Schedule H

Oral, Intravenous

Form Strengths Available

Tablet 300 mg, 500 mg

IV Infusion 400 mg/100 mL, 800 mg/100 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Amoebiasis (Intestinal)

Parameter Details

Starting dose 2 g orally once daily after food

Titration Not applicable

Usual maintenance dose 2 g once daily

Maximum dose 2 g/day

Duration 3 days

Clinical Notes:

• Combine with luminal amoebicide (diloxanide furoate 500 mg TDS × 10 days) to eradicate intestinal cysts

• Administer after meals to reduce GI intolerance

1. Amoebiasis (Hepatic/Amoebic Liver Abscess)

Parameter Oral Intravenous (if oral not feasible)

Starting dose 2 g once daily 800 mg once daily

Titration Not applicable Not applicable

Usual maintenance dose 2 g once daily 800 mg once daily

Maximum dose 2 g/day 800 mg/day

Duration 5–6 days 5–6 days

Clinical Notes:

• Always combine with luminal amoebicide (diloxanide furoate) after completing tinidazole course

• Consider drainage if abscess >10 cm or left lobe involvement

1. Giardiasis

Option A — Single-Dose Regimen (Preferred):

Parameter Details

Starting dose 2 g orally as single dose after food

Titration Not applicable

Usual maintenance dose Single-dose therapy (no maintenance)

Maximum dose 2 g

Option B — Multi-Day Regimen:

Parameter Details

Starting dose 150 mg orally twice daily

Titration Not applicable

Usual maintenance dose 150 mg twice daily

Maximum dose 300 mg/day

Duration 7 days

Clinical Notes:

• Single-dose regimen preferred for better compliance

• Stool examination at 2–4 weeks to confirm parasitological cure

1. Trichomoniasis

Parameter Details

Starting dose 2 g orally as single dose

Titration Not applicable

Usual maintenance dose Single-dose therapy (no maintenance)

Maximum dose 2 g

Clinical Notes:

• Treat sexual partner simultaneously

• Avoid sexual intercourse until both partners treated and asymptomatic

• Test of cure recommended in pregnant women

1. Bacterial Vaginosis

Option A — Short Course (Preferred):

Parameter Details

Starting dose 2 g orally once daily

Titration Not applicable

Usual maintenance dose 2 g once daily

Maximum dose 2 g/day

Duration 2 days

Option B — Extended Course:

Parameter Details

Starting dose 1 g orally once daily

Titration Not applicable

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Intestinal Amoebiasis

Weight/Age Starting Dose Route Frequency Maximum Dose Duration

All paediatric 50 mg/kg/day Oral Once daily 2 g/day 3 days

Parameter Details

Starting dose 50 mg/kg orally once daily

Titration Not applicable

Usual maintenance dose 50 mg/kg once daily

Maximum dose 2 g/day

Duration 3 days

1. Hepatic Amoebiasis (Amoebic Liver Abscess)

Parameter Details

Starting dose 50 mg/kg orally once daily

Titration Not applicable

Usual maintenance dose 50 mg/kg once daily

Maximum dose 2 g/day

Duration 5–10 days

Clinical Notes:

• Combine with luminal amoebicide after completing course

• Ultrasound follow-up recommended

1. Giardiasis

Parameter Details

Starting dose 50 mg/kg orally as single dose

Titration Not applicable

Usual maintenance dose Single-dose therapy (no maintenance)

Maximum dose 2 g

1. Trichomoniasis (Post-Pubertal Adolescents Only)

Parameter Details

Starting dose 50 mg/kg/day orally in divided doses

Titration Not applicable

Usual maintenance dose 50 mg/kg/day in 2–3 divided doses

Maximum dose 2 g/day

Duration 5–7 days

Clinical Notes:

• Only in post-pubertal sexually active adolescents

• Treat partner simultaneously

• Specialist supervision required

Minimum Age Statement

⚠️ Not recommended in children <3 years except when strongly indicated and under specialist supervision. Limited safety data in this age group.

Safety Monitoring — Paediatrics

• Monitor for GI tolerance (nausea, vomiting)

• Watch for neurological adverse effects during prolonged use (>7 days)

• Assess for signs of peripheral neuropathy if repeat courses given

• Counsel regarding metallic taste (common, harmless)

Secondary Indications — Paediatrics (Off-label)

None established in Indian paediatric practice.

Mild-to-moderate impairment No dose adjustment required

• Known hypersensitivity to tinidazole or other nitroimidazoles (metronidazole, secnidazole, ornidazole)

• First trimester of pregnancy

• History of blood dyscrasias

• Active CNS disorders (epilepsy, organic brain disease)

• Concurrent disulfiram use (within 2 weeks)

• History of seizures or encephalopathy

• Alcohol consumption: Strictly avoid during treatment and for 72 hours post-treatment (disulfiram-like reaction risk)

• Prolonged use >10 days: Risk of peripheral neuropathy — monitor closely

• Pre-existing hepatic dysfunction

• Pre-existing peripheral neuropathy

• Avoid repeated courses unless strongly indicated

• Candida overgrowth with prolonged use

Aspect Details

Overall Safety Contraindicated in first trimester

First Trimester Avoid; Crosses placenta — teratogenicity concern based on animal data

