Ciprofloxacin Hydrochloride

Ciprofloxacin Hydrochloride Manufacturers

• Testpak Holding Company
  

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  Ciprofloxacin Hydrochloride | Testpak Holding Company

  

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  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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.

  ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations †

  * used in conjunction with metronidazole

  † 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).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).

  Urinary Tract Acute Uncomplicated 100 mg or 250 mg q 12 h 3 days Mild/Moderate 250 mg q 12 h 7 to 14 days Severe/Complicated 500 mg q 12 h 7 to 14 days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 days Prostatitis Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections Inhalational anthrax 500 mg q 12 h 60 days (post-exposure)** Conversion of I.V. to Oral Dosing in Adults:

  Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function:

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
  or Peritoneal dialysis
  250 – 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula 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.

  DOSAGE AND ADMINISTRATION - PEDIATRICS

  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).

  Infection Route of Administration Dose
  (mg/kg)
  Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
  
  (patients from 1 to 17 years of age)
  
  
  10-21 days* Oral 10 mg/kg to 20 mg/kg
  (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
  (Post-
  Exposure)**
  
  
  60 days Oral 15 mg/kg
  (maximum 500 mg per dose) Every 12 hours

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

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• State Of Florida Doh Central Pharmacy
  

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  Ciprofloxacin Hydrochloride | State Of Florida Doh Central Pharmacy

  

  ---

  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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.

  ADULT DOSAGE GUIDELINES

  *used in conjunction with metronidazole

  †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).

  **Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX –ADDITIONALINFORMATION.

   Infection  Severity  Dose  Frequency Usual Durations† Urinary Tract     Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg   q 12 h 7 to 14 days Severe/Complicated   500 mg   q 12 h   7 to 14 days Chronic Bacterial Prostatitis   Mild/Moderate   500 mg   q 12 h   28 days   Lower Respiratory Tract   Mild/Moderate   Severe/Complicated 500 mg   q 12 h   7 to 14 days   750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure   Mild/Moderate   Severe/Complicated 500 mg   q 12 h   7 to 14 days   750 mg q 12 h 7 to 14 days Bone and Joint   Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated   750 mg   q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea   Mild/Moderate/Severe   500 mg   q 12 h   5 to 7 days   Typhoid Fever   Mild/Moderate   500 mg   q 12 h   10 days   Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg   single dose single dose Inhalational anthrax (post-exposure)**   500 mg q 12 h   60 days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function

  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 alternate 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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h

  Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula 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.

  Ciproflaxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  Infection

    Route of Administration

  Dose

  (mg/kg)

  Frequency

   

  Total

  Duration

  Complicated

  Urinary Tract

  or

  Pyelonephritis

  (patients from

  1 to 17 years of age)

   

   

  Intravenous

   

   

   

   

  6 to 10 mg/kg

  (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 8

  hours

   

   

   

   

   

   

  10-21 days*

   

   

   

   

   

  Oral

   

   

   

   

  10 mg/kg to 20 mg/kg

  (maximum 750 mg per

  dose; not to be exceeded even in patients weighing

  > 51 kg)

  Every 12

  hours

   

   

   

  Inhalational

  Anthrax

  (Post-

  Exposure)**

  Intravenous

   

  10 mg/kg

  (maximum 400 mg per

  dose)

  Every 12

  hours

   

   

   

   

  60 days

   

  Every 12 hours Oral 15 mg/kg (maximum 500 mg per dose)

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

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• Blenheim Pharmacal, Inc.
  

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  Ciprofloxacin Hydrochloride | Blenheim Pharmacal, Inc.

  

  ---

  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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.

  ADULT DOSAGE GUIDELINES

  *used in conjunction with metronidazole

  †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).

  **Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX –ADDITIONALINFORMATION.

   Infection  Severity  Dose  Frequency Usual Durations† Urinary Tract     Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg   q 12 h 7 to 14 days Severe/Complicated   500 mg   q 12 h   7 to 14 days Chronic Bacterial Prostatitis   Mild/Moderate   500 mg   q 12 h   28 days   Lower Respiratory Tract   Mild/Moderate   Severe/Complicated 500 mg   q 12 h   7 to 14 days   750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure   Mild/Moderate   Severe/Complicated 500 mg   q 12 h   7 to 14 days   750 mg q 12 h 7 to 14 days Bone and Joint   Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated   750 mg   q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea   Mild/Moderate/Severe   500 mg   q 12 h   5 to 7 days   Typhoid Fever   Mild/Moderate   500 mg   q 12 h   10 days   Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg   single dose single dose Inhalational anthrax (post-exposure)**   500 mg q 12 h   60 days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function

  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 alternate 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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h

  Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula 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.

  Ciproflaxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  Infection

    Route of Administration

  Dose

  (mg/kg)

  Frequency

   

  Total

  Duration

  Complicated

  Urinary Tract

  or

  Pyelonephritis

  (patients from

  1 to 17 years of age)

   

   

  Intravenous

   

   

   

   

  6 to 10 mg/kg

  (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 8

  hours

   

   

   

   

   

   

  10-21 days*

   

   

   

   

   

  Oral

   

   

   

   

  10 mg/kg to 20 mg/kg

  (maximum 750 mg per

  dose; not to be exceeded even in patients weighing

  > 51 kg)

  Every 12

  hours

   

   

   

  Inhalational

  Anthrax

  (Post-

  Exposure)**

  Intravenous

   

  10 mg/kg

  (maximum 400 mg per

  dose)

  Every 12

  hours

   

   

   

   

  60 days

   

  Every 12 hours Oral 15 mg/kg (maximum 500 mg per dose)

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

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• Remedyrepack Inc.
  

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  Ciprofloxacin Hydrochloride | Remedyrepack Inc.

  

  ---

  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  
  ADULT DOSAGE GUIDELINES
  InfectionSeverityDoseFrequencyUsual DurationsUrinary TractAcute100 mg or 250 mgq 12 h3 daysUncomplicatedMild/Moderate250 mgq 12 h7 to 14 daysSevere/Complicated500 mgq 12 h7 to 14 daysChronic BacterialMild/Moderate500 mgq 12 h28 daysProstatitisLower RespiratoryMild/Moderate500 mgq 12 h7 to 14 daysTractSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin andMild/Moderate500 mgq 12 h7 to 14 daysSkin StructureSevere/Complicated750 mgq 12 h7 to 14 daysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-Abdominal*Complicated500 mgq 12 h7 to 14 daysInfectious DiarrheaMild/Moderate/500 mgq 12 h5 to 7 daysSevereTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral andUncomplicated250 mgsingle dosesingle doseCervicalGonococcal InfectionsInhalational anthrax500 mgq 12 h60 days(post-exposure)*** used in conjunction with metronidazole
  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).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure.
  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION).
  
  Conversion of I.V. to Oral Dosing in Adults:
  Patients whose therapy is started with ciprofloxacin hydrochloride I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function:
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage.3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula 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.
  
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute ofDoseFrequencyTotal DurationAdministration(mg/kg)ComplicatedOral10 mg/kg to 20 mg/kg (maximumEvery 12 hoursUrinary Tract orPyelonephritisexceeded even in patients weighing>(patients from 1 to51 kg)10-21 days*17 years of age)Inhalational Anthrax Oral15 mg/kgEvery 12 hours(Post-Exposure)**(maximum 500 mg per dose)60 days* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION).
  
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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• Remedyrepack Inc.
  

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  Ciprofloxacin Hydrochloride | Remedyrepack Inc.

  

  ---

  DOSAGE AND ADMINISTRATION - ADULTS
  
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  
  ADULT DOSAGE GUIDELINESInfectionSeverityDoseFrequencyUsual DurationsUrinary TractAcute250 mgq 12 h3 DaysUncomplicatedMild/Moderate250 mgq 12 h7 to 14 DaysSevere/500 mgq 12 h7 to 14 DaysComplicatedChronic BacterialMild/Moderate500 mgq 12 h28 DaysProstatitisLower RespiratoryMild/Moderate500 mgq 12 h7 to 14 daysTractSevere/750 mgq 12 h7 to 14 daysComplicatedAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and SkinMild/Moderate500 mgq 12 h7 to 14 DaysStructureSevere/750 mgq 12 h7 to 14 DaysComplicatedBone and JointMild/Moderate500 mgq 12 hto 6 weeksSevere/750 mgq 12 hto 6 weeksComplicatedIntra-Abdominal*Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/500 mgq 12 h5 to 7 DaysSevereTyphoid FeverMild/Moderate500 mgq 12 h10 DaysUrethral and Cervical Uncomplicated250 mgsingle dosesingle doseGonococcal InfectionsInhalational anthrax500 mg12 h60 Days(post-exposure)*** used in conjunction with metronidazole
  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).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.
  
  
  Conversion of I.V. to Oral Dosing in Adults
  
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage.3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  
  Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min) = 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.
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINESInfectionRoute ofDose (mg/kg)FrequencyTotal DurationAdministrationComplicated Urinary Intravenous6 to 10 mg/kgEvery 8 hoursTract or(maximum 400 mgPyelonephritisexceeded even in10-21 days*patients weighing> 51 kg)(patients from 1 toOral10 mg/kg to 20Every 12 hours17 yearsof age)mg/kg (maximumnot to be exceededeven in patientsweighing >51 kg)Inhalational AnthraxIntravenous10 mg/kg (maximumEvery 12 hours400 mg per dose)60 days(Post-Exposure)**Oral15 mg/kg (maximumEvery 12 hours500 mg per dose)* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.
  
  
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  DOSAGE AND ADMINISTRATION - ADULTS
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
  ADULT DOSAGE GUIDELINES
  InfectionSeverityDoseFrequencyUsual Durations*Urinary TractAcute250 mgq 12 h3 DaysUncomplicatedMild/Moderate250 mgq 12 h7 to 14 DaysSevere/500 mgq 12 h7 to 14 DaysComplicatedChronic BacterialMild/Moderate500 mgq 12 h28 DaysProstatitisLower RespiratoryMild/Moderate500 mgq 12 h7 to 14 daysTractSevere/750 mgq 12 h7 to 14 daysComplicatedAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/750 mgq 12 h7 to 14 DaysComplicatedBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/750 mgq 12 h4 to 6 weeksComplicatedIntra-Abdominal Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/500 mgq 12 h5 to 7 DaysSevereTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and CervicalUncomplicated250 mgsingle dosesingle doseGonococcal InfectionsInhalational anthrax500 mgq 12 h60 Days(post-exposure) *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).
  Used in conjunction with metronidazole
  Drug administration should begin as soon as possible after suspected or confirmed exposure.
       This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.
  
