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CIPRO is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri (diversus), Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or vancomycin-susceptible Enterococcus faecalis.
Acute Uncomplicated Cystitis in Females caused by Escherichia coli or Staphylococcus saprophyticus.
Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.
Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae.* Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.
*Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.
Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.
Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Infectious Diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii †, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.
†Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
Typhoid Fever (Enteric Fever) caused by Salmonella typhi.
NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
Uncomplicated Cervical and Urethral Gonorrhea due to Neisseria gonorrhoeae.
Pediatric Patients (1 to 17 years of age)
Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. (See WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS and Clinical Studies.) Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals. (See Animal Pharmacology.)
Adult and Pediatric Patients
Inhalational Anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.5 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. (See also, Inhalational Anthrax – Additional Information).
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
CIPRO Tablets and Oral Suspension 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.
|Infection||ADULT DOSAGE GUIDELINES|
|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||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 Gonococcal Infections||Uncomplicated||250 mg||single dose||single dose|
|Ihnalational anthrax (post-exposure)||500 mg||q h 12||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.6 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax, Additional Information.
Conversion of IV to Oral Dosing in Adults: Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens
|Cipro Oral Dosage||Equivalent Cipro IV Dosage|
|250 mg Tablet q 12 h||200 mg IV q 12 h|
|500 mg Tablet q 12 h||400 mg IV q 12 h|
|750 mg Tablet q 12 h||400 mg IV 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:||(weight in kg) x (140 – age)|
|(72) x serum creatinine (mg/100 mL)|
|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.
CIPRO Tablets and Oral Suspension 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 (that is, IV 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 IV 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|
|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).
CIPRO (ciprofloxacin hydrochloride) Tablets are available as round, slightly yellowish film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with the word “BAYER” on one side and “CIP 250” on the reverse side. CIPRO is also available as capsule shaped, slightly yellowish film-coated tablets containing 500 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and “CIP 500” on the reverse side. CIPRO 250 mg and 500 mg are available in bottles of 100.
|Strength||NDC Code||Tablet Identification|
|Bottles of 100:||250 mg||NDC 50419-758-01||CIPRO 250|
|500 mg||NDC 50419-754-01||CIPRO 500|
Store below 30°C (86°F).
CIPRO Oral Suspension is supplied in 5% and 10% strengths. The drug product is composed of two components (microcapsules containing the active ingredient and diluent) which must be mixed by the pharmacist. See Instructions To The Pharmacist For Use/Handling.
|Strengths||Total volume after reconstitution||Ciprofloxacin Concentration||Ciprofloxacin contents per bottle||NDC Code|
|5%||100 mL||250 mg/5 mL||5,000 mg||50419-777-01|
|10%||100 mL||500 mg/5 mL||10,000 mg||50419-773-01|
Microcapsules and diluent should be stored below 25°C (77°F) and protected from freezing.
Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing. A graduated teaspoon (5mL) with markings ½ and 1/1 is provided for the patient.
Instructions To The Pharmacist For Use/Handling Of CIPRO Oral Suspension
CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. The drug product is composed of two components (microcapsules and diluent) which must be combined prior to dispensing.
One teaspoonful (5 mL) of 5% ciprofloxacin oral suspension = 250 mg of ciprofloxacin.
One teaspoonful (5 mL) of 10% ciprofloxacin oral suspension = 500 mg of ciprofloxacin.
Appropriate Dosing Volumes of the Oral Suspensions
|250 mg||5 mL||2.5 mL|
|500 mg||10 mL||5 mL|
|750 mg||15 mL||7.5 mL|
Preparation of the suspension
1. The small bottle contains the microcapsules, the large bottle contains the diluent.
2. Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left.
3. Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension.
4. Remove the top layer of the diluent bottle label (to reveal the CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use.
No additions should be made to the mixed final ciprofloxacin suspension. CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics.
Instruct the patient:
- To shake CIPRO Oral Suspension vigorously each time before use for approximately 15 seconds
- To always use the graduated measuring spoon to obtain the exact dose.
- Not chew the microcapsules, but to swallow them.
- That water may be taken afterwards.
- Reclose the bottle properly after each use according to instructions on the cap.
- After treatment has been completed, Cipro Oral Suspension should not be reused.
5. Report presented at the FDA's Anti-Infective Drug and Dermatological Drug Product's Advisory Committee meeting, March 31, 1993, Silver Spring, MD. Report available from FDA, CDER, Advisors and Consultants Staff, HFD-21, 1901 Chapman Avenue, Room 200, Rockville, MD 20852, USA.
6. 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).
7. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.
8. Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.
Revised July 201343. Manufactured for: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ 07470. 07/13
Last reviewed on RxList: 10/28/2013
This monograph has been modified to include the generic and brand name in many instances.
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