GENTAMICIN SULFATE USP, BETAMETHASONE VALERATE, USP, and CLOTRIMAZOLE, USP OINTMENT

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
01-01-2001

Aktivni sastojci:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG), BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M), CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

Dostupno od:

Henry Schein Animal Health

Administracija rute:

AURICULAR (OTIC)

Tip recepta:

PRESCRIPTION

Terapijske indikacije:

INDICATIONS :  Gentamicin-betamethasone-clotrimazole ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis , formerly Pityrosporum canis ) and/or bacteria susceptible to gentamicin. CONTRAINDICATIONS : If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

Proizvod sažetak:

HOW SUPPLIED : Gentamicin-betamethasone-clotrimazole ointment is available in 7.5 gram and 15 gram tubes as well as in 10 gram, 15 gram, 25 gram and 215 gram plastic bottles.

Status autorizacije:

Abbreviated New Animal Drug Application

Svojstava lijeka

                                OTIBIOTIC - GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND
CLOTRIMAZOLE OINTMENT
HENRY SCHEIN ANIMAL HEALTH
----------
GENTAMICIN SULFATE USP, BETAMETHASONE VALERATE, USP, AND
CLOTRIMAZOLE, USP OINTMENT
ANADA # 200-229, APPROVED BY FDA
VETERINARY
FOR OTIC USE IN DOGS ONLY
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DESCRIPTION: Each gram of gentamicin-betamethasone-clotrimazole
ointment contains gentamicin
sulfate USP equivalent to 3 mg gentamicin base; betamethasone valerate
USP equivalent to 1 mg
betamethasone; and 10 mg clotrimazole USP in a mineral oil-based
system containing a plasticized
hydrocarbon gel.
PHARMACOLOGY:
GENTAMICIN: Gentamicin sulfate is an aminoglycoside antibiotic active
against a wide variety of
pathogenic gram-negative and gram-positive bacteria. _In vitro_ tests
have determined that gentamicin is
bactericidal and acts by inhibiting normal protein synthesis in
susceptible microorganisms. Specifically,
gentamicin is active against the following organisms commonly isolated
from canine ears:
_Staphylococcus aureus_, other _Staphylococcus_ spp., _Pseudomonas
aeruginosa_, _Proteus_ spp., and _Escherichia_
_coli_.
BETAMETHASONE: Betamethasone valerate is a synthetic adrenocorticoid
for dermatologic use.
Betamethasone, an analog of prednisolone, has a high degree of
corticosteroid activity and a slight
degree of mineralocorticosteroid activity. Betamethasone valerate, the
17-valerate ester of
betamethasone, has been shown to provide anti-inflammatory and
anti-pruritic activity in the topical
management of corticosteroid-responsive otitis externa. Topical
corticosteroids can be absorbed from
normal, intact skin. Inflammation can increase percutaneous
absorption. Once absorbed through the skin,
topical corticosteroids are handled through pharmacokinetic pathways
similar to systemically
administered corticosteroids.
CLOTRIMAZOLE: Clotrimazole is a broad-spectrum antifungal agent that
is used for
                                
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