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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bausch & Lomb Incoporated

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).

Product summary:

Neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP is supplied in a white plastic dropper bottle in the following size: 10 mL - NDC 24208-631-10 Storage: Store between 15°C to 25°C (59°F to 77°F). Securely tighten cap between uses. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS
BAUSCH & LOMB INCOPORATED
----------
NEOMYCIN AND
POLYMYXIN B SULFATES AND
HYDROCORTISONE
OTIC SOLUTION, USP
(STERILE)
RX ONLY
FOR USE IN EARS ONLY
DESCRIPTION
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, and
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
mg, 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 mg, 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
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_
_a