NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Unit Dose Services

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 10 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS
UNIT DOSE SERVICES
----------
NEOMYCIN AND POLYMYXIN B
SULFATES AND HYDROCORTISONE
OTIC SUSPENSION, USP
(STERILE)
RX ONLY
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:
_ACTIVES:_Neomycin Sulfate equivalent to 3.5 mg neomycin base,
Polymyxin B Sulfate, equal to 10,000
polymyxin B units, and Hydrocortisone, 10 mg (1%); _INACTIVES:_Cetyl
Alcohol (0.9%), Polysorbate
80, Propylene Glycol, Purified Water. Sulfuric Acid may be added to
adjust pH (3.0 - 7.0).
_PRESERVATIVE ADDED:_Thimerosal 0.01%.
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 to 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. 362.46
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