Increxxa: Product Information

INCREXXA- tulathromycin injection
Elanco US Inc.

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

Increxxa Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of Increxxa contains 100 mg of tulathromycin, 500 mg propylene glycol, 19.2 mg citric acid and 5 mg monothioglycerol. Sodium hydroxide or hydrochloric acid may be added to adjust pH. Increxxa 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.

Figure

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-hexopyranosyl]oxy]-2-ethyl-3,4,10- trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3(dimethylamino)-β-D-xylo-hexopyranosyl]-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-1methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)β-D-xylo-hexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Beef and Non-Lactating Dairy Cattle

BRD – Increxxa 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 – Increxxa Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Increxxa 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 – Increxxa Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica , P. multocida , H. somni , and M. bovis.

Swine

Increxxa 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. Increxxa 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. Increxxa 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

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