Plasma Concentrations, Urinary Excretion and Bactericidal Activity of Ciprofloxacin Xr (1000 Mg) Versus Levofloxacin (500 Mg) in Healthy Volunteers Receiving a Single Oral Dose

Wagenlehner, F.; Kinzig‐Schippers, Martina; Tischmeyer, Uwe; Wagenlehner, C.; Sörgel, Fritz; Weidner, W. J.; Naber, K.

doi:10.1016/s1569-9056(06)60495-8

Cited by 16 publications

(25 citation statements)

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“…19 Furthermore, studies in healthy volunteers revealed that, after administration of a single dose, the concentrations of levofloxacin in plasma are higher than those of ciprofloxacin. 20 The present study compared the efficacy and safety of administration of levofloxacin 500 mg q.d and ciprofloxacin 500 mg b.i.d. in patients with chronic bacterial prostatitis.…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of levofloxacin versus ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients

Zhang¹,

Jin²,

Liu³

et al. 2012

Asian J Androl

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Levofloxacin is a synthetic fluoroquinolone that is usually used to treat chronic bacterial prostatitis. We investigated the safety and efficacy of levofloxacin compared with ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients. This was a multicenter, open-label, randomized controlled non-inferiority trial. Four hundred and seventy-one patients with clinical symptoms/ signs were enrolled into the study, and 408 patients were microbiologically confirmed chronic bacterial prostatitis, who were randomized to either oral levofloxacin (500 mg q.d.) or ciprofloxacin (500 mg b.i.d.) for 4 weeks. Bacterial clearance rate, clinical symptoms/signs, adverse reactions and disease recurrence were assessed. The clinical symptoms and signs (including dysuria, perineal discomfort or pain) and bacteria cultures in 209 patients treated with levofloxacin and 199 patients treated with ciprofloxacin were similar. The most common bacteria were Escherichia coli and Staphylococcus aureus. One to four weeks after the end of 4 weeks treatment, the bacterial clearance rate (86.06% vs. 60.03%; P,0.05) and the clinical efficacy (including clinical cure and clinical improvement(93.30% vs. 71.86%; P,0.05)) were significantly higher in the levofloxacin-treated group than in the ciprofloxacin-treated group. The microbiological recurrence rate was significantly lower in the levofloxacin-treated group than in the ciprofloxacin-treated group (4.00% vs. 19.25%; P,0.05). Rates of adverse events and treatment-related adverse events were slightly lower in the levofloxacin-treated group than in ciprofloxacin-treated group. Levofloxacin showed some advantages over ciprofloxacin in terms of clinical efficacy and disease recurrence, with a low rate of adverse events, for the treatment of chronic bacterial prostatitis in Chinese patients.

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Section: Discussionmentioning

confidence: 99%

Safety and efficacy of levofloxacin versus ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients

Zhang¹,

Jin²,

Liu³

et al. 2012

Asian J Androl

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“…52 According to the Biopharmaceutical Drug Disposition Classification System (BDDCS), extensive metabolism of an API indicates a high permeability. 53,54 Levofloxacin is mainly eliminated by renal excretion of the unaltered drug, hence not extensively metabolised, 8,19,[55][56][57] suggesting levofloxacin not to be highly permeable. 53,54 However, BDDCS was developed as a surrogate system for situations in which no BA data are available, which is not so for levofloxacin.…”

Section: Permeabilitymentioning

confidence: 99%

“…The only metabolites identified in humans are the desmethyl and N-oxide inactive metabolites, which account for less than 5% of a dose. 19 Following oral administration in healthy volunteers or patients with complicated urinary infections or pyelonephritis, approximately 80%-87% of an administered dose was recovered as unchanged drug in urine, 8,19,[55][56][57] whereas less than 4% of the dose was recovered in feces. 19 The excretion occurs through glomerular filtration and tubular secretion.…”

Section: Distribution Metabolism and Eliminationmentioning

confidence: 99%

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levofloxacin

Koeppe¹,

Cristofoletti²,

Fernandes³

et al. 2011

Journal of Pharmaceutical Sciences

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“…LLOQ ensures that LOFLX concentrations over the entire plasma profile can be quantified, because the reported Cmax (maximum plasma concentration after an oral dose of 500 mg) of levofloxacin is 6.1 mg/L (Wagenlehner et al, 2006). A lower limit of detection (LLOD) of 1 µg/ml was determined.…”

Section: Lower Limits Of Quantification (Lloq) and Detection (Llod)mentioning

confidence: 99%

Development and validation of RP-HPLC assay for levofloxacin in rat plasma and saliva: Application to pharmacokinetic studies

Sheikh¹,

Tripathi²,

Chitra³

et al. 2011

Afr. J. Pharm. Pharmacol.

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A new, simple, specific, accurate and precise reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for the determination of levofloxacin in rat plasma and saliva was developed. An HPLC system based on a Phenomenex Luna C 18 Column (250 × 4.6 mm) and a UV detector ( = 296 nm) were used. A mixture of Acetonitrile: water (80:20 v/v) adjusted to pH 3.5 by orthophosphoric acid at a flow rate of 1.4 ml/min was used as mobile phase. The proteins were precipitated with methanol. The average recovery was 94.79 and 92.66%, respectively in plasma and saliva. The detection limit for levofloxacin in plasma and saliva was 1 µg/ml. The calibration curve was linear over the concentration range 1 to 16 µ µ µ µg/ml for plasma and saliva. The inter-day and intra-day assay coefficients of variation were found to be less than 5%. The present validated method was successfully used for pharmacokinetic studies of levofloxacin in plasma and saliva.

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Plasma Concentrations, Urinary Excretion and Bactericidal Activity of Ciprofloxacin Xr (1000 Mg) Versus Levofloxacin (500 Mg) in Healthy Volunteers Receiving a Single Oral Dose

Cited by 16 publications

References 0 publications

Safety and efficacy of levofloxacin versus ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients

Safety and efficacy of levofloxacin versus ciprofloxacin for the treatment of chronic bacterial prostatitis in Chinese patients

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levofloxacin

Development and validation of RP-HPLC assay for levofloxacin in rat plasma and saliva: Application to pharmacokinetic studies

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