DURAMYCIN- tetracycline hydrochloride powder

Duramycin by

Drug Labeling and Warnings

Duramycin by is a Animal medication manufactured, distributed, or labeled by Durvet, Bimeda, Inc., Ningxia Qiyuan Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

INDICATIONS:  For use in the control and treatment of the following conditions in swine, calves and poultry.

FOR SWINE AND CALVES

INDICATIONS:  Use for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli; bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp. and Klebsiella spp. sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL:  Use soluble powder in the drinking water at a drug level of tetracycline hydrochloride per gallon to provide 10 mg/lb of body weight per day in divided doses.

RESIDUE WARNING

RESIDUE WARNING:  SWINE - Do not slaughter animals for food purposes within 4 days of treatment.

CALVES - Do not slaughter animals for food purposes within 5 days of treatment.  A withdrawal period has not been established for this product in pre-ruminating calves.

Do not use in calves to be processed for veal.

INDICATIONS & USAGE

CAUTION:  Do not use for more than 5 consecutive days.

DIRECTIONS FOR USE:  Administer for 3-5 days.

FOR CHICKENS

INDICATIONS:  Use for the control of chronic respiratory disease (CRD) and air sac disease caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL:  CRD and air sac disease:  Use soluble powder in the drinking water at a drug level of 400-800 mg tetracycline hydrochloride per gallon.  Infectious synovitis:  Use soluble powder in the drinking water at a drug level of 200-400 mg tetracycline hydrochloride per gallon.

FOR TURKEYS

INDICATIONS:  Use for the control of infectious synovitis caused by Mycoplasma synoviae; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms sensitive to tetracycline hydrochloride.

RECOMMENDED DOSAGE LEVEL:  Infectious synovitis:  Use soluble powder in the drinking water at a drug level of 400 mg tetracycline hydrochloride per gallon.  Bluecomb:  Use soluble powder in the drinking water at a drug level of tetracycline per gallon to provide 25 mg/lb of body weight per day in divided doses.

RESIDUE WARNING

RESIDUE WARNING:  Do not slaughter birds for food within 4 days of treatment.

CAUTION: Not for use in turkeys or chickens producing eggs for human consumption. Do not use for more than 14 consecutive days.

DIRECTIONS FOR USE: Administer for 7-14 days. Medicate at first clinical signs of disease or when experience indicates the disease may be a problem.

GENERAL PRECAUTIONS

CAUTION:  Not for use in turkeys or chickens producing eggs for human consumption.  Do not use for more than 14 consecutive days.

DIRECTIONS FOR USE:  Administer for 7-14 days.  Medicate at first clinical signs of disease or when experience indicates the disease may be a problem.

DOSAGE & ADMINISTRATION

MIXING DIRECTIONS

FOR SWINE, CALVES AND TURKEYS:  2.52 oz. (two scoops) dissolved in 500 mL (approximately 17 fl. oz.) of warm will provide a stock solution of 100 mg of tetracycline hydrochloride activity per mL.

FOR TURKEYS ONLY:  This stock solution when metered at approximately 1 oz. per gallon will provide drinking water containing 2,957 mg of tetracyline hydrochloride activity per gallon.

The contents of two scoops are sufficient to deliver the recommended daily dosage levels as follows:

At 25 mg/lb of body weight ....... 2,040 total lbs. of turkeys to be medicated.

At 10 mg/lb of body weight ....... 5,100 total lbs. of swine or calves to be medicated.

Individual calf treatment ........... 5 mL (1 measuring teaspoonful) twice daily for each 100 lbs. of body weight administered as a drench or by dose syringe.

FOR CHICKENS AND TURKEYS:  To arrive at the recommended dosages, use the contents of 2 scoops to prepare stock solutions as follows:

200 mg/gallon - dissolve 2 scoops (2.52 oz.) in 7,570 mL warm water (2 gallons)

400 mg/gallon - dissolve 2 scoops (2.52 oz.) in 3,785 mL warm water (1 gallon)

800 mg/gallon - dissolve 2 scoops (2.52 oz.) in 1,892 mL warm water (0.5 gallon)

These stock solutions should then be metered into drinking water at approximately 1 oz. per gallon.

At 200-800 mg/gallon two scoops will provide 63.8 to 255 gallons of medicated drinking water.

SPECIAL DIRECTIONS FOR BABY CALVES AND BABY PIGS:

Administer this product one hour before or two hours after feeding milk or milk replacers.  Provide clean (unmedicated) drinking water at all times.

NOTE:  When using a watering trough, this product is to be administered twice a day in the drinking water of swine, calves and poultry.  One-half of the recommended daily dosage level of antibiotic is to be consumed during each administration period, thus providing the drug to treat 162,000 total pounds of swine or calves for a single day at the recommended dosage level of 10 mg/lb of body weight in divided doses.  Or the contents of this container will treat 64,800 lbs of turkeys when supplied at 25 mg/lb or at 200-800 mg/gallon will provide 2,025 to 8,100 gallons of medicated drinking water for chickens or turkeys.

STORAGE AND HANDLING

Store at controlled room temperature 20°C - 25°C (68°F - 77°F), with excursions permitted to 15°C - 30°C (59°F - 86°F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DURAMYCIN 
tetracycline hydrochloride powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 30798-842
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRACYCLINE HYDROCHLORIDE (UNII: P6R62377KV) (TETRACYCLINE - UNII:F8VB5M810T)	TETRACYCLINE HYDROCHLORIDE	1620 g  in 2.27 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30798-842-44	2.27 kg in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200374	09/13/2005

Labeler - Durvet (056387798)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda, Inc.		060492923	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Ningxia Qiyuan Pharmaceutical Co., Ltd.		528397169	api manufacture