MALOTIC- gentamicin sulfate, betamethasone valerate, and clotrimazole ointment

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Vedco

INN (Mezinárodní Name):

GENTAMICIN SULFATE

Složení:

GENTAMICIN 3 mg in 1 g

Podání:

AURICULAR (OTIC)

Druh předpisu:

PRESCRIPTION

Terapeutické indikace:

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.

Přehled produktů:

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.

Stav Autorizace:

Abbreviated New Animal Drug Application

Charakteristika produktu

MALOTIC - GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE
OINTMENT
VEDCO
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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 the treatment of derma