Prescription Drug Information: Ciprofloxacin (Page 2 of 10)

2 DOSAGE AND ADMINISTRATION

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

2.1 Dosage in Adults

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. Ciprofloxacin Tablets may be administered to adult patients when clinically indicted at the discretions of the physician.

Table 1: Adult Dosage Guidelines

Infection

Dose

Frequency

Usual Durations 1

Skin and Skin Structure

500 -750 mg

every 12 hours

7 to 14 days

Bone and Joint

500-750 mg

every 12 hours

4 to 8 weeks

Complicated Intra-Abdominal2

500 mg

every 12 hours

7 to 14 days

Infectious Diarrhea

500 mg

every 12 hours

5 to 7 days

Typhoid Fever

500 mg

every 12 hours

10 days

Uncomplicated Urethral and Cervical Gonococcal Infections

250 mg

single dose

single dose

Inhalational anthrax (post-exposure) 3

500 mg

every 12 hours

60 days

Plague3

500–750 mg

every 12 hours

14 days

Chronic Bacterial Prostatitis

500 mg

every 12 hours

28 days

Lower Respiratory Tract Infections

500 -750 mg

every 12 hours

7 to 14 days

Urinary Tract Infections

250-500 mg

every 12 hours

7 to 14 days

Acute Uncomplicated Cystitis

250 mg

every 12 hours

3 days

Acute Sinusitis

500 mg

every 12 hours

10 days

1 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).

2 Used in conjunction with metronidazole.

3 Begin drug administration as soon as possible after suspected or confirmed exposure.

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with Ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

Table 2: Equivalent AUC Dosing Regimens

Ciprofloxacin Oral Dosage

Equivalent Ciprofloxacin IV 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

2.2 Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.

Table 3: Pediatric Dosage Guidelines

Infection

Dose

Frequency

Total Duration

Complicated

Urinary Tract or Pyelonephritis

(patients from 1 to 17 years of age)

10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded

even in patients weighing more than 51 kg)

Every 12 hours

10–21 days1

Inhalational Anthrax (Post-Exposure)2

15 mg/kg (maximum 500 mg per dose)

Every 12 hours

60 days

Plague2,3

15 mg/kg (maximum 500 mg per dose)

Every 8 to 12

hours

14 days

1. The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

2. Begin drug administration as soon as possible after suspected or confirmed exposure.

3. Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

2.3 Dosage Modifications in Patients with Renal Impairment

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.

Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function

Creatinine Clearance (mL/min)

Dose

> 50

See Usual Dosage.

30–50

250–500 mg every 12 hours

5–29

250–500 mg every 18 hours

Patients on hemodialysis or Peritoneal dialysis

250–500 mg every 24 hours (after dialysis)

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) 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.

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.

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/1.73m2).

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