"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).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Proquin XR (ciprofloxacin hcl) and other antibacterial drugs, Proquin XR (ciprofloxacin hcl) should be used only to treat uncomplicated urinary tract infections that are strongly suspected to be caused by 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.
Uncomplicated Urinary Tract Infections
Proquin XR (ciprofloxacin hcl) is indicated for the treatment of uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli and Klebsiella pneumoniae.
Limitations of Use
Proquin XR is not interchangeable with other ciprofloxacin extended-release or immediate release oral formulations.
The safety and efficacy of Proquin XR (ciprofloxacin hcl) in treating pyelonephritis, complicated urinary tract infections, and infections other than uncomplicated urinary tract infections have not been demonstrated.
DOSAGE AND ADMINISTRATION
Proquin XR (ciprofloxacin hcl) 500 mg tablets should be administered orally once daily for 3 days with a main meal of the day, preferably the evening meal.
Proquin XR (ciprofloxacin hcl) tablets should be taken whole and never split, crushed, or chewed.
Proquin XR (ciprofloxacin hcl) should be administered at least 4 hours before or 2 hours after antacids containing magnesium or aluminum, sucralfate, VIDEX® (didanosine) chewable/buffered tablets or pediatric powder, metal cations such as iron, and multivitamin preparations containing zinc [see DRUG INTERACTIONS].
Concomitant administration of ciprofloxacin with milk products or calcium-fortified juices alone should be avoided since decreased absorption is possible [see DRUG INTERACTIONS].
Adequate hydration of patients receiving Proquin XR (ciprofloxacin hcl) should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria has been reported with quinolones [see ADVERSE REACTIONS and PATIENT INFORMATION].
Dosage Forms And Strengths
Extended release tablets: 500 mg* of ciprofloxacin
*present as 582 mg of ciprofloxacin hydrochloride monohydrate
Storage And Handling
Proquin XR (ciprofloxacin hcl) is available as blue film-coated tablets containing 500 mg ciprofloxacin. The tablet is debossed with “500” on one side and “DMI” on the other side.
|Bottles of 30:||500 mg||13913-001-30|
|Blister Packs of 3:||500 mg||13913-001-03|
Store Proquin XR (ciprofloxacin hcl) at 25°C (77 °F); excursions permitted to 15-30 °C (59-86 °F) [see USP Controlled Room Temperature].
Revised February 2011. Depomed, Inc. 1360 O'Brien Drive, Menlo Park, CA 94025-1436. 1-866-458-6389This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/19/2011
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