Biaxin: Potent Macrolide Antibiotic for Bacterial Infection Resolution
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Biaxin (clarithromycin) is a semi-synthetic macrolide antibiotic indicated for the treatment of a wide spectrum of mild to moderate bacterial infections. Its advanced molecular structure enhances stability against gastric acid, allowing for reliable oral absorption and predictable pharmacokinetics. By inhibiting bacterial protein synthesis, Biaxin effectively halts the proliferation of susceptible pathogens, facilitating clinical recovery. It is a cornerstone therapy in respiratory, skin, and soft tissue infections, particularly where atypical organisms or penicillin allergies are a consideration.
Features
- Active pharmaceutical ingredient: Clarithromycin
- Available formulations: Biaxin® (250 mg and 500 mg tablets), Biaxin® XL (500 mg extended-release tablets), and granules for 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 of activity: Effective against many Gram-positive, some Gram-negative, and atypical bacteria including Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Helicobacter pylori
- Dosing flexibility: BID (twice daily) dosing for immediate-release, QD (once daily) for extended-release formulations
Benefits
- High tissue penetration, achieving concentrations at infection sites that exceed plasma levels, particularly in lung, skin, and tonsillar tissue
- Demonstrated efficacy in eradicating common respiratory pathogens, including those responsible for community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, and acute maxillary sinusitis
- Effective as part of combination therapy for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence
- Convenient dosing schedules that support adherence, with the XL formulation allowing for once-daily administration
- A valuable alternative for patients with hypersensitivity to beta-lactam antibiotics (e.g., penicillins)
- Well-established safety and efficacy profile supported by decades of clinical use and post-marketing surveillance
Common use
Biaxin is commonly prescribed for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms. Its primary uses include:
- Upper respiratory tract infections: Pharyngitis/tonsillitis caused by Streptococcus pyogenes
- Lower respiratory tract infections: Acute bacterial exacerbation of chronic bronchitis due to H. influenzae, M. catarrhalis, or S. pneumoniae; community-acquired pneumonia due to S. pneumoniae, M. pneumoniae, C. pneumoniae, or H. influenzae
- Acute maxillary sinusitis caused by H. influenzae, M. catarrhalis, or S. pneumoniae
- Uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes
- Disseminated mycobacterial infections due to Mycobacterium avium complex (MAC)
- As part of a multi-drug regimen for the eradication of H. pylori and duodenal ulcer disease
Dosage and direction
Dosage must be individualized based on the infection severity, pathogen susceptibility, and patient renal function. Administer with or without food.
Adults:
- Most infections (immediate-release): 250–500 mg every 12 hours for 7–14 days.
- Community-acquired pneumonia (immediate-release): 250 mg every 12 hours for 7–14 days.
- Acute exacerbation of chronic bronchitis or acute maxillary sinusitis: 500 mg every 12 hours for 7–14 days.
- H. pylori eradication: 500 mg BIAXIN twice daily in combination with amoxicillin and a proton pump inhibitor, or with metronidazole and a proton pump inhibitor, for 10–14 days.
- BIAXIN XL extended-release tablets: 1000 mg (two 500 mg tablets) once daily for 7–14 days for indicated infections.
Pediatric patients (≥6 months):
- Dosing based on body weight: 7.5 mg/kg twice daily, not to exceed 500 mg per dose. Duration typically 10 days for pharyngitis/tonsillitis and 7–10 days for other infections.
Dosage adjustment is required in patients with severe renal impairment (CrCl <30 mL/min). Halve the dose or double the dosing interval. The extended-release formulation is not recommended in renal impairment.
Precautions
- Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, discontinue and institute appropriate therapy.
- Use with caution in patients with hepatic impairment. Periodic liver function tests are advisable during prolonged therapy.
- May exacerbate muscle weakness in patients with myasthenia gravis.
- Clarithromycin has the potential to cause QT prolongation and ventricular arrhythmias, including torsades de pointes. Avoid use in patients with known QT prolongation, electrolyte disturbances, or clinical circumstances that increase arrhythmia risk.
- Use during pregnancy only if clearly needed (Pregnancy Category C). Exercise caution when administering to nursing women.
Contraindications
- Known hypersensitivity to clarithromycin, any macrolide antibiotic, or any component of the formulation.
- Concomitant administration with cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine.
- Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior clarithromycin use.
- Concomitant use with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (e.g., lovastatin, simvastatin) due to increased risk of rhabdomyolysis.
- Known QT prolongation or ventricular arrhythmia.
Possible side effect
The most common adverse reactions (≥2%) are:
- Gastrointestinal: Diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain/discomfort, vomiting
- Headache
- Hepatic: Transient elevations in liver enzymes
Serious but less common side effects may include:
- Clostridium difficile-associated diarrhea (CDAD)
- QT prolongation and torsades de pointes
- Hepatotoxicity (hepatic dysfunction, cholestatic jaundice)
- Hearing loss (usually reversible)
- Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
Drug interaction
Biaxin is a potent inhibitor of cytochrome P450 3A4 (CYP3A4) and may increase plasma concentrations of drugs metabolized by this pathway. Significant interactions include:
- Contraindicated: Cisapride, pimozide, astemizole, terfenadine, ergot derivatives. Concomitant use is prohibited due to risk of serious cardiac arrhythmias.
- Use with extreme caution or avoid: Colchicine (in patients with renal or hepatic impairment), HMG-CoA reductase inhibitors (simvastatin, lovastatin; increased risk of myopathy/rhabdomyolysis).
- Requires dose adjustment/monitoring: Warfarin (increased INR), digoxin (increased digoxin levels), theophylline, carbamazepine, phenytoin, cyclosporine, tacrolimus, sildenafil (for pulmonary arterial hypertension), some benzodiazepines (e.g., midazolam).
- Antacids or H2-receptor antagonists: Administer Biaxin at least 2 hours before these agents.
Missed dose
If a dose is missed, take it as soon as remembered. However, if it is almost time for the next scheduled dose, skip the missed dose and resume the usual dosing schedule. Do not double the dose to catch up.
Overdose
Symptoms of overdose are consistent with the known adverse effects of clarithromycin, primarily severe gastrointestinal distress (nausea, vomiting, diarrhea). Hepatic dysfunction and hearing loss have been reported. There is no specific antidote. Treatment should be supportive, with gastric lavage if ingestion was recent. Monitor ECG for QT prolongation. Hemodialysis does not significantly remove clarithromycin from the circulation.
Storage
Store tablets and granules for suspension at room temperature (20°–25°C or 68°–77°F). Keep in the original container, tightly closed, and protect from light and moisture. After reconstitution, the oral suspension is stable for 14 days at room temperature; do not refrigerate. Keep all medications out of the reach of children and pets.
Disclaimer
This information is for educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The efficacy and safety of Biaxin (clarithromycin) must be evaluated by a healthcare professional in the context of the individual patient’s condition.
Reviews
Clinical studies and post-marketing experience have established Biaxin as a highly effective antibiotic for its indicated uses. In clinical trials for community-acquired pneumonia, Biaxin demonstrated clinical cure rates comparable to other first-line agents. Its role in H. pylori eradication regimens is well-supported by meta-analyses, showing high success rates in combination therapy. The twice-daily (or once-daily XL) dosing is frequently cited by clinicians as supporting patient adherence. The most common feedback from prescribers highlights its reliability in respiratory infections and its value as a beta-lactam alternative. The main considerations in its use remain its drug interaction profile and the necessity to monitor for gastrointestinal and cardiac effects in susceptible populations.