Ofloxacin + Ornidazole

Ofloxacin, a fluoroquinolone, inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription. Ornidazole, a nitroimidazole, enters anaerobic cells and protozoa, where it is reduced to reactive intermediates that damage DNA and other macromolecules. This combination provides broad-spectrum bactericidal activity against aerobic and anaerobic bacteria, as well as protozoa, making it effective against mixed infections. Combination rationale: This FDC is rational due to the synergistic activity of its components, providing a broad spectrum of coverage against both aerobic and anaerobic bacteria, as well as protozoal infections. It is particularly useful for treating mixed infections common in conditions like acute infective diarrhea, intra-abdominal infections, and gynaecological infections, reducing the need for multiple drugs.

Adult

Oral: Ofloxacin 200 mg + Ornidazole 500 mg, twice daily for 5-7 days, depending on the severity and type of infection. Common strengths available are 200mg+500mg and 400mg+500mg (Ofloxacin + Ornidazole).

Pediatric

Not generally recommended for children under 12 years due to potential cartilage damage with fluoroquinolones. For older children/adolescents in specific severe indications, consult a pediatrician for weight-based dosing.

Renal adjustment

Creatinine Clearance (CrCl) 20-50 mL/min: Administer usual dose every 24 hours. CrCl < 20 mL/min: Administer half of the usual dose every 24 hours. Both ofloxacin and ornidazole are significantly excreted via the kidneys.

Hepatic adjustment

Use with caution in severe hepatic impairment; dose reduction may be required for both components due to altered metabolism and excretion. Monitor liver function closely.

Geriatric

No specific dose adjustment for elderly patients based on age alone, but caution should be exercised due to potential age-related decrease in renal function. Dose reduction may be necessary if renal impairment is present.

Max dose

Ofloxacin: 400 mg/day; Ornidazole: 1000 mg/day (when used in combination as 200mg+500mg BD).

• Hypersensitivity to ofloxacin, ornidazole, other quinolones, or nitroimidazole derivatives
• Epilepsy or other CNS disorders (e.g., history of seizures, multiple sclerosis)
• Pregnancy (especially first trimester)
• Lactation
• Children below 12 years (or below a certain weight)
• Tendinitis or tendon rupture associated with fluoroquinolone use