Usage
Ofloxacin + Ornidazole is a combination antibiotic used to treat various bacterial and protozoal infections. Ofloxacin is a fluoroquinolone antibiotic, while Ornidazole is a nitroimidazole antibiotic. This combination is effective against a broad spectrum of microorganisms. It is commonly prescribed for:
- Diarrhea caused by mixed infections (bacterial and protozoal): This is one of the primary indications for this drug combination.
- Intra-abdominal infections: Such as peritonitis.
- Gynecological and pelvic infections: Including bacterial vaginosis, trichomoniasis, and pelvic inflammatory disease.
- Skin and soft tissue infections: Such as cellulitis and wound infections.
- Respiratory tract infections: Like bronchitis and pneumonia (though other options might be preferred for these).
- Sexually transmitted infections (STIs): Including gonorrhea, chlamydia, and mixed infections of the urethra and cervix.
- Urinary tract infections (UTIs): Including cystitis and prostatitis.
- Gastrointestinal infections: Such as giardiasis and amoebiasis (including amoebic dysentery and liver abscess).
- Surgical prophylaxis: To prevent infections during surgical procedures, especially involving the colon or gynecological areas.
Pharmacological Classification: Antibiotic (combination of fluoroquinolone and nitroimidazole).
Alternate Names
There isn’t a universally recognized alternate name for this combination. It is generally referred to as “Ofloxacin + Ornidazole” or “Ofloxacin and Ornidazole”.
Brand Names: Several brand names exist depending on the region and manufacturer. Some examples include Oflozole, O-Cebran-OZ, Ornilox and Oflozee OZ.
How It Works
Pharmacodynamics:
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription, leading to bacterial cell death.
- Ornidazole: Disrupts microbial DNA synthesis and structure, causing cell death in both bacteria and protozoa.
Pharmacokinetics:
- Ofloxacin: Well-absorbed orally, reaching peak plasma concentrations within 1-2 hours. Metabolized in the liver to a small extent and primarily excreted by the kidneys.
- Ornidazole: Also well-absorbed orally. Metabolized in the liver, and metabolites are excreted in urine.
Mechanism of Action:
- Ofloxacin: Targets DNA gyrase and topoisomerase IV, which are essential for bacterial DNA replication and repair. By inhibiting these enzymes, Ofloxacin prevents bacterial DNA from unwinding and duplicating, halting bacterial growth.
- Ornidazole: Undergoes reductive activation within anaerobic microorganisms, forming cytotoxic metabolites. These metabolites interact with DNA, causing strand breakage and inhibiting DNA repair and synthesis, leading to cell death.
Elimination Pathways:
- Ofloxacin: Primarily renal excretion.
- Ornidazole: Hepatic metabolism followed by renal excretion of metabolites.
Dosage
Standard Dosage
Adults:
The usual adult dose is one tablet of Ofloxacin 200mg + Ornidazole 500mg twice daily. The dose can be increased in severe infections. Tablets should be taken with or without food.
Children:
Ofloxacin is generally contraindicated in children and growing adolescents due to the risk of cartilage damage. While ornidazole can be used in children, the combined formulation is typically avoided. For children aged 8-12, a lower dose combination (Ofloxacin 100mg + Ornidazole 250mg) may be used, but only under strict medical supervision.
Special Cases:
- Elderly Patients: Dose adjustment based on creatinine clearance may be needed. Close monitoring of renal and hepatic function is recommended.
- Patients with Renal Impairment: Ofloxacin dosage needs to be reduced based on creatinine clearance. Ornidazole dosage does not usually require adjustment.
- Patients with Hepatic Dysfunction: Ofloxacin dose reduction may be necessary in severe liver disease. Ornidazole dosing interval may be doubled in severe hepatic impairment.
- Patients with Comorbid Conditions: Caution should be exercised in patients with epilepsy, multiple sclerosis, myasthenia gravis, heart conditions, coagulation disorders, and diabetes.
Clinical Use Cases
Dosage and duration of treatment in these settings should be determined by the treating physician based on individual patient factors and infection severity. The guidelines provided under ‘Standard Dosage’ generally apply.
Dosage Adjustments
Adjustments are typically required in elderly patients, and those with renal or hepatic impairment, as described above. Genetic polymorphisms affecting drug metabolism are not routinely tested for, but individual patient response should be monitored.
Side Effects
Common Side Effects:
Nausea, vomiting, abdominal pain, headache, dizziness, diarrhea, insomnia, itching, vaginal inflammation.
Rare but Serious Side Effects:
Seizures, peripheral neuropathy, tendonitis, tendon rupture, hypersensitivity reactions (including anaphylaxis), severe skin reactions, hepatotoxicity, QT interval prolongation, Clostridium difficile-associated diarrhea.
Long-Term Effects:
Peripheral neuropathy and tendon damage can potentially have long-term consequences.
