Ciprofloxacin should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
The determination of dosage and duration 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.
|Infection *||Dose||Frequency||Usual Duration|
|Skin and Skin Structure||400 mg||every 8 to 12 hours||7 to 14 days|
|Bone and Joint||400 mg||every 8 to 12 hours||4 to 8 weeks|
|Complicated Intra-Abdominal †||400 mg||every 12 hours||7 to 14 days|
|Nosocomial Pneumonia||400 mg||every 8 hours||10 to 14 days|
|Empirical Therapy In Febrile Neutropenic Patients||Ciprofloxacin 400 mg and Piperacillin 50 mg/kg||every 8 hours___________ every 4 hours||7 to 14 days|
|Inhalational Anthrax (Post-Exposure)‡||400 mg||every 12 hours||60 days|
|Plague ‡||400 mg||every 8 to 12 hours||14 days|
|Chronic Bacterial Prostatitis||400 mg||every 12 hours||28 days|
|Lower Respiratory Tract Infections||400 mg||every 8 to 12 hours||7 to 14 days|
|Urinary Tract Infections||200 mg to 400 mg||every 8 to 12 hours||7 to 14 days|
|Acute Sinusitis||400 mg||every 12 hours||10 days|
Conversion of Intravenous to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin injection may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
|Ciprofloxacin Oral Dosage||Equivalent Ciprofloxacin Injection Dosage|
|250 mg Tablet every 12 hours||200 mg intravenous every 12 hours|
|500 mg Tablet every 12 hours||400 mg intravenous every 12 hours|
|750 mg Tablet every 12 hours||400 mg intravenous every 8 hours|
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.
|Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)*||6 mg/kg to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing more than 51 kg)||Every 8 hours||10 to 21 days *|
|Inhalational Anthrax (Post-Exposure)†||10 mg/kg(maximum 400 mg per dose)||Every 12 hours||60 days|
|Plague †, ‡||10 mg/kg(maximum 400 mg per dose)||Every 8 to 12 hours||10 to 21 days|
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, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.
|Creatinine Clearance (mL/min)||Dose|
|> 30||See Usual Dosage|
|5 to 29||200 to 400 mg every 18 to 24 hours|
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
|Men — Creatinine clearance (mL/min)||= Weight (kg) × (140 − age)72 × serum creatinine (mg/dL)|
|Women — 0.85 × the value calculated for men.|
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment and hepatic insufficiency, careful monitoring is suggested.
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73 m2).
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