Usage
This combination medication is primarily prescribed for bacterial infections, especially those of the respiratory and gastrointestinal tracts. The addition of probiotics ( Lactobacillus sporogenes and Saccharomyces boulardii) aims to mitigate antibiotic-associated diarrhea, a common side effect of azithromycin.
Pharmacological Classification:
- Azithromycin: Macrolide antibiotic
- Lactobacillus sporogenes: Probiotic (although now classified as a species of Bacillus)
- Saccharomyces boulardii: Probiotic yeast
Mechanism of Action:
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of bacteria. This action suppresses bacterial growth and replication. Lactobacillus sporogenes produces lactic acid, creating an environment less hospitable to pathogenic bacteria. Saccharomyces boulardii works through multiple mechanisms: degrading bacterial toxins, improving intestinal barrier function, and exerting anti-inflammatory effects. Combining these agents addresses both the infection and the potential for disruption of the gut microbiome caused by the antibiotic.
Alternate Names
This combination is marketed under various brand names like Azidone SB, Azimed SB, Morzit L, and Zift SL. These can vary regionally.
How It Works
Pharmacodynamics:
Azithromycin’s primary effect is bacteriostatic, achieved by inhibiting protein synthesis in susceptible bacteria. It distributes widely in tissues and achieves high intracellular concentrations. The probiotics exert their effects locally in the gut, promoting a healthy gut microbiome.
Pharmacokinetics:
- Azithromycin: Well-absorbed orally, achieves high tissue concentrations, metabolized in the liver, and excreted primarily in bile.
- Saccharomyces boulardii: Not systemically absorbed; acts locally in the gut, surviving gastric acidity and colonizing the intestinal tract.
- Lactobacillus sporogenes: Not systemically absorbed, and primarily functions within the intestinal tract.
Mode of Action:
- Azithromycin: Binds to the 50S ribosomal subunit of bacteria, inhibiting the transpeptidation and translocation steps of protein synthesis.
- Lactobacillus sporogenes: Produces lactic acid, lowering the pH of the intestinal environment.
- Saccharomyces boulardii: Produces enzymes that degrade bacterial toxins (e.g., C. difficile toxins A and B), strengthens the intestinal barrier function, and modulates local immune responses.
Dosage
Standard Dosage
Adults:
Azithromycin 500 mg once daily for 3-5 days. The probiotic component is typically included in fixed-dose combinations.
Children:
Azithromycin 10 mg/kg once daily for 3-5 days. Pediatric dosages should be confirmed with established pediatric guidelines. Probiotics are typically part of fixed-dose combinations.
Special Cases:
- Elderly Patients: Dosage adjustments are not typically necessary unless significant renal or hepatic impairment exists.
- Patients with Renal Impairment: Dose adjustments may be needed with severe renal dysfunction.
- Patients with Hepatic Dysfunction: Caution and potential dose modifications are warranted.
- Patients with Comorbid Conditions: Dosage should be adjusted carefully considering underlying conditions and potential drug interactions.
Clinical Use Cases
Dosages for specific clinical situations (intubation, surgical procedures, mechanical ventilation, ICU use, emergency situations) are not different from the standard recommendations for the relevant age group. However, these patients may require closer monitoring for potential adverse effects or drug interactions.
Dosage Adjustments
Dose modifications may be necessary based on renal/hepatic function, metabolic disorders, or genetic polymorphisms impacting drug metabolism. Consultation with a pharmacist or specialist is recommended for complex cases.
Side Effects
Common Side Effects
Nausea, diarrhea, vomiting, stomach pain, headache. For the combination product, it’s noteworthy that the probiotic component aims to reduce the risk of antibiotic-associated diarrhea.
Rare but Serious Side Effects
- Cardiac arrhythmias (including QT prolongation)
- Allergic reactions (rash, itching, swelling, difficulty breathing)
- Clostridium difficile-associated diarrhea (though the probiotics aim to mitigate this risk)
- Hepatotoxicity
Long-Term Effects
Chronic complications from prolonged use are rare but can include antibiotic resistance or changes in the gut microbiome.
