MOMETAMAX- 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:

Merck Sharp & Dohme Corp.

Адміністрація маршрут:

AURICULAR (OTIC)

Тип рецепту:

PRESCRIPTION

Терапевтичні свідчення:

INDICATIONS MOMETAMAX Otic Suspension is indicated for the treatment of otitis externa in dogs caused by susceptible strains of yeast (Malassezia pachydermatis ) and bacteria (Pseudomonas spp. [including P. aeruginosa ], coagulasepositive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci). 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.

Огляд продуктів:

HOW SUPPLIED MOMETAMAX Otic Suspension is available in 7.5 g (NDC 0061-1246-05), 15 g (NDC 0061-1246-04), 30 g (NDC 0061-1246-01), and 215 g (NDC 0061-1246-02) plastic bottles. Store between 2° and 25°C (36° and 77°F). Shake well before use. USE WITHIN 28 DAYS OF FIRST USE.

Статус Авторизація:

New Animal Drug Application

Характеристики продукта

MOMETAMAX- GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND
CLOTRIMAZOLE SUSPENSION
MERCK SHARP & DOHME CORP.
----------
MOMETAMAX
(GENTAMICIN SULFATE,
MOMETASONE FUROATE
MONOHYDRATE, AND
CLOTRIMAZOLE,
OTIC SUSPENSION)
Approved by FDA under
NADA # 141-177
PRODUCT
INFORMATION
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 MOMETAMAX 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_), coagulase-positive
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