Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets are for treatment of acute sinusitis in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets are and other antibacterial drugs, ciprofloxacin tablets are 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 ciprofloxacin 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.
Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables.
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. Ciprofloxacin tablets may be administered to adult patients when clinically indicated at the discretion of the physician.
Table 1: Adult Dosage Guidelines
|Skin and Skin Structure||500 to 750 mg||every 12 hours||7 to 14 days|
|Bone and Joint||500 to 750 mg||every 12 hours||4 to 8 weeks|
|Complicated Intra–Abdominal2||500 mg||every 12 hours||7 to 14 days|
|Infectious Diarrhea||500 mg||every 12 hours||5 to 7 days|
|Typhoid Fever||500 mg||every 12 hours||10 days|
|Uncomplicated Urethral and Cervical Gonococcal Infections||250 mg||single dose||single dose|
|Inhalational anthrax (post-exposure)3||500 mg||every 12 hours||60 days|
|Plague 3||500 to 750 mg||every 12 hours||14 days|
|Chronic Bacterial Prostatitis||500 mg||every 12 hours||28 days|
|Lower Respiratory Tract Infections||500 to 750 mg||every 12 hours||7 to 14 days|
|Urinary Tract Infections||250 to 500 mg||every 12 hours||7 to 14 days|
|Acute Uncomplicated Cystitis||250 mg||every 12 hours||3 days|
|Acute Sinusitis||500 mg||every 12 hours||10 days|
1 Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
3 Begin drug administration as soon as possible after suspected or confirmed exposure.
Conversion of IV to Oral Dosing in Adults
Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].
|Ciprofloxacin Oral Dosage||Equivalent Ciprofloxacin IV Dosage|
|250 mg Tablet every 12 hours||200 mg intravenous every 12 hours|
|500 mg Tablet every 12 hours||400 mg intravenous every 12 hours|
|750 mg Tablet every 12 hours||400 mg intravenous every 8 hours|
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin tablets should be administered as described in Table 3.
|1 The 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). 2 Begin drug administration as soon as possible after suspected or confirmed exposure. 3 Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.|
|Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)||10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg)||Every 12 hours||10 to 21 days 1|
|Inhalational Anthrax (Post-Exposure)2||15 mg/kg (maximum 500 mg per dose)||Every 12 hours||60 days|
|Plague2,3||15 mg/kg (maximum 500 mg per dose)||Every 8 to 12 hours||14 days|
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.
|Creatinine Clearance (mL/min)||Dose|
|> 50||See Usual Dosage.|
|30 to 50||250 to 500 mg every12 hours|
|5 to 29||250 to 500 mg every 18 hours|
|Patients on hemodialysis or Peritoneal dialysis||250 to 500 mg every 24 hours (after dialysis)|
When only the serum creatinine concentration is known, the following formulas may be used to estimate creatinine clearance:
Men - Creatinine clearance (mL/min) = Weight (kg) x (140–age)
72 x serum creatinine (mg/dL)
Women - 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
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/1.73 m2).
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