Cefotaxime Sodium and Sulbactam Dry injection Uses, Dosage and Manufacturing Process

Cefotaxime Sodium and Sulbactam Injection is a potent antibiotic mixture widely used in the management of serious bacterial infections. This dry powder injection requires thorough mixing with sterile water before use and is intended for both human and veterinary use.

It contains two active ingredients: cefotaxime sodium, a third-generation cephalosporin antibiotic, and sulbactam sodium, a β-lactamase inhibitor.

Together, these ingredients provide broad-spectrum antibacterial action and improved resistance against β-lactamase-producing microorganisms.

Uses of Cefotaxime Sodium and Sulbactam Dry Injection

This combination proves to be extremely effective in addressing a wide range of bacterial infections caused by both Gram-positive and Gram-negative bacteria.

1. Respiratory Tract Infections:
It is used in conditions like pneumonia, bronchitis and lung abscess caused by susceptible bacteria.

2. Urinary Tract Infections (UTIs):
Effective in the treatment of complicated and uncomplicated urinary tract infections including pyelonephritis and cystitis.

3. Skin and Soft Tissue Infections:
Addresses cellulitis, wound infections, and abscesses associated with resistant bacteria.

4. Intra-abdominal and Pelvic Infections:
It is used in cases of peritonitis, cholecystitis, and pelvic inflammatory disease, which often occur after surgical procedures or traumatic events.

5. Bone and Joint Infections:
Helps manage osteomyelitis and septic arthritis caused by sensitive pathogens.

6. Septicemia and Meningitis:
Cefotaxime, due to its ability to effectively penetrate the cerebrospinal fluid, makes this combination important for the treatment of serious infections such as bacterial meningitis and septicemia.

7. Gynecological and Obstetric Infections:
Beneficial in cases of postpartum infections, endometritis, and as a surgical prophylactic measure to avert post-operative infections.

By integrating sulbactam with cefotaxime, this formulation prevents bacterial resistance, enabling cefotaxime to maintain its efficacy against β-lactamase-producing strains.

Dosage and Administration

The dosage of cefotaxime sodium and sulbactam injection is determined based on the severity of the infection, the patient's age, and body weight. It should always be given under the supervision of a physician.

For Adults:

• Typical dose: 1.5 g to 3 g (Cefotaxime 1 g + Sulbactam 0.5 g) every 8–12 hours.
• In severe infections, the dose may be increased up to 6 g daily, divided into multiple doses.

For Children:

• The recommended dose is 50-100 mg/kg/day, given in divided doses every 6-8 hours, depending on the severity of the infection.

For Neonates and Infants:

• Dosage: 50 mg per kilogram per day, administered in 2 to 4 divided doses, adjustments made according to the patient's clinical condition and renal function.

Route of Administration:
Cefotaxime sodium and sulbactam dry injection is given via intravenous (IV) or intramuscular (IM) administration after appropriate reconstitution with sterile water for injection.

Precautions:

• Perform sensitivity testing before administration.

• Adjust dosage in patients with renal impairment.

• Avoid mixing with other antibiotics in the same syringe or IV line.

Manufacturing Process of Cefotaxime Sodium and Sulbactam Dry Injection

The production of cefotaxime sodium and sulbactam injection requires rigorous compliance with good manufacturing practices (GMP) and a sterile environment to guarantee the safety, stability, and effectiveness of the product.

1. Raw Material Procurement:
High-purity cefotaxime sodium and sulbactam sodium are sourced from recognized API suppliers. Both components undergo stringent quality control evaluations to ensure purity, moisture levels, and potency.

2. Weighing and Mixing:
The API and excipients are precisely measured according to the formulation batch size. The powder is mixed in a sterile, closed-system mixer to ensure uniformity.

3. Sterile Filtration and Sieving:
The combined powder is sieved to achieve a uniform particle size, allowing for consistent reconstitution and increased dosing accuracy.

4. Filling and Sealing:
Using automated filling machines, the sterile powder mixture is filled into sterile glass vials. The vials are then partially sealed with sterile rubber caps and secured with aluminum caps under aseptic conditions.

5. Sterilization and Inspection:
After filling, the vials are sterilized using an autoclave or dry heat sterilizer, depending on the consistency requirements. Each vial is then checked for the presence of granules, the accuracy of the filled volume, and the correctness of the labeling.

6. Packaging:
The finished product is packed in cartons that have appropriate labeling, including manufacturing date, expiry date, batch number and storage instructions.

7. Quality Control and Testing:
Each batch is subjected to testing for sterility, pyrogenicity, potency and pH balance to guarantee compliance with pharmacopoeial standards (IP/BP/USP).

Conclusion

Cefotaxime Sodium and Sulbactam Dry Injection is a reliable broad-spectrum antibiotic formula specifically developed for the effective treatment of serious bacterial infections. The combination of a third-generation cephalosporin and a β-lactamase inhibitor provides superior antibacterial coverage and helps prevent resistance. Through precise dosage and adherence to stringent GMP-controlled manufacturing processes, this formula guarantees safety, efficacy, and reliability for both healthcare professionals and patients.