"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
CIPRO XR is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.
Uncomplicated Urinary Tract Infections (Acute Cystitis)
CIPRO XR is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus.
Because fluoroquinolones, including CIPRO XR, have been associated with serious adverse reactions [see WARNINGS AND PRECAUTIONS] and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve CIPRO XR for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.
Complicated Urinary Tract Infections, And Acute Uncomplicated Pyelonephritis
CIPRO XR is indicated for the treatment of complicated urinary tract infections (cUTI) caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa and acute uncomplicated pyelonephritis (AUP) caused by Escherichia coli.
Limitations Of Use
- The safety and efficacy of CIPRO XR in treating infections other than urinary tract infections has not been demonstrated.
- CIPRO XR is not indicated for pediatric patients.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO XR and other antibacterial drugs, CIPRO XR should be used only to treat 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.
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 XR 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 XR and ciprofloxacin immediate-release tablets are not interchangeable. Cipro XR should beadministered orally once daily (Table 1).
Table 1: Dosage Guidelines
|Uncomplicated Urinary Tract Infection (Acute Cystitis)||500 mg||every 24 hours||3 Days|
|Complicated Urinary Tract Infection and Acute Uncomplicated Pyelonephritis||1000 mg||every 24 hours||7-14 Days|
Patients whose therapy is started with CIPRO IV for UTIs may be switched to CIPRO XR when clinically indicated at the discretion of the physician.
- CIPRO XR tablets should be taken whole and not split, crushed, or chewed.
- CIPRO XR should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum, polymeric phosphate binders (for example, sevelamer, lanthanum carbonate), as well as sucralfate, VIDEX® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, metal cations such as iron, and multivitamin preparations with zinc [see DRUG INTERACTIONS].
- Concomitant administration of Cipro XR with dairy products (like milk or yogurt) or with calcium-fortified products alone should be avoided since decreased absorption is possible. A 2-hour window between substantial calcium intake (greater than 800 mg) and dosing with CIPRO XR is recommended [see PATIENT INFORMATION].
- Adequate hydration of patients receiving CIPRO XR should be maintained to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS and PATIENT INFORMATION].
Impaired Renal Function
- In patients with cUTI and acute uncomplicated pyelonephritis with a creatinine clearance of ≤ 30 mL/min, the dose of CIPRO XR should be reduced from 1000 mg to 500 mg daily. The use of Ciprofloxacin 1000 mg XR tablets is not recommended in this patient population.
- For patients on hemodialysis or peritoneal dialysis, administer CIPRO XR after the dialysis procedure is completed (maximum dose should be Ciprofloxacin 500 mg XR every 24 hours). The use of Ciprofloxacin 1000 mg XR is not recommended in this patient population [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
- For patients on continuous ambulatory peritoneal dialysis (CAPD), the maximum dose should be 500 mg every 24 hours.
Dosage Forms And Strengths
- 500 mg white to slightly yellowish, film-coated, oblong-shaped tablets imprinted with the word “BAYER” on one side and “C500 QD” on the other
- 1000 mg white to slightly yellowish, film-coated, oblong-shaped tablets imprinted the word “BAYER” on one side and “C1000 QD” on the other
Storage And Handling
CIPRO XR is available as nearly white to slightly yellowish, film-coated, oblong-shaped tablets containing 500 mg or 1000 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and “C500 QD” on the reverse side. The 1000 mg tablet is coded with the word “BAYER” on one side and “C1000 QD” on the reverse side.
|Bottles of 50||500 mg||50419-788-01|
|Bottles of 50||1000 mg||50419-789-01|
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Manufactured in Germany. Revised: July 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/8/2016
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