NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE solution/ drops

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Disponível em:

Unit Dose Services

DCI (Denominação Comum Internacional):

NEOMYCIN SULFATE

Composição:

NEOMYCIN 3.5 mg in 1 mL

Tipo de prescrição:

PRESCRIPTION DRUG

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS
UNIT DOSE SERVICES
----------
NEOMYCIN AND POLYMYXIN B SULFATES
AND HYDROCORTISONE OTIC SOLUTION, USP
(STERILE)
RX ONLY
FOR USE IN THE EARS 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: ACTIVES: Neomycin sulfate equivalent to 3.5 mg
neomycin base, polymyxin B
sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10
mg (1%); INACTIVES:
Propylene Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric
Sulfate, Glycerin, Purified
Water. The pH range is 2.0 to 4.5.
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
micrograms of neomycin standard per milligram, calculated on an
anhydrous basis. The structural
formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, 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 milligram, calculated on an anhydrous basis. The
structural formulae are:
Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is
an anti-inflammatory hormone. Its
structural formula is:
C
H O Mol. Wt. 362.46
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 following m