  Conversion of I.V. to Oral Dosing in Adults
  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or250500 mg q 24 hPeritoneal dialysis(after dialysis)When only the serum creatinine concentration is known, the following formula 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.
  
  DOSAGE AND ADMINISTRATIONPEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute ofDose (mg/kg)FrequencyTotalAdmin.DurationComplicatedIntravenous6 to 10 mg/kg (maximumEvery 8Urinary Tracthoursorexceeded even in patientsPyelonephritisweighing > 51 kg)(patients fromoral10mg/kg to 20 mg/kgEvery 1210-21 days *1 to 17 yearshoursof age)not to be exceeded even inpatients weighing > 51kg)InhalationalIntravenous10 mg/kg (maximum 400Every 12Anthrax (Post-mg per dose)hoursExposure) 60 daysOral15 mg/kg (maximum 500Every 12mg per dose)hours *The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.
  
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  ADULTS
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
  ADULT DOSAGE GUIDELINES
  InfectionSeverityDoseFrequencyUsual 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). Used in conjunction with metronidazole Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-Abdominal Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure) 500 mgq 12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults
  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  Men: Creatinine clearance (mL/min) =Weight (kg)(140 - age)72serum creatinine (mg/dL)Women: 0.85the 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.
  
  DOSAGE AND ADMINISTRATIONPEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)IntravenousEvery 8 hours10-21 days *OralEvery 12 hoursInhalational Anthrax (Post-Exposure) Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  DOSAGE AND ADMINISTRATION - ADULTS
  
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  
  ADULT DOSAGE GUIDELINES InfectionSeverityDoseFrequencyUsual Durations* used in conjunction with metronidazoleGenerally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 hto 6 weeksSevere/Complicated750 mgq 12 hto 6 weeksIntra-Abdominal*Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 DaysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure)**500 mg12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults
  
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage.3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  
  Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min) = 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.
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or PyelonephritisIntravenousEvery 8 hours10-21 days*(patients from 1 to 17 years of age)OralEvery 12 hoursInhalational Anthrax (Post-Exposure)**Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hours
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  DOSAGE AND ADMINISTRATION - ADULTS
  
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  
  ADULT DOSAGE GUIDELINES InfectionSeverityDoseFrequencyUsual Durations* used in conjunction with metronidazoleGenerally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 hto 6 weeksSevere/Complicated750 mgq 12 hto 6 weeksIntra-Abdominal*Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 DaysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure)**500 mg12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults
  
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage.3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  
  Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min) = 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.
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or PyelonephritisIntravenousEvery 8 hours10-21 days*(patients from 1 to 17 years of age)OralEvery 12 hoursInhalational Anthrax (Post-Exposure)**Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hours
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
  
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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. 
  ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations Urinary Tract
  Acute Uncomplicated
  250 mg    
  q 12 h
  3 Days
  Mild/Moderate
  250 mg    
  q 12 h
  7 to 14 Days
  Severe/Complicated
  500 mg    
  q 12 h
  7 to 14 Days
  Chronic Bacterial Prostatitis    
  Mild/Moderate
  500 mg    
  q 12 h
  28 Days
  Lower Respiratory Tract
  Mild/Moderate
  500 mg    
  q 12 h
  7 to 14 days
  Severe/Complicated
  750 mg    
  q 12 h
  7 to 14 days
  Acute Sinusitis
  Mild/Moderate
  500 mg    
  q 12 h
  10 days
  Skin and Skin Structure
  Mild/Moderate
  500 mg    
  q 12 h
  7 to 14 Days
  Severe/Complicated
  750 mg    
  q 12 h
  7 to 14 Days
  Bone and Joint
  Mild/Moderate
  500 mg    
  q 12 h
  ≥4 to 6 weeks
  Severe/Complicated
  750 mg    
  q 12 h
  ≥4 to 6 weeks
  Intra-Abdominal*
  Complicated   
  500 mg    
  q 12 h
  7 to 14 Days
  Infectious Diarrhea
  Mild/Moderate/Severe    
  500 mg    
  q 12 h
  5 to 7 Days
  Typhoid Fever
  Mild/Moderate
  500 mg    
  q 12 h
  10 Days
  Urethral and Cervical
     Gonococcal Infections
  Uncomplicated
  250 mg    
  single dose
  single dose
  Inhalational anthrax(post-exposure)**
  
  500 mg    
  q 12 h
      60 Days

      used in conjunction with metronidazole
       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).
       Drug administration should begin as soon as possible after suspected or confirmed exposure.
       This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
       reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
       human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
  
  Conversion of I.V. to Oral Dosing in Adults
  
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).  

