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 every 12 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).
With Multivalent Cations
Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids; polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered drugs; or other products containing calcium, iron or zinc.
With Dairy Products
Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-fortified juices alone should be avoided since decreased absorption is possible; however, ciprofloxacin tablets may be taken with a meal that contains these products.
Hydration of Patients Receiving Ciprofloxacin Tablets
Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly concentrated urine. Crystalluria has been reported with quinolones.
Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling Information (17)].
If a dose is missed, it should be taken anytime but not later than 6 hours prior to the next scheduled dose. If less than 6 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.
- 250 mg are white to off-white, round shaped film coated tablets debossed with ‘C’ on one side and ‘95’ on the other side.
- 500 mg are white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘94’ on the other side.
- 750 mg are white to off-white, capsule shaped film coated tablets debossed with ‘C’ on one side and ‘93’ on the other side.
Ciprofloxacin tablets are contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7)].
Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7)].
5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects
Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions (5.2, 5.3, 5.4)].
Discontinue ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
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