OFLOXACIN OTIC- ofloxacin solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Proficient Rx LP

INN (Medzinárodný Name):

OFLOXACIN

Zloženie:

OFLOXACIN 3 mg in 1 mL

Spôsob podávania:

AURICULAR (OTIC)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

Ofloxacin Otic Solution 0.3% is supplied in bottles containing 5 mL NDC 63187-184-05 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Manufactured by: Manufactured for: Relabeled by: Apotex Inc. Apotex Corp. Proficient Rx LP Toronto, Ontario Weston, Florida 33326 Thousand Oaks, CA 91320 Canada M9L 1T9 247807                                                                               January 2007

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

OFLOXACIN OTIC- OFLOXACIN SOLUTION
PROFICIENT RX LP
----------
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 otitis media
and