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
  200 mg I.V. q 12 h
  500 mg Tablet q 12 h
  400 mg I.V. q 12 h
  750 mg Tablet q 12 h
  400 mg I.V. q 8 h
  
  Adults with Impaired Renal Function
  
  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. The following table provides dosage guidelines for use in patients with renal impairment: 
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose less then 50
  See Usual Dosage.
  30 – 50
  250 – 500 mg q 12 h
  5 – 29
  250 – 500 mg q 18 h
  
     Patients on hemodialysis   
     or Peritoneal dialysis    
     250 – 500 mg q 24 h   
     (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
   
                                                                       Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min)  =         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.DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES .)
   
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician. 
  PEDIATRIC DOSAGE GUIDELINES Infection Route
  of
  Administration Dose
  (mg/kg) Frequency Total
  Duration Complicated
    Urinary Tract or
    Pyelonephritis  
  Intravenous
  6 to 10 mg/kg
  (maximum 400 mg
  per dose; not to be exceeded  
  even in patients weighing 
  > 51 kg)
  Every 8 hours
  
   
  10-21 days*
  (patients from
    1 to 17 years of
    age)
  Oral
  10 mg/kg to 20 mg/kg   
  (maximum 750 mg per 
  dose; not to be exceeded 
  even in patients weighing 
  > 51 kg)
  Every 12 hours
  Inhalational
    Anthrax
    (Post-Exposure)** 
  Intravenous
  10 mg/kg
  (maximum 400 mg per  
  dose)
  Every 12 hours
  
  60 days
  Oral
  15 mg/kg
  (maximum 500 mg per dose)
  Every 12 hours
  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
  
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of greater then 50 mL/min/1.73m 2).

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  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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.

  ADULT DOSAGE GUIDELINES

  *used in conjunction with metronidazole

  †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).

  **Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX –ADDITIONALINFORMATION.

   Infection  Severity  Dose  Frequency Usual Durations† Urinary Tract     Acute Uncomplicated 250 mg q 12 h 3 days Mild/Moderate 250 mg   q 12 h 7 to 14 days Severe/Complicated   500 mg   q 12 h   7 to 14 days Chronic Bacterial Prostatitis   Mild/Moderate   500 mg   q 12 h   28 days   Lower Respiratory Tract Mild/Moderate   500 mg   q 12 h   7 to 14 days   Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure   Mild/Moderate   500 mg   q 12 h   7 to 14 days   Severe/Complicated 750 mg q 12 h 7 to 14 days Bone and Joint   Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated   750 mg   q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days Infectious Diarrhea   Mild/Moderate/Severe   500 mg   q 12 h   5 to 7 days   Typhoid Fever   Mild/Moderate   500 mg   q 12 h   10 days   Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg   single dose single dose Inhalational anthrax (post-exposure)**   500 mg q 12 h   60 days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function

  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 alternate 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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 to 50 250 to 500 mg q 12 h 5 to 29 250 to 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) × (140 – age)

  72 × serum creatinine (mg/dL)

  Women: 0.85 × 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.

  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

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  Ciprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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.

  ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations†

  * used in conjunction with metronidazole

  † 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).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).

  
  

  Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days
  Mild/Moderate 250 mg q 12 h 7 to 14 Days
  Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Mild/Moderate 500 mg q 12 h 28 Days Prostatitis
  
  
  
  Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days
  Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Mild/Moderate 500 mg q 12 h 7 to 14 Days Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks
  Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 Days Urethral and Cervical Uncomplicated 250 mg single dose single dose Gonococcal Infections
  
  
  
  Inhalational anthrax
  500 mg q 12 h 60 Days (post-exposure)**
  
  Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h   200 mg I.V. q 12 h 500 mg Tablet q 12 h   400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min)       Dose less then  50 See Usual Dosage. 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis
  or Peritoneal dialysis
  250 – 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula 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.

  DOSAGE AND ADMINISTRATION - PEDIATRICS

  Ciprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table.

  An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION).

  Infection Route of Administration Dose
  (mg/kg)
  Frequency Total Duration Complicated Urinary Tract or Pyelonephritis
  
  (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
  (maximum 400 mg per dose; not to be exceeded even in patients weighing less then  51 kg) Every 8 hours
  
  
  10 to 21 days* Oral 10 mg/kg to 20 mg/kg
  (maximum 750 mg per dose; not to be exceeded even in patients weighing less then  51 kg) Every 12 hours Inhalational Anthrax
  (Post-
  Exposure)** Intravenous 10 mg/kg
  (maximum 400 mg per dose) Every 12 hours
  
  
  60 days Oral 15 mg/kg
  (maximum 500 mg per dose) Every 12 hours
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of greater then  50 mL/min/1.73m 2).
  
