Drug Information for Ciprofloxacin Injection, USP (In 5% Dextrose) For Intravenous InfusionPremix in INTRAVIA Plastic Container (Baxter Healthcare Corporation): DOSAGE AND ADMINISTRATION - ADULTS

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  • Ciprofloxacin Injection, USP should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of Ciprofloxacin Injection, USP for Administration section).

    The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.

    ADULT DOSAGE GUIDELINES
    InfectionDUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE).SeverityDoseFrequencyUsual Duration
    Urinary Tract Mild/Moderate Severe/Complicated 200 mg 400 mg q12h q12h 7-14 Days 7-14 Days
    Lower Respiratory Tract Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h 7-14 Days 7-14 Days
    Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days
    Skin and Skin Structure Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h 7-14 Days 7-14 Days
    Bone and Joint Mild/Moderate Severe/Complicated 400 mg 400 mg q12h q8h = 4-6 Weeks = 4-6 Weeks
    Intra-Abdominalused in conjunction with metronidazole (See product labeling for prescribing information.) Complicated 400 mg q12h 7-14 Days
    Acute Sinusitis Mild/Moderate 400 mg q12h 10 Days
    Chronic Bacterial Prostatitis Mild/Moderate 400 mg q12h 28 Days
    Empirical Therapy in Febrile Neutropenic Patients Severe
    Ciprofloxacin 400 mg q8h
    + 7-14 Days
    Piperacillin 50 mg/kg Not to exceed 24 g/dayq4h
    Inhalational anthrax (post-exposure) Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations. (See INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION). Total duration of ciprofloxacin administration (I.V. or oral) for inhalational anthrax (post-exposure) is 60 days. 400 mg q12h60 Days

    Ciprofloxacin Injection, USP should be administered by intravenous infusion over a period of 60 minutes.

    Conversion of I.V. to Oral Dosing in Adults: Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician. (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

    Equivalent AUC Dosing Regimens
    Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin Injection, USP Dosage
    250 mg Tablet q12h 200 mg I.V. q12h
    500 mg Tablet q12h 400 mg I.V. q12h
    750 mg Tablet q12h 400 mg I.V. q8h

    Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

  • Adults with Impaired Renal Function:

  • Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

    RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
    Creatinine Clearance (mL/min)Dosage
    > 30 See usual dosage.
    5 - 29 200-400 mg q18-24h

    When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance:

    Men: Creatinine clearance (mL/min) = Weight (kg) X (140 – age)
    72 X serum creatinine (mg/dL)
    Women: 0.85 x the value calculated for men.

    The serum creatinine should represent a steady-state of renal function.

    For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.

  • Drug Information Provided by National Library of Medicine (NLM).
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