Usage
Ofloxacin + Ornidazole + Sodium Chloride is a combination antibiotic used to treat mixed bacterial and protozoal infections, particularly those involving anaerobic bacteria and protozoa susceptible to ornidazole, and aerobic bacteria susceptible to ofloxacin. It is commonly prescribed for diarrheal infections caused by mixed bacterial and protozoal pathogens. Sodium chloride maintains hydration and electrolyte balance during the antibiotic treatment, especially if administered intravenously.
Pharmacological Classification:
- Ofloxacin: Fluoroquinolone antibiotic
- Ornidazole: Nitroimidazole antibiotic (also active against some protozoa)
- Sodium Chloride: Electrolyte and osmotic agent
Mechanism of Action:
Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and repair. Ornidazole disrupts microbial DNA synthesis and causes DNA strand breakage, particularly in anaerobic microorganisms and some protozoa.
Alternate Names
This combination is often referred to as Ornilox, Ofloxacin & Ornidazole Tablets, Ofloxacin and Ornidazole Tablets IP, Floxa OZ, Glofty-OZ, or Oflocin OZ. Brand names vary depending on the manufacturer and region.
How It Works
Pharmacodynamics:
Ofloxacin and ornidazole act synergistically to kill bacteria and some protozoa, providing broad-spectrum coverage. Sodium chloride maintains hydration and electrolyte balance, which can be important during infection and antibiotic treatment.
Pharmacokinetics:
- Absorption: Ofloxacin is well-absorbed orally, while ornidazole absorption may be slightly slower. Intravenous administration provides direct entry into the bloodstream.
- Metabolism: Both ofloxacin and ornidazole are metabolized in the liver. Dosage adjustments are necessary in patients with hepatic impairment.
- Elimination: Ofloxacin is primarily excreted renally, while ornidazole is excreted both renally and in feces. Dose reduction is required in patients with renal dysfunction.
Mode of Action:
Ofloxacin targets DNA gyrase and topoisomerase IV, inhibiting DNA replication and repair in bacteria. Ornidazole forms reactive metabolites that damage microbial DNA.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Ornidazole’s mechanism involves DNA damage via reactive metabolites.
Elimination Pathways: Ofloxacin is primarily eliminated renally. Ornidazole undergoes hepatic metabolism and is excreted via both renal and fecal pathways.
Dosage
Standard Dosage
Adults:
One tablet (Ofloxacin 200 mg + Ornidazole 500 mg) orally twice daily, preferably with or after meals, for 5-10 days or as directed by the physician.
For intravenous infusions of Ofloxacin + Sodium Chloride + Ornidazole, dosing is determined by patient-specific factors and infection severity, and it must be administered by a healthcare professional in a clinical setting.
Children:
Dosage and formulation should be adjusted based on the child’s age and weight. Safety and efficacy in children under 8 years have not been fully established for all formulations. Liquid suspensions (Ofloxacin 50mg/5ml + Ornidazole 125mg/5ml) are often used for pediatric patients.
Special Cases:
- Elderly Patients: Dosage adjustment may be needed due to age-related decline in renal function.
- Patients with Renal Impairment: Dosage reduction based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dosage adjustment is necessary in severe hepatic impairment.
- Patients with Comorbid Conditions: Caution is advised in patients with diabetes, cardiovascular disease, epilepsy, myasthenia gravis, or CNS disorders; dose adjustment may be necessary.
Clinical Use Cases
Dosing in these scenarios should be individualized based on patient-specific factors and the infection’s severity, always under the guidance of a healthcare professional:
- Intubation: Consult latest clinical guidelines.
- Surgical Procedures: Prophylactic dosing as per surgical guidelines.
- Mechanical Ventilation: No specific dosage guidelines are available; adjustments should be patient-specific.
- Intensive Care Unit (ICU) Use: Dosage should be guided by clinical assessment, culture results, and patient response.
- Emergency Situations: Dosage should be based on the specific emergency and the patient’s condition.
Dosage Adjustments
Dose modifications are based on renal/hepatic dysfunction, other metabolic disorders, or genetic polymorphisms affecting drug metabolism. Consult specific guidelines.