  
  

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  DOSAGE AND ADMINISTRATION - ADULTSCiprofloxacin Tablets should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
  
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, 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. 
  ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
  Acute Uncomplicated
  250 mg    
  q 12 h
  3 Days
  Mild/Moderate
  250 mg    
  q 12 h
  7 to 14 Days
  Severe/Complicated
  500 mg    
  q 12 h
  7 to 14 Days
  Chronic Bacterial Prostatitis    
  Mild/Moderate
  500 mg    
  q 12 h
  28 Days
  Lower Respiratory Tract
  Mild/Moderate
  500 mg    
  q 12 h
  7 to 14 days
  Severe/Complicated
  750 mg    
  q 12 h
  7 to 14 days
  Acute Sinusitis
  Mild/Moderate
  500 mg    
  q 12 h
  10 days
  Skin and Skin Structure
  Mild/Moderate
  500 mg    
  q 12 h
  7 to 14 Days
  Severe/Complicated
  750 mg    
  q 12 h
  7 to 14 Days
  Bone and Joint
  Mild/Moderate
  500 mg    
  q 12 h
  lessthen4 to 6 weeks
  Severe/Complicated
  750 mg    
  q 12 h
  lessthen 4 to 6 weeks
  Intra-Abdominal*
  Complicated   
  500 mg    
  q 12 h
  7 to 14 Days
  Infectious Diarrhea
  Mild/Moderate/Severe    
  500 mg    
  q 12 h
  5 to 7 Days
  Typhoid Fever
  Mild/Moderate
  500 mg    
  q 12 h
  10 Days
  Urethral and Cervical
     Gonococcal Infections
  Uncomplicated
  250 mg    
  single dose
  single dose
  Inhalational anthrax(post-exposure)**
  
  500 mg    
  q 12 h
      60 Days

    *  used in conjunction with metronidazole
  † 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).
  **  Drug administration should begin as soon as possible after suspected or confirmed exposure.
       This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans,
       reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various
       human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
  
  Conversion of I.V. to Oral Dosing in Adults
  
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).  

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h
  200 mg I.V. q 12 h
  500 mg Tablet q 12 h
  400 mg I.V. q 12 h
  750 mg Tablet q 12 h
  400 mg I.V. q 8 h
  
  Adults with Impaired Renal Function
  
  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. The following table provides dosage guidelines for use in patients with renal impairment: 
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose less then 50
  See Usual Dosage.
  30 – 50
  250 – 500 mg q 12 h
  5 – 29
  250 – 500 mg q 18 h
  
     Patients on hemodialysis   
     or Peritoneal dialysis    
     250 – 500 mg q 24 h   
     (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
   
                                                                        Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min)  =         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. DOSAGE AND ADMINISTRATION - PEDIATRICSCiprofloxacin Tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES .)
   
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician. 
  PEDIATRIC DOSAGE GUIDELINES Infection Route
  of
  Administration Dose
  (mg/kg) Frequency Total
  Duration Complicated
    Urinary Tract or
    Pyelonephritis  
  Intravenous
  6 to 10 mg/kg
  (maximum 400 mg
  per dose; not to be exceeded  
  even in patients weighing 
  > 51 kg)
  Every 8 hours
  
   
  10-21 days*
  (patients from
    1 to 17 years of
    age)
  Oral
  10 mg/kg to 20 mg/kg   
  (maximum 750 mg per 
  dose; not to be exceeded 
  even in patients weighing 
  > 51 kg)
  Every 12 hours
  Inhalational
    Anthrax
    (Post-Exposure)** 
  Intravenous
  10 mg/kg
  (maximum 400 mg per  
  dose)
  Every 12 hours
  
  60 days
  Oral
  15 mg/kg
  (maximum 500 mg per dose)
  Every 12 hours
  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. 5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX – ADDITIONAL INFORMATION .
  
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of greater then 50 mL/min/1.73m 2).

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  DOSAGE AND ADMINISTRATION - ADULTS

  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

  ADULT DOSAGE GUIDELINES Infection Severity 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). † Used in conjunction with metronidazole ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure.
  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION. Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 Days Mild/Moderate 250 mg q 12 h 7 to 14 Days Severe/Complicated 500 mg q 12 h 7 to 14 Days Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 Days Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days Severe/Complicated 750 mg q 12 h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days Skin and Skin Structure Mild/Moderate 500 mg q 12 h 7 to 14 Days Severe/Complicated 750 mg q 12 h 7 to 14 Days Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks Intra-Abdominal† Complicated 500 mg q 12 h 7 to 14 Days Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 Days Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg single dose single dose Inhalational anthrax (post-exposure)‡ 500 mg q 12 h 60 Days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q 12 h 200 mg I.V. q 12 h 500 mg Tablet q 12 h 400 mg I.V. q 12 h 750 mg Tablet q 12 h 400 mg I.V. q 8 h Adults with Impaired Renal Function

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 – 50 250 – 500 mg q 12 h 5 – 29 250 – 500 mg q 18 h Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age) 72 × serum creatinine (mg/dL) Women: 0.85 × 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.

  DOSAGE AND ADMINISTRATION – PEDIATRICS

  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and CLINICAL STUDIES.)

  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). † Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit 5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX — ADDITIONAL INFORMATION. Complicated Urinary Tract or Pyelonephritis
  (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg
  (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days* Oral 10 mg/kg to 20 mg/kg
  (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax
  (Post-Exposure)† Intravenous 10 mg/kg
  (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg
  (maximum 500 mg per dose) Every 12 hours

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).

