Cefoperazone Sodium and Sulbactam Dry Injection Uses Dosage and Manufacturing Process

Cefoperazone Sodium and Sulbactam for Injection is an exceptionally potent broad-spectrum antibiotic formulation that is extensively utilized in combating bacterial infections. At R K Life Care INC, we produce and export high-quality Cefoperazone Sodium and Sulbactam Dry Injection that complies with international pharmacopeial standards. Our state-of-the-art production facility guarantees the purity, effectiveness, and safety of each vial.

Uses of Cefoperazone Sodium and Sulbactam Injection

Cefoperazone is classified as a third-generation cephalosporin antibiotic. Together, they exhibit a synergistic antibacterial effect against a broad spectrum of both gram-positive and gram-negative bacteria.

This combination is used to treat a variety of severe infections, such as:

• Respiratory tract infections (pneumonia, bronchitis)

• Urinary tract infections

• Intra-abdominal infections

• Biliary tract infections

• Septicemia

• Skin and soft tissue infections

• Bone and joint infections

• Gynecological infections

• Postoperative and hospital-acquired infections

Sulbactam improves the effectiveness of Cefoperazone by blocking the enzymes responsible for antibiotic resistance, thus broadening the antibiotic’s range of action.

Dosage and Administration

The dosage of Cefoperazone and Sulbactam Injection is determined by the nature and intensity of the infection, the age of the patient, and their renal or hepatic function. It is given either intravenously (IV) or intramuscularly (IM) under the guidance of a healthcare professional.

Typical adult dosage:

• The standard dosage consists of Cefoperazone 1–2 g combined with Sulbactam 0.5–1 g, given every 12 hours.

• For severe infections, the dosage can be escalated to Cefoperazone 4 g along with Sulbactam 2 g daily, split into two separate doses.

For children:

• The suggested dosage is 40–80 mg/kg/day for the Cefoperazone component and 20–40 mg/kg/day for the Sulbactam component, administered in two separate doses.

Preparation for injection:

• For IM injection, the dry powder is mixed with sterile water for injection or an appropriate diluent.

• For IV administration, the vial is reconstituted and then diluted with a suitable infusion solution such as 5% Dextrose or Normal Saline.

Important notes:

• The injection must be administered right after it has been reconstituted.

• Patients with liver impairment may need dosage modifications.

• The length of therapy is contingent upon the type of infection and the patient's response, typically ranging from 7 to 14 days.

Manufacturing Process of Cefoperazone Sodium and Sulbactam Dry Injection

At R K Lifecare INC, we adhere to a GMP-plant, sterile manufacturing process that guarantees product safety, stability, and adherence to regulatory standards. The production of Cefoperazone Sodium and Sulbactam for Injection encompasses several essential steps:

1. Raw Material Selection and Testing:
   High-quality Cefoperazone Sodium and Sulbactam Sodium are sourced from accredited suppliers. Every batch is subjected to thorough quality control assessments to ensure its identity, purity, and potency.

2. Blending and Mixing:
   The two active pharmaceutical ingredients (APIs) are carefully measured and blended in specific proportions, usually 2:1 (Cefoperazone:Sulfactam), in a controlled environment to guarantee even distribution.

3. Sterile Filtration:
   The combined powder undergoes sterile processing through validated filtration methods to remove microbial contamination.

4. Filling and Sealing
   The sterile dry powder blend is transferred into glass vials through automated aseptic filling equipment. Each vial is meticulously sealed with a rubber stopper and an aluminum cap to ensure sterility.

5. Lyophilization (if applicable):
   In some cases, the product undergoes freeze-drying to enhance its stability and shelf life.

6. Quality Control Testing:
   Each batch undergoes testing for sterility, assay, pH, particulate matter, moisture content, and endotoxin levels prior to release. Stability studies are performed under various conditions to guarantee reliable performance.

7. Packaging and Labeling:
   The completed vials are enclosed in moisture-resistant cartons that prominently display the product details, batch number, manufacturing date, and expiration date.

Conclusion

Cefoperazone Sodium and Sulbactam Dry Injection represents a vital antibiotic formulation in contemporary healthcare. By utilizing advanced technology, maintaining rigorous quality control, and adhering to sterile manufacturing practices, R K Lifecare INC guarantees dependable, high-quality injections for healthcare markets worldwide. Our dedication to excellence and innovation positions us as a reputable manufacturer and exporter of pharmaceutical dry injections both in India and internationally.