OFLOXACIN solution/ drops
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
01-09-2021
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Active ingredient:
OFLOXACIN (UNII: A4P49JAZ9H) (OFLOXACIN - UNII:A4P49JAZ9H)
Available from:
A-S Medication Solutions
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: 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:
Product: 50090-0891 NDC: 50090-0891-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
OFLOXACIN- OFLOXACIN SOLUTION/ DROPS
A-S MEDICATION SOLUTIONS
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PRESCRIBING INFORMATION
OFLOXACIN OPHTHALMIC SOLUTION USP, 0.3%
Rx only
DESCRIPTION
Ofloxacin Ophthalmic Solution USP, 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 water for injection. May also contain
hydrochloric acid
and/or sodium hydroxide to adjust pH.
Ofloxacin Ophthalmic Solution USP, 0.3% 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 unmodif
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