CORTISPORIN-TC- colistin sulfate, neomycin sulfate, 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), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), THONZONIUM BROMIDE (UNII: JI2B19CR0R) (THONZONIUM BROMIDE - UNII:JI2B19CR0R), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Physicians Total Care, Inc.

INN (International Name):

COLISTIN SULFATE

Composition:

COLISTIN 3 mg in 1 mL

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cortisporin® -TC Otic Suspension is indicated 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. This product should not be used if the external auditory canal disorder is suspected or known to be due to cutaneous viral infection (e.g., herpes simplex virus or varicella zoster virus).

Product summary:

Cortisporin® -TC Otic Suspension is supplied as: NDC 54868-0564-0 ............... 10 mL bottle with dropper Each mL contains: Colistin sulfate equivalent to 3 mg of colistin base activity, Neomycin sulfate equivalent to 3.3 mg neomycin base activity, Hydrocortisone acetate 10 mg (1%), Thonzonium bromide 0.5 mg (0.05%), and Polysorbate 80 in an aqueous vehicle buffered with acetic acid and sodium acetate. Thimerosal (mercury derivative) 0.002% is added as a preservative. A sterilized dropper-cap assembly for use on the bottle of suspension is included in the package. Shake well before using. Store at 20°–25°C (68°–77°F). Rx only.

Authorization status:

New Drug Application

Summary of Product characteristics

CORTISPORIN-TC - COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM
BROMIDE, AND
HYDROCORTISONE ACETATE SUSPENSION
PHYSICIANS TOTAL CARE, 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