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Related Experiment Videos

Multiple-dose ciprofloxacin dose ranging and kinetics.

M A Gonzalez, A H Moranchel, S Duran

    Clinical Pharmacology and Therapeutics
    |June 1, 1985
    PubMed
    Summary
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    Intravenous ciprofloxacin at doses of 25-75 mg was well tolerated in healthy subjects. Urine concentrations remained above pathogen minimum inhibitory concentrations for 12 hours, suggesting adequacy for urinary tract infections.

    Area of Science:

    • Pharmacology
    • Clinical Pharmacy
    • Infectious Diseases

    Background:

    • Ciprofloxacin is a fluoroquinolone antibiotic commonly used for bacterial infections.
    • Understanding the pharmacokinetics and efficacy of intravenous ciprofloxacin is crucial for optimizing treatment regimens.
    • Urinary tract infections (UTIs) and hospital-acquired sepsis are significant clinical concerns requiring effective antibiotic therapy.

    Purpose of the Study:

    • To evaluate the safety, tolerability, and pharmacokinetic profile of multiple intravenous doses of ciprofloxacin in healthy subjects.
    • To determine the adequacy of intravenous ciprofloxacin dosing for maintaining therapeutic concentrations against common urinary tract pathogens.
    • To assess the potential need for higher doses in treating severe infections like hospital-acquired sepsis.

    Main Methods:

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    • A randomized, placebo-controlled study involving nine healthy subjects receiving intravenous ciprofloxacin (25, 50, and 75 mg) and three subjects receiving placebo.
    • Doses were administered over 10 minutes every 12 hours for one week, with a one-week washout period between dose levels.
    • Pharmacokinetic parameters including terminal elimination half-life (t1/2S) and serum clearance were measured. Urine concentrations were assessed for their ability to inhibit pathogen growth.

    Main Results:

    • Mean terminal elimination half-lives ranged from 3.46 to 4.15 hours across the evaluated ciprofloxacin doses.
    • Serum clearances were observed between 31.3 and 35.4 L/hr/1.73 m2.
    • Urine ciprofloxacin concentrations consistently exceeded the minimal inhibitory concentration (MIC) for most urinary tract pathogens throughout the 12-hour dosing interval.

    Conclusions:

    • Intravenously administered ciprofloxacin at doses of 25-75 mg was well-tolerated and demonstrated adequate concentrations for treating urinary tract infections.
    • Renal clearance constituted a significant portion (65-70%) of serum clearance, though active metabolites were noted.
    • For severe conditions such as hospital-acquired sepsis, higher doses of intravenous ciprofloxacin warrant further investigation.