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 indicated at the discretion of the physician. 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 indicated at the discretion of the physician.

Table 1: Adult Dosage Guidelines
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.
Infection Dose Frequency Usual Durations 1
Skin and Skin Structure 500 to 750 mg every 12 hours 7 to 14 days
Bone and Joint 500 to 750 mg every 12 hours 4 to 8 weeks
Complicated Intra–Abdominal 2 500 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
Plague 3 500 to 750 mg every 12 hours 14 days
Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days
Lower Respiratory Tract Infections 500 to 750 mg every 12 hours 7 to 14 days
Urinary Tract Infections 250 to 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

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) 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
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.
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 to 21 days 1
Inhalational Anthrax (Post-Exposure) 2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days
Plague 2,3 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 10 to 21 days

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 to 50 250 to 500 mg every 12 hours
5 to 29 250 to 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis 250 to 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/1.73 m 2).

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