Drug reference

Levofloxacin + Ornidazole

Fluoroquinolone antibiotic + Nitroimidazole antimicrobial/antiprotozoal (FDC) · Antibiotic, Antiprotozoal

Also known as L-Orni, Levoflox-OZ, Leflox-OZ, Levobact-OZ, Glevo-OZ

START

1 tablet BD (Levo 500 mg + Orni 500 mg) after meals; check baseline renal function, QTc if cardiac risk, seizure history; avoid antacids within 2 hours; counsel on tendon rupture risk and alcohol avoidance

TYPICAL MAX

1 tablet BD (do not exceed); duration 5-10 days depending on infection

STOP IF

Tendon pain/swelling, peripheral neuropathy symptoms, severe rash, QT prolongation, persistent diarrhea (C. difficile), signs of hepatotoxicity

WATCH

Tendon symptoms, glucose (dysglycemia in diabetics), QTc if cardiac risk, GI symptoms, C. difficile if diarrhea develops, alcohol avoidance (ornidazole)

CDSCO approvedSchedule HATC J01MA12 + P01AB03

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 1h · Rapid onset of both components
PEAK: 1.8h · Combined peak effect
t½: 10h · Average of components (Levo 6-8h, Orni 12-14h)
DURATION: 12h · 12-hour coverage (BD dosing)

EXCRETION

Renal (both components, primarily as unchanged drug/metabolites)

route + CYP

INTERACTIONS

—

none in our sources

PREGNANCY

Contraindicated in pregnancy; fluoroquinolones risk fetal cartilage/joint damage; nitroimidazoles risk in first trimester

FDA category + note

Available in India

140 branded formulations and 10 fixed-dose combinations. Look up specific brands in the Drugs workspace.

Mechanism

Levofloxacin: Inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, preventing DNA replication in Gram-negative and Gram-positive aerobes. Ornidazole: The nitro group is reduced by ferredoxin in anaerobic organisms, forming toxic radical intermediates that damage DNA. Combined to provide broad-spectrum coverage against aerobic, anaerobic, and protozoal pathogens.

Indications

Mixed aerobic-anaerobic bacterial infections (intra-abdominal, pelvic, diabetic foot)Surgical prophylaxis (colorectal, gynecological)Bacterial vaginosisAmoebiasis (when combined aerobic coverage needed)Helicobacter pylori eradication (as part of combination therapy)Community-acquired pneumonia (when atypical/anaerobic coverage needed)

Dosing

Adult: Levofloxacin 500 mg + Ornidazole 500 mg: 1 tablet BD for 5-10 days (depending on infection severity). Some formulations: Levofloxacin 250 mg + Ornidazole 500 mg BD
Pediatric: Not recommended under 18 years (fluoroquinolone component contraindicated)
Renal adjustment: Levofloxacin component requires adjustment: eGFR 20-49: 500 mg loading then 250 mg q24h; eGFR <20: 500 mg loading then 250 mg q48h. Ornidazole: no adjustment needed
Hepatic adjustment: Avoid in severe hepatic impairment
Geriatric: Use with caution; increased risk of tendon rupture, QT prolongation, and neurotoxicity
Max dose: Levofloxacin 750 mg/day; Ornidazole 1.5 g/day (from FDC)

Pharmacokinetics

Onset

Rapid bactericidal effect (both components)

Peak effect

Levofloxacin: 1-2 hours; Ornidazole: 1.5-2 hours

Duration

12 hours (BD dosing)

Half-life

Levofloxacin: 6-8 hours; Ornidazole: 12-14 hours

Bioavailability

Levofloxacin: ~99%; Ornidazole: ~90%

Protein binding

Levofloxacin: 24-38%; Ornidazole: ~12%

Metabolism

Levofloxacin: Minimal metabolism (<5%); primarily excreted unchanged. Ornidazole: Hepatic oxidation and hydroxylation

Excretion

Levofloxacin: Renal (~87% unchanged). Ornidazole: Renal (20-25% unchanged); fecal (12%)

Contraindications

Hypersensitivity to levofloxacin, ornidazole, or other fluoroquinolones/nitroimidazoles
History of tendon disorders related to fluoroquinolone use
QT prolongation or concurrent QT-prolonging medications
Epilepsy or lowered seizure threshold
Pregnancy (especially first trimester) and breastfeeding
Children and adolescents under 18 years (fluoroquinolone component)
Severe hepatic impairment
Concurrent disulfiram use (within last 2 weeks)