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

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

H.J. Harkins Company, Inc.

SNN (starptautisko nepatentēto nosaukumu):

HYDROCORTISONE

Kompozīcija:

HYDROCORTISONE 10 mg in 1 mL

Ievadīšanas:

AURICULAR (OTIC)

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

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 - Prod. No. 06509 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.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE - NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION/ DROPS
H.J. HARKINS COMPANY, 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.
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:
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:
Hydrocortisone 11β,17, 21-trihydroxypregn-4-ene-3,20-dione, is an
anti-inflammatory hormone. Its
structural formula is:
1
2
C
H O
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:
Propylene Glycol, Cetyl
Alcohol (0.9%), Polysorbate 80, Purified Water. Sulfuric Acid may be
added to adjust pH (3.0 - 7.0).
PRESERVATIVE ADDED: Thimerosal 0.01%.
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