Cefotetan

Overview

A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.

Indication

For prophylaxis and treatment of bacterial infections.

Associated Conditions

Bacterial Infections
Bacterial Urinary Tract Infections
Bone and Joint Infections
Gynecological Infection
Intraabdominal Infections
Lower respiratory tract infection bacterial
Neisseria Gonorrhoeae Infection
Pelvic Inflammatory Disease (PID)
Postoperative Infections
Sepsis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effectiveness of Prophylactic Antibiotics Therapy in Laparoscopic Cholecystectomy on Infection Rate	2021/01/27	NCT04726046	Phase 1	Completed	Chonbuk National University Hospital
Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery	2010/10/14	NCT01220661	Phase 2	Completed	National Cancer Center, Korea
Antibiotics for Postpartum Third and Fourth Degree Perineal Tear Repairs	2005/09/16	NCT00186082	Not Applicable	Completed	Stanford University
A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)	2004/08/27	NCT00090272	Phase 3	Completed	Merck Sharp & Dohme LLC

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
CEFOTAN	Teligent Pharma, Inc.	52565-053	INTRAVENOUS, INTRAMUSCULAR	2 g in 20 mL	2/27/2018
Cefotetan	Hikma Pharmaceuticals USA Inc.	0143-9671	INTRAMUSCULAR, INTRAVENOUS	2 g in 1 1	4/12/2019
Cefotetan	Hikma Pharmaceuticals USA Inc.	0143-9670	INTRAMUSCULAR, INTRAVENOUS	1 g in 1 1	4/12/2019
Cefotan	PAI Holdings, LLC dba PAI Pharma	0121-0976	INTRAMUSCULAR, INTRAVENOUS	1 g in 10 mL	3/28/2024
Cefotetan	Fresenius Kabi USA, LLC	63323-385	INTRAVENOUS, INTRAMUSCULAR	1 g in 10 mL	7/30/2018
Cefotetan	Fresenius Kabi USA, LLC	63323-386	INTRAVENOUS, INTRAMUSCULAR	2 g in 20 mL	7/30/2018
Cefotan	PAI Holdings, LLC dba PAI Pharma	0121-0977	INTRAMUSCULAR, INTRAVENOUS	2 g in 20 mL	3/28/2024
Cefotan	Teligent Pharma, Inc.	52565-052	INTRAVENOUS, INTRAMUSCULAR	1 g in 10 mL	2/27/2018

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
No HSA approvals found for this drug.

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
CEFOTAN INJ 2GM/VIAL	ayerst laboratories	00878839	Powder For Solution - Intravenous , Intramuscular	2 G / VIAL	12/31/1990

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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