Danofloxacin

Indications

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida in beef cattle and for the control of BRD in beef cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida .

Dosage and Administration

Care should be taken to dose accurately. Administered dose volume should not exceed 15 mL per injection site. Single-Dose Therapy (BRD Treatment and Control in Cattle at High Risk): Administer subcutaneously at 8 mg/kg of body weight (2 mL/100 lb) as a one-time injection. Multi-Day Therapy (BRD Treatment): Administer subcutaneously at 6 mg/kg of body weight (1.5 mL/100 lb) with this treatment repeated once approximately 48 hours following the first injection. ADVOCIN Dosage and Treatment Schedule Dose Volume (mL) Cattle Weight (lb) 6 mg/kg, given twice, 48 hours apart (treatment) 8 mg/kg given once (treatment and control in cattle at high risk) 50 0.75 1 100 1.5 2 150 2.25 3 200 3 4 250 3.75 5 300 4.5 6 400 6 8 500 7.5 10 600 9 12 700 10.5 14 800 12 16 Administered dose volume should not exceed 15 mL per injection site. 900 13.5 18 1000 15 20 * Administered dose volume should not exceed 15 mL per injection site. Clinical field studies indicate that ADVOCIN (danofloxacin injection) Sterile Injectable Solution is effective for the control of respiratory disease in beef cattle at high risk of developing BRD. Cattle 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 or poor vaccination history RESIDUE WARNINGS Animals intended for human consumption must not be slaughtered within 4 days from the last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. HUMAN WARNINGS For use in animals only. Keep out of reach of children . Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight. To report adverse reactions or to obtain a copy of the Safety Data Sheet (SDS), call 1-888-963-8471.

Precautions

The effects of danofloxacin 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. Quinolone-class drugs should be used with caution in animals with known or suspected central nervous system (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation, which may lead to convulsive seizures. Quinolone-class drugs have been shown to produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature, rapidly growing animals of various species. Refer to Animal Safety for information specific to danofloxacin.

Adverse Reactions

A hypersensitivity reaction was noted in 2 healthy calves treated with ADVOCIN in a laboratory study. In one location of a multi-site field trial, one out of the 41 calves treated with 6 mg/kg q 48 hours showed lameness on Day 6 only. In this same field trial location one of 38 calves treated with 8 mg/kg once became lame 4 days after treatment and remained lame on the last day of the study (Day 10). Another calf in the same treatment group developed lameness on the last day of the study.

Description

ADVOCIN is a sterile injectable solution containing danofloxacin mesylate, a synthetic fluoroquinolone antimicrobial agent. Danofloxacin mesylate is the non-proprietary designation for (1S)-1cyclopropyl-6-fluoro-1,4-dihydro-7-(5-methyl-2,5-diazabicyclo [2.2.1]hept-2-yl)-4-oxo-3-quinolone carboxylic acid monomethanesulfonate. The empirical formula is C 19 H 20 FN 3 O 3 • CH 3 SO 3 H and the molecular weight is 453.49. Figure 1. The chemical structure of danofloxacin mesylate. Each mL contains 180 mg of danofloxacin as the mesylate salt, 200 mg 2-pyrrolidone, 50 mg polyvinyl pyrrolidone, 20.3 mg heavy magnesium oxide, 2.5 mg phenol, 5 mg monothioglycerol, hydrochloric acid or sodium hydroxide as needed to adjust pH, nitrogen headspace and water for injection, q.s. Chemical Structure

Storage

Store at or below 30°C (86°F). Use this product within 28 days of the first puncture and puncture a maximum of 7 times. If more than 7 punctures are anticipated, the use of automatic injection equipment or a repeater syringe is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any product remaining in the vial immediately after use. Protect from light. Protect from freezing. The color is yellow to amber and does not affect potency.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming danofloxacin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.