CORTISPORIN-TC colistin sulfate neomycin thonzonium bromide and hydrocortisone acetate suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

colistin sulfate (UNII: WP15DXU577) (colistin - UNII:Z67X93HJG1)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

colistin sulfate

Composition:

colistin 3 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

CORTISPORIN-TC- COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM
BROMIDE, AND
HYDROCORTISONE ACETATE SUSPENSION
PAR PHARMACEUTICAL, INC.
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CORTISPORIN -TC OTIC SUSPENSION WITH NEOMYCIN AND
HYDROCORTISONE (COLISTIN SULFATE—NEOMYCIN SULFATE—THONZONIUM
BROMIDE—HYDROCORTISONE ACETATE OTIC SUSPENSION)
DESCRIPTION
Cortisporin -TC Otic Suspension with Neomycin and Hydrocortisone
(colistin sulfate—neomycin
sulfate—thonzonium bromide—hydrocortisone acetate otic suspension)
is a sterile antibacterial and
anti-inflammatory aqueous suspension containing in each mL: Colistin
base activity, 3 mg (as the
sulfate); Neomycin base activity, 3.3 mg (as the sulfate);
Hydrocortisone acetate, 10 mg (1%);
Thonzonium bromide,
0.5 mg (0.05%); Polysorbate 80, acetic acid, and sodium acetate in a
buffered aqueous vehicle.
Thimerosal (mercury derivative), 0.002%, is added as a preservative.
It is a nonviscous liquid, buffered
at pH 5, for instillation into the canal of the external ear or direct
application to the affected aural skin.
The structural formulas of colistin sulfate (mixture of Colistin A &
B), neomycin sulfate (mixture of
neomycin A, B & C), hydrocortisone acetate
((11β)-21-(acetyloxy)-11,17-dihydroxypregn) methyl]-2
pyrimidinylamino] ethyl]-N,N-dimethyl-1-hexadecanaminium, bromide) are
represented below:
_Thonzonium Bromide_
_Colistin sulfate_
®
®
_Neomycin A_
_Neomycin B Sulfate_
_Hydrocortisone Acetate_
_Neomycin C Sulfate_
CLINICAL PHARMACOLOGY
Colistin sulfate is a polypeptide antibiotic which penetrates into and
disrupts the bacterial cell
membrane. Neomycin sulfate is an aminoglycoside antibiotic which
inhibits protein synthesis, disrupting
the normal cycle of ribosomal function. Hydrocortisone acetate is a
corticosteroid hormone which is
thought to act by regulating the rate of protein synthesis; it
controls inflammation, edema, pruritus and
other dermal reactions. Cortiscosteroids suppress the inflammatory
response to a variety of agents and
they may delay healing. Since corticoids may inhibit the