OFLOXACIN solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OFLOXACIN (UNII: A4P49JAZ9H) (OFLOXACIN - UNII:A4P49JAZ9H)

Available from:

Bausch & Lomb Incorporated

INN (International Name):

OFLOXACIN

Composition:

OFLOXACIN 3 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae   Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections. Ofloxacin ophthalmic 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:

Ofloxacin ophthalmic solution, 0.3% is supplied sterile in plastic dropper bottles with tan caps in the following sizes: 5 mL     NDC    24208-434-05 10 mL    NDC    24208-434-10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OFLOXACIN- OFLOXACIN SOLUTION/ DROPS
BAUSCH & LOMB INCORPORATED
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OFLOXACIN OPHTHALMIC
SOLUTION 0.3%
(Sterile)
RX ONLY
DESCRIPTION
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.
Ofloxacin ophthalmic 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
ofloxacin ophthalmic
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 ofloxacin ophthalmic
solution every 30
minutes. Ofloxacin was excreted in the urine primarily unmodified.
_MICROBIOLOGY_
Ofloxacin has _in vi