CIPRO IV should be administered intravenously at dosages 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.
Table 1: Adult Dosage Guidelines
*
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.
Infection*
Dose
Frequency
Usual Duration
Urinary Tract
200 mg to 400 mg
every 12 to every 8 hours
7–14 days
Lower Respiratory Tract
400 mg
every 12 to every 8 hours
7–14 days
Nosocomial Pneumonia
400 mg
every 8 hours
10–14 days
Skin and Skin Structure
400 mg
every 12 to every 8 hours
7–14 days
Bone and Joint
400 mg
every 12 to every 8 hours
4 to 8 weeks
Complicated Intra-Abdominal†
400 mg
every 12 hours
7–14 days
Acute Sinusitis
400 mg
every 12 hours
10 days
Chronic Bacterial prostatitis
400 mg
every 12 hours
28 days
Empirical Therapy In Febrile Neutropenic Patients
CIPRO IV
400 mg
and
every 8 hours
7–14 days
Piperacillin
50 mg/kg
every 4 hours
Inhalational anthrax(post-exposure)‡
400 mg
every 12 hours
60 days
Plague‡
400 mg
every 12 to 8 hours
14 days
Conversion of Intravenous to Oral Dosing in Adults
Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
Table 2:
CIPRO Oral DEquivalent AUC Dosing Regimensosage
Equivalent CIPRO IV Dosage
250 mg Tablet every 12 hours
200 mg intravenous every 12 hours
500 mg Tablet every 12 h
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
*
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.
Infection
Dose
(mg/kg)
Frequency
Total Duration
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
10–21 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 12 to 8 hours
10–21 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.
5–29
200–400 mg every 18–24 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) 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 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/1.73m2).
2.3 Preparation of CIPRO IV for Administration
Flexible Containers
CIPRO IV is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.
2.4 Important Administration Instructions
Intravenous Infusion
CIPRO IV should be administered to by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.
Hydration of Patients Receiving CIPRO IV
Adequate hydration of patients receiving CIPRO IV should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see Warnings and Precautions (5.12), Adverse Reactions (6.1), Nonclinical Toxicology (13.2) and Patient Counseling Information (17)].
