Draxxin 25: Product Information

DRAXXIN 25- tulathromycin injection
Zoetis Inc.

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

DRAXXIN 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 DRAXXIN 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. DRAXXIN 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–methyl-4-C-[(propylamino) methyl]—L-ribohexopyrano-syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)- -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–methyl-4-C-[(propylamino)methyl]—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)- -D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Swine

DRAXXIN 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 — DRAXXIN 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. DRAXXIN 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) body weight (BW). Do not inject more than 11.5 mL per injection site.

Table 2. DRAXXIN 25 Calf Dosing Guide (25 mg/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 DRAXXIN 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 DRAXXIN 25 Injectable Solution. This drug is not for use in ruminating cattle.

PRECAUTIONS

Swine

The effects of Draxxin 25 Injectable Solution 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 Draxxin 25 Injectable Solution 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 DRAXXIN Injectable Solution (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 DRAXXIN Injectable Solution (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 DRAXXIN Injectable Solution (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 a complete listing of adverse reactions for DRAXXIN Injectable Solution or DRAXXIN 25 Injectable Solution reported to the CVM see: http://www.fda.gov/AnimalVeterinary.

CLINICAL PHARMACOLOGY

At physiological pH, tulathromycin (a weak base) is approximately 50 times more soluble in hydrophilic than lipophilic media. This solubility profile is consistent with the extracellular pathogen activity typically associated with the macrolides.1 Markedly higher tulathromycin concentrations are observed in the lung parenchyma as compared to the plasma, and these elevated concentrations can remain in lung tissue for several days beyond that which can be measured in the plasma. However the clinical relevance of these elevated lung concentrations is undetermined.

As a class, macrolides tend to be primarily bacteriostatic, but may be bactericidal against some pathogens.2 When acting as a cidal compound, they tend to exhibit concentration independent killing; the rate of bacterial eradication does not change once serum drug concentrations reach 2 to 3 times the minimum inhibitory concentration (MIC) of the targeted pathogen. Under these conditions, the time that serum concentrations remain above the MIC becomes the major determinant of antimicrobial activity. Macrolides also exhibit a post-antibiotic effect (PAE), the duration of which tends to be both drug and pathogen dependent. In general, by increasing the macrolide concentration and the exposure time, the PAE will increase to some maximal duration.3 Tulathromycin is eliminated from the body primarily unchanged via biliary excretion.

1 Carbon, C. 1998. Pharmacodynamics of Macrolides, Azalides, and Streptogramins: Effect on Extracellular Pathogens. Clin. Infect. Dis., 27:28-32.

2 Nightingale, C.J. 1997. Pharmacokinetics and Pharmacodynamics of Newer Macrolides. Pediatr. Infect. Dis. J., 16:438-443.

3 Andes D, Anon J, Jacobs MR, Craig WA. (2004). Application of pharmacokinetics and pharmacodynamics to antimicrobial therapy of respiratory tract infections. Clin Lab Med., 24:477-502.

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