Side Effects
Common Side Effects:
Nausea, vomiting, abdominal pain, headache, dizziness, insomnia, itching, vaginal inflammation (vaginitis), diarrhea, changes in taste.
Rare but Serious Side Effects:
Tendinitis, tendon rupture, peripheral neuropathy, CNS effects (seizures, hallucinations, confusion), exacerbation of myasthenia gravis, hypersensitivity reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Long-Term Effects:
Chronic complications from prolonged use are rare but can include peripheral neuropathy.
Adverse Drug Reactions (ADR):
Clinically significant ADRs requiring immediate intervention include severe hypersensitivity reactions, seizures, and tendon rupture.
Contraindications
- Hypersensitivity to ofloxacin, ornidazole, or other quinolones/nitroimidazoles.
- Epilepsy or other CNS disorders.
- Myasthenia gravis.
- History of tendon disorders related to quinolone use.
- Pregnancy and breastfeeding (generally avoided, use only if potential benefit outweighs risk).
- Patients with QTc prolongation.
Drug Interactions
Ofloxacin + Ornidazole + Sodium Chloride may interact with antacids (containing magnesium or aluminum), iron supplements, zinc supplements, anticoagulants (warfarin), certain antibiotics (e.g., macrolides), theophylline, NSAIDs, some antidiabetic medications, and other drugs that prolong the QT interval. Alcohol should be avoided during treatment. Check drug databases for detailed interaction information.
Pregnancy and Breastfeeding
This combination is generally avoided during pregnancy and breastfeeding due to potential risks to the fetus/infant (arthropathy, cartilage damage, effects on developing nervous system). If the benefit clearly outweighs the risk, use with extreme caution under strict medical supervision. Consider safer alternatives if available.
Drug Profile Summary
- Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Ornidazole disrupts microbial DNA.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, insomnia, tendinitis, tendon rupture, peripheral neuropathy, CNS effects.
- Contraindications: Hypersensitivity, epilepsy, myasthenia gravis, tendon disorders related to quinolones, pregnancy/breastfeeding.
- Drug Interactions: Antacids, iron/zinc supplements, warfarin, certain antibiotics, theophylline, NSAIDs, some antidiabetic medications.
- Pregnancy & Breastfeeding: Generally avoided.
- Dosage: Adults: One tablet twice daily. Pediatric and special cases: Dosage adjustment required.
- Monitoring Parameters: Renal function, liver function, signs of tendonitis, neurological symptoms, ECG (for QTc prolongation).
Popular Combinations
While not a combination itself, ofloxacin and ornidazole are often used together as a fixed-dose combination. The inclusion of sodium chloride is primarily relevant to intravenous formulations.
Precautions
- Screen for allergies, metabolic disorders, and organ dysfunction before prescribing.
- Caution in pregnant/breastfeeding women, children, and elderly patients.
- Avoid alcohol, monitor for tendonitis and neurological symptoms.
- Caution regarding QTc prolongation.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Ornidazole + Sodium Chloride?
A: Adults: One tablet (Ofloxacin 200 mg + Ornidazole 500 mg) twice daily. Pediatric and special populations require dosage adjustments.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, headache, dizziness.
Q3: What are the serious side effects?
A: Tendinitis, tendon rupture, peripheral neuropathy, CNS effects.
Q4: Can this drug be used in pregnancy?
A: Generally avoided; use only if potential benefit outweighs risk.
Q5: What are the contraindications?
A: Hypersensitivity, epilepsy, myasthenia gravis, history of tendon disorders with quinolones.
Q6: What are the drug interactions?
A: Antacids, iron/zinc, warfarin, certain antibiotics, theophylline, NSAIDs, some antidiabetic drugs.
Q7: How should the drug be administered?
A: Orally with or after food for tablets. Intravenous administration should be done by a healthcare professional.
Q8: Can it be used in children?
A: Yes, but with dosage adjustments and careful monitoring. Liquid formulations are often preferred.
Q9. What are the monitoring parameters?
A: Renal and liver function, signs of tendonitis or peripheral neuropathy, and neurological status. Monitor ECG for QTc prolongation, especially in patients at risk.
