Animal NDC 13985-750-22 Florcon
Florfenicol

Animal Product Information

Field Name Field Value
Animal NDC Code 13985-750-22
Proprietary Name Florcon What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Florfenicol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Mwi Veterinary Supply
Product Type Prescription Animal Drug
Usage Information
    INDICATIONS: FLORCON 2.3% Concentrate Solution is indicated for the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.
Active Ingredient(s)
  • Florfenicol
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200589 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Florcon Images

Florcon Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



FLORCON

(FLORFENICOL) An Antimicrobial

2.3% Concentrate Solution

For Oral Use in Swine Drinking Water Only.

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

ANADA #200-589, Approved by FDA.

For use in Animals Only

IMPORTANT: See Product Information sheet for complete directions and warnings before using.

Distributed By: MWI

Boise, ID 83705

www.VetOne.net

Rev. Date: 02/17


Description



DESCRIPTION: Florfenicol (Oral Concentrate) is a synthetic broad-spectrum antibiotic. Each milliliter (mL) of FLORCON 2.3% Concentrate Solution contains 23 mg florfenicol.


Indications & Usage



INDICATIONS: FLORCON 2.3% Concentrate Solution is indicated for the treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis in swine.


Dosage & Administration



DOSAGE AND ADMINISTRATION:

For Proportioner: To produce drinking water with a final concentration of 400 mg/gallon (100 ppm): Fill the bottle of FLORCON 2.3% Concentrate Solution with water to the fill line.  Add the contents of the bottle to the mixing tank. Mix thoroughly. Confirm that the proportioner is set to deliver 1:128 (0.8%).  Turn on the proportioner. Verify that the drinkers are operational.

For Bulk Tank: To produce drinking water with a final concentration o f 400 mg/gallon (100 ppm): Add the FLORCON 2.3% Concentrate Solution to the drinking water in the bulk tank. Use one bottle of FLORCON 2.3% Concentrate Solution for every 128 gallons of water.

The medicated water should be administered as the only source of drinking water for five (5) consecutive days. Medication should be initiated promptly when swine respiratory disease is diagnosed.


Precautions



PRECAUTIONS: Do not use this product at any other proportioner setting. This will result in precipitation of product. This product is not recommended for use in automatic water proportioners if water hardness is greater than 275 ppm. Water proportioners should be tested for accuracy before use. Do not use or store this product in galvanized metal watering systems or containers. Do not operate chlorinators while administering medication.

PRECAUTION: The effects of FLORCON 2.3% Concentrate Solution on swine reproductive performance, pregnancy, and lactation have not been determined. Do not use in swine intended for breeding.


Warnings



WARNINGS: NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product contains material that can be irritating to skin and eyes. Avoid direct contact with skin, eyes, and clothes. 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. The Safety Data Sheet (SDS) contains more detailed occupational safety information.

For customer service and/or a copy of the SDS, call 1-800-587-4306.

For adverse effects reporting, call 1-800-587-4306.


Adverse Reactions



ADVERSE REACTION: Perianal inflammation may occur transiently following treatment.


Clinical Pharmacology



CLINICAL PHARMACOLOGY: Florfenicol is a bacteriostatic agent whose antimicrobial activity is linked to time above MIC.

The pharmacokinetic disposition of FLORCON 2.3% Concentrate Solution was evaluated in swine following oral gavage dosing (15 mg/kg), intravenous (IV) dosing (15 mg/kg), and during a five (5) day course of ad libitum administration in drinking water (100 ppm) (Table 1).  Despite the rapid elimination seen after IV injection or oral gavage dosing, when administered in medicated drinking water, florfenicol concentrations in the serum of most swine were maintained well above 1.0 mcg/mL for the majority of the (5) day dosing interval. These results are consistent with product effectiveness when administered in drinking water concentrations of 100 ppm over a five (5) day dosing period.

Although the extent of oral drug absorption (F) tended to be variable (24% to 97% following a single oral gavage dose), florfenicol was rapidly absorbed.  Its terminal elimination half-life (T1/2) was also rapid, ranging between two (2) to three (3) hours.

The average systemic clearance (CLB) following IV administration was 5.6 mL/kg/min. Since the florfenicol steady state volume of distribution (VDSS) closely approximates that of total body water, peripheral tissue concentrations are expected to be similar to those concentrations observed in serum.

Table 1. Pharmacokinetic Parameter Values of Florfenicol

following IV or Gavage Dosing

Parameter

Mean Value (% CV)

Vdssa (L/kg)

0.95 (6)

CLBa (mL/kg/min)

5.57 (11)

T ½a (hrs)

2.2 (14)

Fb (%)

24-97

aparameter estimate based on intravenous data

bparameter range based upon a single oral gavage dose


Microbiology



MICROBIOLOGY: Florfenicol is a synthetic broad-spectrum antibiotic active against many gram-negative and gram-positive bacteria isolated from domestic animals.  It acts by inhibiting bacterial protein synthesis.  In vivo and in vitro activity has been demonstrated against commonly isolated pathogens involved in swine respiratory disease including Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.

The minimum inhibitory concentration (MIC) of florfenicol was determined for isolates obtained from natural respiratory infections of swine from  1990-2001 (Table 2).  Susceptibility testing followed the methods of the National Committee of Clinical Laboratory Standards.  Reference strains included Escherichia coli ATCC 25922 with a QC range of 2-8 mcg/mL and Actinobacillus pleuropneumoniae ATCC 27090 with a QC range of 0.25-1 mcg/mL.

Table 2. MIC Values of Florfenicol Against

 Bacterial Isolates from Swine

Organism

     Isolate

     Numbers

     MIC90 *

    (mcg/mL)

    MIC Range

    (mcg/mL)

Actinobacillus

pleuropneumoniae

     360

    0.50

    ≤0.125-2.0

Pasteurella multocida

     335

    0.50

    ≤0.125-2.0

Salmonella

choleraesuis

     46

    4.0

    2.0-4.0

Streptococcus suis

     203

    2.0

    0.5-2.0

*The minimum inhibitory concentration for 90 % of the isolates.


Animal Pharmacology & Or Toxicology



ANIMAL SAFETY: A target animal safety study was conducted to evaluate the tolerance and effects of florfenicol when orally administered to swine via the drinking water at a rate of 400, 1200, and 2000 mg/gal (1x, 3x, or 5x the clinical dose) for fifteen (15) to sixteen (16) consecutive days (3x the clinical duration), and at 4000 mg/gal (10x clinical dose) for five (5) to six (6) consecutive days (1x the clinical duration).  

Transient treatment-related constipation and anal swelling were seen in the 3x, 5x, and 10x treatment groups.  The constipation in these groups was attributed in part to decreased water consumption during the medication period.  There was a decrease in weight gains for the 3x, 5x, and 10x treatment groups compared with the nonmedicated control group.  Transient treatment-related decreases in feed consumption were seen in the 3x, 5x, and 10x treatment groups compared with the nonmedicated control group.  Transient treatment-related decreases in water consumption were noted in all test article-treated groups (1x, 3x, 5x, and 10x) compared with the nonmedicated control group.

The results show that FLORCON 2.3% Concentrate Solution can be safely administered to swine according to the recommended clinical regimen of 400 mg/gal in the drinking water for five (5) consecutive days. 


Storage And Handling



STORAGE CONDITIONS: Store Between 2°- 25°C (36°–77°F).


How Supplied



HOW SUPPLIED: FLORCON 2.3% Concentrate Solution is supplied in one gallon plastic bottles with 2.2 liter fill.


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.