Ciprofloxacindosage

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500-750mg every 12 hours 7 to 14 days Bone and Joint 500-750mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500mg every 12 hours 7 to 14 days Infectious Diarrhea 500mg every 12 hours 5 to 7 days Typhoid Fever 500mg every 12 hours 10 days Uncomplicated Gonorrhea 250mg single dose single dose Inhalational anthrax (post-exposure) 500mg every 12 hours 60 days Plague 500-750mg every 12 hours 14 days Chronic Bacterial Prostatitis 500mg every 12 hours 28 days Lower Respiratory Tract 500-750mg every 12 hours 7 to 14 days Urinary Tract 250-500mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250mg every 12 hours 3 days Acute Sinusitis 500mg every 12 hours 10 days Adults with creatinine clearance 3050 mL/min 250500 mg q 12 h Adults with creatinine clearance 529 mL/min 250500 mg q 18 h Patients on hemodialysis or peritoneal dialysis 250500 mg q 24 h (after dialysis) Pediatric Oral Dosage Guidelines Infection Dose Frequency Duration Complicated UTI and Pyelonephritis (1 to 17 years of age) 10-20 mg/kg (maximum 750 mg per dose) 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 14 days

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.

Table1: Adult Dosage Guidelines Infection Dose Frequency Usual Duration 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). Skin and Skin Structure 500-750mg every 12 hours 7 to 14 days Bone and Joint 500-750mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal Used in conjunction with metronidazole. 500mg every 12 hours 7 to 14 days Infectious Diarrhea 500mg every 12 hours 5 to 7 days Typhoid Fever 500mg every 12 hours 10 days Uncomplicated Gonorrhea 250mg single dose single dose Inhalational anthrax (post-exposure) Begin drug administration as soon as possible after suspected or confirmed exposure. 500mg every 12 hours 60 days Plague 500-750mg every 12 hours 14 days Chronic Bacterial Prostatitis 500mg every 12 hours 28 days Lower Respiratory Tract 500-750mg every 12 hours 7 to 14 days Urinary Tract 250-500mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250mg every 12 hours 3 days Acute Sinusitis 500mg 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 or oral suspension when clinically indicated at the discretion of the physician (Table 2).

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 Oral 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 days 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). Inhalational Anthrax (Post- Exposure) Begin drug administration as soon as possible after suspected or confirmed exposure. 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis. 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 14 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. Missed Doses If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.