OCUFLOX- ofloxacin solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ofloxacin (UNII: A4P49JAZ9H) (ofloxacin - UNII:A4P49JAZ9H)

Available from:

Allergan, Inc.

INN (International Name):

ofloxacin

Composition:

ofloxacin 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OCUFLOX® ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: *Efficacy for this organism was studied in fewer than 10 infections OCUFLOX® solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see Warnings).

Product summary:

OCUFLOX® (ofloxacin ophthalmic solution) 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with tan high impact polystyrene (HIPS) caps as follows: 5mL in 10mL bottle - NDC 11980-779-05 Note: Store at 15°-25°C (59°-77°F) Rx only Revised: 04/2017 © 2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Irvine, CA 92612, U.S.A. Made in the U.S.A. 71589US13

Authorization status:

New Drug Application

Summary of Product characteristics

OCUFLOX- OFLOXACIN SOLUTION/ DROPS
ALLERGAN, INC.
----------
OCUFLOX
(OFLOXACIN OPHTHALMIC SOLUTION) 0.3%
STERILE
DESCRIPTION
OCUFLOX (ofloxacin ophthalmic solution) 0.3% is a sterile ophthalmic
solution. It is a
fluorinated carboxyquinolone anti-infective for topical ophthalmic
use.
CHEMICAL NAME:
(±)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7_H_-
pyrido[1,2,3-_de_]-1,4-benzoxazine-6-carboxylic acid.
CONTAINS: ACTIVE: ofloxacin 0.3% (3 mg/mL). PRESERVATIVE: benzalkonium
chloride
(0.005%).
INACTIVES: sodium chloride and purified water. May also contain
hydrochloric acid
and/or sodium hydroxide to adjust pH.
OCUFLOX solution is unbuffered and formulated with a pH of 6.4 (range
- 6.0 to 6.8).
It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated
4-quinolone which differs
from other fluorinated 4-quinolones in that there is a six member
(pyridobenzoxazine)
ring from positions 1 to 8 of the basic ring structure.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
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.
MICROBIOLOGY
Ofloxacin has _in vitro_ activity against