Meiyou Cefalexin Capsules

1. Indications and Usage
Respiratory Tract Infections: Treatment of acute tonsillitis, pharyngitis, otitis media, sinusitis, bronchitis, and pneumonia caused by susceptible bacteria.
Urinary Tract Infections: Treatment of uncomplicated cystitis and other urinary tract infections.
Skin and Skin Structure Infections: Treatment of cellulitis, abscesses, and other skin and soft tissue infections.
2. Dosage and Administration
Adults: The typical dosage is 250–500 mg orally every 6 hours (up to four times daily). The maximum daily dose is 4 g.
Pediatrics: The pediatric dosage is 25–50 mg/kg/day divided into doses administered every 6 hours.
Renal Impairment: Dosage reduction is necessary for patients with renal impairment based on creatinine clearance.
Administration: The capsules should be swallowed with water.
3. Mechanism of Action
Cell Wall Inhibition: Cefalexin is a bactericidal agent that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
Spectrum: It has a broad spectrum of activity, particularly against gram-positive organisms, though it is less effective against gram-negative bacteria compared to later-generation cephalosporins.
4. Safety and Warnings
Hypersensitivity: Cefalexin should not be used in patients with a history of immediate hypersensitivity reactions (e.g., anaphylaxis) to cephalosporins or penicillins.
Severe Diarrhea: Use with caution in patients with a history of gastrointestinal diseases, particularly colitis.
Renal Function: The drug is primarily excreted by the kidneys, so caution is required in patients with renal failure.
Pregnancy: The drug crosses the placenta and is excreted in breast milk; use with caution in pregnant or lactating women.
5. Adverse Reactions and Clinical Research
Common: Nausea, vomiting, diarrhea, and abdominal discomfort are the most frequently reported adverse reactions.
Serious: Hypersensitivity reactions (including anaphylaxis), dizziness, and transient renal impairment have been reported.
Clinical Research: Pivotal clinical trials have demonstrated the efficacy and safety of cefalexin in treating various gram-positive and susceptible gram-negative bacterial infections.
6. Drug Interactions
Probenecid: Can delay renal excretion of cefalexin, increasing blood concentrations and half-life.
Cholestyramine: Concomitant use may reduce the average plasma concentration of cefalexin.
Warfarin: Cephalosporins may enhance the anticoagulant effect of warfarin; prothrombin time should be monitored.
7. Pharmaceutical Information
Active Ingredient: Cefalexin (as monohydrate).
Excipients: The capsule contains standard excipients such as magnesium stearate and talc.
Appearance: Hard gelatin capsules containing white or off-white granules or powder.
Storage: Store in a well-closed container, protected from light and moisture.