2 DOSAGE AND ADMINISTRATION Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 to 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 to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 to 750 mg every 12 hours 7 to 14 days Urinary Tract 250 to 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 to 50 mL/min 250 to 500 mg q 12 h ( 2.3 ) Adults with creatinine clearance 5 to 29 mL/min 250 to 500 mg q 18 h ( 2.3 ) Patients on hemodialysis or peritoneal dialysis 250 to 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 to 20 mg/kg (maximum 750 mg per dose) Every 12 hours 10 to 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 12 to 8 hours 10 to 21 days Ciprofloxacin for oral suspension should be administered orally as 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. Ciprofloxacin for oral suspension may be administered to adult patients when clinically indicated at the discretion of the physician. Administer ciprofloxacin for oral suspension using the co-packaged graduated twin spoon [see DOSAGE AND ADMINISTRATION ( 2.7 )] Table 1: Adult Dosage Guidelines 1 . 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). 2 . Used in conjunction with metronidazole. 3 . Begin drug administration as soon as possible after suspected or confirmed exposure. Infection Dose Frequency Usual Durations 1 Skin and Skin Structure 500 to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 to 750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal 2 500 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) 3 500 mg every 12 hours 60 days Plague 3 500 to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500 to 750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250 to 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 ciprofloxacin for 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 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. Ciprofloxacin should be administered as described in Table 3. Administer ciprofloxacin for oral suspension using the co-packaged graduated twin spoon [see DOSASGE AND ADMINISTRATION ( 2.7 )]. Table 3: Pediatric Dosage Guidelines 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 . 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 to 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 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 > 50 See Usual Dosage. 30 to 50 250 to 500 mg every 12 hours 5 to 29 250 to 500 mg every 18 hours Patients on hemodialysis or Peritoneal dialysis 250 to 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 for oral suspension 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 for oral suspension with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin for oral suspension may be taken with a meal that contains these products. Hydration of Patients Receiving Ciprofloxacin for Oral Suspension Assure adequate hydration of patients receiving ciprofloxacin for oral suspension to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones. Instruct the patient of the appropriate ciprofloxacin for oral suspension administration [see PATIENT COUNSELING INFORMATION ( 17 )]. 2.5 Directions for Reconstitution of the Ciprofloxacin Granular Blend for Oral Suspension Ciprofloxacin for oral suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin for oral suspension is composed of two components (granular blend 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 diluent, which is clear to yellow oil. Sometimes, you may observe yellow droplets (of one of the component of diluent i.e. polysorbate -20), which should disappear on vigorous shaking. The large bottle contains the ciprofloxacin granular blend. 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 diluent completely into the larger bottle of granular blend. Do not add water to the suspension. Step 4: Remove the top layer of the granular blend bottle label (to reveal the Ciprofloxacin for Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 30 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. Ciprofloxacin for oral suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics. 2.6 Administration Instructions for Ciprofloxacin for Oral Suspension After Reconstitution Shake ciprofloxacin for oral suspension vigorously each time before use for approximately 30 seconds. Administer ciprofloxacin for oral suspension using the co-packaged graduated twin spoon provided for the patient (see Figure 1) Figure 1: Co-packaged graduated twin spoon The Co-packaged graduated twin spoon is provided, with one side 5 mL and other side 2.5 mL After use, clean the graduated twin spoon under running water with dish detergent and dry thoroughly. Do not chew the granular blend in the ciprofloxacin for 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, ciprofloxacin for oral suspension should not be reused. 2.7 Dosing of Ciprofloxacin for Oral Suspension using the Co-Packaged Twin Spoon in Adults and Pediatric Patients Table 6: 5% Ciprofloxacin for Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution * A graduated twin spoon is provided, with one side 5 mL and other side 2.5 mL 1Administer every 12 hours for 10 to 21 days [see DOSAGE AND ADMINISTRATION ( 2.2 )] 2Administer every 8 to 12 hours for 10 to 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 )] 3Administer every 12 hours for 60 days [see DOSAGE AND ADMINISTRATION ( 2.1 and 2.2 )] 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 mg̶̶ 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 Table 7: 10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution (not appropriate for children weighing less than 13 kg) * A graduated twin spoon is provided for the patient, with one side 5 mL and other side 2.5 mL 1Administer every 12 hours for 10 to 21 days [see DOSAGE AND ADMINISTRATION ( 2.2 )] 2Administer every 8 to 12 hours for 10 to 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 )] 3Administer every 12 hours for 60 days [see DOSAGE AND ADMINISTRATION ( 2.1 and 2.2 )] 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 image-01 image-02 image-03 image-04 image-05