Zuprevo™ 18%

Cattle

Therapeutic Class

Sub-species

Pharmaceutical Name
Tildipirosin

Overview
Zuprevo (tildipirosin) antibiotic — an effective new macrolide — concentrates in the lungs for 28 days1 and in bronchial fluid for 21 days1 to control and treat BRD.

Safety
A target animal safety study was conducted using Zuprevo™ 18% administered in 5-month-old cattle as three subcutaneous doses of 4, 12, or 20 mg/kg BW given 7 days apart (1X, 3X, and 5X the labeled dose). Animals remained clinically healthy during the study at the labeled dose. Injection site swelling and inflammation, initially severe in some animals, was observed that persisted to the last day of observation (21 days after injection). No other drug-related lesions were observed macroscopically or microscopically at the labeled dose.
A separate injection site tolerance study was conducted using Zuprevo™ 18% in 5- to 9-month-old cattle administered as a single subcutaneous injection of 10 mL. Injection site swelling and inflammation, initially severe in some animals, was observed that persisted to the last day of observation (35 days after injection). No other drug-related clinical signs were observed.

Description
Zuprevo™ 18% is a ready-to-use sterile injectable solution containing tildipirosin, a semi-synthetic macrolide antibiotic. Each mL of Zuprevo™ 18% contains 180 mg of tildipirosin as the free base, 82.5 mg citric acid monohydrate and 400 mg propylene glycol, and water qs with citric acid monohydrate added to adjust pH.

Indications
Zuprevo™18% is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle, and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Administration and Dosage
Inject subcutaneously as a single dose in the neck at a dosage of 4 mg/kg (1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site. Do not puncture the stopper of the respective vial size more than the tested number of punctures, shown in Table 1.
Clinical field studies indicate that administration of Zuprevo™ 18% (tildipirosin) Injectable Solution is effective for the control of respiratory disease in beef and non-lactating dairy cattle at “high risk” of developing BRD. Calves at high risk of developing BRD typically experience one or more of the following risk factors:
- Commingling from multiple sale barns/sources
- Extended transport times and shrink
- Exposure to wet or cold weather conditions or wide temperature swings
- Stressful arrival processing procedures (such as castration, dehorning, or branding)
- Recent weaning and poor vaccination history

Table 1 Number of punctures tested in the in-use study for the respective vial sizes

Vial size [mL]

Number of punctures tested in the in-use study

50

8

100

8

250

16

Caution

WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. TO AVOID ACCIDENTAL INJECTION, DO NOT USE IN AUTOMATICALLY POWERED SYRINGES WHICH HAVE NO ADDITIONAL PROTECTION SYSTEM. IN CASE OF HUMAN INJECTION, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THE PACKAGE INSERT OR LABEL TO THE PHYSICIAN.

Avoid direct contact with skin and eyes. If accidental eye exposure occurs, rinse eyes with clean water. If accidental skin exposure occurs, wash the skin immediately with soap and water. Tildipirosin may cause sensitization by skin contact.

For technical assistance or to report a suspected adverse reaction, call: 1-800-219-9286.

For customer service or to request a Material Safety Data Sheet (MSDS), call: 1-800-211-3573.

For additional Zuprevo™ 18% information go to www.zuprevo.com.

For a complete listing of adverse reactions for Zuprevo™ 18% reported to CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth.

DO NOT USE ZUPREVO 18% IN SWINE. Fatal adverse events have been reported following the use of tildipirosin in swine. NOT FOR USE IN CHICKENS OR TURKEYS.

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RESIDUE WARNING: Cattle intended for human consumption must not be slaughtered within 21 days of the last treatment. Do not use in female dairy cattle 20 months of age or older. Use of this drug product in these cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

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PRECAUTIONS:The effects of Zuprevo™ 18% on bovine reproductive performance, pregnancy and lactation have not been determined. Swelling and inflammation, which may be severe, may be seen at the injection site after administration. Subcutaneous injection may result in local tissue reactions which persist beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Supply Information

Zuprevo™ 18% is supplied in 50, 100 and 250 mL, amber glass, sterile, multi-dose vials.

Contact information

US only:

Merck Animal Health

livestocktechsrvc@merck-animal-health.com

1-800-211-3574

Website

http://usa.zuprevo.com/cattle/

Product Label(s) and MSDS

1Menge, M. et al., Pharmacokinetics of tildipirosin in bovine plasma, lung tissue, and bronchial fluid (from live, non-anesthetized cattle). J Vet Pharm Therap. Doj: 10.1111/J. 1365-2885, 2011. 1349.x. The correlation between pharmacokinetic data and clinical effectiveness is unknown