Cefuroxime

Overview

Broad-spectrum cephalosporin antibiotic resistant to beta-lactamase. It has been proposed for infections with gram-negative and gram-positive organisms, gonorrhea, and haemophilus.

Indication

For the treatment of many different types of bacterial infections such as bronchitis, sinusitis, tonsillitis, ear infections, skin infections, gonorrhea, and urinary tract infections.

Associated Conditions

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
Animal bite
Bacterial Infections
Bone and Joint Infections
Impetigo
Lower Respiratory Tract Infection (LRTI)
Lyme Disease
Maxillary Sinusitis
Meningitis
Neisseria Gonorrhoeae Infection
Septicemia
Skin and Subcutaneous Tissue Bacterial Infections
Urinary Tract Infection
Bacterial otitis media
Mild Streptococcal pharyngitis
Mild Streptococcal tonsillitis
Moderate Streptococcal pharyngitis
Moderate Streptococcal tonsillitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis	2024/11/29	NCT06709196	Phase 4	Recruiting	Rigshospitalet, Denmark
Clinical Trial Comparing Oral Versus Intravenous Cefuroxime in Pregnant Women With Pyelonephritis	2024/07/30	NCT06527560	Phase 4	Not yet recruiting	Hospital de Clinicas de Porto Alegre
Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin	2024/04/08	NCT06351891	Phase 4	Not yet recruiting	Qilu Hospital of Shandong University
Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)	2023/03/24	NCT05784311	Phase 4	Recruiting	Leiden University Medical Center
Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery	2022/11/08	NCT05609240	Phase 2	Recruiting	University of Leeds
Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections	2022/10/13	NCT05577273	Not Applicable	ENROLLING_BY_INVITATION	Omri Schwarztuch Gildor
Cefuroxime vs Ceftriaxone for SSI Prevention in Neurosurgery	2022/05/31	NCT05398081	Phase 2	Completed	Dr. Promise Tamunoipiriala Jaja
Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates	2022/05/24	NCT05388747	N/A	Recruiting	Shandong University
Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment	2021/01/25	NCT04723472	Not Applicable	Suspended	Shanghai East Hospital
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection	2020/07/21	NCT04479657	Early Phase 1	Recruiting	Zhong Wang

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cefuroxime axetil	American Health Packaging	60687-272	ORAL	250 mg in 1 1	8/6/2025
Cefuroxime	Hikma Pharmaceuticals USA Inc.	0143-9568	INTRAMUSCULAR, INTRAVENOUS	750 mg in 1 1	9/27/2018
cefuroxime axetil	LUPIN LIMITED	57297-303	ORAL	500 mg in 1 1	5/6/2016
Cefuroxime	Hikma Pharmaceuticals USA Inc.	0143-9979	INTRAMUSCULAR, INTRAVENOUS	750 mg in 1 1	4/8/2020
Cefuroxime axetil	RPK Pharmaceuticals, Inc.	53002-2750	ORAL	250 mg in 1 1	7/29/2022
Cefuroxime Axetil	Physicians Total Care, Inc.	54868-4987	ORAL	250 mg in 1 1	12/9/2010
Cefuroxime axetil	Bryant Ranch Prepack	63629-9447	ORAL	250 mg in 1 1	11/23/2021
CEFUROXIME AXETIL	DIRECT RX	61919-145	ORAL	250 mg in 1 1	11/3/2015
Cefuroxime axetil	Rebel Distributors Corp	21695-150	ORAL	500 mg in 1 1	1/17/2008
Cefuroxime Axetil	H.J. Harkins Company, Inc.	52959-939	ORAL	500 mg in 1 1	12/29/2011