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  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  
  ADULT DOSAGE GUIDELINES
  *used in conjunction with metronidazoleciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). **Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONALINFORMATION.InfectionSeverityDoseFrequencyUsual DurationsUrinary TractAcute Uncomplicated250 mgq 12 h3 daysMild/Moderate250 mgq 12 h7 to 14 daysSevere/Complicated500 mgq 12 h7 to 14 daysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 daysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-Abdominal*Complicated500 mgq 12 h7 to 14 daysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 daysTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure)**500 mgq 12 h60 days
  Conversion of I.V. to Oral Dosing in Adults
  Patients whose therapy is started with ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
  
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage30 to 50250 to 500 mg q 12 h5 to 29250 to 500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250 to 500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  Men: Creatinine clearance (mL/min) = Weight (kg)(140age)
  72serum creatinine (mg/dL)
  Women: 0.85the 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.
  
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONS and CLINICAL STUDIES).
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal DurationComplicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)IntravenousEvery 8 hours10 to 21 days*OralEvery 12 hoursInhalational Anthrax (Post- Exposure)**Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hours* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  ADULTS
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
  ADULT DOSAGE GUIDELINES
  InfectionSeverityDoseFrequencyUsual 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). Used in conjunction with metronidazole Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-Abdominal Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure) 500 mgq 12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults
  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  Men: Creatinine clearance (mL/min) =Weight (kg)(140 - age)72serum creatinine (mg/dL)Women: 0.85the 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.
  
  DOSAGE AND ADMINISTRATIONPEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)IntravenousEvery 8 hours10-21 days *OralEvery 12 hoursInhalational Anthrax (Post-Exposure) Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  ADULTS
  
  Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
  
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
  ADULT DOSAGE GUIDELINES InfectionSeverityDoseFrequencyUsual Durations* used in conjunction with metronidazoleGenerally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). ** Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.4 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitsMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 hto 6 weeksSevere/Complicated750 mgq 12 hto 6 weeksIntra-Abdominal*Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 DaysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure)**500 mgq 12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults:
  
  Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Cipro Oral DosageEquivalent Cipro I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function:
  
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage.30-50250-500 mg q 12 h5-29250-500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250-500 mg q 24 h (after dialysis)
  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  
  Weight (kg) x (140 - age)
  Men: Creatinine clearance (mL/min) = 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.
  DOSAGE AND ADMINISTRATION - PEDIATRICS
  
  Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or PyelonephritisIntravenousEvery 8 hours10-21 days*(patients from 1 to 17 years of age)OralEvery 12 hoursInhalational Anthrax (Post-Exposure)**Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hours
  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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• Remedyrepack Inc.
  

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  Ciprofloxacin Hydrochloride | Remedyrepack Inc.

  

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  ADULTS
  Ciprofloxacin tablets should be administered orally to adults as described in the Dosage Guidelines table.
  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.
  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, didanosine chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
  ADULT DOSAGE GUIDELINES
  InfectionSeverityDoseFrequencyUsual 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). Used in conjunction with metronidazole Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit4. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAX - ADDITIONAL INFORMATION.Urinary TractAcute Uncomplicated250 mgq 12 h3 DaysMild/Moderate250 mgq 12 h7 to 14 DaysSevere/Complicated500 mgq 12 h7 to 14 DaysChronic Bacterial ProstatitisMild/Moderate500 mgq 12 h28 DaysLower Respiratory TractMild/Moderate500 mgq 12 h7 to 14 daysSevere/Complicated750 mgq 12 h7 to 14 daysAcute SinusitisMild/Moderate500 mgq 12 h10 daysSkin and Skin StructureMild/Moderate500 mgq 12 h7 to 14 DaysSevere/Complicated750 mgq 12 h7 to 14 DaysBone and JointMild/Moderate500 mgq 12 h4 to 6 weeksSevere/Complicated750 mgq 12 h4 to 6 weeksIntra-Abdominal Complicated500 mgq 12 h7 to 14 DaysInfectious DiarrheaMild/Moderate/Severe500 mgq 12 h5 to 7 DaysTyphoid FeverMild/Moderate500 mgq 12 h10 daysUrethral and Cervical Gonococcal InfectionsUncomplicated250 mgsingle dosesingle doseInhalational anthrax (post-exposure) 500 mgq 12 h60 Days
  Conversion of I.V. to Oral Dosing in Adults
  Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin tablets when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).
  Equivalent AUC Dosing Regimens
  Ciprofloxacin Oral DosageEquivalent Ciprofloxacin I.V. Dosage250 mg Tablet q 12 h200 mg I.V. q 12 h500 mg Tablet q 12 h400 mg I.V. q 12 h750 mg Tablet q 12 h400 mg I.V. q 8 h
  Adults with Impaired Renal Function
  
  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION
  Creatinine Clearance (mL/min)Dose> 50See Usual Dosage3050250500 mg q 12 h529250500 mg q 18 hPatients on hemodialysis or Peritoneal dialysis250500 mg q 24 h (after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
  Men: Creatinine clearance (mL/min) =Weight (kg)(140 - age)72serum creatinine (mg/dL)Women: 0.85the 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.
  
