Gatifloxacin

Overview

Gatifloxacin is an antibiotic agent and a member of the fourth-generation fluoroquinolone family. It works by inhibiting the bacterial enzymes DNA gyrase and topoisomerase IV. It was first introduced by Bristol-Myers Squibb in 1999 under the brand name Tequin® for the treatment of respiratory tract infections. Gatifloxacin is available as tablets and in various aqueous solutions for intravenous therapy. It is also available as eye drops under the brand name Zymar® marketed by Allergan. The FDA withdrew its approval for the use of non-ophthalmic drug products containing gatifloxacin due to the high prevalence of gatifloxacin-associated dysglycemia adverse event reports and the high incidence of hyperglycemic and hypoglycemic episodes in patients taking gatifloxacin compared to those on macrolide antibiotics.

Indication

For the treatment of bronchitis, sinusitis, community-acquired pneumonia, and skin infections (abscesses, wounds) caused by S. pneumoniae, H. influenzae, S. aureus, M. pneumoniae, C. pneumoniae, L. pneumophila, S. pyogenes

Associated Conditions

Bacterial Conjunctivitis
Ocular Infections, Irritations and Inflammations

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.	2018/10/04	NCT03696342	Phase 3	Terminated	Laboratorios Sophia S.A de C.V.
Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen	2018/07/06	NCT03578276	Phase 4	Completed	Carolina Eyecare Physicians, LLC
Safety and Efficacy of PRO-157 vs Moxifloxacin vs Gatifloxacin in Patients With Bacterial Conjunctivitis (Pazufloxacin)	2016/12/02	NCT02980523	Phase 2	Completed	Laboratorios Sophia S.A de C.V.
A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.	2013/08/27	NCT01928693	Phase 2	Terminated	Cornea Consultants Of Nashville
Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever	2011/08/23	NCT01421693	Phase 4	Completed	Oxford University Clinical Research Unit, Vietnam
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis	2011/04/06	NCT01330355	Phase 3	Terminated	Bausch & Lomb Incorporated
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation	2009/05/21	NCT00905762	Phase 1	Completed	Bausch & Lomb Incorporated
A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms	2009/04/03	NCT00874887	Phase 4	Completed	Allergan
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects	2009/01/16	NCT00824070	Phase 1	Completed	Bausch & Lomb Incorporated
Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers	2008/04/03	NCT00651586	Phase 2	Completed	Allergan

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pred-Gati	ImprimisRx NJ	70261-502	OPHTHALMIC	5 mg in 1 mL	2/22/2018
gatifloxacin	Pacific Pharma, Inc.	60758-615	OPHTHALMIC	5 mg in 1 mL	1/17/2023
Gatifloxacin	Sandoz Inc	61314-672	OPHTHALMIC	5 mg in 1 mL	4/20/2016
Pred-Gati-Brom	ImprimisRx NJ	70261-504	OPHTHALMIC	5 mg in 1 mL	2/22/2018
Gatifloxacin	Akorn	50383-189	OPHTHALMIC	5 mg in 1 mL	3/11/2022
ZYMAXID	Allergan, Inc.	0023-3615	OPHTHALMIC	5 mg in 1 mL	11/16/2022
Gatifloxacin	LUPIN LIMITED	57297-435	OPHTHALMIC	5 mg in 1 mL	5/9/2016
ZYMAXID	Physicians Total Care, Inc.	54868-6303	OPHTHALMIC	5 mg in 1 mL	2/6/2012

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
ZYMAR OPHTHALMIC SOLUTION 0.3%	ALLERGAN SALES LLC	SIN12612P	SOLUTION	3 mg/ml	11/5/2004
CALCIUM GLUCONATE INJECTION USP 10%	AMERICAN PHARMACEUTICAL PARTNERS INC	SIN08451P	INJECTION	4.5 mg/ml	11/24/1995

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Gatifloxacin Mesilate Tablets	江苏联环药业股份有限公司	国药准字H20050548	化学药品	片剂	8/10/2020
Gatifloxacin Mesilate Tablets	浙江京新药业股份有限公司	国药准字H20050014	化学药品	片剂	5/19/2020
Gatifloxacin Mesilate Tablets	浙江京新药业股份有限公司	国药准字H20050013	化学药品	片剂	5/19/2020
Gatifloxacin Mesilate Tablets	江苏联环药业股份有限公司	国药准字H20050547	化学药品	片剂	8/10/2020
Gatifloxacin Mesilate Tablets	浙江京新药业股份有限公司	国药准字H20050012	化学药品	片剂	5/19/2020
Gatifloxacin Mesilate Tablets	通化金马药业集团股份有限公司	国药准字H20040834	化学药品	片剂	3/24/2020
Gatifloxacin Capsules	江苏修正制药有限公司	国药准字H20060447	化学药品	胶囊剂	1/9/2020
Gatifloxacin Capsules	天津华津制药有限公司	国药准字H20080057	化学药品	胶囊剂	10/21/2022
Gatifloxacin Capsules	成都恒瑞制药有限公司	国药准字H20051596	化学药品	胶囊剂	6/1/2020
Gatifloxacin Capsules	山东罗欣药业集团股份有限公司	国药准字H20050941	化学药品	胶囊剂	2/3/2020

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.

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