Is Zuprevo An Antibiotic?

ZUPREVO is a clear yellowish ready-to-use sterile injectable solution containing tildipirosin, a semi-synthetic macrolide antibiotic. Each mL of ZUPREVO contains: ACTIVE INGREDIENT: 180.0 mg of tildipirosin as the free base; NON-MEDICINAL INGREDIENTS: citric acid monohydrate, propylene glycol, and water qs.

Zuprevo Indications

ZUPREVO is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. ZUPREVO is also indicated for the reduction of morbidity associated with BRD in feedlot calves, caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, during the first 14 days in the feedlot, when administered at the time of arrival.

Dosage and Administration

ZUPREVO should be administered in the neck of cattle by a single subcutaneous injection at a dose rate of 4 mg/kg body weight (1 mL/45 kg). Do not inject more than 10 mL into a single site. Do not puncture the stopper more than 20 times. Most animals will respond to treatment within 3 to 5 days. If no improvement is observed, the diagnosis should be re-evaluated.

Note: To limit the development of antimicrobial resistance, ZUPREVO should only be used as an arrival treatment in feedlot calves when BRD has been diagnosed and calves are 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 sales barns/sources; extended transport times and shrink; exposure to wet or cold weather conditions or wide temperature swings; and, recent weaning and poor vaccination history.

CONTRA-INDICATIONS: ZUPREVO is contraindicated in animals previously found to be hypersensitive to macrolide antibiotics. Do not use concurrently with other macrolides as cross-resistance may occur.

Injection De Tildipirosine

Warnings

Treated animals must not be slaughtered for use in food for at least 42 days after the latest treatment with this drug. Do not use in female dairy cattle 20 months of age or older. To limit the development of antimicrobial resistance, ZUPREVO should only be used as an arrival treatment in feedlot calves when BRD has been diagnosed and calves are at high risk of developing BRD.

Tildipirosin may cause sensitization by skin contact. Avoid direct contact with skin, eyes and clothes. In case of accidental eye exposure, flush with water for 15 minutes. If accidental skin exposure occurs, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Wash hands after use. Special precaution should be taken to avoid self-injection. In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician. Do not use in automatically powered syringes which have no additional protection system. Keep out of the reach of children.

Adverse Reactions

Swelling and inflammation at the injection site, which may be severe, is commonly observed after administration and can cause transient signs of pain in cattle. As with other macrolide antibiotics, individual hypersensitivity reactions may occur.

Clinical Pharmacology

ZUPREVO is a 16-membered, tribasic semi-synthetic macrolide antibiotic. Tildipirosin has shown in vitro and in vivo antibacterial activity against the bacteria Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, three pathogens associated with bovine respiratory disease (BRD). Similar to other macrolides, tildipirosin inhibits essential bacterial protein biosynthesis with selective binding to ribosomal subunits in a bacteriostatic and time-dependent manner. Tildipirosin may be bactericidal against certain isolates of Mannheimia haemolytica and Pasteurella multocida.