Ruiyouda Cefixime Capsules

1. Indications and Usage
Respiratory Infections: Treatment of tonsillitis, pharyngitis, bronchitis, and pneumonia caused by susceptible bacteria.
Urinary Tract Infections: Treatment of cystitis and pyelonephritis.
Gynecological Infections: Treatment of acute cholecystitis and cholangitis.
Scarlet Fever and Otitis Media: Treatment of scarlet fever, otitis media, and sinusitis.
Gonorrhea: Treatment of urethritis and cervicitis caused by Neisseria gonorrhoeae.
2. Dosage and Administration
Adults: The usual dosage is 0.1 g (100 mg) twice daily or 0.2 g (200 mg) once daily. For severe infections, the dosage may be increased to 0.2 g (200 mg) twice daily.
Pediatrics: 1.5–3.0 mg/kg twice daily.
Renal Impairment: In patients with severe renal dysfunction, the dosage interval should be appropriately prolonged.
Administration: May be taken with or without food.
3. Mechanism of Action
Bactericidal Activity: Cefixime is a bactericidal agent that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
Spectrum: It demonstrates broad-spectrum activity against many Gram-positive and Gram-negative bacteria and is highly stable against many beta-lactamases.
4. Safety and Warnings
Hypersensitivity: Severe and occasionally fatal hypersensitivity reactions have been reported. It should not be used in patients with a history of immediate hypersensitivity to cephalosporins.
Pseudomembranous Colitis: Broad-spectrum antibiotics may cause pseudomembranous colitis; use with caution in patients with a history of gastrointestinal disease.
Renal and Hepatic Function: Use with caution in patients with severe renal impairment or liver damage.
Pregnancy and Lactation: Use during pregnancy only if clearly necessary. Caution is advised during lactation.
5. Adverse Reactions and Clinical Research
Common: Gastrointestinal symptoms such as diarrhea, nausea, vomiting, and abdominal discomfort are the most frequently reported.
Serious: Hypersensitivity reactions, transient elevation of liver enzymes, and eosinophilia.
Clinical Research: Clinical trials have demonstrated the efficacy and safety of cefixime in treating common community-acquired infections.
6. Drug Interactions
Probenecid: Can delay the renal excretion of cefixime, increasing blood concentrations and half-life.
Warfarin: May enhance the anticoagulant effect; prothrombin time should be monitored.
Aminoglycosides and Loop Diuretics: Concomitant use may enhance the risk of nephrotoxicity.
7. Pharmaceutical Information
Active Ingredient: Cefixime.
Excipients: The capsule contains standard excipients such as magnesium stearate and talc.
Appearance: Hard gelatin capsules containing white or off-white powder or granules.
Storage: Store in a well-closed container, protected from light and moisture.