Satranidazole (300mg)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

Satranidazole is a second-generation 5-nitroimidazole derivative antimicrobial and antiprotozoal agent. It is structurally related to metronidazole and tinidazole but exhibits a broader spectrum of activity, improved pharmacokinetics, and a better safety profile, particularly regarding neurological side effects. It is widely used in India for the treatment of amoebiasis, giardiasis, trichomoniasis, and anaerobic bacterial infections.

OnsetDurationBioavailability
Peak plasma concentration (Tmax) is achieved within 2-4 hours of oral administration.Effective therapeutic concentrations are maintained for approximately 12-24 hours, supporting a twice-daily or once-daily dosing regimen.Approximately 85-90% following oral administration.

2. Mechanism of Action

Satranidazole is a prodrug. Its nitro group is reduced intracellularly by low-redox potential electron transport proteins (ferredoxin or flavodoxin) found in anaerobic microorganisms and protozoa. This reduction generates cytotoxic, short-lived nitro radical anions that cause DNA strand breaks, inhibition of nucleic acid synthesis, and ultimately cell death.

3. Indications & Uses

  • Intestinal amoebiasis (Entamoeba histolytica)
  • Giardiasis (Giardia lamblia)
  • Trichomoniasis (Trichomonas vaginalis)
  • Anaerobic bacterial infections (e.g., Bacteroides spp., Clostridium spp.)

4. Dosage & Administration

Adult Dosage: Amoebiasis/Giardiasis/Anaerobic Infections: 300 mg twice daily for 5-7 days. Trichomoniasis: A single dose of 2 grams (four 500mg tablets) OR 300 mg twice daily for 7 days.

Administration: To be taken orally, after food to minimize gastrointestinal upset. Tablet should be swallowed whole with a full glass of water. Do not crush or chew.

5. Side Effects

Common side effects may include:

  • Nausea
  • Metallic/bitter taste in mouth
  • Headache
  • Dizziness
  • Abdominal discomfort

6. Drug Interactions

DrugEffectSeverity
Warfarin and other Coumarin AnticoagulantsSatranidazole may potentiate anticoagulant effect, increasing risk of bleeding.Major
LithiumMay increase lithium serum levels and risk of toxicity.Major
Phenobarbital, PhenytoinEnzyme inducers may reduce plasma concentration of satranidazole.Moderate
CimetidineMay increase plasma concentration of satranidazole by inhibiting metabolism.Moderate
AlcoholRisk of a disulfiram-like reaction (flushing, tachycardia, nausea) is low but possible. Avoidance is still recommended.Moderate

7. Patient Counselling

  • DO complete the full course of treatment, even if you feel better.
  • DO take the medicine after food.
  • DO inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
  • DO NOT consume alcohol during treatment and for at least 72 hours after the last dose.
  • DO NOT drive or operate heavy machinery if you experience dizziness.

8. Toxicology & Storage

Overdose: Nausea, vomiting, ataxia, seizures, and peripheral neuropathy. No specific organ failure pattern is consistently reported.

Storage: Store below 30°C, in a cool, dry place. Protect from light and moisture. Keep out of reach of children.