Cipro Indications, Dosage, Storage, Stability - Ciprofloxacin

Cipro Indications, Dosage, Storage, Stability - Ciprofloxacin

INDICATIONS

CIPROŽ I.V. is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below when the intravenous administration offers a route of administration advantageous to the patient. Please see

DOSAGE AND ADMINISTRATION

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, 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 Streptococcus pneumoniae.

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, 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 pneumonia, or Bacteroides fragilis . (See

DOSAGE AND ADMINISTRATION

Acute Sinusitis caused by Haemophilus influenzae, 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

DOSAGE AND ADMINISTRATION

Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. ⁴ (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 CIPROŽ I.V. 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.

The recommended adult dosage for urinary tract infections of mild to moderate severity is 200 mg I.V. every 12 hours. For severe or complicated urinary tract infections, the recommended dosage is 400 mg I.V. every 12 hours.

The recommended adult dosage for lower respiratory tract infections, skin and skin structure infections, and bone and joint infections of mild to moderate severity is 400 mg I.V. every 12 hours.

For severe/complicated infections of the lower respiratory tract, skin and skin structure, and bone and joint, the recommended adult dosage is 400 mg I.V. every 8 hours.

The recommended adult dosage for mild, moderate, and severe nosocomial pneumonia is 400 mg I.V. every 8 hours.

Complicated Intra-Abdominal Infections:   Sequential therapy [parenteral to oral 400 mg CIPROŽ I.V. q 12 h (plus I.V. metronidazole) -> 500 mg CIPROŽ I.V. Tablets q 12 h (plus oral metronidazole)] can be instituted at the discretion of the physician. Metronidazole should be given according to product labeling to provide appropriate anaerobic coverage.

The recommended dosage for mild to moderate Acute Sinusitis and Chronic Bacterial Prostatitis is 400 mg I.V. every 12 hours.

The recommended adult dosage for empirical therapy of febrile neutropenic patients is 400 mgI.V. every 8 hours in combination with piperacillin sodium 50 mg/kgI.V. q 4 hours, not to exceed 24 g/day (300 mg/kg/day), for 7-14 days.

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.

CIPROŽ I.V. should be administered by intravenous infusion over a period of 60 minutes.

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

Ciprofloxacin hydrochloride (CIPROŽ Tablets) for oral administration are available. Parenteral therapy may be changed to oral CIPROŽ Tablets when the condition warrants, at the discretion of the physician. For complete dosage and administration information, see CIPROŽ Tablets package insert.

Impaired Renal Function:   The following table provides dosage guidelines for use in patients with renal impairment; however, monitoring of serum drug levels provides the most reliable basis for dosage adjustment.

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

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, measurement of serum concentrations of ciprofloxacin will provide additional guidance for adjusting dosage.

INTRAVENOUS ADMINISTRATION

CIPROŽ I.V. should be administered by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a large vein will minimize patient discomfort and reduce the risk of venous irritation.

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 CIPROŽ I.V. This should be diluted with a suitable intravenous solution to a final concentration of 1-2 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 this method or the "piggyback" method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of CIPROŽ I.V.

Flexible Containers:   CIPROŽ I.V. 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 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

If CIPROŽ I.V. is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

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

FLEXIBLE CONTAINER: manufactured for Bayer Corporation by Abbott Laboratories, North Chicago, IL 60064.

FLEXIBLE CONTAINER: manufactured for Bayer Corporation by Baxter Healthcare Corporation, Deerfield, IL 60015.

STORAGE

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

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

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

CIPROŽ I.V. (ciprofloxacin) is also available in a 120 mL Pharmacy Bulk Package.

Ciprofloxacin is also available as CIPROŽ (ciprofloxacin HCl) Tablets 100, 250, 500, and 750 mg and CIPROŽ (ciprofloxacin) 5% and 10% Oral Suspension.

REFERENCES

1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No.2, NCCLS, Wayne, PA, January, 2000.
2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1, NCCLS, Wayne, PA, January, 2000.
3. 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.
4. 21 CFR 314.510 (Subpart H Accelerated Approval of New Drugs for Life-Threatening Illnesses).
5. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166: 1184-7.
6. Friedlander AM, et. al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167: 1239-42.

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Bayer Corporation

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