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

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Rebel Distributors Corp

INN (International ime):

HYDROCORTISONE

Sastav:

HYDROCORTISONE 10 mg in 1 mL

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 supplied in a white plastic dropper bottle in the following size: 10 mL bottles - Prod. No. 06509

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS
REBEL DISTRIBUTORS CORP
----------
NEOMYCIN AND POLYMYXIN B SULFATESAND HYDROCORTISONE OTIC SUSPENSION
USP
DES CRIPTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
USP is a sterile antibacterial
and anti-inflammatory suspension for otic use.
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:
Hydrocortisone 11β,17, 21-trihydroxypregn-4-ene-3,20-dione, is an
anti-inflammatory hormone. Its
structural formula is:
1
2
C
H O Mol. Wt. 362.47
EACH ML CONTAINS:
ACTIVES: Hydrocortisone, 10 mg (1%), Neomycin Sulfate equivalent to
3.5 mg neomycin base,
Polymyxin B Sulfate, equal to 10,000 polymyxin B units; INACTIVES:
Propylene Glycol, Cetyl
Alcohol (0.9%), Polysorbate 80, Purified Water. Sulfuric Acid may be
added to adjust pH (3.0 - 7.0).
PRESERVATIVE ADDED: Thimerosal 0.01%.
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 microorganism