fidaxomicin not available/appropriate.

Viral Gastroenteritis (rotavirus, norovirus) 500 mg twice daily with food 3 days OFF-LABEL — Limited evidence from small RCTs suggesting reduction in duration of diarrhoea. Not standard practice; consider in severe/prolonged cases.

Blastocystis hominis Infection 500 mg twice daily with food 3–5 days OFF-LABEL — Used when metronidazole fails or not tolerated. Based on clinical experience and small studies.

Nitazoxanide Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Diarrhoea caused by Giardia lamblia / Cryptosporidium parvum / Intestinal Amoebiasis

Age-based Dosing (using oral suspension or tablets):

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

1–3 years ~10–15 kg 100 mg (5 mL suspension) Twice daily Suspension

4–11 years ~15–40 kg 200 mg (10 mL suspension OR 200 mg tablet) Twice daily Suspension or tablet

≥12 years >40 kg 500 mg Twice daily Tablet

Alternative Weight-based Dosing:

7.5 mg/kg/dose twice daily (maximum 500 mg per dose)

Parameter Recommendation

Starting dose Age/weight-based as above

Titration Not applicable

Usual maintenance dose As per age/weight table

Maximum dose 500 mg twice daily

Duration: 3 days

Clinical Notes:

Administer with food to improve absorption

Oral suspension preferred for children <6 years

Shake suspension well before each dose

Ensure confirmation of parasitic infection before treatment

Minimum Age Statement: Not recommended in infants below 12 months of age. Use in infants 1–12 months only under paediatric gastroenterologist supervision for severe/refractory parasitic infections.

Safety Monitoring:

Monitor hydration status and electrolytes

Watch for GI adverse effects (abdominal pain, nausea)

Ensure resolution of symptoms; repeat stool examination if symptoms persist beyond 5 days

Secondary Indications — Paediatrics (Off-label)

Indication Age Dose Notes

Refractory Rotavirus Diarrhoea ≥1 year Age-based dosing as above; Duration: 3 days OFF-LABEL — Specialist only. Limited evidence showing reduction in duration of diarrhoea in hospitalised children. Based on small RCTs. Ensure adequate rehydration.

Cryptosporidiosis in HIV-infected Children ≥1 year 7.5 mg/kg/dose twice daily (max 500 mg); Duration: 3–14 days based on response OFF-LABEL — Paediatric ID specialist only. Efficacy reduced in severely immunocompromised; optimise ART concurrently.

Nitazoxanide Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation

Nitazoxanide is rapidly metabolised to active metabolite tizoxanide, which is primarily eliminated via biliary/faecal route with minimal renal excretion (<5%).

eGFR (ml/min/1.73m²)	Recommendation

Mild to moderate impairment No dose adjustment required

eGFR (ml/min/1.73m²)	Recommendation
Haemodialysis	No specific data; unlikely to be significantly dialysed due to high protein binding (>99%); use with caution
Peritoneal dialysis	No specific data; use with caution

Nitazoxanide Hepatic adjustment

Severity	Recommendation
Mild impairment (Child-Pugh A)	No dose adjustment required; use standard dosing
Moderate impairment (Child-Pugh B)	Use with caution; tizoxanide is hepatically glucuronidated; monitor LFTs if treatment exceeds 3 days
Severe impairment (Child-Pugh C)	Use with caution; limited data; avoid prolonged courses; monitor LFTs closely

Note: Active metabolite tizoxanide undergoes hepatic glucuronide conjugation. In significant hepatic impairment, clearance may be reduced.

Nitazoxanide Contraindications

Known hypersensitivity to nitazoxanide or any excipient in the formulation

Known allergy to other thiazolide compounds

Nitazoxanide Cautions

Hepatic impairment — metabolite cleared hepatically; monitor LFTs if prolonged use

Diabetes mellitus — oral suspension contains sucrose; monitor glucose if large volumes used in diabetic children

Patients with G6PD deficiency — rare reports of haemolysis; monitor if using in known G6PD-deficient patients

Empiric use for non-parasitic diarrhoea — avoid; confirm parasitic aetiology before treatment

Immunocompromised patients — reduced efficacy in severe immunosuppression; ensure adequate treatment of underlying condition

Concurrent use of highly protein-bound drugs — tizoxanide is >99% protein-bound; theoretical risk of displacement interactions

Oral suspension contains excipients (sucrose, sorbitol) — may not be suitable in hereditary fructose intolerance or sucrase-isomaltase deficiency

Nitazoxanide Pregnancy

Parameter Recommendation

Safety Category Limited human data; animal studies do not indicate teratogenicity but data insufficient for routine use

Preferred Alternatives Metronidazole (for giardiasis/amoebiasis after first trimester); paromomycin (for giardiasis — not systemically absorbed)

When to Use May be considered in second/third trimester only if clearly needed and preferred alternatives unsuitable; avoid in first trimester if possible

Monitoring Maternal LFTs if prolonged use; standard fetal monitoring

Nitazoxanide Lactation

Parameter Recommendation

Breastfeeding Compatibility Likely compatible; limited data but low systemic absorption expected

Drug Levels in Milk Unknown; expected to be low given extensive protein binding and limited systemic exposure

Preferred Alternatives Metronidazole (well-studied in lactation) for giardiasis/amoebiasis

Infant Monitoring Monitor for diarrhoea, GI upset, or poor feeding (unlikely with short course)

Nitazoxanide Elderly

Parameter Recommendation

Starting dose Standard adult dose (500 mg twice daily)

Titration Not applicable

Additional Risks Age-related renal/hepatic decline (monitor if impairment present); increased dehydration risk with diarrhoeal illness; ensure adequate fluid and electrolyte replacement

Monitoring Hydration status; renal function if concurrent nephrotoxic drugs

Nitazoxanide Major drug interactions

Interacting Drug Mechanism/Effect Management

Warfarin Potential alteration of INR due to effect on gut flora (vitamin K synthesis) or theoretical protein-binding displacement Monitor INR closely during and after nitazoxanide course; adjust warfarin dose as needed

Highly protein-bound drugs (phenytoin, valproate, diazepam) Tizoxanide is >99% protein-bound; theoretical displacement risk Monitor for increased effect/toxicity of co-administered drug; clinical significance uncertain

Note: Nitazoxanide/tizoxanide do not significantly interact with cytochrome P450 enzymes. Major interactions are limited.

