SUSTAIN III- sulfamethazine sustained release tablet, extended release

Drug Labeling and Warnings

Drug Details [pdf]

DESCRIPTION

EACH BOLUS CONTAINS:

Sulfamethazine (formulated in a sustained release base)...........495 grains (32.1 grams)

Sustain III® Boluses (Sulfamethazine Sustained Release Boluses) are intended for oral administration to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement).  Sustain III® Boluses are indicated for the treatment of the following diseases when caused by one or more of the following pathogenic organisms sensitive to sulfamethazine:

Bacterial Pneumonia and Bovine Respiratory Disease Complex (Shipping Fever Complex) (Pasteurella spp.), Colibacillosis (Bacterial Scours) (E. coli), Necrotic pododermatitis (Food rot), Calf Diphtheria (Fusobacterium necrophorum), and Acute Metritis (Streptococcus spp.).

PRECAUTIONS

CAUTION: This drug, like all sulfonamides, may cause toxic reactions and irreparable injury unless administered with adequate and continuous supervision; follow the recommended dosages carefully. 

WARNINGS

RESIDUE WARNING: Treated animals intended for human consumption should not be slaughtered for food for at least 12 days after the last dose.  Exceeding two (2) consecutive doses may cause violative tissue residues to remain beyond the withdrawal time.  Do not use in female dairy cattle 20 months of age or older.  Use of sulfamethazine in this class of cattle may cause milk residues.  Do not use in calves under one (1) month of age or calves being fed an all-milk diet.  Use in these classes of calves may cause violative residues to remain beyond the withdrawal time. 

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Sustain III® Boluses (Sulfamethazine Sustained Release Boluses) are designed to be administered orally to beef cattle and non-lactating dairy cattle (See RESIDUE WARNING Statement). Sustain III® Boluses should be given according to the following dosage schedule:

No. of bolusesAnimal Body Weight

 1                                        200 lbs.

 1.5                                     300 lbs.

 2                                       400 lbs.

 2.5                                    500 lbs.

 3                                       600 lbs.

 3.5                                    700 lbs.

 4                                       800 lbs.

 4.5                                    950 lbs.

 5                                    1,000 lbs.

This bolus may be divided for better approximation of correct dose; however, care should be taken not to crush the bolus.  Care should also be taken to ensure the entire dose has been swallowed by the animal.  Observe animals following administration to ensure boluses are not regurgitated.  Lubricate Sustain III® before dosing animals. 

Sustain III® Boluses are designed to provide a therapeutic sulfamethazine level in approximately 6 hours and persist in providing this level for 72 hours (3 days).  After 72 hours, all animals should be re-examined for persistence of observable disease signs. 

If signs are present, consult a veterinarian.  It is strongly recommended that a second dose be given to provide for an additional 72 hours of therapy, particularly in those more severe cases.  The above dosage schedule should be used at each 72-hour interval.

Fluid intake must be adequate at all times throughout the three-day therapy provided by the sustained release bolus. 

STORAGE AND HANDLING

Store at 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

SUSTAIN III  
sulfamethazine sustained release tablet, extended release

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 30798-109
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfamethazine (UNII: 48U51W007F) (Sulfamethazine - UNII:48U51W007F)	Sulfamethazine	32.1 g  in 34.53 g

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	83mm
Flavor		Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30798-109-69	1726.5 g in 1 BOX
2	NDC: 30798-109-70	3453 g in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA120615	07/14/1981

Labeler - Durvet (056387798)

Registrant - Bimeda, Inc. (060492923)

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