Rulide Roxithromycin Tablets

1. Indications and Usage
Respiratory Tract Infections: Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes; sinusitis, otitis media, acute bronchitis, and acute exacerbations of chronic bronchitis caused by susceptible bacteria; pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae.
Genitourinary Infections: Urethritis and cervicitis caused by Chlamydia trachomatis.
Skin and Soft Tissue Infections: Infections caused by susceptible bacteria.
2. Dosage and Administration
Adults: Usually 150 mg twice daily or 300 mg once daily.
Pediatrics: 2.5 to 5 mg/kg twice daily.
Special Populations: For patients with severe liver cirrhosis, the dosage may be adjusted to 150 mg once daily.
Administration: Oral administration should be taken on an empty stomach (1 hour before or 3 to 4 hours after a meal) to achieve higher blood concentrations.
3. Mechanism of Action
Protein Synthesis Inhibition: Roxithromycin is a semi-synthetic macrolide antibiotic. It penetrates the bacterial cell membrane and binds reversibly to the 50S ribosomal subunit, blocking transfer RNA (t-RNA) binding and inhibiting bacterial protein synthesis.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with known hypersensitivity to roxithromycin, erythromycin, or other macrolide antibiotics.
Hepatotoxicity: Use with caution in patients with hepatic impairment. Liver function should be monitored regularly during treatment.
QT Prolongation: May prolong the QT interval; caution is advised in patients with cardiovascular risk factors.
5. Adverse Reactions and Clinical Research
Common: Gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, and vomiting.
Serious: Occasional adverse reactions include skin rash, pruritus, dizziness, headache, elevated liver enzymes (ALT and AST), and peripheral blood cell reduction.
6. Drug Interactions
Contraindicated Drugs: Do not co-administer with ergotamine, dihydroergotamine, bromocriptine, terfenadine, ketoconazole, or cisapride.
Minimal Interaction: Has little effect on the metabolism of aminophylline and basically no effect on carbamazepine, warfarin, ranitidine, and other antacids.
7. Pharmaceutical Information
Active Ingredient: Roxithromycin.
Appearance: Film-coated tablets; off-white or white after removing the coating.
Storage: Store in a well-closed container in a dry place.