DRAXXIN™ Injectable Solution(tulathromycin)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.
Approved Uses
DRAXXIN Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with
Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis.
Advantages
- DRAXXIN - The one-dose cure for complex swine respiratory disease (SRD).
- Tulathromycin, the active ingredient of DRAXXIN, is a novel antimicrobial from the triamilide class, developed by
Pfizer scientists specifically for swine respiratory disease.
- DRAXXIN provides excellent clinical efficacy against key bacterial pathogens that cause complex swine respiratory disease.
- A complete treatment of swine respiratory disease delivered in a single dose is clearly demonstrated by clinical data.
- Tulathromycin exhibits exceptional pharmacokinetics in swine:
- Rapid release from injection site and absorption into tissue
- Extensive distribution
- Slow elimination and excretion
- High, prolonged lung tissue concentrations
- Recent research indicates that immune cell accumulation is a powerful attribute of tulathromycin, with the drug
accumulating in alveolar macrophages and neutrophils and subsequently released slowly from such cell types.1
Figure 1. DRAXXIN moves to the lungs - the location of SRD
Clinical relevance of these data have not been determined.
- Peak lung tissue concentration of DRAXXIN far exceeded the peak plasma concentration of DRAXXIN, as shown in Figure 1.
- Tulathromycin attains high drug concentrations in the lung and persists for an extended period of time.
Figure 2. Prolonged activity of DRAXXIN
- DRAXXIN administered at 2.5 mg/kg IM provided effective single-dose treatment against pneumonia caused by an
experimental challenge with A. pleuropneumoniae under the conditions of the study.2
- A single dose of DRAXXIN compared favorably to a 3-day regimen of NAXCEL.
Packaging
DRAXXIN Injectable Solution is available in the following package sizes:
100 mL vial, Product Number 8174
250 mL vial, Product Number 8175
500 mL vial, Product Number 8176
Dosage and Administration
Inject intramuscularly as a single dose in the neck of swine at a dosage of 2.5 mg/kg (1 mL/88 lb) body weight (BW). Do
not inject more than 2.5 mL per injection site.
Table 1. DRAXXIN Swine Dosing Guide
Precautions
The effects of DRAXXIN 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.
Residue Warnings
FOR USE IN ANIMALS ONLY.
NOT FOR HUMAN USE.
KEEP OUT OF REACH OF CHILDREN.
NOT FOR USE IN CHICKENS OR TURKEYS.
Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.
Adverse Effects
In one field study, 1 out of 40 pigs treated with DRAXXIN at 2.5 mg/kg BW exhibited mild salivation that resolved in less
than 4 hours. The use of DRAXXIN Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.
Storage
Store at or below 25°C (77°F).
Contact Information
Adverse event reporting or technical inquiries should be directed to Pfizer Animal Health Product Support, 1-800-366-5288 (USA).
To request a material safety data sheet call 1-800-733-5500.
For additional DRAXXIN product information call:
1-888-DRAXXIN or visit the website: www.DRAXXIN.com.
References
1 Siegel TW, et al. Cellular uptake of the triamilide tulathromycin by bovine and porcine phagocytic cells in vitro. J
Anim Sci 2004; 82 (Suppl. 1):186.
2 McKelvie J, et al. Comparative efficacy of tulathromycin injectable solution (DRAXXIN) for the treatment of experimentally induced respiratory infections in swine. American Association of Swine
Veterinarians. Toronto, 2005.
Product Information - PDF File
Material Safety Data Sheet - English
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