Azithromycin + Cefixime + Lactobacillus

Usage

This combination medication is prescribed for various bacterial infections, including those of the ears, skin, nose, throat, lungs, and urinary tract. It is also sometimes used to treat typhoid fever and certain sexually transmitted infections.

• Pharmacological Classification: Antibiotic and Probiotic combination.

• Mechanism of Action: This combination uses two antibiotics and a probiotic. Azithromycin inhibits bacterial protein synthesis, Cefixime disrupts bacterial cell wall formation, and Lactobacillus helps restore the gut flora often affected by antibiotic use.

Alternate Names

This combination medication doesn’t have an official international nonproprietary name (INN). It is often referred to by brand names, which vary depending on the manufacturer. Some examples include Pharmcef AZ, Cfixim-AZ LB, Mixsef-AZ LB, Azicef-LB, Cefixid AZ LB, Aarcim AZ, and Aconcef.

How It Works

• Pharmacodynamics:

  • Azithromycin: A macrolide antibiotic that binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis and thus bacterial growth. It has a long half-life, allowing for once-daily dosing and shorter treatment durations.
  • Cefixime: A third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This leads to bacterial cell death. It is effective against a broad range of gram-positive and gram-negative bacteria.
  • Lactobacillus: A probiotic that helps restore the balance of gut flora, which can be disrupted by antibiotic use. It works by producing lactic acid, creating an acidic environment unfavorable for the growth of many harmful bacteria. It may also have immunomodulatory effects.

• Pharmacokinetics:

  • Azithromycin: Absorbed rapidly from the GI tract, but food can reduce its bioavailability. Widely distributed throughout the body, achieving high tissue concentrations. Metabolized in the liver and excreted primarily in the bile, with a small amount excreted in urine. Its long half-life permits once-daily dosing.
  • Cefixime: Absorbed from the GI tract. Peak serum concentrations are reached within 2 to 6 hours. It is excreted primarily by the kidneys.
  • Lactobacillus: As a live organism, its pharmacokinetics are complex. It colonizes the gut, producing lactic acid and other metabolites. It is not absorbed systemically in significant amounts.

• Elimination Pathways: Primarily hepatic (azithromycin), renal (cefixime), and through feces (lactobacillus and metabolites).

Dosage

Dosage and duration of treatment depend on the specific infection, its severity, and the patient’s age, weight, and overall health. Always follow the prescribed dosage.

Standard Dosage

Adults: A common dosage is Cefixime 200mg + Azithromycin 250/500mg + Lactobacillus 60 million spores once or twice daily, but this can vary. Specific dosages and regimens must be determined by a physician based on the individual patient’s condition.

Children: This medication is typically prescribed for children over 10 years old. Pediatric dosages should be determined by a physician based on the child’s weight and the severity of the infection. Safety and efficacy in children younger than 10 have not been well-established. For certain infections like otitis media, bronchitis, and urinary tract infections, cefixime dosing in children less than 45 kg is often 8mg/kg/day, either once daily or divided every 12 hours, not exceeding 400mg/day.

Special Cases:

• Elderly Patients: Dose adjustments may be necessary depending on renal function.

• Patients with Renal Impairment: Dose adjustments are usually required based on creatinine clearance or glomerular filtration rate (GFR). For cefixime specifically, lower doses and/or less frequent dosing may be needed depending on the degree of impairment.

• Patients with Hepatic Dysfunction: Dose modifications may be needed for azithromycin in cases of severe hepatic impairment.

• Patients with Comorbid Conditions: Conditions such as diabetes, cardiovascular disease, and gastrointestinal disorders like colitis should be considered when prescribing this medication.

Clinical Use Cases

This specific combination (Azithromycin + Cefixime + Lactobacillus) is not typically indicated for use in settings like intubation, surgical procedures, mechanical ventilation, ICU, or emergency situations as a pre-emptive measure. Antibiotic prophylaxis regimens for these scenarios are usually based on different agents and considerations, and the inclusion of Lactobacillus is not standard practice in such contexts.

Dosage Adjustments

Dose modifications are essential based on renal/hepatic function, metabolic disorders, or genetic polymorphisms affecting drug metabolism. Individualized dosing is crucial for optimizing efficacy and minimizing adverse effects.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain, headache, indigestion, flatulence, loss of appetite.