Adverse Drug Reactions (ADR)
Severe allergic reactions (anaphylaxis), severe skin reactions (Stevens-Johnson syndrome), hepatotoxicity, C. difficile infection.
Contraindications
- Hypersensitivity to azithromycin, any macrolide antibiotic, or any component of the formulation.
- Use with caution in patients with a history of hepatic disease or cardiac arrhythmias.
Drug Interactions
- Antacids can reduce azithromycin absorption.
- Azithromycin may interact with warfarin and other anticoagulants.
- Antifungal medications may reduce the efficacy of Saccharomyces boulardii.
- Azithromycin and the probiotics should be administered at least two hours apart.
- Alcohol should be avoided while taking azithromycin.
Pregnancy and Breastfeeding
Azithromycin is generally considered safe during pregnancy. Limited data exist on probiotic use during pregnancy; consult a physician. Azithromycin is present in breast milk in small amounts. The transfer of probiotics into breast milk is not well-established.
Drug Profile Summary
- Mechanism of Action: Azithromycin: Inhibits bacterial protein synthesis. Probiotics: Modulate gut flora, reducing antibiotic-associated diarrhea.
- Side Effects: Common: Nausea, diarrhea, abdominal pain. Serious: Cardiac arrhythmias, allergic reactions, C. difficile infection.
- Contraindications: Hypersensitivity to components, hepatic disease, cardiac arrhythmias.
- Drug Interactions: Antacids, anticoagulants, antifungals.
- Pregnancy & Breastfeeding: Azithromycin generally safe; consult a physician about probiotic use.
- Dosage: Adult: Azithromycin 500 mg daily for 3-5 days. Pediatric: 10 mg/kg daily for 3-5 days.
- Monitoring Parameters: Liver function tests, ECG (in patients at risk for arrhythmias), signs of superinfection (C. difficile).
Popular Combinations
This combination itself is a popular combination, aiming to provide antimicrobial action while maintaining gut health.
Precautions
Screen patients for allergies, metabolic disorders, and organ dysfunction. Pregnant/breastfeeding women should consult their physician. Pediatric and geriatric dosages require careful adjustment. Avoid alcohol.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Azithromycin + Lactobacillus Sporogenes + Saccharomyces boulardii?
A: Adults: Azithromycin 500 mg once daily for 3-5 days. Children: 10 mg/kg once daily for 3-5 days. Adjustments may be required based on individual patient factors.
Q2: How does the addition of probiotics benefit this combination?
A: Probiotics mitigate the risk of antibiotic-associated diarrhea, a common side effect of azithromycin.
Q3: Can this combination be used in patients with liver disease?
A: Use with caution and consider dose adjustments in patients with hepatic dysfunction. Monitor liver function tests.
Q4: What are the most concerning drug interactions?
A: Interactions with warfarin, antacids, and antifungals require careful monitoring. Concurrent use of alcohol should be avoided.
Q5: Are there any contraindications during pregnancy?
A: Azithromycin is generally considered safe; however, consult a physician about probiotic use during pregnancy.
Q6: Can this medication be crushed or chewed?
A: Swallow the medication whole. Do not crush, chew, or break the tablets.
Q7: What should a patient do if they miss a dose?
A: Take the missed dose as soon as remembered. Do not double the dose. Consult a physician if several doses are missed.
Q8: What are the signs of a serious allergic reaction?
A: Difficulty breathing, swelling of the face or throat, hives, severe rash. Seek immediate medical attention.
Q9: Can this medication be taken with food?
A: It can be taken with or without food, but it is best to take it at a fixed time each day.
Q10: How should this medication be stored?
A: Store at room temperature away from moisture and heat. Refer to product packaging for specific instructions.
