Usage
- Nitazoxanide + Ofloxacin is prescribed for the treatment of diarrhea caused by both parasitic (e.g., Cryptosporidium parvum, Giardia lamblia) and bacterial infections. It may also be used for other infections, such as respiratory, urinary tract, skin, soft tissue, and sexually transmitted infections, depending on the identified pathogens and their susceptibility.
- Pharmacological Classification: Antiparasitic and antibacterial (fluoroquinolone antibiotic).
- Mechanism of Action: Nitazoxanide interferes with the energy metabolism of parasites, leading to their death. Ofloxacin inhibits bacterial DNA replication by interfering with DNA gyrase and topoisomerase IV, preventing bacterial growth and reproduction.
Alternate Names
- No widely recognized alternate names exist for the combination itself. The individual components have various international nonproprietary names (INNs).
- Brand Names: Nizonide-O, Netazox OF, Ofalox-NZ, Flagynor, Bestoflox N and others. (Brand names can vary regionally).
How It Works
- Pharmacodynamics: Nitazoxanide disrupts parasitic energy metabolism via inhibition of pyruvate:ferredoxin oxidoreductase (PFOR). Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication and repair.
- Pharmacokinetics: Both drugs are administered orally. Nitazoxanide is metabolized to tizoxanide, its active metabolite. Ofloxacin is primarily excreted renally, with some hepatic metabolism.
- Mode of Action: At the cellular level, nitazoxanide’s disruption of PFOR blocks anaerobic energy metabolism in parasites. Ofloxacin’s inhibition of DNA gyrase and topoisomerase IV prevents the supercoiling and relaxation of bacterial DNA, halting cell division.
- Elimination Pathways: Nitazoxanide is metabolized in the liver and excreted in urine and feces. Ofloxacin is predominantly excreted unchanged in the urine, with a small amount metabolized in the liver.
Dosage
Standard Dosage
Adults: 500 mg nitazoxanide + 200 mg ofloxacin every 12 hours for 3 days.
Children:
- 1-3 years: 5 mL of oral suspension (containing 125 mg nitazoxanide + 50 mg ofloxacin / 5 mL) every 12 hours for 3 days.
- 4-11 years: 10 mL of oral suspension (containing 125 mg nitazoxanide + 50 mg ofloxacin / 5 mL) every 12 hours for 3 days.
- 12 years and above: Adult dose.
Special Cases:
- Elderly Patients: Caution advised; dose adjustments based on renal function may be required.
- Patients with Renal Impairment: Dose reduction based on creatinine clearance is needed.
- Patients with Hepatic Dysfunction: Caution advised.
- Patients with Comorbid Conditions: No specific adjustments mentioned, evaluate case by case.
Clinical Use Cases
Dosage information for specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations, is not available in the provided resources. The standard dosage guidelines are applicable unless specific contraindications exist.
Dosage Adjustments
Adjustments are needed based on renal function. Consult specialized resources for specific recommendations.
Side Effects
Common Side Effects:
Nausea, vomiting, stomach pain, headache, diarrhea.
Rare but Serious Side Effects:
Allergic reactions (rash, itching, swelling, difficulty breathing), tendon rupture, peripheral neuropathy.
Long-Term Effects: Not specifically identified in the provided sources.
Adverse Drug Reactions (ADR): Serious allergic reactions, Clostridium difficile-associated diarrhea, QT prolongation (with ofloxacin).
Contraindications
- Hypersensitivity to nitazoxanide, ofloxacin, or other quinolones.
- Hepatic encephalopathy.
- Clostridium difficile-associated diarrhea.
- History of tendon inflammation or rupture.
- G6PD deficiency.
- Pregnancy and lactation (unless benefits outweigh risks).
Drug Interactions
- Warfarin and other highly protein-bound drugs.
- Multivitamins containing zinc.
- Antidiabetic agents (e.g., metformin).
- NSAIDs (e.g., ibuprofen).
- Some antiarrhythmics (e.g., amiodarone).
- Antacids, sucralfate, metal cations (e.g., iron).
Pregnancy and Breastfeeding
- Pregnancy Safety Category: Not explicitly stated in the provided resources, however, use during pregnancy and breastfeeding not recommended unless clearly needed and the benefits outweigh the potential risks.
- Animal studies with nitazoxanide did not reveal evidence of teratogenicity, but there are no controlled human studies. Ofloxacin use during pregnancy is associated with potential fetal harm.
- Both drugs are excreted in breast milk. The safety during breastfeeding hasn’t been established.
Drug Profile Summary
- Mechanism of Action: Nitazoxanide: inhibits PFOR in parasites. Ofloxacin: inhibits bacterial DNA gyrase and topoisomerase IV.
- Side Effects: Nausea, vomiting, stomach pain, headache, diarrhea; rare but serious: allergic reactions, tendon rupture.
- Contraindications: Hypersensitivity, hepatic encephalopathy, C. difficile infection, tendon issues, G6PD deficiency, pregnancy/lactation.
- Drug Interactions: Warfarin, zinc, metformin, NSAIDs, amiodarone, antacids.
- Pregnancy & Breastfeeding: Use with caution if benefits outweigh risks. Not generally recommended.
- Dosage: Adults: 500mg/200mg twice daily for 3 days. Pediatric dosage available for oral suspension based on age.
- Monitoring Parameters: Renal function, signs of allergic reaction, tendon pain.
Popular Combinations
- No specific “popular combinations” beyond the given combination itself were found in the provided resources.
Precautions
- Renal and hepatic impairment.
- History of seizures or QT prolongation.
- Hypersensitivity reactions.
- Pregnancy and breastfeeding.
- Alcohol should be avoided.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Nitazoxanide + Ofloxacin?
A: Adults: 500 mg nitazoxanide + 200 mg ofloxacin every 12 hours for 3 days. Pediatric dosages are based on age and available as an oral suspension.
Q2: What are the common side effects?
A: Nausea, vomiting, stomach pain, headache, and diarrhea are common side effects.
Q3: Is Nitazoxanide + Ofloxacin safe in pregnancy?
A: Not generally recommended. Consult a doctor for risk/benefit assessment if considering use during pregnancy.
Q4: Can I take this medication with antacids?
A: No, antacids can interfere with the absorption of Ofloxacin. Avoid taking them within two hours of each other.
Q5: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s close to your next scheduled dose. Do not double the dose.
Q6: Can this medication be used in children?
A: Yes, but the dosage is different for younger children, typically administered as an oral suspension. Consult a doctor for pediatric dosing.
Q7: How does this medication work against parasites and bacteria?
A: Nitazoxanide targets parasite energy metabolism. Ofloxacin targets bacterial DNA replication.
Q8: What are the serious side effects I should watch out for?
A: Allergic reactions (rash, itching, swelling, breathing problems), tendon rupture, and peripheral neuropathy. Seek immediate medical attention if any of these develop.
Q9: Are there any dietary restrictions while taking this medication?
A: Maintaining adequate hydration is especially important, especially if diarrhea is present. Avoid alcohol. No other specific restrictions are mentioned.
