Lactobacillus + Norfloxacin + Tinidazole

Usage

This combination medication is prescribed for the treatment of diarrhea and dysentery, particularly those caused by bacterial, amoebic, or mixed infections. It combines the antibacterial actions of norfloxacin and tinidazole with the probiotic benefits of lactobacillus.

• Pharmacological Classification: Antibiotic, Antiprotozoal, Probiotic.

• Mechanism of Action: Norfloxacin inhibits bacterial DNA replication and repair, while tinidazole damages bacterial DNA. Lactobacillus helps restore the gut’s normal flora, which may be disrupted by the antibiotics or infection.

Alternate Names

This combination may not have a universally recognized International Nonproprietary Name (INN). Regional variations may exist.

• Brand Names: Norflox TZ, Norflox-TZ RF, NOR TZ, Noxitef TZ, and others.

How It Works

• Pharmacodynamics: Norfloxacin and tinidazole exert bactericidal and antiprotozoal effects. Norfloxacin inhibits DNA gyrase and topoisomerase IV, enzymes crucial for bacterial DNA replication and repair. Tinidazole’s nitro group is reduced within microbial cells, forming cytotoxic radicals that damage DNA. Lactobacillus produces lactic acid, creating an environment unfavorable for the growth of many pathogenic bacteria. It also competes with pathogens for resources and adhesion sites in the gut.

• Pharmacokinetics: Norfloxacin is partially absorbed orally, reaching peak plasma concentrations within 1-2 hours. It’s primarily eliminated renally. Tinidazole is well-absorbed orally, with peak levels achieved in about 2 hours. It’s metabolized in the liver and excreted in urine and feces. Lactobacillus, being a live organism, colonizes the gut and exerts its effects locally. Specific details on its elimination aren’t typically assessed as it’s a normal component of the gut flora.

• Receptor binding, enzyme inhibition, or neurotransmitter modulation: Norfloxacin and tinidazole target bacterial enzymes involved in DNA replication (DNA gyrase, topoisomerase IV). Tinidazole’s mechanism also involves the formation of free nitro radicals. Lactobacillus, on the other hand, does not have a specific receptor binding or enzyme inhibition mechanism. Its action is primarily through competition and altering the gut environment (pH).

• Elimination pathways: Norfloxacin is primarily excreted renally. Tinidazole is metabolized hepatically and excreted in urine and feces.

Dosage

Standard Dosage

Adults: The typical dosage is one tablet twice daily. The duration of treatment is usually 3-7 days and depends on the severity and type of infection.

Children: This combination is generally not recommended for children. Safety and efficacy have not been established in pediatric populations.

Special Cases:

• Elderly Patients: Dosage adjustments may be needed depending on kidney function.

• Patients with Renal Impairment: Dose reduction or increased dosing intervals may be necessary.

• Patients with Hepatic Dysfunction: Caution is advised; dose adjustments may be needed.

• Patients with Comorbid Conditions: Consider underlying conditions like diabetes, cardiovascular disease, and neurological disorders when prescribing, as interactions or exacerbations may occur.

Clinical Use Cases

The use of this combination in specialized medical settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations is generally not indicated. Its primary role is in treating specific types of diarrhea and dysentery.

Dosage Adjustments:

Dosage adjustments are primarily based on renal and hepatic function. Genetic polymorphisms affecting drug metabolism are not routinely considered.

Side Effects

Common Side Effects:

Nausea, vomiting, diarrhea, abdominal pain or cramps, headache, dizziness, metallic taste, dry mouth.

Rare but Serious Side Effects:

Peripheral neuropathy, tendon rupture (especially Achilles tendon), seizures (especially in patients with predisposing factors), allergic reactions (including skin rashes, itching, and swelling).

Long-Term Effects:

Long-term use of this combination is generally not recommended due to the potential for antibiotic resistance and adverse effects on the gut microbiome.

