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:

Proficient Rx LP

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 - NDC 63187-308-10 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
PROFICIENT RX LP
----------
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: 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
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 mi