24 HR Ciprofloxacin 1000 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Ciprofloxacin extended-release tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below . Ciprofloxacin extended-release tablets are a fluoroquinolone antibacterial indicated in adults (≥ 18 years of age) with infections caused by designated, susceptible bacteria: • Uncomplicated Urinary tract infections ( 1.1 ) • Complicated Urinary tract infections, and acute uncomplicated pyelonephritis ( 1.2 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin extended-release tablets and other antibacterial drugs, ciprofloxacin extended-release tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.4 ) 1.1 Uncomplicated Urinary Tract Infections (Acute Cystitis) Ciprofloxacin extended-release tablets are indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus. Because fluoroquinolones, including ciprofloxacin extended-release tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 – 5.16)] and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve ciprofloxacin extended-release tablets for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options. 1.2 Complicated Urinary Tract Infections, and Acute Uncomplicated Pyelonephritis Ciprofloxacin extended-release tablets are 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 . 1.3 Limitations of Use • The safety and efficacy of ciprofloxacin extended-release tablets in treating infections other than urinary tract infections has not been demonstrated. • Ciprofloxacin extended-release tablets are not indicated for pediatric patients. 1.4 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin extended-release tablets and other antibacterial drugs, ciprofloxacin extended-release tablets 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 ciprofloxacin extended-release tablets 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.
Mylan Pharmaceuticals Inc.
OVAL ORANGE M 1745
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16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin Extended-Release Tablets, USP are available containing ciprofloxacin, USP and ciprofloxacin hydrochloride, USP equivalent to 500 mg or 1000 mg of ciprofloxacin. The 500 mg tablets are orange, film-coated, modified capsule shaped, unscored tablets debossed with M 1743 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1743-89 bottles of 50 tablets The 1000 mg tablets are orange, film-coated, modified capsule shaped, unscored tablets debossed with M 1745 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-1745-89 bottles of 50 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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