Sulbactam

Overview

Sulbactam is a β-lactamase inhibitor given in combination with β-lactam antibiotics to inhibit β-lactamase, an enzyme produced by bacteria that destroys antibiotic activity.

Indication

Sulbactam is currently available in combination products with ampicillin. Within this formulation it is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli, Klebsiella spp. (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter spp., and Acinetobacter calcoaceticus. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae), Bacteroides spp. (including B. fragilis), and Enterobacter spp. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli, and Bacteroides spp. (including B. fragilis).

Associated Conditions

Animal bite
Bacterial Infections
Bacterial Infections caused by Beta lactamase producing bacteria
Bacterial Sinusitis
Bites, Human
Catheter Related Infections
Community Acquired Pneumonia (CAP)
Gynecological Infection
Infective Endocarditis (IE)
Intraabdominal Infections
Nosocomial Pneumonia
Postoperative Infections
Postoperative Wound Infection
Skin and Subcutaneous Tissue Bacterial Infections
Complicated Bacterial Infections caused by Beta lactamase producing bacteria
Moderate Bacterial Infections
Severe Bacterial Infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex	2019/03/28	NCT03894046	Phase 3	Completed	Entasis Therapeutics
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria	2018/03/26	NCT03477422	Phase 3	Completed	Venus Remedies Limited
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects	2017/10/06	NCT03303924	Phase 1	Completed	Entasis Therapeutics
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects	2016/11/23	NCT02971423	Phase 1	Completed	Entasis Therapeutics
Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections	2016/02/23	NCT02688322	Phase 4	Completed	Sutep Jaruratanasirikul
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -	2013/02/15	NCT01793688	N/A	Completed	Pfizer
Ampicillin / Sulbactam vs. Ampicillin / Gentamicin for Treatment of Chorioamnionitis	2009/04/09	NCT00879190	Phase 2	Completed	Stanford University
Preventing Complications in Cleft Palate Repair With Antibiotics	2008/09/25	NCT00760006	Phase 2	Completed	Joseph Losee

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
UNASYN 750 FOR INJECTION	Haupt Pharma Latina S.r.L	SIN01950P	INJECTION, POWDER, FOR SOLUTION	250 mg/vial	6/23/1988
UNASYN 1500 FOR INJECTION	Haupt Pharma Latina S.r.L	SIN01948P	INJECTION, POWDER, FOR SOLUTION	500 mg/vial	6/23/1988
UNASYN 3000 FOR INJECTION	Haupt Pharma Latina S.r.L	SIN01949P	INJECTION, POWDER, FOR SOLUTION	1 g/vial	6/23/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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