NADA Number: 011-315

Proprietary Name Neomycin 325 Soluble Powder
Neomix® 325 Soluble Powder
Neomix® AG 325 Soluble Powder
Sponsor Pharmacia & Upjohn Co.
Sponsor Address a Division of Pfizer, Inc.
235 East 42nd St.
New York, NY    10017
USA
Ingredients Neomycin Sulfate
Species Cattle, excluding veal calves
Turkey, growing
Goat, no use class stated or implied
Sheep, no use class stated or implied
Swine, no use class stated or implied
Routes of Administration Per Os
Dose Form Liquid (solution)
Drug Form Powder
Pharmacia & Upjohn Co. Has Pioneered:                   Neo-Sol 50®
    Alpharma, Inc.
                  NeoMed® Soluble Powder
    Cross Vetpharm Group Ltd.
                  NEORAL Oral Solution
    Med-Pharmex, Inc.
                  Neosol Soluble Powder
    Med-Pharmex, Inc.
                  Neomycin Soluble Powder 325g/lb
    Pfizer, Inc.
                  Neomycin Sulfate Soluble Powder, 325 g/lb
    Pfizer, Inc.
                  Biosol® Liquid
    Pharmacia & Upjohn Co.
                  Neomycin Sulfate 325
    Sparhawk Laboratories, Inc.
                  Neo 200 Oral Solution
    Teva Animal Health, Inc.
                  Neomycin Oral Solution
    Teva Animal Health, Inc.
Dispensing Status OTC
Exclusivity Granted for the use in growing turkeys to control mortality associated with E. coli organisms susceptible to neomycin sulfate in growing turkeys
Withdrawal Time Cattle excluding veal calves: 1 day before slaughter Sheep: 2 days before slaughter Swine and goats: 3 days before slaughter Turkey: zero days before slaughter
Dosage Amount,
Indications
& Limitations

520.1484 Neomycin sulfate soluble powder.

Specifications: The drug contains 20.3 grams of neomycin sulfate per ounce which is equivalent to 14.2 grams of neomycin base.

Conditions of use:

Cattle (excluding veal calves)

Amount: 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) in divided doses for a maximum of 14 days.

Indications: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves).

Limitations: Add to drinking water or milk. Not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24-48 hours beyond remission of disease symptoms, but not to exceed a total of 14 days. Discontinue treatment 1 day prior to slaughter in cattle (not for use in veal calves).

Sheep

Amount: 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) in divided doses for a maximum of 14 days.

Indications: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves) sheep.

Limitations: Add to drinking water or milk. Not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24-48 hours beyond remission of disease symptoms, but not to exceed a total of 14 days. Discontinue treatment 2 days prior to slaughter in sheep.

Swine

Amount: 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) in divided doses for a maximum of 14 days.

Indications: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in swine.

Limitations: Add to drinking water or milk. Not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24-48 hours beyond remission of disease symptoms, but not to exceed a total of 14 days. Discontinue treatment 3 days prior to slaughter in swine.

Goats

Amount: 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) in divided doses for a maximum of 14 days.

Indications: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in goats.

Limitations: Add to drinking water or milk. Not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24-48 hours beyond remission of disease symptoms, but not to exceed a total of 14 days. Discontinue treatment 3 days prior to slaughter in goats.

Turkeys (growing)

Amount: 10 milligrams of neomycin sulfate per pound of body weight per day (22 milligrams per kilogram) for 5 days.

Indications: For the control of mortality associated with E. coli organisms susceptible to neomycin sulfate in growing turkeys.

Limitations: Add to drinking water. Not for use in liquid supplements. Prepare a fresh solution daily. If symptoms persist after using this preparation for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of disease symptoms, but not to exceed a total of 5 consecutive days.

Tolerances

Tolerances are established for residues of parent neomycin in uncooked edible tissues as follows:

a. In cattle, swine, sheep, and goats: 7.2 parts per million in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle.

b. In turkeys: 7.2 ppm in skin with adhering fat, 3.6 parts per million in liver, and 1.2 ppm in muscle.

c. In milk: 0.15 part per million.