ANADA Number: 200-178

Proprietary Name Amikacin Sulfate Injection
Sponsor Teva Animal Health, Inc.
Sponsor Address 3915 South 48th Street Ter.
St. Joseph, MO    64506
USA
Ingredients Amikacin Sulfate
Species Dog, no use class stated or implied
Routes of Administration Intramuscular
Subcutaneous
Dose Form Liquid (solution)
Drug Form Liquid (solution)
This Document (200-178) Was Pioneered By:     Fort Dodge Animal Health, Division of Wyeth
Dispensing Status RX
Dosage Amount,
Indications
& Limitations

522.56 Amikacin sulfate injection.

Specifications: Each milliliter of sterile aqueous solution contains 50 milligrams of amikacin (as the sulfate).

Conditions of use:

Dogs

Amount: 5 milligrams per pound of body weight twice daily. The drug is administered intramuscularly or subcutaneously.

Indications: The drug is used for treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus species and skin and soft tissue infections caused by susceptible strains of Pseudomonas species and E. coli.

Limitations: Treat dogs with skin and soft tissue infections for a minimum of 7 days and those with genitourinary infections for 78 to 21 days or until culture is negative and asymptomatic. If no response is observed after 3 days of treatment, therapy should be discontinued and the case reevaluated. Maximum duration of therapy should not exceed 30 days. Systemic aminoglycoside therapy is contraindicated in dogs with seriously impaired renal function. Not for use in breeding dogs as reproductive studies have not been conducted. Use with extreme caution in dogs in which hearing acuity is required for functioning. Federal law restricts this drug to use by or on the order of a licensed veterinarian.