Usage
This combination medication is prescribed for the treatment of bacterial and protozoan infections, particularly those affecting the gastrointestinal and genitourinary tracts. Conditions such as infectious diarrhea, dysentery, traveler’s diarrhea, and mixed gastrointestinal infections are commonly treated with this combination. It is also used for amebiasis, giardiasis, trichomoniasis, bacterial vaginosis, and some respiratory and dental infections.
Its pharmacological classifications include:
- Antibiotic: Both Norfloxacin and Ornidazole are antibiotics. Norfloxacin is a fluoroquinolone, and Ornidazole is a nitroimidazole.
- Probiotic: Lactobacillus is a probiotic.
Mechanism of Action: Norfloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, thereby preventing bacterial growth. Ornidazole damages bacterial and protozoal DNA, leading to cell death. Lactobacillus helps restore the balance of healthy gut flora, which can be disrupted by the antibiotics.
Alternate Names
While there isn’t a universally recognized international nonproprietary name (INN) for this specific combination, the individual components have their own INNs (Lactobacillus, Norfloxacin, Ornidazole).
Brand Names: This combination is marketed under various brand names, including Norflox OZ LB, Oflox OZ LB, and others. Brand names can vary regionally.
How It Works
Pharmacodynamics: Norfloxacin disrupts bacterial DNA replication. Ornidazole damages DNA in susceptible bacteria and protozoa. Lactobacillus helps maintain a healthy gut microbiome by producing lactic acid and competing with pathogenic bacteria.
Pharmacokinetics:
- Absorption: Norfloxacin is orally absorbed. Ornidazole is well-absorbed after oral administration. Lactobacillus colonizes the gut.
- Metabolism: Norfloxacin undergoes partial hepatic metabolism. Ornidazole is metabolized in the liver.
- Elimination: Norfloxacin is excreted primarily in the urine and feces. Ornidazole is excreted mainly in the urine.
Mode of Action: Norfloxacin inhibits topoisomerase II (DNA gyrase) and topoisomerase IV. These enzymes are crucial for bacterial DNA replication, transcription, repair, and recombination. Ornidazole forms reactive intermediates that damage microbial DNA. Lactobacillus produces lactic acid and other substances that inhibit the growth of certain pathogenic bacteria.
Receptor Binding, Enzyme Inhibition, or Neurotransmitter Modulation: Norfloxacin and Ornidazole act directly on bacterial enzymes and DNA, respectively. They do not directly involve receptor binding or neurotransmitter modulation in humans.
Dosage
Standard Dosage
Adults: The typical adult dose is one tablet containing Norfloxacin 400mg, Ornidazole 500mg, and Lactobacillus (various strengths) twice daily for up to 10 days or as prescribed by the physician.
Children: This combination is generally not recommended for children under 18 years of age.
Special Cases:
- Elderly Patients: Dose adjustments may be needed based on renal function.
- Patients with Renal Impairment: Dose reduction is usually required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Close monitoring and dose adjustment may be necessary.
- Patients with Comorbid Conditions: Dose adjustment may be necessary depending on the co-existing medical condition.
Clinical Use Cases
Dosage in these settings should be individualized based on patient-specific factors and should be determined by a physician.
Dosage Adjustments
Dose modifications are based on renal and hepatic function, other medical conditions, and patient response.
Side Effects
Common Side Effects:
Nausea, vomiting, abdominal pain, bloating, dizziness, headache, photosensitivity.
Rare but Serious Side Effects:
Peripheral neuropathy, seizures, tendon rupture, severe allergic reactions (anaphylaxis).
Long-Term Effects:
Peripheral neuropathy (with prolonged use of nitroimidazoles like Ornidazole).
Adverse Drug Reactions (ADR): Anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Contraindications
Hypersensitivity to any component of the medication, history of tendon disorders related to fluoroquinolone use, epilepsy, myasthenia gravis, pregnancy, breastfeeding.
Drug Interactions
Antacids, sucralfate, multivitamins or iron supplements can reduce the absorption of Norfloxacin. Drugs that prolong the QT interval should be used with caution. Alcohol should be avoided during and after treatment with Ornidazole.
Pregnancy and Breastfeeding
This combination is contraindicated in pregnancy and breastfeeding due to potential risks to the fetus/infant.
Drug Profile Summary
- Mechanism of Action: Norfloxacin inhibits bacterial DNA gyrase; Ornidazole disrupts bacterial/protozoal DNA; Lactobacillus promotes gut health.
- Side Effects: Nausea, vomiting, abdominal pain, dizziness, headache; rarely, seizures, tendon rupture.
- Contraindications: Hypersensitivity, tendon disorders (with fluoroquinolone use), epilepsy, pregnancy, breastfeeding.
- Drug Interactions: Antacids, QT-prolonging drugs, alcohol.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Typically, one tablet (Norfloxacin 400mg, Ornidazole 500mg, Lactobacillus as per formulation) twice daily. Adjust for renal/hepatic impairment.
- Monitoring Parameters: Renal function, liver function tests, signs of peripheral neuropathy, tendon inflammation.
Popular Combinations
This combination itself is a popular combination utilized clinically.
Precautions
Standard precautions for administering medications, including patient history review, allergy screening, and monitoring for adverse events. Renal and liver function tests should be monitored in patients with pre-existing renal or hepatic impairment.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Lactobacillus + Norfloxacin + Ornidazole?
A: The usual adult dose is one tablet twice daily. However, the specific dosage should be determined by a physician based on the patient’s condition, age, and other factors.
Q2: What are the most common side effects?
A: The common side effects include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness.
Q3: Can this combination be used in pregnant women?
A: No, it is contraindicated during pregnancy due to potential harm to the fetus.
Q4: Can this combination be used during breastfeeding?
A: No, it’s contraindicated while breastfeeding. The drugs can be excreted in breast milk and potentially affect the infant.
Q5: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. However, if it’s almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose.
Q6: How long does the treatment typically last?
A: The duration of treatment depends on the infection being treated and the patient’s response. It typically ranges from 3 to 10 days but can be longer for some conditions.
Q7: Are there any dietary restrictions while taking this medication?
A: It’s generally recommended to maintain adequate hydration while taking this medication. Alcohol should be avoided when taking Ornidazole. Consult your doctor regarding specific dietary restrictions.
Q8: Can I drive while taking this medication?
A: This medication may cause dizziness or drowsiness. Avoid driving or operating machinery if you experience these side effects.
Q9: What should I do if I experience severe side effects?
A: Discontinue the medication immediately and contact your doctor or seek emergency medical attention.
