IV Dilution &
Medication Reference

Ciprofloxacin - Cipro ®

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

Primary:
-------Ready to Use------------
Ciprofloxacin in 5% dextrose injection, USP is available in 200 mg and 400 mg strengths. The 2 mg/mL infusion solution is supplied in latex-free flexible containers as follows:

Stability / Miscellaneous

EXP: 14 DAYS (RT/REF).
Cipro 400mg ivpb produces the same levels as 500mg tablet.

DOSAGE AND ADMINISTRATION - ADULTS
Ciprofloxacin injection 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 Ciprofloxacin Injection 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

Ciprofloxacin injection should be administered by intravenous infusion over a period of 60 minutes.

Conversion of IV to Oral Dosing in Adults: Ciprofloxacin tablets and oral suspension for oral administration are available. Parenteral therapy may be switched to oral ciprofloxacin when the condition warrants, at the discretion of the physician.

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:

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.

DOSAGE AND ADMINISTRATION - PEDIATRICS
Ciprofloxacin injection should be administered by intravenous infusion 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 package insert for ADVERSE REACTIONS and CLINICAL STUDIES.)

Dosing and initial route of therapy (i.e., 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

* 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.

Preparation of Ciprofloxacin Injection 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 ciprofloxacin injection. This should be diluted with a suitable intravenous solution to a final concentration of 1 to 2 mg/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 ciprofloxacin injection. If the concomitant use of ciprofloxacin injection and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

COMPATIBILITY AND STABILITY
Ciprofloxacin injection 1% (10 mg/mL), when diluted with the following intravenous solutions to concentrations of 0.5 to 2 mg/mL, is stable for up to 14 days at refrigerated or room temperature storage.

0.9% Sodium Chloride Injection
5% Dextrose Injection
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

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED
Ciprofloxacin Injection USP is available as a clear, colorless to slightly yellowish solution. Ciprofloxacin Injection is available in 200 mg and 400 mg strengths. The concentrate is supplied in vials as follows:

NDC 55390-197-01 - 200 mg, 1%, 20 mL Vial; individually boxed
NDC 55390-198-01 - 400 mg, 1%, 40 mL Vial; individually boxed

STORAGE
Store between 5° to 30°C (41° to 86°F).
Protect from light, avoid excessive heat, protect from freezing.

Bedford Laboratories™
Bedford, OH 44146
November 2007 CPRO-P02