Ofloxacin clinical pharmacology

Ofloxacin

OCUFLOX ® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief:  Sophia Saad, Associate Editor - WikiDoc [2]

## Clinical Pharmacology

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### Pharmacokinetics

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Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with OCUFLOX®solution. The mean serum ofloxacin concentration ranged from 0.4 ng/mL to 1.9 ng/mL. Maximum ofloxacin concentration increased from 1.1 ng/mL on day one to 1.9 ng/mL on day 11 after QID dosing for 10 1/2 days. Maximum serum ofloxacin concentrations after ten days of topical ophthalmic dosing were more than 1000 times lower than those reported after standard oral doses of ofloxacin.

Tear ofloxacin concentrations ranged from 5.7 to 31 mcg/g during the 40 minute period following the last dose on day 11. Mean tear concentration measured four hours after topical ophthalmic dosing was 9.2 mcg/g.

Corneal tissue concentrations of 4.4 mcg/mL were observed four hours after beginning topical ocular application of two drops of OCUFLOX® ophthalmic solution every 30 minutes. Ofloxacin was excreted in the urine primarily unmodified.[1]

## References

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1. ↑ "NOROXIN (NORFLOXACIN) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]". Retrieved 8 January 2014.

Adapted from the FDA Package Insert.