Draxxin: Product Information

DRAXXIN- tulathromycin injection, solution
Zoetis Inc.

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.

Chemical Structure
(click image for full-size original)

The chemical names of the isomers are (2R,3S, 4R,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-Ο-methyl-4-C-[(propylamino) methyl]-α-L-ribo-hexopyrano-syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylohexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-one and (2R, 3R,6R, 8R,9R,10S,11S,12R)-11-[[2,6-dideoxy-3-C-methyl- 3-Ο-methyl-4-C-[(propylamino)methyl]-α-L-ribo-hexopyrano-syl]oxy]-2-[(1R,2R)-1,2-dihydroxy-1-methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Beef and Non-Lactating Dairy Cattle

BRDDRAXXIN 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.

RESIDUE WARNINGS

Cattle

Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. Do not use in female dairy cattle 20 months of age or older.

Swine

Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.

Page 1 of 4 1 2 3 4

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2024. All Rights Reserved.