GENTAMICIN-BETAMETHASONE OTIC SOLUTION- gentamicin sulfate with betamethasone valerate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GENTAMICIN SULFATE (UNII: 8X7386QRLV) (GENTAMICIN - UNII:T6Z9V48IKG), BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Available from:

Covetrus North America

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Gentamicin Sulfate with Betamethasone Valerate Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin. CONTRAINDICATIONS: If hypersensitivity of any of the components occurs, treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with Gentamicin Sulfate with Betamethasone Valerate Otic Solution.

Product summary:

HOW SUPPLIED: Gentamicin Sulfate with Betamethasone Valerate Otic Solution, squeeze bottles of 7.5 mL, 15 mL and 240 mL (8 fl. Oz.). Store between 2°C and 25°C (36°F and 77°F).

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

GENTAMICIN-BETAMETHASONE OTIC SOLUTION- GENTAMICIN SULFATE WITH
BETAMETHASONE VALERATE SOLUTION
COVETRUS NORTH AMERICA
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GENTAMICIN-BETAMETHASONE OTIC SOLUTION
GENTAMICIN SULFATE WITH BETAMETHASONE VALERATE OTIC SOLUTION
ANADA # 200-183, APPROVED BY FDA
FOR USE IN DOGS AND CAT ONLY.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A LICENSED VETERINARIAN.
DESCRIPTION: Gentamicin Sulfate with Betamethasone Valerate Otic
Solution is packaged in a
convenient plastic squeeze bottle for easy application. Each mL of
Gentamicin Sulfate with
Betamethasone Valerate Otic Solution contains gentamicin sulfate
equivalent to 3 mg gentamicin base,
betamethasone valerate equivalent to 1 mg betamethasone, 1.0 mg
hydroxyethylcellulose, 2.5 mg glacial
acetic acid, 200 mg purified water, 19% ethanol, 9.4 mg benzyl alcohol
as preservative, 300 mg
glycerin and propylene glycol q.s.
CHEMISTRY: Gentamicin is a bactericidal antibiotic of the
aminoglycoside group derived from
_Micromonosporapurpurea_ of the _Actinomyces_ group. It is a powder,
white to buff in color, basic in
nature, readily soluble in water and highly stable in solution.
Betamethasone valerate is a synthetic corticosteroid derivative of
prednisolone.
ACTION: Gentamicin Sulfate with Betamethasone Valerate Otic Solution
combines the broad-spectrum
activity of gentamicin sulfate with the anti-inflammatory and
antipruritic activity of betamethasone
valerate. _In vitro_ antibacterial activity has shown that gentamicin
is active against most gram-negative
bacteria including _Pseudomonas aeruginosa_, indole-positive and
negative _proteus sp_., _Escherichia coli_,
_Klebsiella pneumonia_e, _Aerobacter aerogenes_, and _Neisseria_.
Gentamicin is also active against strains of
gram-positive bacteria including _Staphylococcus_ species and some
_Streptococcus_ species.
Betamethasone valerate has emerged from intensive research as the most
promising of some 50 newly
synthesized corticosteroids in the experimental model described by
McKenzie et al. This hum