  DOSAGE AND ADMINISTRATIONPEDIATRICS
  Ciprofloxacin tablets should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONSand CLINICAL STUDIES.)
  Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
  PEDIATRIC DOSAGE GUIDELINES
  InfectionRoute of AdministrationDose (mg/kg)FrequencyTotal Duration* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days). Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit5. For a discussion of ciprofloxacin serum concentrations in various human populations, see INHALATIONAL ANTHRAXADDITIONAL INFORMATION.Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)IntravenousEvery 8 hours10-21 days *OralEvery 12 hoursInhalational Anthrax (Post-Exposure) Intravenous10 mg/kg (maximum 400 mg per dose)Every 12 hours60 daysOral15 mg/kg (maximum 500 mg per dose)Every 12 hoursPediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m2).
  
  

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  Adults

  Ciprofloxacin tablets USP should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered 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.

  ADULT DOSAGE GUIDELINES

  *Used in conjunction with metronidazole

  †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).

  **Drug administration should begin as soon as possible after suspected or confirmed exposure.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information .

   Infection  Severity  Dose  Frequency Usual Durations† Urinary Tract     Acute Uncomplicated 250 mg q12h 3 days Mild/Moderate 250 mg   q12h 7 to 14 days Severe/Complicated   500 mg   q12h   7 to 14 days Chronic Bacterial Prostatitis   Mild/Moderate   500 mg   q12h   28 days   Lower Respiratory Tract Mild/Moderate   500 mg   q12h   7 to 14 days   Severe/Complicated 750 mg q12h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q12h 10 days Skin and Skin Structure   Mild/Moderate   500 mg   q12h   7 to 14 days   Severe/Complicated 750 mg q12h 7 to 14 days Bone and Joint   Mild/Moderate 500 mg q12h ≥ 4 to 6 weeks Severe/Complicated   750 mg   q12h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q12h 7 to 14 days Infectious Diarrhea   Mild/Moderate/Severe   500 mg   q12h   5 to 7 days   Typhoid Fever   Mild/Moderate   500 mg   q12h   10 days   Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg   single dose single dose Inhalational anthrax (post-exposure)**   500 mg q12h   60 days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets USP when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q12h 200 mg I.V. q12h 500 mg Tablet q12h 400 mg I.V. q12h 750 mg Tablet q12h 400 mg I.V. q8h Adults with Impaired Renal Function

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 to 50 250 to 500 mg q12h 5 to 29 250 to 500 mg q18h Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age)

  72 × serum creatinine (mg/dL)

  Women: 0.85 × 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.

  Ciprofloxacin tablets USP should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONSand CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours

   

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information .

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection 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).

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• Medvantx, Inc.
  

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  Ciprofloxacin Hydrochloride | Medvantx, Inc.

  

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  Adults

  Ciprofloxacin tablets USP should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered 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.

  ADULT DOSAGE GUIDELINES *Used in conjunction with metronidazole †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). **Drug administration should begin as soon as possible after suspected or confirmed exposure. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.

   Infection

   Severity

   Dose

   Frequency

  Usual Durations†

  Urinary Tract    

  Acute Uncomplicated

  250 mg

  q12h

  3 days

  Mild/Moderate

  250 mg  

  q12h

  7 to 14 days

  Severe/Complicated  

  500 mg  

  q12h  

  7 to 14 days

  Chronic Bacterial Prostatitis  

  Mild/Moderate  

  500 mg  

  q12h  

  28 days  

  Lower Respiratory Tract

  Mild/Moderate  

  500 mg  

  q12h  

  7 to 14 days  

  Severe/Complicated

  750 mg

  q12h

  7 to 14 days

  Acute Sinusitis

  Mild/Moderate

  500 mg

  q12h

  10 days

  Skin and Skin Structure  

  Mild/Moderate  

  500 mg  

  q12h  

  7 to 14 days  

  Severe/Complicated

  750 mg

  q12h

  7 to 14 days

  Bone and Joint  

  Mild/Moderate

  500 mg

  q12h

  ≥ 4 to 6 weeks

  Severe/Complicated  

  750 mg  

  q12h

  ≥ 4 to 6 weeks

  Intra-Abdominal*

  Complicated

  500 mg

  q12h

  7 to 14 days

  Infectious Diarrhea  

  Mild/Moderate/Severe  

  500 mg  

  q12h  

  5 to 7 days  

  Typhoid Fever  

  Mild/Moderate  

  500 mg  

  q12h  

  10 days  

  Urethral and Cervical Gonococcal Infections

  Uncomplicated

  250 mg  

  single dose

  single dose

  Inhalational anthrax (post-exposure)**

   

  500 mg

  q12h  

  60 days

  Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets USP when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens

  Ciprofloxacin Oral Dosage

  Equivalent Ciprofloxacin I.V. Dosage

  250 mg Tablet q12h

  200 mg I.V. q12h

  500 mg Tablet q12h

  400 mg I.V. q12h

  750 mg Tablet q12h

  400 mg I.V. q8h

  Adults With Impaired Renal Function

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION

  Creatinine Clearance (mL/min)

  Dose

  > 50

  See Usual Dosage

  30 to 50

  250 to 500 mg q12h

  5 to 29

  250 to 500 mg q18h

  Patients on hemodialysis or Peritoneal dialysis

  250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age)

  72 × serum creatinine (mg/dL)

  Women: 0.85 × 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.