Rare but Serious Side Effects

Severe allergic reactions (anaphylaxis, angioedema), Clostridium difficile-associated diarrhea (CDAD), liver dysfunction, cardiac arrhythmias (including QT prolongation), Stevens-Johnson syndrome.

Long-Term Effects

Antibiotic resistance, disruption of gut microbiota, vitamin K deficiency (with prolonged cefixime use).

Adverse Drug Reactions (ADR)

Any signs of hypersensitivity, severe gastrointestinal issues, hepatotoxicity, or cardiac events require immediate medical attention.

Contraindications

Hypersensitivity to any component of the formulation (azithromycin, cefixime, lactobacillus, or any other macrolides, cephalosporins), history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use, severe colitis or other significant gastrointestinal diseases.

Drug Interactions

This combination can interact with several medications. Examples include:

• Antacids (aluminum or magnesium-containing): Can reduce the absorption of azithromycin and cefixime.
• Warfarin: Cefixime can potentiate the anticoagulant effect of warfarin, increasing bleeding risk.
• Digoxin: Azithromycin can increase digoxin levels.
• Other antibiotics (e.g., clarithromycin): May lead to additive or synergistic effects, but also increased risk of side effects.
• Diuretics (e.g., furosemide): Cefixime can reduce the effectiveness of some diuretics.

Pregnancy and Breastfeeding

• Pregnancy Safety Category: Azithromycin and cefixime are generally considered safe to use during pregnancy (Category B), but use with caution and under physician guidance. Discuss with your doctor to assess the benefit-risk ratio. Some studies suggest potential risks like preterm birth and low birth weight, especially with first-trimester exposure, although the evidence is not conclusive.

• Breastfeeding: Azithromycin and cefixime are excreted in breast milk, although the amount is generally considered small. The effects on nursing infants are not well-established. Discuss the benefits and risks with your doctor.

Drug Profile Summary

(Refer to sections above for detailed information. This is a summary.)

Popular Combinations

Azithromycin and cefixime are sometimes combined for specific indications like gonorrhea, where their combined activity against different bacterial mechanisms offers improved efficacy. The addition of lactobacillus is aimed at mitigating antibiotic-associated diarrhea.

Precautions

(See above sections for details.)

FAQs (Frequently Asked Questions)

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

A: Dosage varies based on infection and patient factors. Common adult dosages include Cefixime 200mg + Azithromycin 250/500mg + Lactobacillus 60 million spores once or twice daily. Pediatric dosing should be determined by a physician.

Q2: Can this combination be used in pregnant or breastfeeding women?

A: Generally considered safe (Category B), but use with caution and under physician guidance. Weigh the potential benefits against possible risks, especially in the first trimester.

Q3: What are the common side effects?

A: Nausea, vomiting, diarrhea, abdominal pain, headache, indigestion are common. More serious side effects are possible, including allergic reactions and C. difficile infection.

Q4: What are the major drug interactions to be aware of?

A: Antacids, warfarin, digoxin, some other antibiotics and diuretics can interact with this combination. Inform your physician about all concomitant medications.

Q5: Are there any contraindications to using this combination?

A: Hypersensitivity to any components, prior cholestatic jaundice/hepatic dysfunction with azithromycin, and severe colitis are contraindications.

Q6: How does Lactobacillus interact with the antibiotics in this combination?

A: Lactobacillus is included to help restore the gut flora balance, which can be disturbed by antibiotic use. It does not directly interact with the antibiotics’ antibacterial activity. It is recommended to take probiotics a few hours before or after antibiotics.

Q7: How long does treatment typically last?

A: The treatment duration depends on the infection being treated. It typically ranges from 3 to 7 days but may be longer in some cases. Always complete the full course of antibiotics as prescribed, even if symptoms improve earlier.

Q8: Can this combination be used to treat viral infections?

A: No. This is an antibiotic combination and is not effective against viruses.

Q9: What should I do if I miss a dose?

A: Take the missed dose as soon as you remember. However, if it is near the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.

Q10: What monitoring parameters are recommended during therapy?

A: Monitor for signs of improvement or worsening of the infection. Monitor liver and renal function, and watch for signs of superinfection (e.g., CDAD) or cardiac issues (QT interval).