Adults
Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, polymeric phosphate binders (e.g., sevelamer, lanthanum carbonate) or sucralfate, Videx®† (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES
*
Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
†
used in conjunction with metronidazole
‡
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.
6 For a discussion of ciprofloxacin serum concentrations in various human populations, see
INHALATIONAL ANTHRAX: Additional Information.
Infection
Severity
Dose
Frequency
Usual Durations*
Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatitis
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 Days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥ 4 to 6 Weeks
Severe/Complicated
750 mg
q 12 h
≥ 4 to 6 Weeks
Intra-Abdominal†
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical Gonococcal Infections
Uncomplicated
250 mg
Single Dose
Single Dose
Inhalational Anthrax (post-exposure)‡
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated 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 I.V. Dosage
250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
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, particularly 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)
Dose
> 50
See Usual Dosage.
30 to 50
250 mg to 500 mg q 12 h
5 to 29
250 mg to 500 mg q 18 h
Patients on hemodialysis or
Peritoneal dialysis
250 mg to 500 mg q 24 h
(after dialysis)
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
The serum creatinine should represent a steady-state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Pediatrics
Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES
*
The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
†
Drug administration should begin as soon as possible after suspected or confirmed exposure to
Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.
6 For a discussion of ciprofloxacin serum concentrations in various human populations, see
INHALATIONAL ANTHRAX IN ADULTS AND PEDIATRICS: Additional Information.
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis
Intravenous
6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 8 hours
10 to 21 days*
(patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)
Every 12 hours
Inhalational Anthrax (Post-Exposure)†
Intravenous
10 mg/kg (maximum 400 mg per dose)
Every 12 hours
60 days
Oral
15 mg/kg (maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
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