Concentrated combination antibiotic oral solution for poultry containing florfenicol (250 mg/ml) and colistin sulfate (0.5 MIU/ml). Provides broad-spectrum bactericidal activity against gram-negative and gram-positive bacteria with synergistic efficacy against E. coli, Salmonella, and Clostridium infections.
Product Name: FENICZONE-25
Type: Oral Liquid Solution - Antibiotic Combination
COMPOSITION
Each ml contains:
- Florfenicol (innovator specs) ...... 250 mg
- Colistin Sulfate BP ...... 0.5 MIU (500,000 International Units)
DESCRIPTION
FENICZONE-25 is a concentrated, broad-spectrum antibiotic oral solution combining florfenicol and colistin sulfate for the treatment of bacterial infections in poultry. This synergistic combination provides enhanced antibacterial activity against both gram-positive and gram-negative pathogens, making it an essential tool in poultry health management [citation:1].
Florfenicol is a synthetic broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit [citation:9]. Colistin sulfate (polymyxin E) is a polypeptide antibiotic that increases bacterial cell membrane permeability by interacting with phospholipids, leading to cell death [citation:1]. When combined, these two agents exhibit synergistic activity, with colistin facilitating florfenicol entry into bacterial cells for enhanced bactericidal effect, achieving a "1+1>2" synergy [citation:1].
MECHANISM OF ACTION
Florfenicol:
- Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit [citation:9]
- Blocks peptidyl transferase activity, preventing peptide bond formation
- Exhibits time-dependent bactericidal activity; low concentration bacteriostasis, high concentration bactericidal [citation:1]
Colistin Sulfate:
- Acts as a surface-active agent, disrupting bacterial cell membrane integrity [citation:1]
- Increases membrane permeability, leading to leakage of cellular contents
- Exhibits concentration-dependent bactericidal activity; promotes digestion and aids growth [citation:1]
Synergistic Combination:
- Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells [citation:1]
- The combination provides a "1+1>2" synergistic effect, enhancing bactericidal activity while expanding the antibacterial spectrum [citation:1]
- Simultaneous administration in a single formulation ensures both drugs reach target bacteria together, maximizing therapeutic efficacy [citation:5]
- Promotes feed utilization and reduces feed-to-egg ratio [citation:1]
INDICATIONS
FENICZONE-25 is indicated for the treatment and control of diseases caused by bacteria sensitive to florfenicol and colistin sulfate in poultry [citation:1].
Target Pathogens:
- Escherichia coli - including avian pathogenic E. coli (APEC) causing colibacillosis [citation:1]
- Salmonella spp. - including Salmonella Gallinarum (fowl typhoid) and Salmonella Pullorum (pullorum disease) [citation:1]
- Clostridium perfringens - causing necrotic enteritis and enterotoxic syndrome [citation:1]
- Pasteurella multocida - causing fowl cholera [citation:9]
- Shigella spp., Klebsiella spp. and other susceptible gram-negative bacteria [citation:1]
- Staphylococcus aureus and Streptococcus spp. [citation:3]
- Mycoplasma - against Mycoplasma gallisepticum and Mycoplasma synoviae
Disease Conditions:
- Necrotic Enteritis and Enterotoxic Syndrome - intractable diarrhea, red or black stool, undigested feed particles in stool, thinned intestinal wall with mucosal detachment [citation:1]
- Chronic Respiratory Disease (CRD) - complicated by bacterial infections
- Colibacillosis - E. coli infections causing airsacculitis, pericarditis, and perihepatitis [citation:9]
- Fowl Cholera - caused by Pasteurella multocida [citation:9]
- Fowl Typhoid and Pullorum Disease - Salmonella infections [citation:1]
- Pneumonia and Airsacculitis - bacterial respiratory infections
- White Dysentery - caused by Salmonella Pullorum [citation:1]
- Endocarditis and Yolk Sac Infections
ANTIMICROBIAL SPECTRUM
- Gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Pasteurella multocida, Klebsiella spp., Haemophilus paragallinarum [citation:1][citation:9]
- Gram-positive bacteria: Staphylococcus aureus, Streptococcus spp., Clostridium perfringens [citation:1][citation:3]
- Mycoplasma: Mycoplasma gallisepticum, Mycoplasma synoviae
- Note: Florfenicol shows excellent activity against bacteria that have developed resistance to chloramphenicol due to acetylation [citation:9]
DOSAGE & ADMINISTRATION
FENICZONE-25 is administered via drinking water. For optimal results, fresh solution should be prepared daily.
