OFLOXACIN OTIC- ofloxacin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, 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 aureus. 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 bottles containing 5 mL and 10 mL. The NDC codes are: 60505-0363-1    5 mL 60505-0363-2    10 mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light. Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, FL Canada 33326 M9L 1T9 000000                                                                               September 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OFLOXACIN OTIC- OFLOXACIN SOLUTION
PREFERRED PHARMACEUTICALS, INC.
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OFLOXACIN OTIC SOLUTION 0.3%
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 carboxy-
quinolone 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 0.3% (3 mg/mL) ofloxacin with
benzalkonium chloride (0.0025%),
hydrochloric acid, sodium chloride, and water for injection.
Additional hydrochloric acid and/or
sodium hydroxide may be added to adjust the pH (6.5 ± 0.5).
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