Cipro

2 DOSAGE AND ADMINISTRATION CIPRO Tablets and Oral Suspension should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 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 Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 -750 mg every 12 hours 7 to 14 days Urinary Tract 250-500 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 • Adults with creatinine clearance 30–50 mL/min 250–500 mg q 12 h (2.3 ) • Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h ( 2.3 ) • Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) ( 2.3 ) 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. CIPRO Tablets or CIPRO for Oral Suspension may be administered to adult patients when clinically indicated at the discretion of the physician. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration ( 2.7 )]. Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations 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 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal Used in conjunction with metronidazole. 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) Begin drug administration as soon as possible after suspected or confirmed exposure. 500 mg every 12 hours 60 days Plague 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500–750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250–500 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 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: Equivalent AUC Dosing Regimens CIPRO Oral Dosage Equivalent CIPRO 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. CIPRO should be administered as described in Table 3. Administer CIPRO for Oral Suspension using the co-packaged graduated spoon [see Dosage and Administration (2.7)]. Table 3: Pediatric 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 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 14 days 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. 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 CIPRO 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 CIPRO with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, CIPRO may be taken with a meal that contains these products. Hydration of Patients Receiving CIPRO Assure adequate hydration of patients receiving CIPRO to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones. Instruct the patient of the appropriate CIPRO administration [see Patient Counseling Information (17)]. 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. Splitting CIPRO Tablets CIPRO Tablets, 250 mg and 500 mg are functionally scored tablets which can be split into one-half at the scored line to provide a 125 mg and 250 mg strength, respectively. 2.5 Directions for Reconstitution of the CIPRO Microcapsules for Oral Suspension CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. CIPRO oral suspension is composed of two components (microcapsules and diluent) that must be combined prior to dispensing. Table 5: Appropriate Dosing Volumes of the Reconstituted Oral Suspensions Dose 5% (250 mg/5 mL) 10% (500 mg/5 mL) 250 mg 5 mL 2.5 mL 500 mg 10 mL 5 mL 750 mg 15 mL 7.5 mL Preparation of the suspension: Step1 The small bottle contains the microcapsules, the large bottle contains the diluent. Step 2 Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left. Step 3 Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension. Step 4 Remove the top layer of the diluent bottle label (to reveal the CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use. Step 5: Write the expiration date of the re-constituted oral suspension on the bottle label. Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing. No additions should be made to the mixed final ciprofloxacin suspension. CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics. Step 1 Step 2 Step 3 Step 4 2.6 Administration Instructions for CIPRO for Oral Suspension After Reconstitution • Shake CIPRO Oral Suspension vigorously each time before use for approximately 15 seconds. • Administer CIPRO Oral Suspension using the co-packaged graduated teaspoon provided for the patient (see Figure 1) Figure 1: Co-packaged 5 mL graduated teaspoon The Co-packaged graduated teaspoon (5mL) is provided, with markings for 1/2 (2.5 mL) and 1/1 (5 mL) • After use, clean the graduated teaspoon under running water with dish detergent and dry thoroughly. • Do Not chew the microcapsules in the CIPRO Oral Suspension, instead swallow them whole. • Water may be taken afterwards. • Reclose the bottle properly after each use according to instructions on the cap. • After treatment has been completed, CIPRO Oral Suspension should not be reused. gradated spoon 2.7 Dosing of CIPRO for Oral Suspension using the Co-Packaged Spoon in Adults and Pediatric Patients Table 6: 5% Cipro for Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution Infection Body weight (kg) Dose by Measuring Spoonful(s) using Co-Packed Spoon* (teaspoonful (s) (volume (mL)) Dose Strength (mg) Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 1 and Plague 2 9 kg to 12 kg ½ teaspoonful (2.5 mL) 125 mg 13 kg to 18 kg 1 teaspoonful (5 mL) 250 mg 19 kg to 24 kg 1 to 1 ½ teaspoonful(s) (5 mL to 7.5 mL) 250 mg to 375 mg 25 kg to 31 kg 1 ½ to 2 teaspoonfuls (7.5 mL to 10 mL) 375 mg to 500 mg 32 kg to 37 kg 1 ½ to 2 ½ teaspoonfuls (7.5 mL to 12.5 mL) 375 mg to 625 mg 38 kg or more 2 to 3 teaspoonfuls (10 mL to 15 mL) 500 mg to 750 mg Inhalational Anthrax (Post-Exposure) 3 9 kg to 12 kg ½ teaspoonful (2.5 mL) 125 mg 13 kg to 18 kg 1 teaspoonful (5 mL) 250 mg 19 kg to 24 kg 1 to 1 ½ teaspoonful(s) (5 mL to 7.5 mL) 250 mg to 375 mg 25 kg or more 2 teaspoonfuls (10 mL) 500 mg * A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient. 1 Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)] 2 Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)] ; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)] 3 Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)] Table 7: 10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution (not appropriate for children weighing less than 13 kg) Infection Body weight (kg) Dose by Measuring Spoonful(s) using Co-Packed Spoon* (teaspoonful (s) (volume (mL)) Dose Strength (mg) Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 1 and Plague 2 13 kg to 24 kg ½ teaspoonful (2.5 mL) 250 mg 25 kg ½ to 1 teaspoonful (2.5 mL to 5 mL) 250 mg to 500 mg 26 kg to 37 kg 1 teaspoonful (5 mL) 500 mg 38 kg or more 1 to 1½ teaspoonful(s) (5 mL to 7.5 mL) 500 mg to maximum dose of 750 mg Inhalational Anthrax (Post-Exposure) 3 13 kg to 24 kg ½ teaspoonful (2.5 mL) 250 mg 25 kg or more 1 teaspoonful (5 mL) 500 mg * A graduated teaspoon (5mL) with markings 1/2 (2.5) mL and 1/1 (5 mL) is provided for the patient. 1 Administer every 12 hours for 10-21 days [see Dosage and Administration (2.2)] 2 Administer every 8-12 hours for 10-21 days for Pediatric patients [see Dosage and Administration (2.2)] ; for adults administer every 12 hours for 14 days [see Dosage and Administration (2.1)] 3 Administer every 12 hours for 60 days [see Dosage and Administration (2.1 and 2.2)]

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1 INDICATIONS AND USAGE CIPRO is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: • Skin and Skin Structure Infections ( 1.1 ) • Bone and Joint Infections ( 1.2 ) • Complicated Intra-Abdominal Infections ( 1.3 ) • Infectious Diarrhea ( 1.4 ) • Typhoid Fever (Enteric Fever) ( 1.5 ) • Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) • Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7) • Plague in adult and pediatric patients ( 1.8 ) • Chronic Bacterial Prostatitis ( 1.9 ) • Lower Respiratory Tract Infections ( 1.10 ) • Acute Exacerbation of Chronic Bronchitis • Urinary Tract Infections ( 1.11 ) • Urinary Tract Infections (UTI) • Acute Uncomplicated Cystitis • Complicated UTI and Pyelonephritis in Pediatric Patients • Acute Sinusitis ( 1.12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO and other antibacterial drugs, CIPRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.