CIPROFLOXACIN (Page 2 of 13)

2 DOSAGE AND ADMINISTRATION

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.

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.

Table 1: Adult Dosage Guidelines
Infection * Dose Frequency Usual Duration
*
Due to the designated pathogens (see Indications and Usage).
Used in conjunction with metronidazole.
Begin administration as soon as possible after suspected or confirmed exposure.
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)].

Table 2: Equivalent AUC Dosing Regimens
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

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.

Table 3: Pediatric Dosage Guidelines
Infection Dose(mg/kg) Frequency Total Duration
*
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).
Begin drug administration as soon as possible after suspected or confirmed exposure.
Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.
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

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
> 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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