Flomox Cefcapene Pivoxil Hydrochloride Granules

1. Indications and Usage
Infections: Treatment of infections caused by susceptible bacteria, including:
Respiratory Tract: Pharyngitis, tonsillitis, chronic respiratory disease secondary infections, pneumonia.
Ear, Nose, and Throat: Otitis media, sinusitis.
Urinary Tract: Cystitis, pyelonephritis.
Others: Skin and soft tissue infections.
2. Dosage and Administration
Route of Administration: Oral administration ONLY.
Recommended Dosage (Adults): 200 mg twice daily. For severe infections, the dose may be increased to 400 mg twice daily.
Recommended Dosage (Pediatrics): 1.5 to 3 mg/kg twice daily (based on body weight).
Critical Administration Instructions:
Timing: Can be taken with or after meals.
Administration: Mix the granules with water before administration.
Renal Impairment: Dosage adjustment is generally not necessary for mild to moderate impairment, but caution is advised for severe renal impairment.
3. Mechanism of Action
Cell Wall Synthesis Inhibition: Cefcapene is a prodrug that is converted into its active form (cef capene) after absorption. It inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
Broad-Spectrum Activity: It exhibits broad-spectrum antibacterial activity against both Gram-positive and Gram-negative bacteria and is highly stable against β-lactamases.
4. Safety and Warnings
Hypersensitivity: Contraindicated in patients with a history of hypersensitivity to cephalosporins or penicillins. Cross-sensitivity may occur.
Serious Adverse Reactions: May cause shock or anaphylaxis.
Gastrointestinal Toxicity: May cause diarrhea or pseudomembranous colitis.
Hematological and Hepatic Effects: May result in abnormalities in renal function or liver function.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Diarrhea, nausea, vomiting, abdominal discomfort, and rash.
Laboratory Abnormalities: Occasional increases in AST, ALT, ALP, and BUN.
6. Drug Interactions
Antacids or H2 Blockers: May reduce the absorption of cefcapene.
Probenecid: May increase plasma concentrations of cefcapene.
Aminoglycosides: May increase nephrotoxicity if used concurrently.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Cefcapene Pivoxil Hydrochloride.
Appearance: Pale yellow to yellow granules.
Packaging: Aluminum-plastic blister packaging or bottles.
Storage: Store in a well-closed container at controlled room temperature; protect from moisture.