Increxxa 25: Product Information

INCREXXA 25- tulathromycin injection
Elanco US Inc.

Injectable Solution
Antibiotic
25 mg of tulathromycin/mL

For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Increxxa 25 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 25 contains 25 mg of tulathromycin as the free base in a 50% propylene glycol vehicle, monothioglycerol (5 mg/mL), citric acid (4.8 mg/mL) with hydrochloric acid and sodium hydroxide added to adjust pH. Increxxa 25 consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio. 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-ribohexopyrano-syl]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-ribohexopyrano-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-xylo-hexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Swine

Increxxa 25 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.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Increxxa 25 Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

DOSAGE AND ADMINISTRATION

Swine

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) Body Weight (BW). Do not inject more than 4 mL per injection site.

Table 1. Increxxa 25 Swine Dosing Guide (25 mg/mL)

Animal Weight (Pounds)

Dose Volume (mL)

4

0.2

10

0.5

15

0.7

20

0.9

22

1.0

25

1.1

30

1.4

50

2.3

70

3.2

90

4.0

Calves

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) BW. Do not inject more than 11.5 mL per injection site.

Table 2. Increxxa 25 Calf Dosing Guide (25mg/mL)

Animal Weight (Pounds)

Dose Volume (mL)

50

2.3

75

3.4

100

4.5

150

7.0

200

9.0

250

11.5

CONTRAINDICATIONS

The use of Increxxa 25 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

Swine

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

Calves

Calves intended for human consumption must not be slaughtered within 22 days from the last treatment with Increxxa 25 Injectable Solution. This drug is not for use in ruminating cattle.

PRECAUTIONS

Swine

The effects of tulathromycin injection 25 mg/mL on porcine reproductive performance, pregnancy, and lactation have not been determined.
Intramuscular injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.

Cattle

The effects of tulathromycin injection 25 mg/mL on bovine reproductive performance, pregnancy, and lactation have not been determined.
Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter

ADVERSE REACTIONS

Swine

In one field study, one out of 40 pigs treated with tulathromycin injection 100 mg/mL at 2.5 mg/kg BW exhibited mild salivation that resolved in less than four hours.

Calves

In one BRD field study, two calves treated with tulathromycin injection 100 mg/mL at 2.5 mg/kg BW exhibited transient hypersalivation. One of these calves also exhibited transient dyspnea, which may have been related to pneumonia.

Post Approval Experience

The following adverse events are based on post approval adverse drug experience reporting for tulathromycin injection 100 mg/mL. Not all adverse events are reported to the FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of reporting frequency in cattle: Injection site reactions and anaphylaxis/anaphylactoid reactions. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS or http://www.fda.gov/reportanimalae.

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