Wantuoxin Vancomycin Hydrochloride Capsules

1. Indications and Usage
Clostridioides difficile-Associated Pseudomembranous Colitis: Treatment of pseudomembranous colitis associated with Clostridioides difficile (when methionazole is ineffective).
Staphylococcal Enterocolitis: Treatment of multiple drug-resistant staphylococcal enterocolitis.
2. Dosage and Administration
Route of Administration: Oral administration ONLY. Intravenous administration is required for systemic infections, as oral vancomycin is poorly absorbed.
Recommended Dosage (Adults): 125-500 mg every 6 hours, for 5-10 days. The maximum daily dose should not exceed 4 g.
Recommended Dosage (Pediatrics): 10 mg/kg every 6 hours, for 5-10 days.
Critical Administration Instructions:
Intake: Capsules should be swallowed with water. Dilution in 30 mL of water or flavored syrup is permissible if necessary (e.g., via nasogastric tube).
Dietary Impact: Can be taken with or without food.
3. Mechanism of Action
Cell Wall Synthesis Inhibition: Vancomycin is a glycopeptide antibiotic.
Target Binding: It binds with high affinity to the D-alanyl-D-alanine terminal of peptidoglycan precursors.
Bactericidal Effect: This binding blocks the polymerization and cross-linking of peptidoglycan, leading to defective bacterial cell walls and subsequent cell death. It exhibits strong bactericidal activity against Gram-positive bacteria.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with known hypersensitivity to vancomycin or other glycopeptide antibiotics.
Renal and Ototoxicity: Although oral absorption is minimal, systemic exposure can occur, especially in patients with renal impairment. Monitoring of renal function and auditory function is necessary during prolonged therapy.
C. difficile-Associated Diarrhea: Worsening of diarrhea or development of bloody stools should prompt immediate discontinuation of the drug.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Nausea, vomiting, and oral metallic taste.
Systemic Risks (via Absorption): Renal impairment, hearing loss, reversible neutropenia, and thrombocytopenia.
Clinical Research Highlights: Clinical data confirm that oral vancomycin is highly effective for C. difficile-associated colitis, with superior tolerability compared to parenteral administration.
6. Drug Interactions
Ototoxic and Nephrotoxic Agents: Concomitant use with aminoglycosides, amphotericin B, or loop diuretics may potentiate auditory and renal toxicity.
Antihistamines: Concomitant use may mask symptoms of ototoxicity (tinnitus, vertigo).
Alcohol: Concomitant intake may cause a disulfiram-like reaction in some cases.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Vancomycin Hydrochloride.
Appearance: Hard opaque capsules (typically 125 mg or 250 mg).
Packaging: Aluminum-plastic blister packaging.
Storage: Store in a well-closed container at controlled room temperature (below 25°C).