Changsheng Cefotaxime Sodium and Tazobactam Sodium for Injection

1. Indications and Usage
Mixed Infections:
Treatment of moderate to severe bacterial infections caused by susceptible bacteria, including sepsis, lower respiratory tract infections, intra-abdominal infections, urinary tract infections, and gynecologic infections.
Antibacterial Spectrum:
Effective against aerobic Gram-negative bacteria (including β-lactamase-producing strains) and certain Gram-positive bacteria and anaerobes.
2. Dosage and Administration
Route of Administration:
For Intravenous (IV) Infusion ONLY.
Recommended Dosage:
Adults: Typically 1 g to 2 g (based on the cefotaxime component) every 8 to 12 hours.
Severe Infections: Daily doses up to 6 g may be administered in divided doses.
Renal Impairment: Dosage adjustment is required for patients with creatinine clearance < 80 mL/min.
Critical Administration Instructions:
Reconstitution: Dissolve the powder with Sterile Water for Injection or 0.9% Sodium Chloride Injection.
Dilution: Further dilute with 50 to 250 mL of 0.9% Sodium Chloride or 5% Glucose Injection.
Infusion Time: Administer over 30 to 60 minutes. Do not administer as an IV bolus or push.
Compatibility: Do not mix with solutions containing calcium (e.g., Ringer’s injection).
3. Mechanism of Action
Cefotaxime (Antibiotic):
Binds to penicillin-binding proteins (PBPs), inhibiting bacterial cell wall synthesis and causing cell death.
Tazobactam (Enzyme Inhibitor):
Inhibits β-lactamases produced by resistant bacteria, protecting cefotaxime from degradation and broadening its antibacterial spectrum.
4. Safety and Warnings
Hypersensitivity:
Serious and occasionally fatal anaphylactic reactions. Contraindicated in patients with severe hypersensitivity to cefotaxime or other β-lactam antibiotics.
Clostridioides difficile-Associated Diarrhea:
Broad-spectrum antibiotics may alter normal gut flora, leading to pseudomembranous colitis.
Hepatobiliary Effects:
May cause transient elevations in liver enzymes; cholestasis has been reported.
5.Adverse Reactions and Clinical Research
Most Common Adverse Reactions:
Nausea, vomiting, diarrhea, rash, pruritus, and injection site reactions.
Serious Adverse Events:
Severe skin reactions, renal impairment, and pseudomembranous colitis.
6.Drug Interactions
Probenecid:
May increase and prolong cefotaxime serum concentrations.
Anticoagulants:
May enhance the anticoagulant effect of warfarin.
Aminoglycosides:
Potentially increased risk of nephrotoxicity if used concomitantly (must be administered separately).
7.Pharmaceutical Information
Chemical Composition:
Active Ingredients: Cefotaxime Sodium and Tazobactam Sodium.
Appearance: White to off-white lyophilized powder.
Packaging: Single-use vial (e.g., 1.5 g or 3 g total weight).
Storage: Store at controlled room temperature.