Ciprofloxacin (Page 3 of 14)

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or oral suspension 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 should be administered as described in Table 3.

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

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 days *

Inhalational Anthrax (Post-Exposure)

15 mg/kg (maximum 500 mg per dose)

Every 12 hours

60 days

Plague ,

15 mg/kg (maximum 500 mg per dose)

Every 8 to 12 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

>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/1.73m 2).

2.4 Important Administration Instructions

With Multivalent Cations
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, 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.

With Dairy Products
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin Tablets
Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate ciprofloxacin tablet administration [see Patient Counseling Information (17)].

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