Description
Cefoperazone & Sulbactam Injection (Human Use)
Healthy Inc is a specialized global supplier and exporter of advanced beta-lactamase inhibitor combinations. We provide high-purity Cefoperazone & Sulbactam Injection, sourced from WHO–GMP certified sterile facilities. This “MDR-Shield” antibiotic is a top export to critical care units (ICUs), government hospitals, and tender boards in Africa, LATAM, and Southeast Asia, specifically valued for its efficacy against resistant Gram-negative pathogens, including Pseudomonas aeruginosa.
Product Overview
This formulation contains a strategic combination of Cefoperazone Sodium (3rd Gen Cephalosporin) and Sulbactam Sodium (Beta-lactamase Inhibitor).
The “Pseudomonas & MDR” Specialist:
- Dual Action: Sulbactam irreversibly blocks beta-lactamase enzymes produced by resistant bacteria, restoring the bactericidal activity of Cefoperazone.
- Pseudomonas Coverage: Cefoperazone is distinct among cephalosporins for its potent anti-pseudomonal activity, making this combination essential for hospital-acquired infections.
- Biliary Excretion: Unlike most antibiotics which are cleared by the kidneys, Cefoperazone is largely excreted in the bile, making it the drug of choice for Hepato-Biliary infections (Cholecystitis, Cholangitis).
- Anaerobic Activity: Sulbactam adds coverage against Bacteroides species, useful in intra-abdominal sepsis.
Product Composition & Strength
We supply this product as a Sterile Dry Powder in glass vials (requires reconstitution). Available in 1:1 and 2:1 ratios.
| Product Strength | Cefoperazone Content | Sulbactam Content | Ratio |
|---|---|---|---|
| 1 gm Vial | 500 mg | 500 mg | 1 : 1 |
| 1.5 gm Vial | 1000 mg | 500 mg | 2 : 1 |
| 2 gm Vial | 1000 mg | 1000 mg | 1 : 1 |
| Diluent | 10 mL / 20 mL | — | Sterile Water for Injection |
*Pack Sizes: Single vial with WFI ampoule, or bulk hospital tray packs.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.20.19 (Medicaments containing Cephalosporins) |
| Dosage Form | Sterile Dry Powder for Injection (Reconstitution required) |
| Packaging | Clear Glass Vial with Flip-off Seal |
| Storage | Store below 25°C. Protect from light and moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate, CTD Dossier |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Formulation Stability: Manufactured using aseptic blending technology to ensure a uniform ratio of Cefoperazone to Sulbactam in every vial.
- Solubility: Optimized for rapid reconstitution without foaming, ensuring quick preparation in emergency ICU settings.
- Moisture Control: Strictly controlled humidity during filling to prevent degradation (hydrolysis) of the beta-lactam ring.
Therapeutic Indications (Human Use)
Indicated for moderate to severe infections in Adults and Children:
- Intra-Abdominal Infections: Peritonitis, Cholecystitis, Cholangitis (Excellent biliary penetration).
- Respiratory Tract: Hospital-Acquired Pneumonia (HAP), Ventilator-Associated Pneumonia (VAP).
- Urinary Tract: Complicated UTIs caused by resistant pathogens.
- Septicemia: Sepsis caused by Gram-negative organisms like Pseudomonas.
- Gynecological Infections: PID, Endometritis.
Dosage & Administration
Recommended Dosage (Strictly as per Physician):
- Route: Intravenous (IV) Infusion or Deep Intramuscular (IM).
- Adults: 2 gm to 4 gm (Combined Activity) daily, administered in divided doses every 12 hours.
- Severe Infections: Dose can be increased up to 8 gm daily (1:1 ratio) in divided doses.
- Pediatrics: 40 to 80 mg/kg/day in divided doses.
- Renal Impairment: Dosage adjustment is usually not required (due to biliary excretion) unless impairment is severe.
Safety Warnings:
- Disulfiram-Like Reaction: ALCOHOL WARNING: Ingestion of alcohol within 72 hours of administration can cause severe nausea, vomiting, and flushing (Antabuse effect) due to the N-methylthiotetrazole (NMTT) side chain.
- Hypersensitivity: Contraindicated in patients allergic to Penicillins or Cephalosporins.
- Bleeding Risk: Prolonged use may occasionally cause hypoprothrombinemia (Vitamin K deficiency); monitor clotting times in high-risk patients.
Commercial Inquiries
For hospital tenders, bulk export, or distributor pricing, please contact our export team.
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