Recommended Dosage:
- Poultry (Broilers, Layers, Breeders, Turkeys, Ducks, Geese): 1 ml per 4-5 liters of drinking water
- Alternative Dose: 0.2-0.25 ml per liter of drinking water
- Duration: 3-5 consecutive days [citation:9]
- Dosage Calculation: At 1 ml/4L, each ml treats 4 liters of drinking water
Administration Guidelines:
- Calculate total daily water consumption based on flock size, age, and environmental temperature
- Prepare fresh medicated water daily; discard any unused solution after 24 hours
- Ensure medicated water is the only source of drinking water during treatment
- Clean water lines before and after treatment to prevent biofilm accumulation
- For best results, administer over 4-8 hours; may withhold water for 1-2 hours before treatment to encourage rapid consumption
- Note: For young chicks under 20 days of age, use with caution or reduce dosage
PHARMACOKINETIC PROPERTIES
- Absorption: Florfenicol is rapidly absorbed after oral administration, reaching therapeutic blood concentrations within 1 hour and peak concentrations at 1-3 hours [citation:9]
- Bioavailability: Approximately 80% or higher [citation:9]
- Distribution: Widely distributed throughout the body; can cross the blood-brain barrier [citation:9]
- Elimination: Primarily excreted unchanged in urine, with small amounts excreted in feces [citation:9]
EFFICACY DATA
Synergistic Activity:
- Research confirms that the combination of florfenicol and colistin provides superior bactericidal activity compared to either agent alone, with a "1+1>2" synergistic effect [citation:1]
- The combination is particularly effective against intestinal bacterial infections including E. coli, Salmonella, and Clostridium perfringens [citation:1]
- Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells for enhanced efficacy [citation:1]
Florfenicol Activity:
- Florfenicol demonstrates MIC and MBC values ≤1.6 μg/ml against common poultry pathogens, showing comparable or superior activity to chloramphenicol and significantly stronger activity than thiamphenicol [citation:3]
- Florfenicol produces longer post-antibiotic effects (PAE) against E. coli compared to thiamphenicol [citation:3]
- Studies show that florfenicol exhibits stronger antibacterial activity against E. coli than against S. aureus [citation:3]
Colistin Benefits:
- Not only provides low-concentration bacteriostasis and high-concentration bactericidal activity, but also promotes digestion, aids growth, improves feed utilization, and reduces feed-to-egg ratio [citation:1]
- Simultaneous administration in a single formulation ensures both drugs enter the body together, maximizing synergistic antibacterial action [citation:5]
DRUG INTERACTIONS
- Antagonistic: Macrolides and lincosamides share the same binding site (50S ribosomal subunit) and may produce antagonistic effects when used concurrently [citation:9]
- Potential antagonism: May antagonize the bactericidal activity of penicillins or aminoglycosides, though this has not been demonstrated in vivo [citation:9]
- Synergistic: Colistin enhances the efficacy of florfenicol by increasing bacterial cell membrane permeability [citation:1]
CONTRAINDICATIONS & PRECAUTIONS
- Egg production: Not for use in birds producing eggs for human consumption during treatment period (withdrawal period required). Laying hens should use with caution [citation:9]
- Young birds: Use with caution in chicks under 20 days of age; consult veterinary guidance
- Immunocompromised animals: Do not use in animals with severely compromised immune function or during vaccination periods [citation:9]
- Renal impairment: Dose reduction or extended dosing intervals may be necessary in animals with renal impairment [citation:9]
- Embryotoxicity: Has embryotoxic effects; use with caution in breeding animals [citation:9]
- Do not use in animals with known hypersensitivity to florfenicol, colistin, or polymyxin antibiotics
- Avoid concurrent use with other nephrotoxic drugs
- Keep out of reach of children
- Store in a cool, dry place away from direct sunlight
- Shake well before use
- Use within 28 days after first opening
WITHDRAWAL PERIOD
- Meat (Poultry): 5 days [citation:9]
- Eggs: Not for use in laying hens producing eggs for human consumption [citation:9]
- Fish: 375 degree-days [citation:9]
STORAGE
- Store in a cool, dry place below 30°C
- Protect from direct sunlight and freezing
- Keep container tightly closed when not in use
- Do not freeze
Target Species: Poultry (Broilers, Layers, Breeders, Turkeys, Ducks, Geese, Pigeons, Quail, Ornamental Birds)
Pack Sizes: 1 Liter HDPE bottle
PRODUCT SUMMARY
FENICZONE-25 Liquid Antibiotic Florfenicol innovator specs 250mg/ml, Colistin sulphate BP 0.5 MIU/ml Poultry 1 Liter
FOR VETERINARY USE ONLY