MOMETAVET- gentamicin sulfate, mometasone furoate anhydrous, and clotrimazole suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG), MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8), CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)

Available from:

Clipper Distribution Company LLC

INN (International Name):

GENTAMICIN SULFATE

Composition:

GENTAMICIN 3 mg in 1 g

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous; and Clotrimazole, USP, 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 ], coagulase-positive 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.

Product summary:

H O W SUPPLIED: Gentamicin Sulfate, USP; Mometasone Furoate Anhydrous; and Clotrimazole, USP Otic Suspension is available in 7.5 g tubes and plastic bottles, 15 g tubes and plastic bottles, 30 g plastic bottles, and 215 g plastic bottles.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

MOMETAVET- GENTAMICIN SULFATE, MOMETASONE FUROATE ANHYDROUS, AND
CLOTRIMAZOLE SUSPENSION
CLIPPER DISTRIBUTION COMPANY LLC
----------
MOMETAVET
(GENTAMICIN SULFATE, USP; MOMETASONE FUROATE ANHYDROUS; AND
CLOTRIMAZOLE, USP, OTIC SUSPENSION)
ANADA # 200-536, 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 Sulfate, USP; Mometasone Furoate
Anhydrous; and
Clotrimazole, USP, Otic Suspension contains gentamicin sulfate, USP
equivalent to 3 mg gentamicin
base; mometasone furoate anhydrous equivalent to 1 mg mometasone; 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 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 anhydrous 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 e