Nitazoxanide Moderate drug interactions

Interacting Drug Effect Management

Oral antidiabetic agents Diarrhoeal illness may affect absorption; sucrose in suspension may affect glucose Monitor blood glucose; adjust antidiabetic dose if needed

Immunosuppressants (tacrolimus, ciclosporin) Diarrhoea may reduce absorption of immunosuppressants Monitor immunosuppressant levels during diarrhoeal illness

Oral contraceptives Diarrhoea/vomiting may reduce absorption Advise additional contraceptive precautions during and 7 days after treatment

Metformin Additive GI effects (nausea, diarrhoea) Monitor GI tolerability

Nitazoxanide Common Adverse effects

Abdominal pain

Nausea

Diarrhoea (may be difficult to distinguish from underlying infection)

Headache

Vomiting

Flatulence

Discoloured urine (yellow-green) — benign, resolves after stopping

Anorexia

Dizziness

Nitazoxanide Serious Adverse effects

Adverse Effect Clinical Significance

Hypersensitivity reactions Rash, pruritus, urticaria, angioedema (rare); discontinue if occurs

Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis Very rare; discontinue immediately if mucocutaneous reaction occurs

Hepatotoxicity Elevated transaminases (rare); monitor LFTs if prolonged use; discontinue if significant elevation

Haemolytic anaemia Very rare; reported in G6PD-deficient patients; monitor if known G6PD deficiency

Thrombocytopenia Very rare; discontinue if occurs

Tachycardia Rare; mechanism unclear

Nitazoxanide Monitoring requirements

Baseline:

Stool microscopy or antigen testing to confirm parasitic infection

Liver function tests (if hepatic impairment or prolonged therapy anticipated)

Glucose monitoring (if diabetic and using suspension)

After Initiation/During Therapy:

Clinical assessment of diarrhoea resolution

Watch for adverse effects (nausea, abdominal pain)

Monitor for hypersensitivity reactions (rash, jaundice)

Long-term (if extended therapy):

Repeat stool examination if symptoms persist beyond 5–7 days

LFTs if treatment extended beyond 5 days

Assessment for superinfection

Nitazoxanide Brands in India

Nizonide® (Lupin)

Nitazet® (Cipla)

Zintacide® (Zydus Cadila)

Nidazox® (Aristo)

Nitax® (Mankind)

Nitazox® (Sun Pharma)

Nitopar® (Micro Labs)

Entamizole-N® (various — FDC)

Fixed-Dose Combinations (FDCs):

Nitazoxanide + Ofloxacin

Nitazoxanide + Albendazole

Note: FDCs should be used judiciously; avoid unless specific clinical indication for both components.

Nitazoxanide Price range (INR)

Formulation	Approximate Price (per tablet)
Nitazoxanide 200 mg tablet ₹5–₹12 per tablet
Nitazoxanide 500 mg tablet ₹12–₹35 per tablet
Nitazoxanide oral suspension 100 mg/5 mL (30 mL) ₹30–₹60 per bottle
Nitazoxanide oral suspension 100 mg/5 mL (60 mL) ₹50–₹90 per bottle

Not included in NLEM 2022

Not under NPPA price control

Available in private market; limited government supply

Significant price variation between brands

Nitazoxanide Clinical pearls

Confirm diagnosis first: Avoid empiric use for all acute diarrhoea; best results when parasitic infection (Giardia, Cryptosporidium, amoeba) is confirmed by stool microscopy or antigen testing

Take with food: Bioavailability significantly enhanced when administered with food; always counsel patients/caregivers to give with meals

Yellow-green urine is benign: Warn patients about harmless discolouration of urine/sclera; prevents unnecessary concern and treatment discontinuation

Not first-line for helminths: Albendazole/mebendazole remain first-choice for routine helminthic infections; nitazoxanide is alternative when these are contraindicated or in mixed protozoal-helminthic infections

Avoid in neonates: Safety not established below 12 months; use only under specialist supervision in this age group

Broad-spectrum advantage: Unique among antiparasitics for activity against protozoa, helminths, and some bacteria/viruses — useful when mixed or uncertain parasitic aetiology

Nitazoxanide Tags

nitazoxanide; antiprotozoal; giardiasis; cryptosporidiosis; amoebiasis; helminthiasis; acute diarrhoea; paediatric-safe; gastroenterology; parasitic-infection

Nitazoxanide Version

RxIndia v1.0 — 10 Jan 2025

Nitazoxanide Reference

CDSCO approved prescribing information

Indian Pharmacopoeia (IP)

National Formulary of India (NFI)

API Textbook of Medicine

IAP Guidelines for Management of Diarrhoeal Diseases

ICMR Guidelines for Parasitic Infections

AIIMS Antimicrobial Policy (Enteric Infections)

Goodman & Gilman's The Pharmacological Basis of Therapeutics

International RCTs (for C. difficile and viral gastroenteritis — off-label indications only)

RxIndia

The Drug Registry

Ivermectin

Nitazoxanide