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

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Sandoz Inc.

INN (Tarptautinis Pavadinimas):

NEOMYCIN SULFATE

Sudėtis:

NEOMYCIN 3.5 mg in 1 mL

Vartojimo būdas:

AURICULAR (OTIC)

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is available in a bottle containing 10mL NDC 61314-645-11. Store at 15° to 25°C (59° to 77°F). Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP bottle of 10 mL with sterilized dropper.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION
SANDOZ INC.
----------
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:
neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B
sulfate equivalent to
10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle
contains
thimerosal 0.01% (added as a preservative) and the inactive
ingredients cetyl alcohol,
propylene glycol, polysorbate 80, glacial acetic acid and Water for
Injection.
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 mcg of neomycin standard per mg,
calculated on an
anhydrous basis. The structural formula are:
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
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 formula are:
1
2
2
2
1
2
2
2
1
2
Hydrocortisone, 11β,17, 21-trihydroxypregn-4-ene-3, 20-dione, is an
anti-inflammatory
hormone. Its structural formula is:
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 a