Cefixime + Clavulanic Acid + Lactobacillus

Usage

Cefixime + Clavulanic Acid + Lactobacillus is a combination drug primarily used for the treatment of various bacterial infections, especially those affecting the respiratory and urinary tracts. Lactobacillus is included to mitigate gastrointestinal side effects commonly associated with antibiotic use.

• Pharmacological Classification: Antibiotic (Cefixime and Clavulanic Acid), Probiotic (Lactobacillus)
• Mechanism of Action: Cefixime, a third-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). Clavulanic acid, a beta-lactamase inhibitor, enhances Cefixime’s activity by preventing its degradation by bacterial enzymes. Lactobacillus helps restore the balance of gut flora often disrupted by antibiotics.

Alternate Names

This specific combination drug may not have a widely recognized international nonproprietary name (INN). The individual components are often found in various combinations with different brand names.

• Brand Names: Brand names can vary regionally and are best confirmed locally in India. Some examples from the sources provided are: Taxim O CV, Ceftaclav. These may or may not contain Lactobacillus. Thenfix LB includes Lactobacillus Sporogenes as the probiotic component.

How It Works

• Pharmacodynamics: Cefixime exerts a bactericidal effect by disrupting cell wall synthesis. Clavulanic acid itself has little antibacterial activity but protects Cefixime from beta-lactamase degradation. Lactobacillus helps maintain a healthy gut microbiome.
• Pharmacokinetics:
  • Cefixime: Administered orally, partially absorbed, and excreted renally.
  • Clavulanic acid: Administered orally, well-absorbed, and excreted mainly in urine.
  • Lactobacillus: Taken orally, colonizes the GI tract.
• Mode of Action: Cefixime binds to PBPs, inhibiting transpeptidation and peptidoglycan synthesis, leading to bacterial cell lysis. Clavulanic acid inhibits beta-lactamase enzymes, preventing Cefixime inactivation. Lactobacillus produces lactic acid, creating an acidic environment unfavorable to some pathogenic bacteria.
• Elimination: Cefixime is primarily eliminated by the kidneys. Clavulanic acid is also mainly excreted renally. Lactobacillus is not absorbed and is eliminated through the GI tract.

Dosage

The dosage for Cefixime + Clavulanic Acid + Lactobacillus is dependent on the patient’s age, weight, the severity of the infection, and renal function. As this is a combination often prescribed according to local clinical practice, dosing can vary.

Standard Dosage

Adults: Typically, Cefixime 200 mg + Clavulanic Acid 125 mg is given twice a day or Cefixime 400 mg + Clavulanic Acid 125 mg is given once a day. Lactobacillus dosage varies depending on the specific strain and formulation. It’s crucial to consult the specific product information for combined formulations including Lactobacillus.

Children: Dosing is based on weight, typically 8 mg/kg/day of Cefixime, given as a single dose or divided into two doses. Clavulanic acid is dosed proportionally. Lactobacillus dosing should be adjusted according to the product information.

Special Cases:

• Elderly Patients: Dosage adjustments may be necessary in patients with impaired renal function.
• Patients with Renal Impairment: Dose reduction or increased dosing intervals may be required.
• Patients with Hepatic Dysfunction: Caution is advised, and monitoring is essential.
• Patients with Comorbid Conditions: Adjustments may be needed based on specific conditions and concomitant medications.

Clinical Use Cases Specific dosage recommendations for clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, and emergency situations may vary according to local or institutional protocols and are not fixed for this specific combination. Dosage will likely follow guidelines based on the infectious organism and site of infection.

Dosage Adjustments

Dosage modifications should be made based on renal and hepatic function, and other patient-specific factors.

Side Effects

Common Side Effects:

• Diarrhea
• Nausea
• Vomiting
• Abdominal pain
• Headache

Rare but Serious Side Effects:

• Allergic reactions (rash, itching, swelling, difficulty breathing)
• Pseudomembranous colitis (severe diarrhea caused by Clostridium difficile)
• Stevens-Johnson syndrome

Long-Term Effects:

Long-term effects are rare but can include Candida overgrowth or vitamin K deficiency.

Adverse Drug Reactions (ADR): Severe hypersensitivity reactions and Clostridium difficile infection require immediate intervention.

Contraindications

• Hypersensitivity to cephalosporins, penicillins, or any components of the formulation.
• History of severe gastrointestinal disease, particularly colitis.

Drug Interactions

• Anticoagulants (e.g., warfarin): Increased risk of bleeding
• Anticonvulsants (e.g., carbamazepine): Altered drug levels
• Probenecid: Decreased Cefixime excretion
• Oral contraceptives: Reduced efficacy
• Alcohol: potential for interactions; caution advised
• Other antibiotics (e.g., tetracyclines): Possible interference

Pregnancy and Breastfeeding

Limited data exists regarding the use of this specific combination during pregnancy and lactation. If possible, alternative therapies should be considered, and consultation with a specialist is recommended.

Drug Profile Summary

• Mechanism of Action: See “How It Works”
• Side Effects: Diarrhea, nausea, vomiting, abdominal pain, hypersensitivity reactions
• Contraindications: Hypersensitivity to components, history of severe colitis
• Drug Interactions: Anticoagulants, anticonvulsants, probenecid, oral contraceptives
• Pregnancy & Breastfeeding: Caution advised; consult a specialist
• Dosage: See “Dosage” section
• Monitoring Parameters: Renal function, liver function, signs of allergic reactions

Popular Combinations

Data on popular combinations specifically for this triple-drug regimen is not readily available. It is more common to see Cefixime combined with Clavulanic Acid. Lactobacillus may be prescribed concurrently but separately.

Precautions

• Allergy pre-screening
• Renal and hepatic function assessment
• Monitoring for C. difficile
• Complete full course of antibiotics
• Avoid alcohol

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Cefixime + Clavulanic Acid + Lactobacillus?

A: See the “Dosage” section for specific guidelines based on age, weight, and renal function. Always consult the prescribing information for the combined formulation containing Lactobacillus.

Q2: What infections is this combination effective against?

A: It is commonly used for bacterial infections of the respiratory tract (bronchitis, pneumonia, sinusitis, tonsillitis, pharyngitis), urinary tract (cystitis, pyelonephritis), and other infections like otitis media and gonorrhea.

Q3: Can this combination be used in children?

A: Yes, but the dosage must be adjusted based on weight. Lactobacillus can also be prescribed for children, always checking product information for combined formulations.

Q4: What are the most common side effects?

A: Diarrhea, nausea, vomiting, abdominal pain/cramps, and headache.

Q5: Are there any serious side effects I should be aware of?

A: Yes, rare but serious side effects include allergic reactions (including anaphylaxis), Clostridium difficile infection, and Stevens-Johnson syndrome. Seek immediate medical attention if these occur.

Q6: Can I take this medication if I’m allergic to penicillin?

A: Use with caution, as cross-reactivity between cephalosporins and penicillins can occur. Inform your physician about any penicillin allergy.

Q7: Can I drink alcohol while taking this medication?

A: It’s best to avoid alcohol during treatment. Consult your doctor or pharmacist.

Q8: 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 your next dose, skip the missed dose and continue with your regular schedule. Don’t double the dose.

Q9: Why is Lactobacillus included in this combination?

A: Lactobacillus is a probiotic that helps to restore the balance of gut bacteria often disrupted by antibiotic use, thus reducing or preventing antibiotic-associated diarrhea.

Q10: How long should I take this medication?

A: Complete the full course prescribed by your doctor, even if you feel better, to prevent antibiotic resistance.