Product Details
Cefotaxime Injection powder for solution
250mg/500mg/1g/2g
Product Description :
CEFOTAXIME INJECTION 250 mg / 500 mg / 1 g / 2 g
Sterile Powder for Solution for Intravenous or Intramuscular Administration
1. COMPOSITION
Each vial contains:
• Cefotaxime Sodium equivalent to Cefotaxime 250 mg / 500 mg / 1 g / 2 g.
• Excipients: As applicable.
2. PHARMACEUTICAL FORM
Sterile, white to off-white powder for solution for intravenous or intramuscular administration.
3. THERAPEUTIC CLASS
Third-Generation Cephalosporin Antibiotic.
4. INDICATIONS
Cefotaxime Injection is indicated for the treatment of susceptible bacterial infections, including:
• Lower respiratory tract infections.
• Urinary tract infections.
• Intra-abdominal infections.
• Skin and soft-tissue infections.
• Bone and joint infections.
• Gynecological and pelvic infections.
• Septicemia and other serious bacterial infections.
• Meningitis caused by susceptible organisms.
Treatment should be guided by the susceptibility of the causative organism and applicable antimicrobial guidelines.
5. CONTRAINDICATIONS
• Hypersensitivity to cefotaxime, cephalosporins, or any component of the formulation.
• History of severe immediate hypersensitivity reactions to beta-lactam antibiotics.
6. DRUG INTERACTIONS
• Concomitant nephrotoxic medicines may increase the risk of renal toxicity.
• Probenecid may affect the renal elimination of cefotaxime.
• Anticoagulants may require appropriate monitoring.
• Other medicines affecting renal function should be used with caution.
The treating physician should review all concomitant medications before administration.
7. ADMINISTRATION
For intravenous or intramuscular administration after reconstitution with a compatible diluent under aseptic conditions. Administer according to the approved product information and institutional protocol. Dose adjustment may be required in patients with significant renal impairment.
8. STORAGE
Store according to the storage conditions stated on the approved product label. Protect from excessive heat, moisture and light. After reconstitution, use within the period specified in the approved product information. Do not use if the reconstituted solution shows visible particles, precipitation or unexpected discoloration.