OFLOXACIN solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Akorn

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: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae 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.

Product summary:

Ofloxacin ophthalmic solution 0.3% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with beige high impact polystyrene (HIPS) caps as follows: 5 mL - NDC 50383-024-05 10 mL - NDC 50383-024-10 Note: Store at 20-25°C (68 - 77°F) [see USP Controlled Room Temperature]. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 12/08 MG #24681

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OFLOXACIN- OFLOXACIN SOLUTION/ DROPS
AKORN
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OFLOXACIN OPHTHALMIC SOLUTION, 0.3%
STERILE
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-7H-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 µg/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 µg/g.
Corneal tissue concentrations of 4.4 µg/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 vitro activity against a broad range