NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE suspension/ drops

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

DIRECT RX

INN (Medzinárodný Name):

HYDROCORTISONE

Zloženie:

HYDROCORTISONE 10 mg in 1 mL

Spôsob podávania:

AURICULAR (OTIC)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

- 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. 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.

Prehľad produktov:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension USP is supplied in a white plastic dropper bottle in the following size: 10 mL bottles - NDC 24208-635-62 Storage: Store at 15°-25°C (59°-77°F). FOR OTIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN AND
POLYMYXIN B SULFATES AND HYDROCORTISONE SUSPENSION/ DROPS
DIRECT RX
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NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
DESCRIPTION SECTION
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
USP is a sterile antibacterial
and anti-inflammatory suspension for otic use.
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 milligram, calculated on an
anhydrous basis. The structural
formulae are:
[Neomycin Sulfate (structural formula)]
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 milligram, calculated on an anhydrous basis. The
structural formulae are:
[Polymyxin B Sulfate (structural formula)]
Hydrocortisone 11β,17, 21-trihydroxypregn-4-ene-3,20-dione, is an
anti-inflammatory hormone. Its
structural formula is:
[Hydrocortisone (structural formula)]
C21H30O5
Mol. Wt. 362.47
Each mL Contains:
ACTIVES: Hydrocortisone, 10 mg (1%), Neomycin Sulfate equivalent to
3.5 mg neomycin base,
Polymyxin B Sulfate, equal to 10,000 polymyxin B units; 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%.
CLINICAL PHARMACOLOGY SECTION
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 sul