Ofloxacin

Overview

A synthetic fluoroquinolone (fluoroquinolones) antibacterial agent that inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.

Indication

For the treatment of infections (respiratory tract, kidney, skin, soft tissue, UTI), urethral and cervical gonorrhoea.

Associated Conditions

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
Acute Otitis Media (AOM)
Bacterial Infections
Cervicitis
Community Acquired Pneumonia (CAP)
Complicated Urinary Tract Infection
Conjunctivitis
Epididymitis
Hansen's Disease
Nongonococcal urethritis
Otitis Externa
Prostatitis
Skin and Subcutaneous Tissue Bacterial Infections
Spontaneous Bacterial Peritonitis (SBP)
Traveler's Diarrhea
Ulcerative keratitis
Acute Pelvic inflammatory disease
Acute, uncomplicated Gonorrhea
Chronic suppurative Otitis media
Uncomplicated Cystitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Diagnostics of Chronic Endometritis in Infertility	2023/07/14	NCT05946655	Not Applicable	Completed	Jagiellonian University
Trial to Evaluate the Efficacy and Safety of IVIEW-1201 in Acute Bacterial Conjunctivitis	2023/04/18	NCT05816070	Phase 2	Completed	IVIEW Therapeutics Inc.
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome	2022/03/31	NCT05302531	Phase 1	Recruiting	Central Hospital, Nancy, France
Ofloxacin Concentration-toxicity Relationship in the Elderly	2020/08/03	NCT04496024	Not Applicable	Recruiting	Centre Hospitalier Universitaire, Amiens
Nasal Ointment on Epistaxis of Nasotracheal Intubation in Children	2020/06/11	NCT04426409	Not Applicable	Completed	Ajou University School of Medicine
Alternative Antibiotic Regimen in Periodontitis Treatment	2020/04/20	NCT04353362	Phase 4	Completed	Istanbul Medipol University Hospital
Pilocarpine After Combined Cataract/Trabectome Surgery	2019/07/02	NCT04005079	Phase 3	Withdrawn	Montefiore Medical Center
Pilocarpine Use After Kahook Goniotomy	2019/05/01	NCT03933631	Phase 3	Suspended	Montefiore Medical Center
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present	2018/08/31	NCT03655665	Phase 4	Recruiting	Boston Children's Hospital
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media	2015/10/05	NCT02567825	Not Applicable	Completed	Alejandro Hoberman

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ofloxacin	Akorn	50383-025	AURICULAR (OTIC)	3 mg in 1 mL	10/17/2022
OFLOXACIN OTIC	DIRECT RX	72189-108	AURICULAR (OTIC)	3 mg in 1 mL	6/11/2020
Ofloxacin	NuCare Pharmaceuticaals,Inc.	68071-2544	OPHTHALMIC	3 mg in 1 mL	7/17/2023
ofloxacin	Lifestar Pharma LLC	70756-650	OPHTHALMIC	3 mg in 1 mL	8/31/2023
Ofloxacin	Proficient Rx LP	63187-268	OPHTHALMIC	3 mg in 1 mL	4/1/2022
Ofloxacin	American Regent, Inc.	0517-0760	OPHTHALMIC	3 mg in 1 mL	7/8/2010
ofloxacin	RPK Pharmaceuticals, Inc.	53002-6324	OPHTHALMIC	3 mg in 1 mL	8/31/2023
Ofloxacin Otic	Proficient Rx LP	63187-184	AURICULAR (OTIC)	3 mg in 1 mL	9/1/2022
Ofloxacin Otic	RPK Pharmaceuticals, Inc.	53002-2604	AURICULAR (OTIC)	3 mg in 1 mL	11/17/2022
Ofloxacin	Keltman Pharmaceuticals Inc.	68387-106	OPHTHALMIC	3 mg in 1 mL	8/3/2010