Second/Third Trimester Use only if benefit clearly outweighs risk; Specialist input advised

Preferred Alternatives Metronidazole (more extensive human pregnancy data, though similar cautions apply)

Monitoring Fetal growth and well-being; Maternal liver function

Aspect Details

Compatible with Breastfeeding Not recommended during treatment and for 3 days after last dose

Drug Levels in Milk High; Excreted in significant concentrations in breast milk

Preferred Alternatives Metronidazole (shorter half-life; can time breastfeeding around doses)

Infant Monitoring If unavoidable use: GI disturbance (diarrhoea, vomiting), oral candidiasis, hypersensitization

Aspect Recommendation

Starting dose Standard adult dose (2 g for single-dose regimens)

Titration Slower titration not usually required

Special Considerations Extra caution if hepatic impairment or baseline neurological symptoms present

Monitoring Peripheral neuropathy with prolonged use; CNS effects (confusion, dizziness)

Dose Adjustment No routine adjustment if hepatic and renal function normal

Interacting Drug Mechanism/Effect Management

Alcohol (ethanol) Disulfiram-like reaction (flushing, nausea, vomiting, tachycardia, hypotension) Avoid alcohol during and for 72 hours after last dose

Disulfiram Acute psychotic reactions, confusional states Contraindicated — do not co-administer; Minimum 2-week gap

Warfarin Potentiates anticoagulant effect via CYP2C9 inhibition → Increased INR and bleeding risk Monitor INR closely; May need warfarin dose reduction

CYP3A4 substrates May alter metabolism (less potent than metronidazole) Monitor for altered efficacy/toxicity of substrate drugs

Interacting Drug Effect Management

Phenytoin/Phenobarbital CYP induction may reduce tinidazole levels Monitor clinical efficacy; Consider alternative or dose adjustment

Lithium May increase lithium levels → Toxicity risk Monitor serum lithium levels

Fluorouracil (5-FU) Reduced 5-FU clearance → Increased toxicity Monitor for 5-FU toxicity signs; Oncology input advised

Cyclosporine Possible increase in cyclosporine levels Monitor renal function; Drug level if available

Carbamazepine May reduce tinidazole efficacy Monitor clinical response

• Metallic or bitter taste (very common)

• Nausea, vomiting

• Anorexia

• Abdominal cramps/discomfort

• Headache

• Dizziness

• Fatigue/malaise

• Darkened urine (harmless chromogenic metabolite)

Adverse Effect Clinical Action

Peripheral neuropathy (paraesthesia, numbness) Discontinue immediately — may be irreversible with prolonged use

Seizures Rare, dose-related — Discontinue; Supportive care

Disulfiram-like reaction (with alcohol) Supportive management; Counsel strictly about alcohol avoidance

Hypersensitivity reactions (rash, urticaria, angioedema) Discontinue; Antihistamines/steroids if severe

Leukopenia Usually reversible — Monitor CBC; Discontinue if severe

Stevens-Johnson Syndrome/TEN Very rare — Immediate discontinuation; Urgent dermatology/burns referral

After initiation GI tolerance; CNS symptoms (headache, dizziness); Reinforce alcohol avoidance counselling

Long-term (>10 days) CBC; Neurological examination for peripheral neuropathy (paraesthesia, numbness, weakness)

Brand Name Manufacturer Notes

Tiniba Zydus Cadila Tablets

Fasigyn Pfizer Tablets

Tinicip Cipla Tablets

Tinidaz Cipla Tablets

Tini Alkem Tablets

Tozyme Mankind Tablets

Common FDCs:

NLEM Status: Included in NLEM 2022 — NPPA ceiling price applicable

1. Better tolerance than metronidazole: Tinidazole offers superior GI tolerability and once-daily dosing compared to metronidazole — Preferred choice for patients with metronidazole intolerance

1. Longer half-life advantage: Half-life ~12–14 hours allows once-daily dosing and single-dose regimens for giardiasis/trichomoniasis

1. Neuropathy vigilance: Discontinue at first sign of peripheral neuropathy (paraesthesia, numbness) — May be irreversible if continued

1. 72-hour alcohol rule: Counsel explicitly about strict alcohol abstinence during treatment AND for 72 hours after completion (longer window than metronidazole due to longer half-life)

1. Luminal agent essential: For amoebiasis (intestinal or hepatic), ALWAYS follow tinidazole with diloxanide furoate (500 mg TDS × 10 days) to eliminate cyst carriage and prevent relapse

1. Avoid empirical repeated use: Not recommended for routine antibiotic prophylaxis; Reserve for documented indications to minimize resistance and neurotoxicity risk

tinidazole; nitroimidazole; antiprotozoal; amoebiasis; giardiasis; trichomoniasis; bacterial vaginosis; anaerobic infections; alcohol-avoid; NLEM India

RxIndia v1.0 — 28 Apr 2025

• CDSCO Product Information

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• NLEM 2022

• API Textbook of Medicine

• AIIMS Adult and Pediatric Antimicrobial Guidelines

• IAP Textbook of Paediatrics

• ICMR Antimicrobial Resistance Surveillance India

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics