SUSTAIN III- sulfamethazine sustained release tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Sulfamethazine (UNII: 48U51W007F) (Sulfamethazine - UNII:48U51W007F)

Available from:

Durvet

INN (International Name):

Sulfamethazine

Composition:

Sulfamethazine 32.1 g in 34.53 g

Prescription type:

OTC

Therapeutic indications:

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.).

Authorization status:

New Animal Drug Application

Summary of Product characteristics

SUSTAIN III - SULFAMETHAZINE SUSTAINED RELEASE TABLET, EXTENDED
RELEASE
DURVET
----------
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.).
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.
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 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 b