September 1, 2015
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Cipro IV

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Cipro I.V.




Indications
Dosage
How Supplied

INDICATIONS

CIPRO IV is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below when the intravenous administration is needed [see DOSAGE AND ADMINISTRATION].

Urinary Tract Infections

CIPRO IV 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.

Lower Respiratory Tract Infections

CIPRO IV 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.* Also, CIPRO IV is indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis [see Limitation of Use].

Nosocomial Pneumonia

CIPRO IV is indicated in adult patients for treatment of nosocomial pneumonia caused by caused by Haemophilus influenzae or Klebsiella pneumoniae.

Skin And Skin Structure Infections

CIPRO IV 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 IV 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 IV 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.

Acute Sinusitis

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

Chronic Bacterial Prostatitis

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

Empirical Therapy For Febrile Neutropenic Patients

CIPRO IV is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies].

Complicated Urinary Tract Infections And Pyelonephritis

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

Inhalational Anthrax (post-exposure)

CIPRO IV is indicated in adults and pediatric patients from birth to 17 years of age for treatment of 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 IV 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].

Limitation Of Use

Use in Pediatric Patients

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. CIPRO IV, 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].

Lower Respiratory Tract Infections

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

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO IV and other antibacterial drugs, CIPRO 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.

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 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 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 IV should be administered intravenously at dosages 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

Infection1 Dose Frequency Usual Duration
Urinary Tract 200 mg to 400 mg every 12 to every 8 hours 7–14 days
Lower Respiratory Tract 400 mg every 12 to every 8 hours 7–14 days
Nosocomial Pneumonia 400 mg every 8 hours 10–14 days
Skin and Skin Structure 400 mg every 12 to every 8 hours 7–14 days
Bone and Joint 400 mg every 12 to every 8 hours 4 to 8 weeks
Complicated Intra-Abdominal2 400 mg every 12 hours 7-14 days
Acute Sinusitis 400 mg every 12 hours 10 days
Chronic Bacterial prostatitis 400 mg every 12 hours 28 days
Empirical Therapy In Febrile Neutropenic Patients
CIPRO IV 400 mg and Piperacillin 50 mg/kg
every 8 hours
7-14 days
every 4 hours
Inhalational anthrax(post-exposure)3 400 mg every 12 hours 60 days
Plague3 400 mg every 12 to 8 hours 14 days
1Due to the designated pathogens.
2Used in conjunction with metronidazole.
3Begin administration as soon as possible after suspected or confirmed exposure.

Conversion of Intravenous 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 h 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.

Table 3: Pediatric Dosage Guidelines

Infection Dose (mg/kg) Frequency Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)1 6 mg/kg to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 8 hours 10-21 days1
Inhalational Anthrax (Post-Exposure)2 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days
Plague2,3 10 mg/kg (maximum 400 mg per dose) Every 12 to 8 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
> 30 See Usual Dosage.
5-29 200-400 mg every 18-24 hours

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 and hepatic insufficiency, careful monitoring is suggested.

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).

Preparation Of CIPRO IV For Administration

Flexible Containers

CIPRO IV is available as a 0.2% premixed solution in 5% dextrose in flexible containers of 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described above.

Important Administration Instructions

Intravenous Infusion

CIPRO IV should be administered to by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.

Hydration of Patients Receiving CIPRO IV

Adequate hydration of patients receiving CIPRO IV should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS, Nonclinical Toxicology and PATIENT INFORMATION].

HOW SUPPLIED

Dosage Forms And Strengths

Injection (200 mL in 5% Dextrose, 400 mg, 0.2%) Premix in Flexible Containers, for intravenous infusion

Storage And Handling

CIPRO IV (ciprofloxacin) is available as a clear, colorless to slightly yellowish solution in flexible containers not made with natural rubber latex.

SIZE STRENGTH NDC NUMBER
200 mL 5% Dextrose 400 mg, 0.2% 50419-759-01

Storage

Store between 5–25°C (41–77°F).

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

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

REFERENCES

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

Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Manufactured in Germany. Revised: March 2015

Last reviewed on RxList: 4/13/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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