COLY-MYCIN S- colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate suspension

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

COLISTIN SULFATE (UNII: WP15DXU577) (COLISTIN - UNII:Z67X93HJG1), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), THONZONIUM BROMIDE (UNII: JI2B19CR0R) (THONZONIUM - UNII:Z05ZE98FV8), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Dostupno od:

Endo Pharmaceuticals Inc.

INN (International ime):

COLISTIN SULFATE

Sastav:

COLISTIN 3 mg in 1 mL

Administracija rute:

AURICULAR (OTIC)

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Coly-Mycin® S Otic 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).

Proizvod sažetak:

Coly-Mycin® S Otic is supplied as: NDC 63481-421-05............... 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.

Status autorizacije:

New Drug Application

Svojstava lijeka

COLY-MYCIN S- COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE
AND HYDROCORTISONE
ACETATE SUSPENSION
ENDO PHARMACEUTICALS, INC.
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COLY-MYCIN S OTIC WITH NEOMYCIN AND HYDROCORTISONE (COLISTIN
SULFATE—NEOMYCIN SULFATE—THONZONIUM BROMIDE—HYDROCORTISONE
ACETATE OTIC SUSPENSION)
DESCRIPTION
Coly-Mycin S Otic 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 body's
defense mechanism a