OFLOXACIN- ofloxacin otic solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Proficient Rx LP

Администрация маршрут:

AURICULAR (OTIC)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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.

Обзор продуктов:

Ofloxacin Otic Solution 0.3% is supplied in plastic dropper bottles in the following sizes: NDC 82804-061-05      5 mL Storage: Store at 20º to 25°C (68º to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

OFLOXACIN- OFLOXACIN OTIC SOLUTION
PROFICIENT RX LP
----------
OFLOXACIN OTIC SOLUTION 0.3% (STERILE)
RX ONLY
DESCRIPTION
Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective
(antibacterial) 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 molecular 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, USP with
benzalkonium
chloride (0.0025%), sodium chloride (0.9%), and water for injection.
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
18
20
3
4
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 mcg/g after otic administration of a 0.3% solution. Ofloxacin was
present in high
concentrations in otorrhea (389 - 2850 mcg/g, n=13) 30 minutes after
otic
administration of a 0.3% solution in subjects with chronic suppurative
otitis medi