Description
Indication & Scope
Sulbactam and Durlobactam proceeds treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
- Mechanism: Durlobactam is a novel diazabicyclooctane β-lactamase inhibitor that protects sulbactam from hydrolysis by class A, C, D carbapenemases produced by Acinetobacter baumannii. Sulbactam exerts bactericidal activity against target pathogens by inhibiting bacterial cell wall synthesis.
- Drug class: Combination β-lactam antibiotic + β-lactamase inhibitor, anti-infective agent.
- Clinical use: Empiric and targeted therapy for multidrug-resistant Acinetobacter baumannii lower respiratory tract infections in hospitalized critically ill patients.
| Generic Name | Sulbactam and Durlobactam |
| Brand Name | XACDURO |
| Ingredient | Sulbactam and Durlobactam |
| Dosage Form | Sterile powder for intravenous injection |
| Package | 1g(Sulbactam)*1 vial/box; 0.5g(Durlobactam)*2 vials/box |
| Conditions Treated | Hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia due to susceptible Acinetobacter baumannii-calcoaceticus complex strains |
| Taboos | 1. Severe hypersensitivity to sulbactam, durlobactam, other β-lactam antibiotics or excipients.
2. History of severe anaphylactic reactions to penicillin or cephalosporin class antimicrobials. |
| Place of origin | 930 Winter St – Suite 1500, Waltham, MA 02451 United States of America |
| Prescription type | Prescription-only |
| Storage Conditions | Store unopened vials at 20°C to 25°C, protected from light and moisture. Reconstituted solution must be used within 6 hours at room temperature |
| Manufacturer | Entasis Therapeutics, Inc., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20240024 |
| Approval Date | May 15, 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Sulbactam 1 g + Durlobactam 1 g, administered intravenously every 6 hours for 7 to 14 days. Dose adjustment required for renal impairment.
Time: Infuse intravenously over 3 hours every 6 hours at fixed intervals.
Instructions for use:
1. Reconstitute sterile powder with sterile water for injection before dilution.
2. Perform renal function assessment before treatment to adjust dosage.
3. Monitor for diarrhea and superinfection during the full treatment course.
4. Do not administer via intramuscular injection.
Interaction:
1. Concurrent nephrotoxic agents (aminoglycosides, vancomycin) increase renal injury risk.
2. Probenecid reduces renal clearance and elevates systemic drug exposure.
3. May reduce efficacy of oral contraceptives.
Side effects:
1. Common: Diarrhea, nausea, headache, elevated liver transaminases, infusion site reactions.
2. Severe: Clostridioides difficile-associated diarrhea, hypersensitivity anaphylaxis, acute kidney injury, neutropenia.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is the main indication of Sulbactam and Durlobactam?
It treats hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible Acinetobacter baumannii complex.
Who cannot use Sulbactam and Durlobactam?
Patients with severe hypersensitivity to β-lactam drugs or a history of severe penicillin/cephalosporin anaphylaxis.
What are the most common side effects of Sulbactam and Durlobactam?
Diarrhea, nausea, headache, elevated liver enzymes, and infusion site reactions.
How should the reconstituted solution of Sulbactam and Durlobactam?
The diluted solution must be used within 6 hours at room temperature.
XACDURO® | Sulbactam and Durlobactam | HABP and VABP | DengYueRX
INN: Sulbactam and Durlobactam
Indications: HABP and VABP
Dosage Form: Sterile powder for intravenous injection
Strength: 1g(Sulbactam Sodium)/vial; 0.5g(Durlobactam Sodium)/vial
