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:

Bausch & Lomb Incorporated

DCI (Denominação Comum Internacional):

HYDROCORTISONE

Composição:

HYDROCORTISONE 10 mg in 1 mL

Via de administração:

AURICULAR (OTIC)

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics. 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: 10 mL bottle - NDC 24208-635-62 Storage: Store at 15°C to 25°C (59°F to 77°F). FOR USE IN EARS ONLY. KEEP OUT OF REACH OF CHILDREN. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2022 Bausch & Lomb Incorporated or its affiliates Revised: December 2022 9115706 (Folded) 9115606 (Flat)

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
BAUSCH & LOMB INCORPORATED
----------
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
equivalent 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: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 of not less than 600 mcg of neomycin standard per mg,
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 mg, 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:
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 microorganisms:
_Staphylococcus_
_au