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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CEFOTAXIME SODIUM FOR INJECTION BP	aurobindo pharma limited (unit vi)	02352168	Powder For Solution - Intravenous , Intramuscular	0.5 G / VIAL	N/A
CLAFORAN - PWS INJ 1.0G/VIAL	sanofi-aventis canada inc	02225093	Powder For Solution - Intravenous , Intramuscular	1 G / VIAL	10/10/2003
CEFOTAXIME SODIUM FOR INJECTION BP	aurobindo pharma limited (unit vi)	02352184	Powder For Solution - Intravenous , Intramuscular	2 G / VIAL	N/A
CEFOTAXIME SODIUM FOR INJECTION BP	aurobindo pharma limited (unit vi)	02352176	Powder For Solution - Intravenous , Intramuscular	1 G / VIAL	N/A
CLAFORAN - PWS INJ 500MG/VIAL	sanofi-aventis canada inc	02225085	Powder For Solution - Intramuscular , Intravenous	500 MG / VIAL	12/19/2003
CEFOTAXIME SODIUM FOR INJECTION, BP	Sterimax Inc	02434105	Powder For Solution - Intramuscular , Intravenous	2 G / VIAL	3/12/2015
CEFOTAXIME SODIUM FOR INJECTION, BP	Sterimax Inc	02434091	Powder For Solution - Intramuscular , Intravenous	1 G / VIAL	3/12/2015
CEFOTAXIME SODIUM FOR INJECTION, BP	Sterimax Inc	02434083	Powder For Solution - Intravenous , Intramuscular	500 MG / VIAL	N/A
CLAFORAN - PWS INJ 2.0G/VIAL	sanofi-aventis canada inc	02225107	Powder For Solution - Intravenous , Intramuscular	2 G / VIAL	8/11/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CEFOTAXIMA TORLAN 2000 MG POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Ldp Laboratorios Torlan S.A.	65931	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VALORAN 1 G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Medochemie Limited	83550	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Diagnóstico Hospitalario	Commercialized
CEFOTAXIMA TORLAN 500 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE IV/IM EFG	Ldp Laboratorios Torlan S.A.	62593	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
VALORAN 2 G POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Medochemie Limited	83551	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CEFOTAXIMA TORLAN 1000 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE IM EFG	Ldp Laboratorios Torlan S.A.	62595	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
CEFOTAXIMA TORLAN 1000 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE IV/IM EFG	Ldp Laboratorios Torlan S.A.	62594	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized

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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