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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

STAT Rx USA LLC

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN SULFATE 3.5 mg in 1 mL

Οδός χορήγησης:

AURICULAR (OTIC)

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics. This product is contraindicated in those individuals who have shown hypersensitivity to any of its components. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (for example, herpes simplex virus or varicella zoster virus).

Περίληψη προϊόντος:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP is supplied in a white plastic dropper bottle in the following size: 10 mL - Prod. No. 10009 Store between 15°-30°C (59°- 86°F). Securely tighten cap between uses. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT KEEP OUT OF REACH OF CHILDREN.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE - NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE, HYDROCORTISONE SOLUTION/ DROPS
STAT RX USA LLC
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SOLUTION USP
(STERILE)
RX ONLY
FOR USE IN THE EARS ONLY
NOT FOR USE IN THE EYES
DESCRIPTION:
Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Solution USP
is a sterile antibacterial and
anti-inflammatory solution for otic use.
EACH ML CONTAINS: ACTIVES: Neomycin Sulfate equivalent to 3.5 mg
neomycin base, Polymyxin B
Sulfate equivalent to 10,000 polymyxin B units, Hydrocortisone 10 mg
(1%). INACTIVES: Propylene
Glycol, Hydrochloric Acid, Potassium Metabisulfite, Cupric Sulfate,
Glycerin, Purified Water. The pH
range is 2.0 to 4.5.
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 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:
Hydrocortisone, 11β, 17, 21 - trihydroxypregn-4-ene-3, 20-dione, is
an anti-inflammatory hormone. Its
structural formula is:
C
H O Mol. Wt. 362.47
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