Sulfadimethoxine description, usages, side effects, indications, overdosage, supplying and lots more!

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Sulfadimethoxine

Teva Animal Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Sulfadimethoxine 12.5 % Oral Solution,

Antibacterial For Oral Use in Drinking Water

3.75g sulfadimethoxine/fl oz

Protect From Light

For Oral Use in Chickens, Turkeys, and Cattle

ANADA 200-192, Approved by FDA

Active ingredient

Sulfadimethoxine Base

Inactive Ingredients

Sodium Hydroxide, Sodium Metabisulfite, Edetate Disodium, Purified Water, and Hydrochloric Acid .

Indications:

INDICATIONS:

BROILER AND REPLACEMENT CHICKENS-Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.

MEAT PRODUCING TURKEYS-Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.

DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE- Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp.. Sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.

Cautions

CAUTION: Store at room temperature; if freezing occurs, thaw before using. Protect from light; direct sunlight may cause discoloration. Freezing or discoloration does not affect potency. Prepare a fresh stock solution daily.

CHICKENS AND TURKEYS- If animals show no improvement within 5 days, discontinue treatment and re-evaluate diagnosis. Handle the recommended dilutions (chickens 0.05% and turkeys 0.0.25%) as regular drinking water. Administer as sole source of drinking water and sulfonamide medication. Chickens and turkeys that have survived fowl cholera outbreaks should not be kept for replacements or breeders.

CATTLE- During treatment period, make certain that animals maintain adequate water intake. If animals show no improvement within 2 or 3 days, re-evaluate diagnosis. Treatment should not be continued beyond 5 days.

Residue Warnings:

RESIDUE WARNINGS:

CHICKENS AND TURKEYS- Withdraw 5 days before slaughter. Do not administer to chickens over 16 weeks (112 days) of age or to turkeys over 24 weeks (168 days) of age.

CATTLE- Withdraw 7 days before slaughter. For dairy calves, dairy heifers and beef cattle only. A withdrawal period has not been established for this product in pre-ruminating calves. DO NOT USE IN CALVES TO BE PROCESSED FOR VEAL.

Storage

Store at controlled room temperature 20°-25°C (68°-77°F)

Warnings:

RESTRICTED DRUG (CALIFORNIA)

USE ONLY AS DIRECTED

NOT FOR HUMAN USE

Dosage and Administration

Dosage and Administration Table
Dosage and Administration Table
TREATMENT PERIOD – 6 consecutive days
Species Concentration Use Directions
CHICKENS 0.05% Add 1 fl oz* to 2 gallons of drinking water or
25 fl oz to 50 gallons of drinking water
TURKEYS 0.025% Add 1 fl oz* to 4 gallons of drinking water or
25 fl oz to 100 gallons of drinking water
Automatic Proportioners **Stock Solution-To make 2 gallons of Stock Solution use:
CHICKENS Add gal Sulfadimethoxine 12.5% Drinking Water Solution Concentrate to 1 gal of water
TURKEYS Add 2 qts Sulfadimethoxine 12.5% Drinking Water Solution Concentrate to 6 qts of water
* 1 fl oz Sulfadimethoxine 12.5% Oral Solution -30mL or 2 tablespoonfuls.
**Set Proportioner to a feed rate of 1 fl oz of Sulfadimethoxine Stock Solution per gallon of water.
TREATMENT PERIOD – 5 consecutive days
DOSAGE: SULFADIMETHOXINE IN WATER
DAIRY CALVES 25 mg/lb first day WATER CONSUMPTION
DAIRY HEIFERS followed by (SUMMER) (WINTER)
AND BEEF 12.5 mg/lb/day 1 gallon/† 1 gallon/†
CATTLE for 4 days. 100 lb. b.w. 150 lb. b.w.
FIRST DAY ADD: 1 pint (16 fl oz) to: 25 gallons 16 gallons
1 quart (32 fl oz) to: 50 gallons 33 gallons
1 gallon (128 fl oz) to: 200 gallons 127 gallons
NEXT 4 ADD: 1 pint (16 fl oz) to: 50 gallons 33 gallons
1 quart (32 fl oz) to: 100 gallons 66 gallons
1 gallon (128 fl oz) to: 400 gallons 266 gallons
† Dosage recommendations are based on an estimated summer water intake of 1 gal of water for every 100 lb of body weight per day, and an estimated winter water intake of 1 gal of water for every 150 lb of body weight per day.
For individual treatment of cattle, Sulfadimethoxine 12.5% Oral Solution may be given as a drench. Administer using initial dose of 25 mg/lb followed by 4 maintenance doses of 12.5 mg/lb/day. One fl oz will medicate one 150 lb animal initially and ½ fl oz will medicate one 150 lb animal on maintenance dose.

 

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Sulfadimethoxine

Sulfadimethoxine

Sulfadimethoxine SOLUTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:59130-662
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
sulfadimethoxine Sulfadimethoxine 125 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59130-662-05 3785 in 1 JUG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200192 2012-04-05


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