Usage
This combination medication is prescribed for the treatment of bacterial infections, especially those of the urinary tract, ears, nose, throat, chest, and lungs. It combines a third-generation cephalosporin antibiotic (Cefixime) with probiotics (Lactobacillus and Saccharomyces boulardii). The probiotics are included to help maintain or restore the balance of beneficial gut bacteria that may be disrupted by antibiotic use, particularly to prevent or treat antibiotic-associated diarrhea.
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Pharmacological Classification: Antibiotic (Cefixime), Probiotic (Lactobacillus and Saccharomyces boulardii)
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Mechanism of Action: Cefixime inhibits bacterial cell wall synthesis, leading to bacterial cell death. Lactobacillus and Saccharomyces boulardii help maintain and restore healthy gut flora. Saccharomyces boulardii also produces proteases that degrade bacterial toxins.
Alternate Names
This specific combination medication doesn’t have a standard international non-proprietary name, and its alternate names are typically brand names, which vary by region and manufacturer. Some examples include Cefigard, Fenium SLB, and Rezix.
How It Works
Cefixime:
- Pharmacodynamics: Cefixime is a bactericidal antibiotic, meaning it kills bacteria. It exerts its effect by disrupting the synthesis of the bacterial cell wall. It binds to penicillin-binding proteins (PBPs), essential enzymes for the final transpeptidation step of peptidoglycan synthesis. This leads to a weakened cell wall, causing cell lysis and bacterial death.
- Pharmacokinetics: Cefixime is orally administered and absorbed variably, reaching peak serum concentrations in approximately 2-6 hours. Food may slightly delay absorption but doesn’t significantly affect the overall bioavailability. It’s primarily excreted unchanged in the urine, with a half-life of around 3-4 hours. Dose adjustments are required for patients with renal impairment.
Lactobacillus and Saccharomyces boulardii:
- Pharmacodynamics: These probiotics work by competing with pathogenic bacteria for resources in the gut and may also produce substances that inhibit bacterial growth, which may include antimicrobial peptides and short-chain fatty acids. Saccharomyces boulardii specifically can produce proteases that degrade bacterial toxins. They work synergistically to help maintain or restore a healthy gut microbiota, which can be disrupted by antibiotic use.
- Pharmacokinetics: Lactobacillus and Saccharomyces boulardii are not absorbed systemically. They exert their effects within the gastrointestinal tract. Saccharomyces boulardii is not colonized in the gut and is eliminated in the stool after discontinuation.
Dosage
Standard Dosage
Adults:
The standard dose is 200-400 mg of Cefixime per day, usually divided into two doses, taken with the prescribed amount of probiotics. Probiotic dosage varies depending on the specific product.
Children:
Dosing is weight-based and should be determined by a physician. For children 6 months to 12 years, the usual dose is 8 mg/kg/day, given as a single dose or divided into two doses (4 mg/kg every 12 hours). For children weighing over 45 kg, adult dosing applies. Safety and efficacy have not been fully established in children younger than 6 months.
Special Cases:
- Elderly Patients: Dosage adjustments may be needed based on renal function.
- Patients with Renal Impairment: Dosage reduction is required based on creatinine clearance.
- Patients with Hepatic Dysfunction: Caution and monitoring are advised, although dosage adjustments might not always be necessary.
- Patients with Comorbid Conditions: Requires individualized assessment.
Clinical Use Cases
Dosage for specific clinical settings (intubation, surgery, mechanical ventilation, ICU, emergencies) should be determined by a physician based on the patient’s condition and is not standardized.
Dosage Adjustments
Dose modifications are needed for renal or hepatic dysfunction and other patient-specific factors.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal pain, indigestion, flatulence, headache, dizziness.
Rare but Serious Side Effects:
Severe allergic reactions (anaphylaxis, angioedema), Clostridium difficile-associated diarrhea (pseudomembranous colitis), Stevens-Johnson syndrome, toxic epidermal necrolysis.
Long-Term Effects:
Alterations in gut microbiota, increased risk of C. difficile infection, antibiotic resistance.
Adverse Drug Reactions (ADR):
Any severe or persistent side effects, especially signs of an allergic reaction or superinfection, are considered ADRs and require immediate medical attention.
Contraindications
Hypersensitivity to cefixime, other cephalosporins, or any component of the formulation; severe renal or hepatic impairment; history of C. difficile infection (for Saccharomyces boulardii); immunocompromised individuals (use with caution).
Drug Interactions
Anticoagulants (e.g., warfarin), probenecid, antacids, antifungals, antibiotics. It’s crucial to disclose all medications, including OTC drugs and supplements, to the prescribing physician.
Pregnancy and Breastfeeding
Cefixime is generally considered safe during pregnancy. The safety of Saccharomyces boulardii during pregnancy and breastfeeding isn’t fully established. Consult a physician.
Drug Profile Summary
- Mechanism of Action: Cefixime: inhibits bacterial cell wall synthesis. Probiotics: restore gut flora.
- Side Effects: Nausea, vomiting, diarrhea, allergic reactions.
- Contraindications: Hypersensitivity, severe renal/hepatic impairment.
- Drug Interactions: Anticoagulants, probenecid, antacids, antifungals.
- Pregnancy & Breastfeeding: Cefixime: generally safe. Saccharomyces boulardii: consult a physician.
- Dosage: Adults: 200-400 mg/day. Children: weight-based.
- Monitoring Parameters: Renal and hepatic function, signs of superinfection.
Popular Combinations
This combination itself is a popular formulation.
Precautions
Standard precautions for antibiotic and probiotic use, including screening for allergies and organ dysfunction. Exercise caution in immunocompromised patients.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Cefixime + Lactobacillus + Saccharomyces boulardii?
A: Adults: 200-400 mg Cefixime/day, divided into two doses. Children: 8 mg/kg/day, single or divided dose. Adjustments needed for renal impairment. Probiotic dose varies by product.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness.
Q3: What are the contraindications?
A: Hypersensitivity, severe renal/hepatic impairment, history of C. difficile infection.
Q4: Can this combination be used in pregnant or breastfeeding women?
A: Cefixime generally considered safe. Saccharomyces boulardii safety not fully established; consult physician.
Q5: How does Cefixime work?
A: Inhibits bacterial cell wall synthesis leading to cell death.
Q6: How do Lactobacillus and Saccharomyces boulardii work?
A: Maintain/restore healthy gut flora, compete with pathogenic bacteria, degrade toxins (Saccharomyces boulardii).
Q7: Are there any significant drug interactions?
A: Yes, with anticoagulants, probenecid, antacids, antifungals, and other antibiotics. Consult a physician regarding current medications.
Q8: What should be monitored during treatment?
A: Renal and hepatic function, signs of superinfection or allergic reactions.
Q9: Can the combination be used in children?
A: Yes, but dosing is weight-based. Not recommended for children under six months.
Q10: What is the role of probiotics in this combination?
A: Primarily to mitigate antibiotic-associated diarrhea and restore gut flora balance.
