Usage
Nimorazole + Ofloxacin is a combination antibiotic used to treat specific bacterial and protozoal infections, particularly diarrhea and dysentery. Its pharmacological classifications include:
- Antibacterial: Both components exhibit activity against a broad spectrum of bacteria, including anaerobes.
- Antiprotozoal: Nimorazole specifically targets certain protozoa.
Alternate Names
- Nimoraz O (brand name)
- Ofloxacin + Nimorazole
How It Works
Pharmacodynamics:
- Nimorazole: Disrupts DNA synthesis and function in anaerobic microorganisms and some protozoa. It forms cytotoxic metabolites within anaerobic cells, leading to DNA damage and cell death.
- Ofloxacin: A fluoroquinolone that inhibits bacterial DNA gyrase and topoisomerase IV. These enzymes are essential for bacterial DNA replication, transcription, repair, and recombination. By inhibiting them, Ofloxacin effectively halts bacterial proliferation.
Pharmacokinetics:
- Absorption: Both drugs are well-absorbed orally.
- Metabolism: Nimorazole is metabolized in the liver. Ofloxacin undergoes partial hepatic metabolism.
- Elimination: Primarily renal excretion for both drugs. Dose adjustment is necessary in patients with renal impairment.
Dosage
Standard Dosage
Adults:
- Nimorazole 500 mg + Ofloxacin 200 mg twice daily. The duration of treatment is typically 5-7 days, depending on the infection’s severity and type.
Children:
This combination is generally not recommended for children under 18 due to the risk of adverse effects on developing cartilage and joints, particularly with Ofloxacin.
Special Cases:
- Elderly Patients: Dose adjustment may be required based on renal function and increased susceptibility to tendon rupture and other fluoroquinolone-related adverse events.
- Patients with Renal Impairment: Dosage adjustments are necessary based on creatinine clearance.
- Patients with Hepatic Dysfunction: Caution is advised, and dose adjustment might be necessary.
- Patients with Comorbid Conditions: Use cautiously in patients with epilepsy, multiple sclerosis, myasthenia gravis, or prolonged QT interval.
Clinical Use Cases
Specific dosage guidelines for clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations are not explicitly defined for this combination. Treatment should be individualized based on the infection and patient factors.
Dosage Adjustments
Adjustments should be made based on renal/hepatic function, and other relevant patient factors.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Stomach pain
- Loss of appetite
- Dizziness
- Headache
- Dry mouth
- Metallic taste
Rare but Serious Side Effects:
- Tendon rupture
- Peripheral neuropathy
- Seizures
- QT prolongation
- Severe allergic reactions (rash, itching, swelling, shortness of breath)
- Clostridium difficile-associated diarrhea
Long-Term Effects:
Chronic complications from prolonged use are rare, but peripheral neuropathy can persist after discontinuation.
Adverse Drug Reactions (ADR):
Clinically significant ADRs include tendon rupture, severe allergic reactions, QT prolongation, and Clostridium difficile infection.
Contraindications
- Hypersensitivity to Nimorazole, Ofloxacin, or other fluoroquinolones
- Myasthenia gravis
- Epilepsy
- Prolonged QT interval
- Pregnancy (unless benefits outweigh risks)
- Breastfeeding
Drug Interactions
- Antacids, iron supplements, multivitamins: Reduce Ofloxacin absorption.
- Drugs that prolong the QT interval (e.g., antiarrhythmics, some antipsychotics): Increase the risk of Torsades de Pointes.
- NSAIDs: May increase the risk of seizures with Ofloxacin.
- Alcohol: Can worsen side effects like dizziness and drowsiness.
- Warfarin: Nimorazole may enhance the anticoagulant effect.
- Disulfiram: Avoid concurrent use with Nimorazole.
Pregnancy and Breastfeeding
- Pregnancy: Not recommended unless the potential benefits outweigh the risks. Ofloxacin is Pregnancy Category C.
- Breastfeeding: Not recommended as both drugs are excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Nimorazole: DNA damage in anaerobes. Ofloxacin: Inhibits DNA gyrase and topoisomerase IV.
- Side Effects: See above.
- Contraindications: See above.
- Drug Interactions: See above.
- Pregnancy & Breastfeeding: Not recommended.
- Dosage: See above.
- Monitoring Parameters: Renal function, liver function, signs of tendonitis, neurological symptoms, ECG (if at risk for QT prolongation).
Popular Combinations
No specific popular combinations are described for this fixed-dose combination.
Precautions
- General Precautions: Assess renal and hepatic function, history of seizures or QT prolongation, and allergies.
- Pregnant Women: Avoid unless benefits clearly outweigh risks.
- Breastfeeding Mothers: Avoid.
- Children & Elderly: Not generally recommended for children. Use with caution in the elderly.
- Lifestyle Considerations: Avoid alcohol. May impair ability to drive or operate machinery.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Nimorazole + Ofloxacin?
A: The typical adult dose is 500 mg Nimorazole + 200 mg Ofloxacin twice daily. Dosage adjustments are needed for renal impairment, hepatic dysfunction, and elderly patients.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, headache, dizziness, dry mouth, and metallic taste.
Q3: Is it safe to take during pregnancy or while breastfeeding?
A: No, it’s generally contraindicated during pregnancy and breastfeeding.
Q4: Can I drink alcohol while taking this medication?
A: No, alcohol can exacerbate side effects like dizziness and drowsiness and may interact with Nimorazole.
Q5: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s almost time for your next dose. Do not double the dose.
Q6: What infections does this combination treat?
A: Primarily indicated for bacterial and protozoal infections causing diarrhea and dysentery.
Q7: Are there any serious side effects I should be aware of?
A: Yes, rare but serious side effects include tendon rupture, peripheral neuropathy, seizures, and cardiac arrhythmias. Seek immediate medical attention if these occur.
Q8: Does this medicine interact with other drugs?
A: Yes, it can interact with antacids, iron supplements, multivitamins, QT-prolonging drugs, NSAIDs, and alcohol. Inform your doctor about all other medications you are taking.
Q9: How long should I take this medicine?
A: The usual course of therapy is 5–7 days but can be longer depending on the type and severity of infection. Always complete the full course prescribed by your doctor, even if symptoms improve.
