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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 10 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components, and in herpes simplex, vaccinia, and varicella infections.

Product summary:

Product: 50090-0431 NDC: 50090-0431-0 10 mL in a BOTTLE, DROPPER / 1 in a CARTON

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
A-S MEDICATION SOLUTIONS
----------
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 aga