Adverse Drug Reactions (ADR):

Severe allergic reactions (anaphylaxis), Stevens-Johnson syndrome, toxic epidermal necrolysis, and Clostridium difficile-associated diarrhea.

Contraindications

Hypersensitivity to any component of the medication, history of tendon disorders related to quinolone use, epilepsy or other seizure disorders, pregnancy, breastfeeding, myasthenia gravis.

Drug Interactions

Antacids (reduce absorption of norfloxacin), iron supplements, anticoagulants (warfarin – tinidazole may potentiate its effects), immunosuppressants (cyclosporine), anti-seizure medications (phenytoin), alcohol (may cause disulfiram-like reaction with tinidazole).

Pregnancy and Breastfeeding

This combination is contraindicated during pregnancy and breastfeeding due to potential risks to the fetus or neonate. Norfloxacin is associated with fetal cartilage damage in animal studies.

Drug Profile Summary

• Mechanism of Action: Norfloxacin and tinidazole are bactericidal and antiprotozoal. Lactobacillus restores gut flora.
• Side Effects: Nausea, vomiting, diarrhea, headache, dizziness, metallic taste, tendon rupture, seizures.
• Contraindications: Hypersensitivity, tendon disorders, epilepsy, pregnancy, breastfeeding, myasthenia gravis.
• Drug Interactions: Antacids, iron, warfarin, cyclosporine, phenytoin, alcohol.
• Pregnancy & Breastfeeding: Contraindicated.
• Dosage: Adults: One tablet twice daily for 3-7 days. Children: Not recommended.
• Monitoring Parameters: Observe for signs of tendonitis or rupture, neurological symptoms, and allergic reactions. Monitor renal and hepatic function if necessary.

Popular Combinations

This combination itself is a popular therapeutic approach for bacterial and amoebic diarrhea and dysentery. Combining it with other medications is not typically required.

Precautions

• General Precautions: Assess for allergies, renal/hepatic function, and neurological history.
• Specific Populations: Avoid in pregnancy/breastfeeding, children, and elderly patients with renal impairment.
• Lifestyle Considerations: Avoid alcohol during treatment and for 3 days after tinidazole discontinuation. Caution with driving due to potential dizziness.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Lactobacillus + Norfloxacin + Tinidazole?

A: The usual adult dosage is one tablet twice a day for 3-7 days, depending on the infection. It is generally not recommended for children.

Q2: What are the common side effects?

A: Common side effects include nausea, vomiting, diarrhea, abdominal pain, headache, dizziness, metallic taste, and dry mouth.

Q3: Can this combination be used during pregnancy or breastfeeding?

A: No, this combination is contraindicated during pregnancy and breastfeeding.

Q4: What are the serious side effects to watch out for?

A: Serious side effects include peripheral neuropathy, tendon rupture (especially Achilles tendon), seizures, and severe allergic reactions.

Q5: What should patients avoid while taking this medication?

A: Patients should avoid alcohol during treatment and for 3 days after stopping tinidazole. Caution is advised with driving or operating machinery due to potential dizziness.

Q6: How does Lactobacillus help in this combination?

A: Lactobacillus helps restore the balance of beneficial gut bacteria, which can be disrupted by antibiotics or infection.

Q7: Are there any drug interactions I should be aware of?

A: Yes, this medication can interact with antacids, iron supplements, warfarin, cyclosporine, phenytoin, and alcohol.

Q8: What should I do if a dose is missed?

A: Take the missed dose as soon as you remember unless it is almost time for your next dose. Do not double the dose.

Q9: What are the contraindications for this medicine?

A: Contraindications include hypersensitivity to any component, history of tendon disorders related to quinolone use, epilepsy, pregnancy, breastfeeding, and myasthenia gravis.

Q10: How long does the treatment usually last?

A: Treatment duration is typically 3-7 days, depending on the severity and type of infection. Your doctor will determine the appropriate duration for your specific case.