Vancomycin

Overview

Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to ristocetin that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear. As of January 29 2018, CutisPharma's Firvanq is the only FDA approved vancomycin oral liquid treatment option available for the the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains [LP1196]. Such an oral liquid formulation is expected to make Clostridium difficile associated diarrhea therapy more accessible in comparison to previously available specialty compounding products [LP1196].

Indication

Administered intravenously, vancomycin is indicated in adult and pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. Administered orally, vancomycin is indicated in adult and pediatric patients for the treatment of Clostridium difficile-associated diarrhea and for enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).

Associated Conditions

Clostridium Difficile Associated Diarrhea (CDAD)
Enterocolitis caused by Staphylococcus aureus
Infection caused by staphylococci
Severe Staphylococcal infection

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Antibiotics Continuous Infusion at Home	2021/03/25	NCT04816968	Phase 1	UNKNOWN	Ospedale San Carlo Borromeo
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects	2021/03/17	NCT04802837	Phase 3	Terminated	Summit Therapeutics
Vancomycin Dosing for Serious MRSA Infections: A Non-inferiority Randomized Trial of Trough Level Versus AUC/MIC	2021/03/11	NCT04793152	Not Applicable	Recruiting	Anthony Bai
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia	2021/03/01	NCT04775953	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders	2021/01/28	NCT04729322	Phase 2	Active, not recruiting	M.D. Anderson Cancer Center
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT	2020/12/21	NCT04678154	Phase 3	Recruiting	Major Extremity Trauma Research Consortium
Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration	2020/12/17	NCT04673877	Phase 1	Completed	Mayo Clinic
Precision Dosing of Vancomycin in Critically Ill Children	2020/12/14	NCT04666948	Phase 4	Active, not recruiting	University Hospital, Ghent
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin	2020/12/01	NCT04648696	Phase 4	Terminated	Wake Forest University Health Sciences
Topical Vancomycin Over Sternal Edge in Cardiac Surgery	2020/08/05	NCT04500275	Phase 4	Completed	National Cheng-Kung University Hospital

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Vancomycin Hydrochloride	Fresenius Kabi, LLC	63323-314	INTRAVENOUS	10 g in 100 mL	9/1/2017
Vancomycin Hydrochloride	Hospira, Inc.	0409-3515	INTRAVENOUS	1.5 g in 1 1	8/7/2023
Vancomycin	Xellia Pharmaceuticals USA LLC	70594-040	INTRAVENOUS	5 g in 100 mL	9/10/2021
Vancomycin Hydrochloride	Hikma Pharmaceuticals USA Inc.	0143-9359	INTRAVENOUS	10 g in 1 1	12/7/2021
Vancomycin Hydrochloride	Meitheal Pharmaceuticals Inc.	71288-022	INTRAVENOUS	500 mg in 10 mL	8/11/2022
VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	0338-3581	INTRAVENOUS	500 mg in 100 mL	1/25/2024
Vancomycin	Xellia Pharmaceuticals USA LLC	70594-057	INTRAVENOUS	1.25 g in 250 mL	9/16/2020
Vancomycin Hydrochloride	Gland Pharma Limited	68083-144	INTRAVENOUS	1 g in 20 mL	2/23/2022
Vancomycin hydrochloride	Eugia US LLC	55150-471	INTRAVENOUS	1.25 g in 25 mL	8/5/2023
Vancomycin Hydrochloride	Eugia US LLC	55150-206	INTRAVENOUS	10 g in 1 1	12/7/2023

EMA Drug Approvals

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

HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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