Draxxin 100mg
Ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. For SQ injection in beef and non-lactating dairy cattle and IM injection in swine only.
CATTLE: Indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (Haemophilus somnus), and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. Also indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
SWINE: Indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae.
Draxxin®
Zoetis
(tulathromycin injection)
Injectable Solution
Antibiotic
100 mg of tulathromycin/mL
For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
DRAXXIN Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of DRAXXIN contains 100 mg of tulathromycin as the free base in a 50% propylene glycol vehicle, monothioglycerol (5 mg/mL), with citric and hydrochloric acids added to adjust pH.
DRAXXIN consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio. Structures of the isomers are shown below.
Figure 1.
INDICATIONS
Beef and Non-lactating Dairy Cattle
BRD - DRAXXIN Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.
IBK - DRAXXIN Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.
Foot Rot - DRAXXIN Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.
Suckling Calves, Dairy Calves, and Veal Calves
BRD - DRAXXIN Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis.
Swine
DRAXXIN Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
DOSAGE AND ADMINISTRATION
Cattle
Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.
Table 1. DRAXXIN Cattle Dosing Guide
|
Animal Weight (Pounds)
|
Dose Volume (mL)
|
|
100
|
1.1
|
|
200
|
2.3
|
|
300
|
3.4
|
|
400
|
4.5
|
|
500
|
5.7
|
|
600
|
6.8
|
|
700
|
8.0
|
|
800
|
9.1
|
|
900
|
10.2
|
|
1000
|
11.4
|
Swine
Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.
Table 2. DRAXXIN Swine Dosing Guide
|
Animal Weight (Pounds)
|
Dose Volume (mL)
|
|
15
|
0.2
|
|
30
|
0.3
|
|
50
|
0.6
|
|
70
|
0.8
|
|
90
|
1.0
|
|
110
|
1.3
|
|
130
|
1.5
|
|
150
|
1.7
|
|
170
|
1.9
|
|
190
|
2.2
|
|
210
|
2.4
|
|
230
|
2.6
|
|
250
|
2.8
|
|
270
|
3.1
|
|
290
|
3.3
|
CONTRAINDICATIONS
The use of DRAXXIN Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.
WARNINGS
FOR USE IN ANIMALS ONLY.
NOT FOR HUMAN USE.
KEEP OUT OF REACH OF CHILDREN.
NOT FOR USE IN CHICKENS OR TURKEYS.
STORAGE CONDITIONS
Store at or below 25°C (77°F)
HOW SUPPLIED
DRAXXIN Injectable Solution is available in the following package sizes:
50 mL vial
100 mL vial
250 mL vial
500 mL vial
NADA 141-244, Approved by FDA
Distributed by: Zoetis Inc., Kalamazoo, MI 49007
To report a suspected adverse reaction or to request a safety data sheet call 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at https://www.fda.gov/AnimalVeterinary/SafetyHealth.
