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New Insights on the Pharmacokinetics of Ulifloxacin After Administration of Prulifloxacin in Patients with Mild, Moderate and Severe Renal Impairment
- Source :
- Drugs in R&D
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
Abstract
- Background The antibacterial agent prulifloxacin, a prodrug of ulifloxacin, is indicated in the treatment of acute lower urinary tract infections, acute exacerbation of chronic bronchitis and acute bacterial rhinosinusitis. Objective We aimed to provide new insights on the pharmacokinetics (PK) of ulifloxacin in patients with different degrees of renal impairment. Methods A two-site, international, open-label, parallel-group, single- and repeated-dose study was performed. The drug was administered as a single dose of 600 mg to subjects with normal renal function and patients with mild, moderate and severe renal impairment. Subsequently, the same dose was administered daily for 7 days to subjects with normal renal function and patients with mild and moderate renal impairment, while a dose of 300 mg was administered daily for 7 days to patients with severe renal impairment. Plasma and urine ulifloxacin levels were measured. Complete safety evaluation was performed. Results Exposure to ulifloxacin increased as renal function decreased due to a lower ulifloxacin clearance. Ulifloxacin PK were significantly changed only in patients with severe renal impairment. The amount of ulifloxacin excreted in urine over a 24-h dosing period was similar in subjects with normal renal function and patients with mild impaired renal function, but lower in those with moderate and severe renal impairment. Conclusion Our data show that prulifloxacin is a safe quinolone and is well tolerated in both subjects with normal renal function and patients with impaired renal function, requiring a minimal dosage adjustment only in patients with severe renal impairment.
- Subjects :
- Adult
Male
0301 basic medicine
Chronic bronchitis
medicine.medical_specialty
Adolescent
Exacerbation
Urinary system
030106 microbiology
Urology
Administration, Oral
Renal function
Urine
urologic and male genital diseases
030226 pharmacology & pharmacy
Piperazines
Young Adult
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Pharmacokinetics
medicine
Humans
Renal Insufficiency
Original Research Article
Aged
Antibacterial agent
Pharmacology
Dose-Response Relationship, Drug
business.industry
Dioxolanes
Middle Aged
Anti-Bacterial Agents
chemistry
Prulifloxacin
Female
business
Fluoroquinolones
Subjects
Details
- ISSN :
- 11796901 and 11745886
- Volume :
- 18
- Database :
- OpenAIRE
- Journal :
- Drugs in R&D
- Accession number :
- edsair.doi.dedup.....68154f38227598a3e3ae19f0a437c513