CORTOMYCIN neomycin and polymyxin b sulfates hydrocortisone solution/ drops

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Disponible depuis:

Major Pharmaceuticals

DCI (Dénomination commune internationale):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 mg in 1 mL

Type d'ordonnance:

PRESCRIPTION DRUG

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CORTOMYCIN- NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
SOLUTION/ DROPS
MAJOR PHARMACEUTICALS
----------
NEOMYCIN AND POLYMYXIN B SULFATES
AND HYDROCORTISONE
DES CRIPTION
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, 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. 362.47
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 microorganisms: _Staphylococcus aureus,
Escherichia coli, Haemophilus_
_influenzae, Klebsiella-Enterobacter_ sp