MOTAZOL- gentamicin sulfate, mometasone furoate monohydrate, and clotrimazole suspension

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG), Mometasone Furoate Monohydrate (UNII: MTW0WEG809) (Mometasone - UNII:8HR4QJ6DW8), Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)

Доступна з:

MWI

ІПН (Міжнародна Ім'я):

Gentamicin Sulfate

Склад:

Gentamicin 3 mg in 1 g

Адміністрація маршрут:

AURICULAR (OTIC)

Тип рецепту:

PRESCRIPTION

Терапевтичні свідчення:

DESCRIPTION Each gram of MotaZol™ Otic Suspension contains gentamicin sulfate, equivalent to 3 mg gentamicin base; mometasone furoate monohydrate equivalent to 1 mg mometasone furoate; and 10 mg clotrimazole, in a mineral oil-based system containing a plasticized hydrocarbon gel.

Статус Авторизація:

New Animal Drug Application

Характеристики продукта

MOTAZOL- GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND
CLOTRIMAZOLE SUSPENSION
MWI
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VET ONE
MOTAZOL™
(GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND
CLOTRIMAZOLE, OTIC SUSPENSION)
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 MotaZol™ Otic Suspension contains
gentamicin sulfate,
equivalent to 3 mg gentamicin base; mometasone furoate monohydrate
equivalent to 1
mg mometasone furoate; and 10 mg clotrimazole, 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 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. In clinical trials, gentamicin was shown to have a
range of activity
against the following organisms commonly isolated from infected canine
ears:
_Pseudomonas_ spp. (including _P. aeruginosa_), coagulasepositive
staphylococci,
_Enterococcus faecalis_, _Proteus mirabilis_ and beta-hemolytic
streptococci.
MOMETASONE: Mometasone furoate monohydrate is a synthetic
adrenocorticoid
characterized by a novel (2) furoate 17-ester having chlorine at the 9
and 21 positions,
which have shown to possess high topical potency.
Systemic absorption of mometasone furoate ointment was found to be
minimal (2%)
over 1 week when applied topically to dogs with intact skin. In a
6-month dermal toxicity
study using 0.1% mometasone ointment on healthy intact skin in dogs,
systemic effects
typical of corticosteroid therapy were noted.
The extent of percutaneous absorption of topical corticosteroids is
determined by many
factors including the integrity of the epidermal barrier. Topical
corticosteroids can be
absorbed from normal, intact skin. Inflammation can increase
percutaneous abso