NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- neomycin sulfate, polymyxin b sulfate and hydrocortisone solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Доступна с:

Lake Erie Medical DBA Quality Care Products LLC

ИНН (Международная Имя):

NEOMYCIN SULFATE

состав:

NEOMYCIN 3.5 mg in 1 mL

Администрация маршрут:

AURICULAR (OTIC)

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).

Обзор продуктов:

Bottle of 10 mL with sterilized dropper NDC 55700-282-10 Store at 15 ° to 25 °C (59 ° to 77 °F). Rx Only Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension, USP bottle of 10 mL with sterilized dropper.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SOLUTION
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION,
USP
STERILE
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution,
USP is a sterile antibacterial
and anti-inflammatory solution for otic use. Each mL contains:
neomycin sulfate equivalent to 3.5 mg
neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B
units, and hydrocortisone 10 mg
(1%). The vehicle contains potassium metabisulfite 0.1% (added as a
preservative) and the inactive
ingredients glycerin, propylene glycol, hydrochloric acid, and Water
for Injection.
Neomycin sulfate is the sulfate salt of neomycin B and C, which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetaceae). It has a
potency equivalent of not less than 600
mcg of neomycin standard per mg, calculated on an anhydrous basis. The
structural formulae are:
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
Polymyxin B sulfate is the sulfate salt of polymyxin B and B , which
are produced by the growth of
_Bacillus polymyxa _(Prazmowski) Migula (Fam. Bacillaceae). It has a
potency of not less than 6,000
polymyxin B units per mg, calculated on an anhydrous basis. The
structural formulae are:
1
2
2
2
1
2
2
2
1
2
Hydrocortisone, 11β,17,21-trihydroxypregn-4-ene-3, 20-dione, is an
anti-inflammatory hormone. Its
structural formula is:
CLINICAL PHARMACOLOGY
Corticoids suppress the inflammatory response to a variety of agents
and they may delay healing. Since
corticoids may inhibit the body's defense mechanism against infection,
a concomitant antimicrobial drug
may be used when this inhibition is considered to be clinically
significant in a particular case.
The anti-infective components in the combination are included to
provide action against specific
organisms susceptible to them. Neomycin sulfate and polymyxin B
sulfate together are c