Loncor 300: Product Information

LONCOR 300- florfenicol injection, solution
Elanco US Inc.

For intramuscular and subcutaneous use in beef and non-lactating dairy cattle only

Not for use in female dairy cattle 20 months of age or older or in calves to be processed for veal

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

LONCOR™ 300 Injectable Solution is a solution of the synthetic antibiotic florfenicol. Each milliliter of sterile LONCOR™ 300 contains 300 mg of florfenicol, 250 mg N-Methyl-2-pyrrolidone, 150 mg propylene glycol, and polyethylene glycol qs.

INDICATIONS

LONCOR™ 300 is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni , and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni.

DOSAGE AND ADMINISTRATION

For treatment of bovine respiratory disease (BRD) and bovine interdigital phlegmon (foot rot): LONCOR™ 300 should be administered by intramuscular injection to cattle at a dose rate of 20 mg/kg body weight (3 mL/100 lbs). A second dose should be administered 48 hours later. Alternatively, LONCOR™ 300 can be administered by a single subcutaneous (SC) injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

NOTE: Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

For control of respiratory disease in cattle at high risk of developing BRD: LONCOR™ 300 should be administered by a single subcutaneous injection to cattle at a dose rate of 40 mg/kg body weight (6 mL/100 lbs). Do not administer more than 10 mL at each site. The injection should be given only in the neck.

LONCOR™ 300 DOSAGE GUIDE
ANIMALWEIGHT (lbs) IMLONCOR 300 DOSAGE3.0 mL/100 lb Body Weight(mL) SC LONCOR 300DOSAGE6.0 mL/100 lbBody Weight (mL)
100 3.0 6.0
200 6.0 12.0
300 9.0 18.0
400 12.0 24.0
500 15.0 30.0
600 18.0 36.0
700 21.0 42.0
800 24.0 48.0
900 27.0 54.0
1000 30.0 60.0

Clinical improvement should be evident in most treated subjects within 24 hours of initiation of treatment. If a positive response is not noted within 72 hours of initiation of treatment, the diagnosis should be re-evaluated.

RECOMMENDED INJECTIONLOCATION

Figure

Do not inject more than 10 mL per injection site.

CONTRAINDICATIONS

Do not use in animals that have shown hypersensitivity to florfenicol.

WARNINGS:

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN.

This product contains materials that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothing. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. Consult a physician if irritation persists. Accidental injection of this product may cause local irritation. Consult a physician immediately. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For customer service, adverse effects reporting, and/or a copy of the SDS, call 1-800-422-9874.

PRECAUTIONS

Not for use in animals intended for breeding purposes. The effects of florfenicol on bovine reproductive performance, pregnancy, and lactation have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy. Intramuscular injection may result in local tissue reaction which persists beyond 28 days. This may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck is likely to be more severe.

RESIDUE WARNINGS

Animals intended for human consumption must not be slaughtered within 28 days of the last intramuscular treatment. Animals intended for human consumption must not be slaughtered within 38 days of subcutaneous treatment. This product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or calves born to these cows. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal.

ADVERSE REACTIONS

Inappetence, decreased water consumption, or diarrhea may occur transiently following treatment.

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Elanco at 1-800-422-9874. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY

The pharmacokinetic disposition of florfenicol was evaluated in feeder calves following single intramuscular (IM) administration at the recommended dose of 20 mg/kg body weight. Florfenicol was also administered intravenously (IV) to the same cattle in order to calculate the volume of distribution, clearance, and percent bioavailability1 (Table 1).

TABLE 1. Pharmacokinetic Parameter Values for Florfenicol Following IM Administration of 20 mg/kg Body Weight to Feeder Calves (n=10).

* harmonic mean

** mean value

*** following IV administration

Cmax Maximum serum concentration

Tmax Time at which Cmax is observed

T 1/2 Biological half-life

AUC Area under the curve

Vdss Volume of distribution at steady state

Clt Total body clearance

Parameter Median Range
Cmax (μg/mL) 3.07* 1.43 — 5.60
Tmax (hr) 3.33 0.75 — 8.00
T 1/2 (hr) 18.3** 8.30 — 44.0
AUC (μg•min/mL) 4242 3200 — 6250
Bioavailability (%) 78.5 59.3 — 106
Vdss (L/kg)*** 0.77 0.68 — 0.85
Clt (mL/min/kg)*** 3.75 3.17 — 4.31

Florfenicol was detectable in the serum of most animals through 60 hours after intramuscular administration with a mean concentration of 0.19 μg/mL. The protein binding of florfenicol was 12.7%, 13.2%, and 18.3% at serum concentrations of 0.5, 3.0, and 16.0 μg/mL, respectively.

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