NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- neomycin sulfate, polymyxin b sulfate and hydrocortisone suspension/ drops

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

NuCare Pharmaceuticals,Inc.

DCI (Denominação Comum Internacional):

HYDROCORTISONE

Composição:

HYDROCORTISONE 10 mg in 1 mL

Via de administração:

AURICULAR (OTIC)

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

Resumo do produto:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is supplied in a white plastic dropper bottle in the following size: NDC 66267-951-10 Box of 10mL Store at 15°-25°C (59°-77°F). Rx only FOR USE IN EARS ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B
SULFATES AND HYDROCORTISONE
OTIC SUSPENSION, USP
(STERILE)
RX ONLY
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
USP, is a sterile antibacterial
and anti-inflammatory suspension for otic use.
EACH ML CONTAINS:
_ACTIVES:_Neomycin Sulfate equivalent to 3.5 mg neomycin base,
Polymyxin B Sulfate, equal to 10,000
polymyxin B units, and Hydrocortisone, 10 mg (1%); _INACTIVES:_Cetyl
Alcohol (0.9%), Polysorbate
80, Propylene Glycol, Purified Water. Sulfuric Acid may be added to
adjust pH (3.0 - 7.0).
_PRESERVATIVE ADDED:_Thimerosal 0.01%.
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 to 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 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 milligram, calculated on an anhydrous basis. The
structural formulae are:
1
2
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 aga