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:

Med-Pharmex, Inc

INN (International Name):

GENTAMICIN SULFATE

Composition:

GENTAMICIN 3 mg in 1 g

Administration route:

AURICULAR (OTIC)

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS:  Mometavet™ 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: Mometavet™ 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
MED-PHARMEX, INC
----------
MOMETAVET OTIC SUSPENSION
(GENTAMICIN SULFATE, MOMETASONE FUROATE ANHYDROUS, AND CLOTRIMAZOLE)
VETERINARY - - FOR OTIC USE IN DOGS ONLY
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
APPROVED BY FDA UNDER ANADA # 200-536
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
DESCRIPTION: Each gram of Mometavet™ Otic Suspension contains
gentamicin
sulfate, equivalent to 3 mg gentamicin base; mometasone furoate
anhydrous equivalent
to 1 mg mometasone; 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 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 epidermal barrier. Topical
corticosteroids can be
absorbed from normal, intact skin. Inflamma