  Pediatrics

  Ciprofloxacin tablets USP should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONSand CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  Infection

  Route of Administration

  Dose (mg/kg)

  Frequency

  Total Duration

  Complicated Urinary Tract or Pyelonephritis

  Intravenous

  6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 8 hours

  10 to 21 days*

  (patients from 1 to 17 years of age)

  Oral

  10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 12 hours

  Inhalational Anthrax (Post- Exposure)**

  Intravenous

  10 mg/kg (maximum 400 mg per dose)

  Every 12 hours

  60 days

  Oral

  15 mg/kg (maximum 500 mg per dose)

  Every 12 hours

   

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection 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).

  Pediatrics

  Ciprofloxacin tablets USP should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONSand CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES

  Infection

  Route of Administration

  Dose (mg/kg)

  Frequency

  Total Duration

  Complicated Urinary Tract or Pyelonephritis

  Intravenous

  6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 8 hours

  10 to 21 days*

  (patients from 1 to 17 years of age)

  Oral

  10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg)

  Every 12 hours

  Inhalational Anthrax (Post- Exposure)**

  Intravenous

  10 mg/kg (maximum 400 mg per dose)

  Every 12 hours

  60 days

  Oral

  15 mg/kg (maximum 500 mg per dose)

  Every 12 hours

   

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection 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).

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  Adults

  Ciprofloxacin tablets USP should be administered orally to adults as described in the Dosage Guidelines table.

  The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.

  The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered 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.

  ADULT DOSAGE GUIDELINES

  *Used in conjunction with metronidazole

  †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).

  **Drug administration should begin as soon as possible after suspected or confirmed exposure.

  This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.

   Infection  Severity  Dose  Frequency Usual Durations† Urinary Tract     Acute Uncomplicated 250 mg q12h 3 days Mild/Moderate 250 mg   q12h 7 to 14 days Severe/Complicated   500 mg   q12h   7 to 14 days Chronic Bacterial Prostatitis   Mild/Moderate   500 mg   q12h   28 days   Lower Respiratory Tract Mild/Moderate   500 mg   q12h   7 to 14 days   Severe/Complicated 750 mg q12h 7 to 14 days Acute Sinusitis Mild/Moderate 500 mg q12h 10 days Skin and Skin Structure   Mild/Moderate   500 mg   q12h   7 to 14 days   Severe/Complicated 750 mg q12h 7 to 14 days Bone and Joint   Mild/Moderate 500 mg q12h ≥ 4 to 6 weeks Severe/Complicated   750 mg   q12h ≥ 4 to 6 weeks Intra-Abdominal* Complicated 500 mg q12h 7 to 14 days Infectious Diarrhea   Mild/Moderate/Severe   500 mg   q12h   5 to 7 days   Typhoid Fever   Mild/Moderate   500 mg   q12h   10 days   Urethral and Cervical Gonococcal Infections Uncomplicated 250 mg   single dose single dose Inhalational anthrax (post-exposure)**   500 mg q12h   60 days Conversion of I.V. to Oral Dosing in Adults

  Patients whose therapy is started with ciprofloxacin I.V. may be switched to ciprofloxacin tablets USP when clinically indicated at the discretion of the physician (see CLINICAL PHARMACOLOGYand table below for the equivalent dosing regimens).

  Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin I.V. Dosage 250 mg Tablet q12h 200 mg I.V. q12h 500 mg Tablet q12h 400 mg I.V. q12h 750 mg Tablet q12h 400 mg I.V. q8h Adults With Impaired Renal Function

  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. The following table provides dosage guidelines for use in patients with renal impairment:

  RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50 See Usual Dosage 30 to 50 250 to 500 mg q12h 5 to 29 250 to 500 mg q18h Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg q 24 h (after dialysis)

  When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

  Men: Creatinine clearance (mL/min) = Weight (kg) × (140 - age)

  72 × serum creatinine (mg/dL)

  Women: 0.85 × 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.

  Pediatrics

  Ciprofloxacin tablets USP should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONSand CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours

   

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection 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).

  Pediatrics

  Ciprofloxacin tablets USP should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed (see ADVERSE REACTIONSand CLINICAL STUDIES).

  Dosing and initial route of therapy (that is, I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

  PEDIATRIC DOSAGE GUIDELINES Infection Route of Administration Dose (mg/kg) Frequency Total Duration Complicated Urinary Tract or Pyelonephritis Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10 to 21 days* (patients from 1 to 17 years of age) Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours Inhalational Anthrax (Post- Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours

   

  * The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).

  ** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax In Adults and Pediatrics, Additional Information.

  Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection 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).

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  Ciprofloxacin Hydrochloride | Remedyrepack Inc.

  

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  There is currently no dosage information available for this product. We apologize for any inconvenience.

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  Ciprofloxacin Hydrochloride | Remedyrepack Inc.

  

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