From the FDA Drug Label
Administer ofloxacin with caution in the presence of renal or hepatic insufficiency/impairment. In patients with known or suspected renal or hepatic insufficiency/impairment, careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of ofloxacin may be reduced In patients with impaired renal function (creatinine clearance ≤ 50 mg/mL), alteration of the dosage regimen is necessary (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Clearance of ofloxacin is reduced in patients with impaired renal function (creatinine clearance rate ≤50 mL/min), and dosage adjustment is necessary (see PRECAUTIONS, General and DOSAGE AND ADMINISTRATION)
Ofloxacin can be given in patients with Chronic Kidney Disease (CKD), but with caution. The dosage regimen may need to be altered in patients with impaired renal function (creatinine clearance ≤ 50 mL/min).
- Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy.
- Dosage adjustment is necessary for patients with impaired renal function.
- The drug should be administered with caution in the presence of renal insufficiency/impairment. 1 1 1
From the Research
Ofloxacin can be given in chronic kidney disease (CKD), but dose adjustment is necessary based on the patient's creatinine clearance. The most recent and highest quality study on this topic is from 2020 2, which provides an update on antibiotic dosing in CKD patients. According to this study, antibiotic prescription in CKD patients poses a twofold problem, and dosages should be adapted to the renal function to prevent adverse effects.
Dose Adjustment Recommendations
- For patients with a creatinine clearance of 20-50 mL/min, the recommended dose is 200-400 mg once daily.
- For those with a creatinine clearance less than 20 mL/min, the dose should be reduced to 100-200 mg once daily.
- In patients on hemodialysis or peritoneal dialysis, a dose of 100-200 mg every 24 hours is appropriate, with administration after dialysis on dialysis days.
Rationale for Dose Adjustment
Ofloxacin is primarily eliminated by the kidneys, so reduced renal function leads to drug accumulation, potentially increasing the risk of adverse effects such as:
- Tendinopathy
- QT prolongation
- CNS effects
Monitoring and Precautions
Close monitoring for side effects is essential, and alternative antibiotics should be considered if the patient has a history of fluoroquinolone-related adverse reactions. Adequate hydration should be maintained during treatment to help prevent crystalluria, which can be more problematic in patients with reduced urine output. Other studies, such as 3, 4, and 5, also support the need for dose adjustment in CKD patients, but the 2020 study 2 provides the most recent and comprehensive guidance on this topic.