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Cipro IV

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Cipro I.V.

Cipro I.V.

INDICATIONS

CIPRO I.V. (ciprofloxacin iv) is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Adult Patients

Urinary Tract Infections caused by Escherichia coli (including cases with secondary bacteremia),

Klebsiella pneumoniae subspecies 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.

Lower Respiratory Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies 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.

Nosocomial Pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.

Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae subspecies 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 conjunction with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.

Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

Empirical Therapy for Febrile Neutropenic Patients in combination with piperacillin sodium. (See Clinical Studies.)

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.4 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 I.V. (ciprofloxacin iv) 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 I.V. (ciprofloxacin iv) and other antibacterial drugs, CIPRO I.V. (ciprofloxacin iv) 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 I.V. (ciprofloxacin iv) should be administered to adults by intravenous infusion over a period of 60 minutes at dosages described in the Dosage Guidelines table. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation. (See Preparation of CIPRO I.V. (ciprofloxacin iv) for Administration section.)

The determination of dosage 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.

ADULT DOSAGE GUIDELINES

Infection Severity Dose Frequency Usual Duration
Urinary Tract Mild/Moderate 200 mg q12h 7-14 Days
Severe/Complicated 400 mg q12h 7-14 Days
Lower Respiratory Tract Mild/Moderate 400 mg q12h 7-14 Days
Severe/Complicated 400 mg q8h 7-14 Days
Nosocomial Pneumonia Mild/Moderate/Severe 400 mg q8h 10-14 Days
Skin and Mild/Moderate 400 mg q12h 7-14 Days
Skin Structure Severe/Complicated 400 mg q8h 7-14 Days
Bone and Joint Mild/Moderate 400 mg q12h ≥ 4-6 Weeks
Severe/Complicated 400 mg q8h ≥ 4-6 Weeks
Intra-Abdominal* Complicated 400 mg q12h 7-14 Days
Acute Sinusitis Mild/Moderate 400 mg q12h 10 Days
Chronic Bacterial Mild/Moderate 400 mg q12h 28 Days
Prostatitis        
Empirical Therapy Severe      
in Febrile Neutropenic Patients Ciprofloxacin + Piperacillin 400 mg q8h 7-14 Days
Ciprofloxacin + Piperacillin 50 mg/kg Not to exceed 24 g/day q4h
Inhalational anthrax (post-exposure)**   400 mg q12h 60 Days
*used in conjunction with metronidazole. (See product labeling for prescribing information.)
DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS)
** 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. Total duration of ciprofloxacin administration (I.V. or oral) for inhalational anthrax (post-exposure) is 60 days.

CIPRO I.V. (ciprofloxacin iv) should be administered by intravenous infusion over a period of 60 minutes.

Conversion of I.V. to Oral Dosing in Adults: CIPRO Tablets and CIPRO Oral Suspension for oral administration are available. Parenteral therapy may be switched to oral CIPRO when the condition warrants, 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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

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 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) Dosage
> 30 See usual dosage.
5 - 29 200-400 mg q 18-24 hr

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.

For patients with changing renal function or for patients with renal impairment and hepatic insufficiency, careful monitoring is suggested.

Pediatrics

CIPRO I.V. (ciprofloxacin iv) should be administered 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
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.4 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).

Preparation of CIPRO I.V. (ciprofloxacin iv) for Administration

Vials (Injection Concentrate): THIS PREPARATION MUST BE DILUTED BEFORE USE. The intravenous dose should be prepared by aseptically withdrawing the concentrate from the vial of CIPRO I.V. (ciprofloxacin iv) This should be diluted with a suitable intravenous solution to a final concentration of 1–2mg/mL. (See Compatibility and Stability.) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.

If the Y-type or "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of CIPRO I.V. (ciprofloxacin iv) If the concomitant use of CIPRO I.V. (ciprofloxacin iv) and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

Flexible Containers: CIPRO I.V. (ciprofloxacin iv) is also available as a 0.2% premixed solution in 5% dextrose in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.

Compatibility and Stability

Ciprofloxacin injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2.0 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.

0.9% Sodium Chloride Injection, USP
5% Dextrose Injection, USP
Sterile Water for Injection
10% Dextrose for Injection
5% Dextrose and 0.225% Sodium Chloride for Injection
5% Dextrose and 0.45% Sodium Chloride for Injection
Lactated Ringer's for Injection

HOW SUPPLIED

CIPRO I.V. (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution. CIPRO I.V. (ciprofloxacin iv) is available in 200 mg and 400 mg strengths. The concentrate is supplied in vials while the premixed solution is supplied in latex-free flexible containers as follows:

VIAL: Manufactured for Bayer HealthCare Pharmaceuticals Inc. by Bayer HealthCare LLC, Shawnee, Kansas.

SIZE STRENGTH NDC NUMBER
20 mL 200 mg, 1% 0085-1763-03
40 mL 400 mg, 1% 0085-1731-01

FLEXIBLE CONTAINER: Manufactured for Bayer HealthCare Pharmaceuticals Inc. by Hospira, Inc., Lake Forest, IL 60045.

SIZE STRENGTH NDC NUMBER
100 mL 5% Dextrose 200 mg, 0.2% 0085-1755-02
200 mL 5% Dextrose 400 mg, 0.2% 0085-1741-02

FLEXIBLE CONTAINER: Manufactured for Bayer HealthCare Pharmaceuticals Inc. by Baxter Healthcare Corporation, Deerfield, IL 60015.

SIZE STRENGTH NDC NUMBER
100 mL 5% Dextrose 200 mg, 0.2% 0085-1781-01
200 mL 5% Dextrose 400 mg, 0.2% 0085-1762-01

Storage

Vial: Store between 5 – 30C (41 – 86F).

Flexible Container: Store between 5 – 25C (41 – 77F).

Protect from light, avoid excessive heat, protect from freezing.

Ciprofloxacin is also available as CIPRO (ciprofloxacin HCl) Tablets 250, 500, and 750 mg and CIPRO (ciprofloxacin*) 5% and 10% Oral Suspension.

* Does not comply with USP with regards to "loss on drying" and "residue on ignition".

REFERENCES

4. 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Distributed by: Schering Corporation Kenilworth, NJ 07033. R.0 10/08. FDA rev date: 10/3/2008

Last reviewed on RxList: 12/30/2008
This monograph has been modified to include the generic and brand name in many instances.

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