FINAFLOXACIN HYDROCHLORIDE

US Previously Marketed

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C20H19FN4O4.ClH
Molecular Weight	434.849
Optical Activity	UNSPECIFIED
Defined Stereocenters	2 / 2
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

Cl.[H][C@]12CN(C[C@]1([H])OCCN2)C3=C(C#N)C4=C(C=C3F)C(=O)C(=CN4C5CC5)C(O)=O

InChI

InChIKey=CQMSQUOHWYYEKM-MOGJOVFKSA-N

InChI=1S/C20H19FN4O4.ClH/c21-14-5-11-17(25(10-1-2-10)7-13(19(11)26)20(27)28)12(6-22)18(14)24-8-15-16(9-24)29-4-3-23-15;/h5,7,10,15-16,23H,1-4,8-9H2,(H,27,28);1H/t15-,16-;/m0./s1

HIDE SMILES / InChI

Molecular Formula	C20H19FN4O4
Molecular Weight	398.3877
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	2 / 2
E/Z Centers	0
Optical Activity	UNSPECIFIED

Molecular Formula	ClH
Molecular Weight	36.461
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf
Curator's Comment: Description was created based on several sources, including http://www.ncbi.nlm.nih.gov/pubmed/?term=25808831; http://www.ncbi.nlm.nih.gov/pubmed/26068714;

Finafloxacin is a fluoroquinolone antimicrobial agent that exhibits optimum efficacy in slightly acidic environments and is a highly potent eradicator of Helicobacter pylori. Being developed to treat serious bacterial infections associated with an acidic environment, including urinary tract infections and Helicobacter pylori infections finafloxacin is approved for treatment of acute otitis externa (swimmer’s ear) caused by the bacteria Pseudomonas aeruginosa and Staphylococcus aureus. XTORO (finafloxacin otic suspension), 0.3% is supplied as a sterile, preserved, aqueous suspension. Finafloxacin is a drug with a favorable safety profile.

Originator

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
DNA gyrase subunit A 7 Target ID: 950199.0 Gene Symbol: gyrA Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=25808831	Inhibitor 8297
DNA topoisomerase IV subunit A 2 Target ID: 950391.0 Gene Symbol: parC Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=25808831	Inhibitor 8297

Conditions

Condition	Modality	Targets	Highest Phase	Product
Acute otitis externa 2 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf	Curative		Approved 8429	XTORO Approved Use Indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. Launch Date 2014

C_max

Value	Dose	Analyte	Population
7.67 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	600 mg single, oral dose: 600 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
6.76 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	600 mg 1 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
8.68 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
8.84 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
9.15 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg 1 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
8.95 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg 1 times / day multiple, oral dose: 800 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
1.69 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
11.5 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg single, intravenous dose: 800 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
37.8 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg 1 times / day multiple, intravenous dose: 800 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
1.5 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
17.1 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
18.1 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg 1 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.96 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
4.15 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	300 mg 1 times / day multiple, oral dose: 300 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
0.44 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
6 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	400 mg single, intravenous dose: 400 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
8 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
11.1 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
13.3 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg single, intravenous dose: 800 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
1.9 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
20.2 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
2.56 mg/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	200 mg single, intravenous dose: 200 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

AUC

Value	Dose	Analyte	Population
18.7 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	600 mg single, oral dose: 600 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
19.2 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	600 mg 1 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
20.8 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
21.8 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
24.3 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg 1 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
26.1 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg 1 times / day multiple, oral dose: 800 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
3.76 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	150 mg single, oral dose: 150 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
32 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg single, intravenous dose: 800 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
35.4 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg 1 times / day multiple, intravenous dose: 800 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
4.01 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
49.8 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
64.1 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg 1 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
8.75 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	300 mg single, oral dose: 300 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
9.09 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	300 mg 1 times / day multiple, oral dose: 300 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
1.26 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
14.7 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	400 mg single, intravenous dose: 400 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
21.8 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
29.2 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
31.7 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg single, intravenous dose: 800 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
4.08 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
46.9 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
6.85 mg × h/L EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	200 mg single, intravenous dose: 200 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

T_1/2

Value	Dose	Analyte	Population
8.8 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	600 mg 1 times / day multiple, oral dose: 600 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
11.9 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg 1 times / day multiple, intravenous dose: 600 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
14 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg 1 times / day multiple, oral dose: 800 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
15 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg 1 times / day multiple, intravenous dose: 800 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
5.3 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	150 mg 1 times / day multiple, oral dose: 150 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
16.9 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg 1 times / day multiple, intravenous dose: 1000 mg route of administration: Intravenous experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
6.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	300 mg 1 times / day multiple, oral dose: 300 mg route of administration: Oral experiment type: MULTIPLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
3.8 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED
12.1 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	400 mg single, intravenous dose: 400 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
11.7 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	600 mg single, intravenous dose: 600 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
10.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	800 mg single, oral dose: 800 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
15.3 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	800 mg single, intravenous dose: 800 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
4.06 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/21709093/	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: FASTED
17.1 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	1000 mg single, intravenous dose: 1000 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN
10.6 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/28784673/	200 mg single, intravenous dose: 200 mg route of administration: Intravenous experiment type: SINGLE co-administered:	FINAFLOXACIN plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN

Doses

Dose	Population	Adverse events
0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21	unhealthy, 11 months - 84 years n = 618 Health Status: unhealthy Condition: Acute otitis externa Age Group: 11 months - 84 years Sex: M+F Population Size: 618 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21	Other AEs: Ear pruritus, Nausea... Other AEs: Ear pruritus (1.3%) Nausea (1.1%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21
1000 mg 1 times / day multiple, intravenous Highest studied dose Dose: 1000 mg, 1 times / day Route: intravenous Route: multiple Dose: 1000 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/28784673 Page: p.4	healthy, 53 (5.9) n = 8 Health Status: healthy Age Group: 53 (5.9) Sex: M+F Population Size: 8 Sources: https://pubmed.ncbi.nlm.nih.gov/28784673 Page: p.4	Sources: https://pubmed.ncbi.nlm.nih.gov/28784673 Page: p.4
800 mg 1 times / day multiple, oral Highest studied dose Dose: 800 mg, 1 times / day Route: oral Route: multiple Dose: 800 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/21709093 Page: p.4390	healthy n = 6 Health Status: healthy Sex: M Population Size: 6 Sources: https://pubmed.ncbi.nlm.nih.gov/21709093 Page: p.4390	Sources: https://pubmed.ncbi.nlm.nih.gov/21709093 Page: p.4390
0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1	unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1	Other AEs: Overgrowth of nonsusceptible organisms, Allergic reaction... Other AEs: Overgrowth of nonsusceptible organisms Allergic reaction Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1

AEs

AE	Significance	Dose	Population
Nausea	1.1%	0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21	unhealthy, 11 months - 84 years n = 618 Health Status: unhealthy Condition: Acute otitis externa Age Group: 11 months - 84 years Sex: M+F Population Size: 618 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21
Ear pruritus	1.3%	0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21	unhealthy, 11 months - 84 years n = 618 Health Status: unhealthy Condition: Acute otitis externa Age Group: 11 months - 84 years Sex: M+F Population Size: 618 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206307Orig1s000CrossR.pdf Page: p.18, p.21
Allergic reaction		0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1	unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1
Overgrowth of nonsusceptible organisms		0.3 % 2 times / day multiple, topical Recommended Dose: 0.3 %, 2 times / day Route: topical Route: multiple Dose: 0.3 %, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1	unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206307s000lbl.pdf Page: p.1

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:85176	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:85176
ChemicalBook	CB42605885	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB42605885
MolPort	MolPort-046-418-103	https://www.molport.com/shop/molecule-link/MolPort-046-418-103
MolPort	MolPort-047-151-608	https://www.molport.com/shop/molecule-link/MolPort-047-151-608
ZINC	ZINC000003985346	http://zinc15.docking.org/substances/ZINC000003985346

PubMed

Title	Date	PubMed
Comparative in vitro activity of finafloxacin against staphylococci displaying normal and small colony variant phenotypes.	2011 Dec	21948963
In vitro spectrum of activity of finafloxacin, a novel, pH-activated fluoroquinolone, under standard and acidic conditions.	2011 Sep	21709094
Human pharmacokinetics and safety profile of finafloxacin, a new fluoroquinolone antibiotic, in healthy volunteers.	2011 Sep	21709093

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Sample Use Guides

In Vivo Use Guide

Instill four drops into the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days.

Route of Administration: Otic (auricular)

In Vitro Use Guide

At low pH=5,8 and in range of concentrations: 0,006 - 0,25 mg/L finafloxacin showed the highest activity among all tested fluoroquinolones against S. aureus, including the methicillin-resistant S. aureus (MRSA) pairs and coagulase-negative staphylococcal (CoNS) tested

Substance Class	Chemical Created by `admin` on `Sat Dec 16 08:12:07 GMT 2023` Edited by `admin` on `Sat Dec 16 08:12:07 GMT 2023`
Record UNII	2G22PNZ052
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

FINAFLOXACIN HYDROCHLORIDE

Common Name

English

BAY-353377

Code

English

3-QUINOLINECARBOXYLIC ACID, 8-CYANO-1-CYCLOPROPYL-6-FLUORO-7-((4AS,7AS)-HEXAHYDROPYRROLO(3,4-B)-1,4-OXAZIN-6(2H)-YL)-1,4-DIHYDRO-4-OXO-, MONOHYDROCHLORIDE

Systematic Name

English

BAY 35-3377

Code

English

BAY35-3377

Code

English

FINAFLOXACIN HYDROCHLORIDE [MI]

Common Name

English

BAY-35-3377

Code

English

Code System Code Type Description

FDA UNII

2G22PNZ052