NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION- neomycin and polymyxin b sulfates and hydrocortisone otic

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Rising Pharma Holdings, Inc.

Az alkalmazás módja:

AURICULAR (OTIC)

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

10 mL bottle (NDC 64980-448-01). Store at 15° to 25°C (59° to 77°F). Rx only KEEP OUT OF REACH OF CHILDREN. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Code No.: TS/DRUGS/13/2010 Made in India PIA44801-02 Revised: 02/2022

Engedélyezési státusz:

New Drug Application Authorized Generic

Termékjellemzők

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC
SUSPENSION - NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
OTIC SUSPENSION
RISING PHARMA HOLDINGS, INC.
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NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION,
USP
STERILE
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, and Water for Injection. Sulfuric
acid may be added to
adjust pH.
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 formulae are:
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, 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:
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 followin