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Cipro (Ciprofloxacin Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CIPRO is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Adult Patients:

Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or 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.

NOTE: Although effective in clinical trials, 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 strains), Campylobacter jejuni, Shigella boydii , Shigella dysenteriae, Shigella flexneri or Shigella sonnei when antibacterial therapy is indicated.

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).

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.

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 strains 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 - ADULTS

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, 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 1
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 2 * 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) 3 **

1 Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
2 used in conjunction with metronidazole
3 Drug administration should begin as soon as possible after suspected or confirmed exposure.

Conversion of I.V. to Oral Dosing in Adults:

Patients whose therapy is started with CIPRO I.V. 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 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

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 (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 1
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) 2
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

1 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).
2 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).

HOW SUPPLIED

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 or 750 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and “CIP 500” on the reverse side. The 750 mg tablet is coded with the word “BAYER” on one side and “CIP 750” on the reverse side. CIPRO 250 mg, 500 mg, and 750 mg are available in bottles of 50, 100, and Unit Dose packages of 100.

Strength NDC Code Tablet Identification
Bottles of 50: 750 mg NDC 0085-1756-01 CIPRO 750
Bottles of 100: 250 mg NDC 0085-1758-01 CIPRO 250
500 mg NDC 0085-1754-01 CIPRO 500
Unit Dose
Package of 100: 250 mg NDC 0085-1758-02 CIPRO 250
500 mg NDC 0085-1754-02 CIPRO 500
750 mg NDC 0085-1756-02 CIPRO 750

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 0085-1777-01
10% 100 mL 500 mg/5 mL 10,000 mg 0085-1773-01

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 teaspoon is provided for the patient.

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