Adverse Drug Reactions (ADR):
Severe allergic reactions, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatotoxicity, seizures, and tendon rupture require immediate medical attention.
Contraindications
- Hypersensitivity to Ofloxacin, Ornidazole, or other quinolones/nitroimidazoles.
- Epilepsy or conditions that lower seizure threshold.
- Myasthenia gravis.
- Pregnancy (especially first trimester, though Ornidazole is generally avoided throughout pregnancy).
- Breastfeeding.
- Children and growing adolescents (due to Ofloxacin).
- History of tendon disorders related to fluoroquinolone use.
- G6PD deficiency.
Drug Interactions
- Antacids: Reduce the absorption of Ofloxacin.
- Anticoagulants (e.g., warfarin): Ofloxacin may enhance the effects of warfarin.
- Antidiabetics: May interact with Ofloxacin, potentially causing hypoglycemia.
- Corticosteroids: Increase the risk of tendon rupture.
- Theophylline: Ofloxacin can increase theophylline levels.
- Cimetidine: May increase Ofloxacin levels.
- Probenecid: May reduce Ofloxacin elimination.
- Drugs that prolong QT interval: Use with caution as both Ofloxacin and Ornidazole can prolong the QT interval.
- Alcohol: May increase the risk of adverse effects, particularly dizziness and gastrointestinal issues.
- Dairy products: May reduce Ofloxacin absorption.
Pregnancy and Breastfeeding
- Pregnancy: Contraindicated. Ofloxacin can cause cartilage damage in immature animals. Ornidazole carries potential risks to the fetus.
- Breastfeeding: Contraindicated. Both drugs are excreted in breast milk, with potential risks to the infant.
Drug Profile Summary
- Mechanism of Action: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV. Ornidazole damages microbial DNA.
- Side Effects: Nausea, vomiting, diarrhea, headache, dizziness; rarely seizures, tendon rupture, and hypersensitivity reactions.
- Contraindications: Hypersensitivity, epilepsy, myasthenia gravis, pregnancy, breastfeeding, children.
- Drug Interactions: Antacids, anticoagulants, antidiabetics, corticosteroids, theophylline, alcohol, dairy.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: Ofloxacin 200mg + Ornidazole 500mg twice daily. Adjust for renal/hepatic impairment.
- Monitoring Parameters: Renal function, liver function, signs of tendonitis, neurological status, ECG (for QT interval prolongation) if clinically indicated.
Popular Combinations
Ofloxacin + Ornidazole is often used as a standalone combination. There is no widely established ‘popular combination’ where additional drugs are added to this specific combination.
Precautions
- Evaluate renal and hepatic function before and during treatment, particularly in elderly patients.
- Monitor for signs of tendinitis or tendon rupture.
- Discontinue immediately if signs of peripheral neuropathy or CNS effects appear.
- Advise patients about potential drug interactions and avoid concurrent use with contraindicated drugs.
- Caution against alcohol consumption during treatment.
- Maintain adequate hydration.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ofloxacin + Ornidazole?
A: The usual adult dose is Ofloxacin 200mg + Ornidazole 500mg twice daily. Dosage adjustments are needed for patients with renal or hepatic impairment.
Q2: Can Ofloxacin + Ornidazole be used in children?
A: Ofloxacin is contraindicated in children and growing adolescents. The combined formulation is generally avoided in children except in specific situations, and with dose reduction, for children aged 8-12 under strict medical supervision.
Q3: What are the most common side effects?
A: Nausea, vomiting, abdominal pain, headache, dizziness, and diarrhea are commonly reported.
Q4: What are the serious side effects to watch out for?
A: Tendon rupture, seizures, peripheral neuropathy, severe allergic reactions, and liver toxicity are rare but serious side effects.
Q5: Can pregnant or breastfeeding women take Ofloxacin + Ornidazole?
A: No, this combination is contraindicated in both pregnancy and breastfeeding due to potential risks to the fetus/infant.
Q6: What should I do if a patient experiences tendon pain while taking this medication?
A: Discontinue the medication immediately and evaluate the patient for tendinitis or tendon rupture.
Q7: Does Ofloxacin + Ornidazole interact with other medications?
A: Yes, it can interact with several medications, including antacids, anticoagulants, antidiabetics, and theophylline. A full list of interactions is mentioned in the ‘Drug Interactions’ section.
Q8: How long does the treatment with Ofloxacin + Ornidazole typically last?
A: The duration of treatment depends on the type and severity of the infection. It typically ranges from 5 to 10 days but can be longer for some infections.
Q9: What precautions should be taken while prescribing Ofloxacin + Ornidazole?
A: Assess renal and hepatic function, monitor for tendonitis, avoid in patients with contraindications, and educate patients about potential side effects and drug interactions.
Q10: What is the mechanism of action of this drug combination?
A: Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, interfering with bacterial DNA replication. Ornidazole disrupts microbial DNA structure and function, leading to cell death in both bacteria and protozoa.
