Ofloxacin (Page 8 of 10)

OVERDOSAGE

Information on overdosage with ofloxacin is limited. One incident of accidental overdosage has been reported. In this case, an adult female received 3 grams of ofloxacin intravenously over 45 minutes. A blood sample obtained 15 minutes after the completion of the infusion revealed an ofloxacin level of 39.3 mcg/mL. In 7 h, the level had fallen to 16.2 mcg/mL, and by 24 h to 2.7 mcg/mL. During the infusion, the patient developed drowsiness, nausea, dizziness, hot and cold flushes, subjective facial swelling and numbness, slurring of speech, and mild to moderate disorientation. All complaints except the dizziness subsided within 1 h after discontinuation of the infusion. The dizziness, most bothersome while standing, resolved in approximately 9 h. Laboratory testing reportedly revealed no clinically significant changes in routine parameters in this patient.

In the event of an acute overdose, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Ofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

DOSAGE AND ADMINISTRATION

The usual dose of ofloxacin tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance ≤ 50 mL/min), see the Patients With Impaired Renal Function subsection.

Infection

Unit Dose

Frequency

Duration

Daily Dose

Acute Bacterial Exacerbation of Chronic Bronchitis

400 mg

q12h

10 days

800 mg

Comm. Acquired Pneumonia

400 mg

q12h

10 days

800 mg

Uncomplicated Skin and Skin Structure Infections

400 mg

q12h

10 days

800 mg

Acute, Uncomplicated Urethral and Cervical Gonorrhea

400 mg

single dose

1 day

400 mg

Nongonococcal Cervicitis/Urethritis Due to C. Trachomatis

300 mg

q12h

7 days

600 mg

Mixed Infection of the Urethra and Cervix Due to C. Trachomatis and N. Gonorrhoeae

300 mg

q12h

7 days

600 mg

Acute Pelvic Inflammatory Disease

400 mg

q12h

10 to 14 days

800 mg

Uncomplicated Cystitis Due to E. Coli or K. Pneumoniae

200 mg

q12h

3 days

400 mg

Uncomplicated Cystitis Due to Other Approved Pathogens

200 mg

q12h

7 days

400 mg

Complicated UTI’s

200 mg

q12h

10 days

400 mg

Prostatitis Due to E. Coli

300 mg

q12h

6 weeks

600 mg

DUE TO THE DESIGNATED PATHOGENS (see INDICATIONS AND USAGE).

Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or didanosine, chewable/buffered tablets or the pediatric powder for oral solution should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin (see PRECAUTIONS).

Patients With Impaired Renal Function

Dosage should be adjusted for patients with a creatinine clearance ≤ 50 mL/min. After a normal initial dose , dosage should be adjusted as follows:

Creatinine Clearance

Maintenance Dose

Frequency

20 to 50 mL/min

the usual recommended unit dose

q24h

< 20 mL/min

½ the usual recommended unit dose

q24h

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.

Formulation
(click image for full-size original)

Women: 0.85 × the value calculated for men.

The serum creatinine should represent a steady-state of renal function.

Patients With Cirrhosis

The excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded.

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