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

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Asclemed USA, Inc.

Stjórnsýsluleið:

AURICULAR (OTIC)

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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).

Vörulýsing:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution, USP is supplied in a white plastic dropper bottle in the following size: 10 mL - NDC 76420-104-10 (relabeled from NDC 24208-631-10) DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Securely tighten cap between uses. Keep out of reach of children.

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS
ASCLEMED USA, INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES
AND HYDROCORTISONE OTIC SOLUTION, USP
(Sterile)
RX ONLY
FOR USE IN 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 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 against the following mi