August 31, 2016
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Cipro

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Cipro




Indications
Dosage
How Supplied

INDICATIONS

Skin And Skin Structure Infections

CIPRO is indicated in adult patients for treatment of 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, methicillinsusceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections

CIPRO is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections

CIPRO is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea

CIPRO is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii , Shigella dysenteriae, Shigella flexneri or Shigella sonneiwhen 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)

CIPRO is indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated Cervical And Urethral Gonorrhea

CIPRO is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see WARNINGS AND PRECAUTIONS].

Inhalational Anthrax (Post-Exposure)

CIPRO is indicated in adults and pediatric patients from birth to 17 years of age for 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.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies].

Plague

CIPRO is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies].

Chronic Bacterial Prostatitis

CIPRO is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections

CIPRO is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.

CIPRO is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

CIPRO is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS] and for some patients AECB is self-limiting, reserve CIPRO for treatment of AECB in patients who have no alternative treatment options.

Urinary Tract Infections

Urinary Tract Infections in Adults

CIPRO is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis

CIPRO is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS] and for some patients acute uncomplicated cystitis is self-limiting, reserve CIPRO for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.

Complicated Urinary Tract Infection And Pyelonephritis In Pediatric Patients

CIPRO is indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations].

Although effective in clinical trials, CIPRO is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. CIPRO, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Use In Specific Populations and Nonclinical Toxicology].

Acute Sinusitis

CIPRO is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including CIPRO, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS] and for some patients acute sinusitis is self-limiting, reserve CIPRO for treatment of acute sinusitis in patients who have no alternative treatment options.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO and other antibacterial drugs, CIPRO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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.

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.

DOSAGE AND ADMINISTRATION

CIPRO Tablets and Oral Suspension should be administered orally as described in the appropriate Dosage Guidelines tables.

Dosage In Adults

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

Table 1: Adult Dosage Guidelines

Infection Dose Frequency Usual Durations1
Skin and Skin Structure 500-750 mg every 12 hours 7 to 14 days
Bone and Joint 500-750 mg every 12 hours 4 to 8 weeks
Complicated Intra-Abdominal2 500 mg every 12 hours 7 to 14 days
Infectious Diarrhea 500 mg every 12 hours 5 to 7 days
Typhoid Fever 500 mg every 12 hours 10 days
Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose
Inhalational anthrax (postexposure)3 500 mg every 12 hours 60 days
Plague 3 500-750 mg every 12 hours 14 days
Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days
Lower Respiratory Tract Infections 500-750 mg every 12 hours 7 to 14 days
Urinary Tract Infections 250-500 mg every 12 hours 7 to 14 days
Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days
Acute Sinusitis 500 mg every 12 hours 10 days
1 Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
2 Used in conjunction with metronidazole.
3 Begin drug administration as soon as possible after suspected or confirmed exposure.

Conversion Of IV To Oral Dosing In Adults

Patients whose therapy is started with CIPRO IV may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see CLINICAL PHARMACOLOGY].

Table 2: Equivalent AUC Dosing Regimens

CIPRO Oral Dosage Equivalent CIPRO IV Dosage
250 mg Tablet every 12 hours 200 mg intravenous every 12 hours
500 mg Tablet every 12 hours 400 mg intravenous every 12 hours
750 mg Tablet every 12 hours 400 mg intravenous every 8 hours

Dosage In Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. CIPRO should be administered as described in Table 3.

Table 3: Pediatric Dosage Guidelines

Infection Dose Frequency Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 hours 10-21 days1
Inhalational Anthrax (Post-Exposure)2 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days
Plague2,3 15 mg/kg (maximum 500 mg per dose) Every 8 to 12 hours 10-21 days
1The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
2Begin drug administration as soon as possible after suspected or confirmed exposure.
3Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

Dosage Modifications In Patients With Renal Impairment

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal Function

Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage.
30-50 250-500 mg every12 hours
5-29 250-500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis 250-500 mg every 24 hours (after dialysis)

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

Males: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females: (0.85) x (above value)

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

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

Important Administration Instructions

With Multivalent Cations

Administer CIPRO at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx®(didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of CIPRO with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, CIPRO may be taken with a meal that contains these products.

Hydration Of Patients Receiving CIPRO

Assure adequate hydration of patients receiving CIPRO to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate CIPRO administration [see PATIENT INFORMATION].

Directions For Reconstitution Of The CIPRO Microcapsules For Oral Suspension

CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. CIPRO oral suspension is composed of two components (microcapsules and diluent) that must be combined prior to dispensing.

Table 5: Appropriate Dosing Volumes of the Reconstituted Oral Suspensions

Dose 5% 10%
250 mg 5 mL 2.5 mL
500 mg 10 mL 5 mL
750 mg 15 mL 7.5 mL

Preparation Of The Suspension:

Step 1

Bottle contents - Illustration

The small bottle contains the microcapsules, the large bottle contains the diluent

Step 2

Pour the microcapsules completely into the larger bottle - Illustration

Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension.

Step 3

Opening child-proof cap - Illustration

Open both bottles. Child-proof cap: Press down according to instructions oa the cap while turning to the left.

Step 4

Remove the top layer of the diluent bottle label - Illustration

Remove the top layer of the diluent bottle label (to reveal the CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use.

Step 5

Write the expiration date of the re-constituted oral suspension on the bottle label.

Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing.

No additions should be made to the mixed final ciprofloxacin suspension. CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics.

HOW SUPPLIED

Dosage Forms And Strengths

Tablets
  • 250 mg slightly yellowish, film-coated, round, imprinted with “BAYER” on one side and “CIP 250” on the other
  • 500 mg, slightly yellowish, film-coated, capsule shaped, imprinted with “BAYER” on one side and “CIP 500” on the other
Oral Suspension
  • 5% Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution
  • 10% Oral Suspension: 500 mg ciprofloxacin per 5 mL after reconstitution

Storage And Handling

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 at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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 DOSAGE AND ADMINISTRATION].

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

Store microcapsules and diluent below 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

The reconstituted product may be stored at 25°C (77°F) for 14 days; excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

A graduated teaspoon (5mL) with markings ½ (2.5 mL and 1/1 (5 mL) is provided for the patient.

REFERENCES

1. 21 CFR 314.510 (Subpart H–Accelerated Approval of New Drugs for Life-Threatening Illnesses).

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981 Manufactured in Germany CIPRO is a registered trademark of Bayer Aktiengesellschaft. Revised: July 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/9/2016

Indications
Dosage
How Supplied

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