MAXI-OTIC- gentamicin sulfate, mometasone furoate monohydrate, and clotrimazole suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Butler Animal Health Supply

Οδός χορήγησης:

AURICULAR (OTIC)

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

F-27078915 NADA #141-177, Approved by FDA. 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. INDICATIONS Maxi-Otic 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.

Περίληψη προϊόντος:

HOW SUPPLIED Maxi-Otic Otic Suspension is available in 7.5 g (NDC 11695-7025-7), 15 g (NDC 11695-7025-1), 30 g (NDC 11695-7025-3), and 215 g (NDC 11695-7025-2) plastic bottles. Store between 2° and 25°C (36° and 77°F). Shake well before use.

Καθεστώς αδειοδότησης:

New Animal Drug Application

Αρχείο Π.Χ.Π.

MAXI-OTIC- GENTAMICIN SULFATE, MOMETASONE FUROATE MONOHYDRATE, AND
CLOTRIMAZOLE SUSPENSION
BUTLER ANIMAL HEALTH SUPPLY
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MAXI-OTIC™
(GENTAMICIN SULFATE, USP; MOMETASONE FUROATE MONOHYDRATE; AND
CLOTRIMAZOLE, USP, OTIC SUSPENSION)
F-27078915
NADA #141-177, Approved by FDA.
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 Maxi-Otic™ Otic Suspension contains
gentamicin sulfate, USP
equivalent to 3 mg gentamicin base; mometasone furoate monohydrate
equivalent to 1 mg mometasone;
and 10 mg clotrimazole, USP in a mineral oilbased system containing a
plasticized hydrocarbon gel.
PHARMACOLOGY
GENTAMICIN: Gentamicin sulfate is an aminoglycoside antibiotic active
against a wide variety of gram-
negative and grampositive 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
cortic