Levaquin, Quinsair(levofloxacin)
Iquix, Levaquin, Quinsair, Quixin (levofloxacin) is a small molecule pharmaceutical. Levofloxacin was first approved as Levaquin on 1996-12-20. It is used to treat bacterial eye infections, bacterial infections, bacterial pneumonia, bacterial skin diseases, and bronchitis amongst others in the USA. It has been approved in Europe to treat cystic fibrosis and respiratory tract infections.
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Therapeutic Areas
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EMA
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Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Levofloxacin
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
LEVAQUIN | Johnson & Johnson | N-020634 DISCN | 1996-12-20 | 3 products, RLD |
LEVAQUIN | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 2 products, RLD |
LEVAQUIN | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | Johnson & Johnson | N-020635 DISCN | 1996-12-20 | 1 products, RLD |
LEVAQUIN | Johnson & Johnson | N-021721 DISCN | 2004-10-21 | 1 products, RLD |
QUIXIN | Santen | N-021199 DISCN | 2000-08-18 | 1 products, RLD |
IQUIX | Santen | N-021571 DISCN | 2004-03-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
levaquin | ANDA | 2016-05-26 |
levofloxacin | ANDA | 2023-06-07 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
bacterial eye infections | — | D015818 | — |
bacterial infections | — | D001424 | A49 |
bacterial pneumonia | EFO_1001272 | D018410 | J15.9 |
bacterial skin diseases | — | D017192 | — |
bronchitis | — | D001991 | J40 |
chlamydia infections | EFO_0007205 | D002690 | A74.9 |
escherichia coli infections | EFO_1001318 | D004927 | B96.20 |
haemophilus infections | EFO_1001127 | D006192 | — |
klebsiella infections | EFO_1001353 | D007710 | — |
legionnaires' disease | EFO_0007343 | D007877 | A48.1 |
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Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01M: Quinolone antibacterials
— J01MA: Fluoroquinolone antibacterials, systemic
— J01MA12: Levofloxacin
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA05: Levofloxacin and ornidazole
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AE: Fluoroquinolone antiinfectives, ophthalmologic
— S01AE05: Levofloxacin
HCPCS
Code | Description |
---|---|
J1956 | Injection, levofloxacin, 250 mg |
Clinical
Clinical Trials
263 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infections | D007239 | EFO_0000544 | — | — | 10 | 22 | 7 | 39 | |
Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 2 | 8 | 6 | — | 16 |
Healthy volunteers/patients | — | 6 | 1 | — | 3 | 1 | 11 | ||
Pneumonia | D011014 | EFO_0003106 | J18 | — | 2 | 8 | 1 | — | 10 |
Cataract | D002386 | EFO_0001059 | H26.9 | 3 | 1 | 1 | 4 | — | 9 |
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | 4 | 5 | 1 | — | 9 | |
Endophthalmitis | D009877 | 3 | 3 | — | 1 | 1 | 5 | ||
Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | 2 | 2 | — | 4 |
Pelvic inflammatory disease | D000292 | EFO_1001388 | N70-N77 | — | — | 2 | 2 | — | 4 |
Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | 3 | 1 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 2 | 5 | — | — | 7 |
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | 2 | 3 | — | 1 | 6 |
Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | 1 | — | 2 | 5 |
Chronic bronchitis | D029481 | J42 | — | 1 | 5 | — | — | 5 | |
Prostatitis | D011472 | EFO_0003830 | N41 | — | 1 | 4 | — | — | 5 |
Diabetic foot | D017719 | EFO_1001459 | — | 3 | 2 | — | — | 5 | |
Bacterial infections | D001424 | A49 | 1 | — | 3 | — | — | 4 | |
Neoplasms | D009369 | C80 | — | 2 | 3 | — | — | 4 | |
Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | — | 2 | — | — | 4 |
Maxillary sinusitis | D015523 | EFO_0007361 | J32.0 | — | — | 3 | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | — | — | — | — | 1 |
Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | — | — | — | — | 1 |
Hearing loss | D034381 | EFO_0004238 | H91.9 | 1 | — | — | — | — | 1 |
Escherichia coli infections | D004927 | EFO_1001318 | B96.20 | 1 | — | — | — | — | 1 |
Short bowel syndrome | D012778 | 1 | — | — | — | — | 1 | ||
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sepsis | D018805 | A41.9 | — | — | — | — | 2 | 2 | |
Microbiota | D064307 | — | — | — | — | 1 | 1 | ||
Chemical and drug induced liver injury | D056486 | — | — | — | — | 1 | 1 | ||
Refractive errors | D012030 | EFO_0003908 | H52.7 | — | — | — | — | 1 | 1 |
Therapeutics | D013812 | — | — | — | — | 1 | 1 | ||
Helicobacter pylori | D016480 | NCBITaxon_210 | B96.81 | — | — | — | — | 1 | 1 |
Radiotherapy | D011878 | — | — | — | — | 1 | 1 | ||
Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 1 | 1 | |
Drug monitoring | D016903 | — | — | — | — | 1 | 1 | ||
Epistaxis | D004844 | EFO_0003895 | R04.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | LEVOFLOXACIN |
INN | levofloxacin |
Description | Levofloxacin is an optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase. It has a role as a DNA synthesis inhibitor, an antibacterial drug, a topoisomerase IV inhibitor and an EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor. It is a quinolone antibiotic, a fluoroquinolone antibiotic and a 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid. It is an enantiomer of a dextrofloxacin. |
Classification | Small molecule |
Drug class | antibacterials (quinolone derivatives) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | C[C@H]1COc2c(N3CCN(C)CC3)c(F)cc3c(=O)c(C(=O)O)cn1c23 |
Identifiers
PDB | — |
CAS-ID | 100986-85-4 |
RxCUI | 1546009 |
ChEMBL ID | CHEMBL33 |
ChEBI ID | 63598 |
PubChem CID | 149096 |
DrugBank | DB01137 |
UNII ID | RIX4E89Y14 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
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Financial
Quinsair - Horizon Therapeutics Public
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Additional graphs summarizing 34,614 documents
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Safety
Black-box Warning
Black-box warning for: Levofloxacin
Adverse Events
Top Adverse Reactions
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56,462 adverse events reported
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