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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

AURICULAR (OTIC)

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

INDICATIONS AND USAGE: For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. CONTRAINDICATIONS: 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).

Produkt oppsummering:

HOW SUPPLIED: Bottle of 10 mL with sterilized dropper NDC 68071-2735-1 Store at 15 ° to 25 ° C (59 ° to 77 ° F). Rx Only Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP DROP-TAINER* bottle containing 10 mL NDC 61314-645-11. * DROP-TAINER is a Registered trademark of Alcon Research, Ltd.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SOLUTION
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION,
USP
STERILE
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
1
2
2
2
1
2
2
2
1
2
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 a