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

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Sandoz Inc

INN (Международно Name):

NEOMYCIN SULFATE

Композиция:

NEOMYCIN 3.5 mg in 1 mL

Начин на приложение:

AURICULAR (OTIC)

Вид предписание :

PRESCRIPTION DRUG

Терапевтични 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).

Каталог на резюме:

Bottle of 10 mL with sterilized dropper NDC 61314-646-10 Store at 15 ° to 25 °C (59 ° to 77 °F). Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP in a bottle containing 10 mL NDC 61314-645-11.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SOLUTION
SANDOZ INC
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION,
USP
STERILE
RX ONLY
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 considered active against the