Usage
- This combination medication is primarily prescribed for gastrointestinal infections caused by susceptible bacteria and protozoa, including diarrhea and dysentery.
- Pharmacological Classification: Antibiotic, antiprotozoal.
- Mechanism of Action: Norfloxacin, a fluoroquinolone antibiotic, inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair. Tinidazole, a nitroimidazole antibiotic, disrupts the DNA of anaerobic bacteria and some protozoa. Beta-cyclodextrin enhances the solubility and absorption of norfloxacin and tinidazole.
Alternate Names
- Norflosh-TZ
- N Flox TZ
- Floxnor TZ
- Brand Names: Floxnor TZ, N Flox TZ, Norpex TZ
How It Works
- Pharmacodynamics: Norfloxacin exerts a bactericidal effect by inhibiting bacterial topoisomerase II (DNA gyrase) and topoisomerase IV. Tinidazole interacts with microbial DNA, causing strand breakage and inhibiting nucleic acid synthesis, ultimately leading to cell death. Beta-cyclodextrin improves the solubility and dissolution rate of norfloxacin and tinidazole, thereby enhancing their absorption.
- Pharmacokinetics: Norfloxacin is partially absorbed orally and undergoes hepatic metabolism. It is primarily excreted renally. Tinidazole is well-absorbed orally, metabolized hepatically, and also excreted renally. Beta-cyclodextrin improves the bioavailability of both norfloxacin and tinidazole.
- Elimination Pathways: Primarily renal excretion for both norfloxacin and tinidazole.
Dosage
Standard Dosage
Adults:
One tablet (Norfloxacin 400mg + Tinidazole 600mg + Beta-cyclodextrin 10mg) twice daily for 3 to 7 days. The maximum dosage should not exceed 800mg of Norfloxacin and 1200mg of Tinidazole per day. Administer orally, with or without food.
Children:
This combination is generally not recommended for children due to the risk of tendon rupture and cartilage damage.
Special Cases:
- Elderly Patients: Administer with caution due to potential age-related decline in renal function. Dosage adjustments may be necessary based on creatinine clearance.
- Patients with Renal Impairment: Dosage adjustment is necessary based on creatinine clearance.
- Patients with Hepatic Dysfunction: Dosage adjustment may be necessary.
- Patients with Comorbid Conditions: Caution advised, especially in patients with diabetes, cardiovascular disease, seizures, or myasthenia gravis.
Clinical Use Cases
This combination is not typically used in clinical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations. It is specifically indicated for gastrointestinal infections.
Dosage Adjustments
Dosage adjustments may be required for patients with renal or hepatic impairment based on creatinine clearance or liver function tests, respectively.
Side Effects
Common Side Effects
- Nausea
- Dry mouth
- Vomiting
- Diarrhea
- Stomach pain/discomfort
- Metallic taste
- Headache
- Dizziness
Rare but Serious Side Effects
- Tendon rupture
- Peripheral neuropathy (numbness, tingling, pain in extremities)
- Seizures
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- Severe skin reactions (blistering, peeling)
- Clostridium difficile-associated diarrhea
- Myasthenia gravis exacerbation
- Hepatotoxicity
Long-Term Effects
Peripheral neuropathy and tendon damage (rare).
Adverse Drug Reactions (ADR)
Tendon rupture, seizures, severe allergic reactions, C. difficile infection.
Contraindications
- Hypersensitivity to norfloxacin, tinidazole, other fluoroquinolones, nitroimidazoles, or beta-cyclodextrin.
- History of tendon rupture with fluoroquinolones.
- Myasthenia gravis.
- Pregnancy (especially first trimester).
- Breastfeeding.
- Children.
Drug Interactions
- Antacids, sucralfate, metal cations (calcium, magnesium, iron, zinc), and multivitamins can reduce norfloxacin absorption.
- Norfloxacin can enhance the effects of warfarin and other anticoagulants.
- Concurrent use with other QT-prolonging drugs should be avoided.
- Alcohol should be avoided during and shortly after tinidazole treatment.
- Probenecid may increase tinidazole levels.
- Other antibiotics (e.g., amoxicillin), NSAIDs (e.g., aspirin), vaccines for cholera and typhoid.
Pregnancy and Breastfeeding
- Pregnancy: Contraindicated, especially during the first trimester, due to the potential for fetal harm.
- Breastfeeding: Contraindicated as norfloxacin and tinidazole are excreted in breast milk.
Drug Profile Summary
- Mechanism of Action: Norfloxacin inhibits bacterial DNA gyrase and topoisomerase IV; tinidazole disrupts microbial DNA; beta-cyclodextrin enhances absorption.
- Side Effects: Nausea, diarrhea, headache, dizziness, tendon rupture, peripheral neuropathy, seizures.
- Contraindications: Hypersensitivity, tendon rupture history, myasthenia gravis, pregnancy, breastfeeding, children.
- Drug Interactions: Antacids, warfarin, QT prolonging drugs, alcohol, probenecid, other antibiotics, NSAIDs.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: Adults: One tablet (400mg/600mg/10mg) twice daily for 3-7 days. Adjust for renal/hepatic impairment.
- Monitoring Parameters: Renal function, liver function, signs of tendonitis/rupture, neurological symptoms.
Popular Combinations
This medication is a combination product. Combining it with other antibiotics is not typically recommended unless specifically indicated by a specialist for complex or resistant infections.
Precautions
- General Precautions: Assess renal and hepatic function before and during treatment. Screen for allergies.
- Pregnant Women: Contraindicated.
- Breastfeeding Mothers: Contraindicated.
- Children & Elderly: Not recommended for children. Use with caution in the elderly.
- Lifestyle Considerations: Avoid alcohol during and shortly after tinidazole treatment. Avoid prolonged sun exposure.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Beta-Cyclodextrin + Norfloxacin + Tinidazole?
A: The standard adult dose is one tablet (400mg/600mg/10mg) twice daily for 3-7 days. Dosage adjustment is required for patients with renal/hepatic impairment. This combination is not recommended for children.
Q2: What are the most common side effects?
A: Nausea, dry mouth, vomiting, diarrhea, stomach pain/discomfort, metallic taste, headache, dizziness.
A: Tendon rupture, peripheral neuropathy, seizures, severe allergic reactions, C. difficile infection, myasthenia gravis exacerbation.
Q4: Can this drug be taken during pregnancy or while breastfeeding?
A: No, this drug is contraindicated during pregnancy and breastfeeding.
Q5: Are there any drug interactions I should be aware of?
A: Yes. This drug interacts with antacids, sucralfate, metal cations, multivitamins, warfarin, other QT prolonging drugs, alcohol, probenecid, some antibiotics, and NSAIDs. Please consult with a healthcare professional for personalized advice.
Q6: Can I consume alcohol while taking this medication?
A: No, alcohol should be avoided during and shortly after treatment with tinidazole due to the risk of a disulfiram-like reaction.
Q7: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Q8: How should this medication be stored?
A: Store at room temperature, away from heat, moisture, and direct light.
Q9: Can this drug affect my ability to drive or operate machinery?
A: It is unlikely to impair the mental alertness or coordination required for driving. However, if you experience dizziness or drowsiness, avoid driving.
Q10: Should I stop taking this medication if I start feeling better before completing the course?
A: No. Complete the full course of treatment even if symptoms improve to ensure that the infection is completely eradicated and to prevent recurrence.