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
CEFUROXIME-AFT POWDER FOR INJECTION 1.5G/VIAL	Qilu Pharmaceutical Co., Ltd.	SIN15154P	INJECTION, POWDER, FOR SOLUTION	1.5g	1/12/2017
CEFUROXIME-AFT POWDER FOR INJECTION 750MG/VIAL	Qilu Pharmaceutical Co., Ltd.	SIN15155P	INJECTION, POWDER, FOR SOLUTION	750mg	1/12/2017
ZINNAT FOR SUSPENSION 125 mg/5 ml	Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)	SIN07013P	GRANULE, FOR SUSPENSION	125 mg/5 ml	5/15/1992
SHINCEF FOR INJECTION 1.5 g/ vial	SHIN POONG PHARMACEUTICAL CO LTD	SIN10947P	INJECTION, POWDER, FOR SOLUTION	1.5 g/ vial	5/25/1999
AXETINE film coated tablet 500mg	MEDOCHEMIE Ltd, Factory C	SIN14346P	TABLET, FILM COATED	500mg	5/6/2013
SHINCEF FOR INJECTION 750 mg/ vial	SHIN POONG PHARMACEUTICAL CO LTD	SIN10946P	INJECTION, POWDER, FOR SOLUTION	750 mg/vial	5/25/1999
AXETINE FILM COATED TABLET 250MG	MEDOCHEMIE Ltd, Factory C	SIN14566P	TABLET, FILM COATED	250 mg	6/30/2014
ZINNAT TABLET 250 mg	Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)	SIN02365P	TABLET, FILM COATED	250 mg	11/3/1988
Xorimax 250mg coated tablets	Sandoz Private Limited (Intermediate), Pencef Pharma GmbH, Sandoz GmbH, Aurobindo Pharma Limited (Intermediate)	SIN13287P	TABLET, COATED	250 mg	6/1/2007
CEFUROXIME-AFT POWDER FOR INJECTION 250MG/VIAL	Qilu Pharmaceutical Co., Ltd.	SIN15156P	INJECTION, POWDER, FOR SOLUTION	250mg	1/12/2017

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
CEFUROXIME SXP cefuroxime (as sodium) 750 mg powder for injection vial	310373	Southern XP IP Pty Ltd	Medicine	A	11/14/2019
ZINNAT cefuroxime (as axetil) 125 mg/5mL granules for oral suspension bottle	81297	Aspen Pharmacare Australia Pty Ltd	Medicine	A	2/25/2002
ZINNAT cefuroxime (as axetil) 250 mg/5mL granules for oral suspension bottle	81301	Aspen Pharmacare Australia Pty Ltd	Medicine	A	2/25/2002
CEFUROXIME-WGR cefuroxime 250mg (as axetil) film coated tablet blister pack	464767	Pharmacor Pty Ltd	Medicine	A	2/6/2025
AL-Cefuroxime cefuroxime 500mg film coated tablet blister pack	273226	Pharmacor Pty Ltd	Medicine	A	3/27/2017
ZINNAT cefuroxime (as axetil) 125 mg/5mL granules for oral suspension bottle	178687	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/10/2011
CEFINTRA cefuroxime (as sodium) 50 mg powder for injection vial	388237	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/24/2023
PHARMACOR CEFUROXIME cefuroxime 250mg film coated tablet blister pack	273229	Pharmacor Pty Ltd	Medicine	A	3/27/2017
CEFUROXIME ANS cefuroxime (as sodium) 750 mg powder for injection vial	310372	Southern XP IP Pty Ltd	Medicine	A	11/14/2019
CEFUROXIME SXP cefuroxime (as sodium) 1500 mg powder for injection vial	310375	Southern XP IP Pty Ltd	Medicine	A	11/14/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ZINACEF INJECTION - PWS IM IV 750MG/VIAL	GlaxoSmithKline Inc	02213532	Powder For Solution - Intravenous , Intramuscular	750 MG / VIAL	8/20/2001
ZINACEF INJECTION - PWS IV 7.5GM/VIAL	GlaxoSmithKline Inc	02213559	Powder For Solution - Intravenous	7.5 G / VIAL	1/17/2002
KEFUROX INJ PWS 1.5GM/ADD-VANTAGE VIAL	eli lilly canada inc	01940252	Powder For Solution - Intravenous	1.5 G / VIAL	12/31/1991
ZINACEF INJECTION - PWS IV 1.5GM/VIAL	GlaxoSmithKline Inc	02213540	Powder For Solution - Intravenous	1.5 G / VIAL	1/1/2002

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ZANETIN 750 MG POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Medochemie Iberia S.A.	84567	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
CEFUROXIMA SUN 500 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sun Pharmaceutical Industries (Europe) B.V.	81011	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
ZANETIN 1500 MG POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION EFG	Medochemie Iberia S.A.	84566	POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
CEFUROXIMA RANBAXY 500 mg COMPRIMIDOS EFG	Laboratorios Ranbaxy, S.L.	68230	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not 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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