Cefotaxime

Overview

Cefotaxime is a third-generation cephalosporin antibiotic. Like other third-generation cephalosporins, it has broad spectrum activity against Gram positive and Gram negative bacteria. In most cases, it is considered to be equivalent to ceftriaxone in terms of safety and efficacy. Cefotaxime sodium is marketed under various trade names including Claforan (Sanofi-Aventis).

Indication

Used to treat gonorrhoea, meningitis, and severe infections including infections of the kidney (pyelonephritis) and urinary system. Also used before an operation to prevent infection after surgery.

Associated Conditions

Bone and Joint Infections caused by susceptible Bacterial Infections
Central Nervous System Infections caused by susceptible Bacterial Infections
Genitourinary tract infection caused by susceptible Bacterial Infections
Gynaecological infection caused by susceptible bacteria
Intraabdominal Infections caused by susceptible Bacterial Infections
Lower Respiratory Tract Infection (LRTI) caused by susceptible bacteria
Postoperative Wound Infection
Septicemia caused by susceptible Bacterial Infections
Skin and skin-structure infections caused by susceptible bacteria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Aminoglycosides in Early Sepsis	2024/12/02	NCT06712641	Phase 4	Not yet recruiting	University Hospital, Akershus
LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media	2023/04/07	NCT05804123	Not Applicable	Completed	Anabio R&D
Meropenem vs Cefotaxime as Empirical Treatment of SBP	2022/06/22	NCT05427747	Phase 4	UNKNOWN	Assiut University
Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial Peritonitis	2019/11/19	NCT04168099	Phase 3	Recruiting	Tanta University
Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)	2019/04/22	NCT03922919	Phase 4	UNKNOWN	Centre Hospitalier Universitaire de Besancon
Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections	2016/11/09	NCT02959957	Phase 4	Completed	Håkan Hanberger
Impact of the Choice of 3rd Generation Cephalosporins on the Emergence of Resistance in the Microbiota Intestinal.	2016/01/20	NCT02659033	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris
Randomized Trial of Continuous Versus Intermittent Cefotaxime Infusion on ICU.	2015/09/25	NCT02560207	Phase 4	Completed	University Medical Center Groningen
Is Spontaneous Bacterial Peritonitis Still Responding to 3rd Generation Cephalosporins?	2015/05/13	NCT02443285	Phase 3	UNKNOWN	Tanta University
Cefotaxime Resistance in Treatment of Spontaneous Bacterial Peritonitis	2015/03/13	NCT02388035	Not Applicable	Completed	Dr Ahmed Ali Elbaz

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cefotaxime	Wockhardt USA LLC.	64679-986	INTRAMUSCULAR, INTRAVENOUS	1 g in 1 1	11/26/2019
Cefotaxime	Wockhardt USA LLC.	64679-948	INTRAMUSCULAR, INTRAVENOUS	2 g in 1 1	11/26/2019
Cefotaxime	SteriMax Inc.	21586-012	INTRAMUSCULAR, INTRAVENOUS	2 g in 1 1	8/1/2019
Cefotaxime	Hikma Pharmaceuticals USA Inc.	0143-9930	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 1	5/25/2021
CEFOTAXIME	WOCKHARDT LIMITED	55648-986	INTRAMUSCULAR, INTRAVENOUS	1 g in 1 mL	11/20/2009
Cefotaxime	West-Ward Pharmaceuticals Corp	0143-9935	INTRAVENOUS	10 g in 1 1	9/17/2018
Cefotaxime	SteriMax Inc.	21586-011	INTRAMUSCULAR, INTRAVENOUS	1 g in 1 1	8/1/2019
Cefotaxime	Wockhardt USA LLC.	64679-947	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 1	11/26/2019
Cefotaxime	Hikma Pharmaceuticals USA Inc.	0143-9931	INTRAMUSCULAR, INTRAVENOUS	1 g in 1 1	5/25/2021
Cefotaxime	Hikma Pharmaceuticals USA Inc.	0143-9933	INTRAMUSCULAR, INTRAVENOUS	2 g in 1 1	5/25/2021

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
CYTAXIN POWDER FOR SOLUTION FOR INJECTION 0.5G/VIAL	TENAMYD PHARMACEUTICAL CORPORATION	SIN16367P	INJECTION, POWDER, FOR SOLUTION	0.5g/vial	11/10/2021
CYTAXIN POWDER FOR SOLUTION FOR INJECTION 1G/VIAL	TENAMYD PHARMACEUTICAL CORPORATION	SIN16368P	INJECTION, POWDER, FOR SOLUTION	1g/vial	11/10/2021

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Cefotaxime Sodium for Injection	南京恩泰医药科技有限公司	国药准字H32021187	化学药品	注射剂	6/15/2020
Cefotaxime Sodium for Injection	石药集团欧意药业有限公司	国药准字H20057348	化学药品	注射剂	10/23/2020
Cefotaxime Sodium for Injection	海南海药股份有限公司海口市制药厂	国药准字H20023890	化学药品	注射剂	4/8/2020
Cefotaxime Sodium for Injection	海南海灵化学制药有限公司	国药准字H20033428	化学药品	注射剂	5/21/2020
Cefotaxime Sodium for Injection	海南海药股份有限公司海口市制药厂	国药准字H20023891	化学药品	注射剂	3/26/2020
Cefotaxime Sodium for Injection	丽珠集团丽珠制药厂	国药准字H44024074	化学药品	注射剂	4/13/2020
Cefotaxime Sodium for Injection	海南广升誉制药有限公司	国药准字H46020189	化学药品	注射剂	6/15/2020
Cefotaxime Sodium for Injection	广东博洲药业有限公司	国药准字H20046517	化学药品	注射剂	4/7/2021
Cefotaxime Sodium for Injection	珠海联邦制药股份有限公司中山分公司	国药准字H20023014	化学药品	注射剂	6/21/2024
Cefotaxime Sodium for Injection	四川省长征药业股份有限公司	国药准字H51020519	化学药品	注射剂	5/14/2021

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
VALORAN FOR INJ 1G	N/A	STAR MEDICAL AND GENERAL SUPPLIES (PTY) LTD	N/A	N/A	8/31/1991

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
DBL CEFOTAXIME SODIUM for injection 1g vial	78702	Pfizer Australia Pty Ltd	Medicine	A	8/22/2001

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