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

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:

Proficient Rx LP

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN 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, 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.

Περίληψη προϊόντος:

Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, USP is available in a DROP-TAINER* bottle containing 10mL NDC 63187-648-10. * DROP-TAINER is a Registered trademark of Alcon Manufacturing, Ltd. Store at 15° to 25°C (59° to 77°F). Rx Only Also Available: Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP bottle of 10 mL with sterilized dropper.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE SUSPENSION
PROFICIENT RX LP
----------
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, glacial acetic acid and Water for
Injection.
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 formula are:
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
1
2
2
2
1
2
2
2
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 mg, calculated on an
anhydrous basis. The
structural formula 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 a