Biaxin: Effective Macrolide Antibiotic for Bacterial Infection Resolution
Biaxin
| Product dosage: 250mg | |||
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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 mechanism of action involves binding to the 50S ribosomal subunit of susceptible microorganisms, thereby inhibiting protein synthesis and halting bacterial proliferation. Clinically, it demonstrates high tissue penetration and bioavailability, making it a cornerstone in respiratory, dermatological, and certain atypical pathogen treatment protocols. This product card provides a comprehensive overview for healthcare professionals to ensure informed, safe, and effective prescribing practices.
Features
- Active ingredient: Clarithromycin
- Available formulations: 250 mg and 500 mg tablets; granules for oral suspension (125 mg/5 mL and 250 mg/5 mL)
- Pharmacologic class: Macrolide antibiotic
- Half-life: 3–4 hours; prolonged in hepatic impairment
- Metabolism: Hepatic, via CYP3A4; active metabolite: 14-hydroxyclarithromycin
- Excretion: Primarily urinary and fecal
Benefits
- Demonstrates broad-spectrum activity against Gram-positive, Gram-negative, and atypical pathogens
- High oral bioavailability and excellent tissue penetration, particularly in lung and skin structures
- Convenient twice-daily dosing regimen supports patient adherence
- Effective against Helicobacter pylori as part of combination therapy for ulcer eradication
- Proven clinical efficacy in community-acquired pneumonia, acute exacerbations of chronic bronchitis, and acute maxillary sinusitis
- Well-established safety profile with extensive post-marketing surveillance data
Common use
Biaxin is commonly prescribed for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms. These include upper and lower respiratory tract infections such as pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, and community-acquired pneumonia. It is also indicated for uncomplicated skin and skin structure infections. Furthermore, Biaxin is used in combination with other antimicrobial agents and acid-suppressing drugs for the eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence. Off-label uses may include, under specialist guidance, certain mycobacterial infections.
Dosage and direction
Dosage must be individualized based on the infection severity, pathogen susceptibility, and patient’s renal/hepatic function. The usual adult dose is 250 mg to 500 mg orally every 12 hours for 7 to 14 days. For Helicobacter pylori eradication, a triple therapy regimen including Biaxin 500 mg, amoxicillin 1000 mg, and a proton pump inhibitor (e.g., lansoprazole 30 mg), all taken twice daily for 10 to 14 days, is recommended. Pediatric dosing is weight-based: 7.5 mg/kg every 12 hours, not to exceed adult doses. Tablets should be taken with food to minimize gastrointestinal upset; the oral suspension may be taken with or without food. Complete the full course of therapy even if symptoms subside earlier to prevent resistance development.
Precautions
Use with caution in patients with renal impairment (CrCl <30 mL/min): consider dosage reduction. Hepatic impairment necessitates close monitoring; avoid in severe hepatic dysfunction with concomitant renal impairment. May prolong QT interval; avoid in patients with known QT prolongation, hypokalemia, or concurrent use of other QT-prolonging drugs. Caution advised in myasthenia gravis due to risk of symptom exacerbation. Superinfections, including Clostridioides difficile-associated diarrhea, may occur. Monitor for signs of hepatotoxicity. Not recommended during pregnancy unless potential benefit justifies potential risk (Pregnancy Category C). Excreted in breast milk; use caution when administering to nursing women.
Contraindications
Biaxin is contraindicated in patients with known hypersensitivity to clarithromycin, any macrolide antibiotic, or any component of the formulation. Concomitant use with cisapride, pimozide, astemizole, terfenadine, ergot alkaloids, or HMG-CoA reductase inhibitors extensively metabolized by CYP3A4 (e.g., simvastatin, lovastatin) is contraindicated due to risk of serious adverse events, including arrhythmias and rhabdomyolysis. Should not be used in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior clarithromycin use.
Possible side effect
Common adverse reactions (≥1%) include diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain, and headache. Less frequently, vomiting, glossitis, stomatitis, oral moniliasis, and transient elevations in liver enzymes may occur. Serious side effects, though rare, include QT prolongation and torsades de pointes, acute liver injury, Clostridioides difficile-associated diarrhea, severe skin reactions (e.g., Stevens-Johnson syndrome), and reversible hearing loss. Allergic reactions, ranging from rash to anaphylaxis, may occur. Report any persistent or severe symptoms to a healthcare provider immediately.
Drug interaction
Clarithromycin is a potent inhibitor of CYP3A4 and a substrate; significant interactions are likely. Concomitant use with drugs metabolized by CYP3A4 may increase their concentrations and risk of toxicity: examples include colchicine, some benzodiazepines, sildenafil, and certain immunosuppressants (e.g., cyclosporine, tacrolimus). Avoid concurrent use with CYP3A4 inducers (e.g., rifampin). May increase serum concentrations of digoxin, carbamazepine, theophylline, and oral anticoagulants (e.g., warfarin)—monitor levels and adjust doses accordingly. Concomitant use with other QT-prolonging agents increases arrhythmia risk. Antacids and H2-receptor antagonists may reduce absorption; administer Biaxin at least 2 hours before these agents.
Missed dose
If a dose is missed, it should be taken 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 make up for a missed one. Maintaining consistent antibiotic levels is important for efficacy, so advise patients to try to adhere strictly to the prescribed timing.
Overdose
Symptoms of overdose may include severe nausea, vomiting, diarrhea, and abdominal pain. Transient hearing loss, QT prolongation, and pancreatitis have been reported. There is no specific antidote. Management is supportive and symptomatic, including ECG monitoring for QT prolongation and hydration for gastrointestinal losses. Gastric lavage may be considered if ingestion was recent. Hemodialysis does not significantly remove clarithromycin.
Storage
Store tablets and granules for oral suspension at room temperature (20°–25°C or 68°–77°F), in a tightly closed container, and protect from light and excessive moisture. Keep out of reach of children. Once reconstituted, the oral suspension is stable for 14 days at room temperature; do not refrigerate. Discard any unused portion after this period.
Disclaimer
This information is intended for healthcare professionals 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 product usage. Never disregard professional medical advice or delay in seeking it because of something you have read in this document. The prescribing physician should be aware of the complete prescribing information and latest clinical guidelines.
Reviews
Biaxin has been extensively studied and is generally regarded by the medical community as an effective and well-tolerated antibiotic for indicated uses. Clinical trials demonstrate high efficacy rates in respiratory and skin infections, with a predictable side effect profile. Many clinicians appreciate its convenient dosing and reliable tissue penetration. However, awareness of its drug interaction potential and QT effects is critical. Post-marketing reports and continued pharmacovigilance support its favorable benefit-risk profile when used appropriately in accordance with prescribing guidelines.