Biaxin: Potent Macrolide Antibiotic for Bacterial Infection Resolution

Biaxin
| Product dosage: 250mg | |||
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Biaxin (clarithromycin) is a advanced-generation macrolide antibiotic prescribed for the treatment of a wide spectrum of bacterial infections. Its formulation demonstrates enhanced stability in acidic environments and superior tissue penetration compared to earlier macrolides, making it a frontline choice for respiratory, skin, and soft tissue infections. By inhibiting bacterial protein synthesis, Biaxin effectively halts the proliferation of susceptible organisms, facilitating rapid clinical improvement. It is available in both immediate-release and extended-release tablets, as well as oral suspension, allowing for tailored therapeutic regimens based on infection severity and patient-specific factors.
Features
- Active ingredient: Clarithromycin
- Available forms: 250 mg and 500 mg immediate-release tablets; 500 mg extended-release tablets (Biaxin XL); oral suspension (125 mg/5 mL and 250 mg/5 mL)
- Pharmacologic class: Macrolide antibiotic
- Mechanism of action: Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis
- Spectrum: Effective against many Gram-positive, some Gram-negative, and atypical bacteria
- Administration: Oral, with or without food (though consistency in administration relative to meals is advised)
Benefits
- Rapid onset of action with bactericidal activity against key respiratory pathogens
- High bioavailability and extensive tissue distribution, including lung epithelial lining fluid
- Convenient twice-daily dosing for most indications improves adherence
- Effective against common and atypical pathogens, including Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, and Chlamydophila pneumoniae
- Extended-release formulation allows for once-daily dosing, minimizing peak-trough fluctuations
- Well-established safety profile with decades of clinical use and post-marketing surveillance
Common use
Biaxin is indicated for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms. Common uses include acute bacterial exacerbation of chronic bronchitis due to H. influenzae, H. parainfluenzae, M. catarrhalis, or S. pneumoniae; community-acquired pneumonia due to S. pneumoniae, H. influenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae; acute maxillary sinusitis; pharyngitis/tonsillitis; and uncomplicated skin and skin structure infections. It is also used as part of combination therapy for Helicobacter pylori eradication in peptic ulcer disease and for the prevention and treatment of Mycobacterium avium complex (MAC) disease in immunocompromised patients.
Dosage and direction
Dosage varies based on indication, formulation, renal function, and severity of infection. For most adult infections using immediate-release tablets: 250–500 mg every 12 hours for 7–14 days. For Biaxin XL extended-release tablets: two 500 mg tablets (1000 mg) once daily with food for 7–14 days. Pediatric dosing is weight-based using the oral suspension. For H. pylori eradication, it is used in combination with a proton pump inhibitor and amoxicillin or metronidazole. Dosage must be adjusted in patients with severe renal impairment (CrCl <30 mL/min). Tablets should be swallowed whole; the suspension should be shaken well before each use.
Precautions
Use with caution in patients with hepatic impairment; periodic liver function tests are advisable during prolonged therapy. May prolong the QT interval; avoid use in patients with known QT prolongation, hypokalemia, or concurrent use of other QT-prolonging drugs. Use in pregnancy only if clearly needed (Pregnancy Category C). Excreted in breast milk; caution advised during lactation. Superinfection with resistant bacteria or fungi may occur. Not recommended for use in patients with porphyria. Prescribers should verify bacterial susceptibility and consider local resistance patterns.
Contraindications
Hypersensitivity to clarithromycin, other macrolide antibiotics, or any component of the formulation. Concomitant use with cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine. Contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction with prior clarithromycin use. Should not be used concomitantly with colchicine in patients with renal or hepatic impairment.
Possible side effect
Common adverse reactions (≥1%) include diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain, and headache. Less frequently reported: vomiting, rash, elevated liver enzymes, and oral moniliasis. Serious but rare side effects include QT prolongation, ventricular arrhythmias, hepatotoxicity, Stevens-Johnson syndrome, Clostridioides difficile-associated diarrhea, and hearing loss (usually reversible). Most adverse effects are mild to moderate and self-limiting.
Drug interaction
Clarithromycin is a potent inhibitor of CYP3A4 and may increase plasma concentrations of drugs metabolized by this pathway. Significant interactions include: increased levels of simvastatin, lovastatin, colchicine, midazolam, triazolam, sildenafil (for pulmonary hypertension), and many antiretroviral agents. Concomitant use with warfarin may potentiate anticoagulant effect. May reduce efficacy of oral contraceptives; alternative contraception should be considered. Concurrent use with theophylline may increase theophylline levels. Dose adjustments or alternative therapies may be required.
Missed dose
If a dose is missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and the regular dosing schedule resumed. Doubling the dose is not recommended.
Overdose
Symptoms may include severe nausea, vomiting, diarrhea, and abdominal pain. QT prolongation and hearing loss have been reported. Management is supportive; gastric lavage may be considered if presented soon after ingestion. Hemodialysis does not significantly remove clarithromycin.
Storage
Store at room temperature (20–25°C/68–77°F). Keep tablets in their original container, tightly closed. Oral suspension should be stored refrigerated (2–8°C/36–46°F) and discarded after 14 days. Keep out of reach of children and protected from light and moisture.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional for diagnosis and individualized treatment recommendations. Do not initiate, discontinue, or change the dosage of any medication without professional supervision.
Reviews
Biaxin has been extensively studied in clinical trials and is widely regarded as an effective and well-tolerated antibiotic for approved indications. In studies of community-acquired pneumonia, clinical cure rates typically exceed 85%. For acute bacterial exacerbations of chronic bronchitis, success rates are similarly high. Patient-reported outcomes often note rapid symptom improvement, though taste disturbance and gastrointestinal effects are occasionally mentioned. Long-term post-marketing surveillance continues to support its favorable benefit-risk profile when used appropriately.