OFLOXACIN solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

OFLOXACIN

Composition:

OFLOXACIN 3 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aereus . Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus . Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus, and Streptococcus pneumoniae . Ofloxacin Otic Solution 0.3% 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 Otic Solution 0.3% is supplied in plastic droppered bottles of the following sizes: NDC 54868-6035-0 Ofloxacin Otic Solution 5 mL NDC 54868-6035-1 Ofloxacin Otic Solution 10 mL Note: Store at 20-25°C (68-77°F)[see USP Controlled Room Temperature]. Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 025:01 12/08 MG #18057 Distributed by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OFLOXACIN - OFLOXACIN SOLUTION/ DROPS
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective
(anti-bacterial) solution for otic use.
Chemically, ofloxacin has three condensed 6-membered rings made up of
a fluorinated
carboxyquinolone with a benzoxazine ring. The chemical name of
ofloxacin is (±)-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. The empirical formula of ofloxacin is C
H FN O and its molecular weight is
361.38. The structural formula is:
Ofloxacin Otic Solution contains:
Active: Ofloxacin 0.3% (3 mg/mL)
Preservative: Benzalkonium chloride (0.0025%)
Inactives: Purified water and sodium chloride. Hydrochloric acid and
sodium hydroxide added to adjust
pH
CLINICAL PHARMACOLOGY
Pharmacokinetics
Drug concentrations in serum (in subjects with tympanostomy tubes and
perforated tympanic membranes),
in otorrhea, and in mucosa of the middle ear (in subjects with
perforated tympanic membranes) were
determined following otic administration of ofloxacin solution. In two
single-dose studies, mean
ofloxacin serum concentrations were low in adult patients with
tympanostomy tubes, with and without
otorrhea, after otic administration of a 0.3% solution (4.1 ng/mL
(n=3) and 5.4 ng/mL (n=5),
respectively). In adults with perforated tympanic membranes, the
maximum serum drug level of
ofloxacin detected was 10 ng/mL after administration of a 0.3%
solution. Ofloxacin was detectable in
the middle ear mucosa of some adult subjects with perforated tympanic
membranes (11 of 16 subjects).
The variability of ofloxacin concentration in middle ear mucosa was
high. The concentrations ranged
from 1.2 to 602 µg/g after otic administration of a 0.3% solution.
Ofloxacin was present in high
concentrations in otorrhea (389 - 2850 µg/g, n=13) 30 minutes after
otic administration of a 0.3%
solution in subjects with chronic suppurative otitis media and
perforated tympanic membranes.
However, the measurem