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

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NuCare Pharmaceuticals,Inc.

Administracija rute:

AURICULAR (OTIC)

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is available in a DROP-TAINER* bottle containing 10mL NDC 68071-4577-1. * DROP-TAINER is a Registered trademark of Alcon Manufacturing, Ltd. Store at 15° to 25°C (59° to 77°F). Rx Only Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP bottle of 10 mL with sterilized dropper.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION,
USP
STERILE
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: 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 thimerosal 0.01%
(added as a preservative) and the
inactive ingredients cetyl alcohol, propylene glycol, polysorbate 80,
glacial acetic 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 formula 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 of not less than 6,000
polymyxin B units per mg, calculated on an anhydrous basis. The
structural formula are:
1
2
2
2
1
2
2
2
1
2
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 cons