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
OFCIN FILM COATED TABLET 400 mg	Y.S.P. INDUSTRIES (M) SDN BHD	SIN10118P	TABLET, FILM COATED	400 mg	9/25/1998
FLOVID 200	HOVID Bhd.	SIN13219P	TABLET, FILM COATED	200.00 MG	9/28/2006
OFCIN FILM COATED TABLET 200 mg	YUNG SHIN PHARMACEUTICAL IND CO LTD, YSP Industries (M) Sdn Bhd	SIN10119P	TABLET, FILM COATED	200 mg	9/25/1998
OFLOX TABLET 200 mg	BROWN & BURK PHARMACEUTICAL LTD	SIN11433P	TABLET, FILM COATED	200 mg	12/13/2000
AKILEN TABLET 200 mg	PT SANBE FARMA	SIN11377P	TABLET, FILM COATED	200 mg	8/24/2000
FUGACIN TABLET 200 mg	SHIN POONG PHARMACEUTICAL CO LTD	SIN08409P	TABLET, FILM COATED	200 mg	10/26/1995

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
AFLOCIN CAP 200MG	N/A	NEOCHEM PHARMACEUTICAL LABORATORIES LIMITED	N/A	N/A	12/6/2002
KORUCIN EYE DROPS 0.3%W/V	N/A	LSB (HK) LIMITED	N/A	N/A	5/4/2012
TARIVID EYE DROPS 0.3%	N/A	Santen Pharmaceutical (Hong Kong) Limited	N/A	N/A	1/20/1989
FLOVID 200 TAB 200MG	N/A	HOVID LIMITED	N/A	N/A	11/16/2002
SINFLO TABLETS 200MG	N/A	TOP HARVEST PHARMACEUTICALS COMPANY LIMITED	N/A	N/A	3/30/2016
EARFLO OTIC SOLUTION 0.3%	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	10/19/2009

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OCUFLOX ofloxacin 3mg/mL (0.3%) sterile ophthalmic solution	47485	AbbVie Pty Ltd	Medicine	A	2/18/1994

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FLOXIN I.V. LIQ 20MG/ML	ortho pharmaceutical, division of janssen-ortho inc.	02049414	Liquid - Intravenous	20 MG / ML	N/A
FLOXIN TABLETS 300MG	Janssen Inc	01968416	Tablet - Oral	300 MG	12/31/1990
OCUFLOX	Abbvie Corporation	02143291	Solution - Ophthalmic	0.3 % / W/V	12/31/1995
NOVO-OFLOXACIN	novopharm limited	02243475	Tablet - Oral	300 MG	6/11/2004
APO-OFLOXACIN	Apotex Inc	02248398	Solution - Ophthalmic	0.3 %	1/22/2004
NOVO-OFLOXACIN	novopharm limited	02243474	Tablet - Oral	200 MG	6/11/2004
FLOXIN TABLETS 400MG	Janssen Inc	01968408	Tablet - Oral	400 MG	12/31/1990
FLOXIN TABLETS 200MG	Janssen Inc	01968424	Tablet - Oral	200 MG	12/31/1992
OFLOXACIN TABLETS	aa pharma inc	02231529	Tablet - Oral	200 MG	2/4/1998
OFLOXACIN TABLETS	aa pharma inc	02231532	Tablet - Oral	400 MG	2/17/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
OFLOXACINO POS 3 MG/ML COLIRIO EN SOLUCION	Brill Pharma S.L.	81022	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
OFLOXAVIS 3 mg/ml COLIRIO EN SOLUCIÓN	Pharma Stulln Gmbh	77631	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OCULAFLOX 3 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS	Ntc S.R.L.	84144	COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OCULAFLOX 3 MG/ML COLIRIO EN SOLUCION	Ntc S.R.L.	84143	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
FARMIFLOX 3 MG/ML COLIRIO EN SOLUCION	Farmigea S.P.A.	82188	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
OFLOXACINO ALTAN 2 MG/ML SOLUCION PARA PERFUSION EFG	Altan Pharmaceuticals Sa	67741	SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
FARMIFLOX 3 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS	Farmigea S.P.A.	82189	COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS	Medicamento Sujeto A Prescripción Médica	Not Commercialized
EXOCIN 3 MG/ML COLIRIO EN SOLUCION	Abbvie Spain, S.L.U.	62560	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
OFLOVIR 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Industria Quimica Y Farmaceutica Vir S.A.	59653	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	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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