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

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Preferred Pharmaceuticals, Inc.

投与経路:

AURICULAR (OTIC)

処方タイプ:

PRESCRIPTION DRUG

適応症:

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, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics. CONTRAINDICATIONS: This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

製品概要:

How Supplied: Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is available in a DROP-TAINER* bottle containing 10mL NDC 68788-7684-01. * DROP-TAINER is a Registered trademark of Alcon Research, 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.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION
PREFERRED 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 ar