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
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
DescriptionCurator'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;
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 |
---|---|---|---|
Target ID: 950199.0 Gene Symbol: gyrA Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=25808831 |
|||
Target ID: 950391.0 Gene Symbol: parC Sources: http://www.ncbi.nlm.nih.gov/pubmed/?term=25808831 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Curative | XTORO Approved UseIndicated 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 Date2014 |
Cmax
Value | Dose | Co-administered | 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 | Co-administered | 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 |
T1/2
Value | Dose | Co-administered | 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: 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: Page: p.18, p.21 |
Other AEs: Ear pruritus, Nausea... Other AEs: Ear pruritus (1.3%) Sources: Page: p.18, p.21Nausea (1.1%) |
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: Page: p.4 |
healthy, 53 (5.9) n = 8 Health Status: healthy Age Group: 53 (5.9) Sex: M+F Population Size: 8 Sources: 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: Page: p.4390 |
healthy n = 6 Health Status: healthy Sex: M Population Size: 6 Sources: 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: Page: p.1 |
unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: Page: p.1 |
Other AEs: Overgrowth of nonsusceptible organisms, Allergic reaction... Other AEs: Overgrowth of nonsusceptible organisms Sources: Page: p.1Allergic reaction |
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: 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: 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: 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: 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: Page: p.1 |
unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: 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: Page: p.1 |
unhealthy Health Status: unhealthy Condition: Acute otitis externa Sources: Page: p.1 |
Sample Use Guides
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
Sources: http://www.ncbi.nlm.nih.gov/pubmed/21948963
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
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2G22PNZ052
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DBSALT001107
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11662028
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m5382
Created by
admin on Sat Dec 16 08:12:07 GMT 2023 , Edited by admin on Sat Dec 16 08:12:07 GMT 2023
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209342-41-6
Created by
admin on Sat Dec 16 08:12:07 GMT 2023 , Edited by admin on Sat Dec 16 08:12:07 GMT 2023
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DTXSID70175097
Created by
admin on Sat Dec 16 08:12:07 GMT 2023 , Edited by admin on Sat Dec 16 08:12:07 GMT 2023
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300000042581
Created by
admin on Sat Dec 16 08:12:07 GMT 2023 , Edited by admin on Sat Dec 16 08:12:07 GMT 2023
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