Concentrated combination antibiotic oral solution for poultry containing 10% florfenicol (100 mg/ml) and 2.5% colistin sulfate (25 mg/ml). Provides synergistic broad-spectrum bactericidal activity against gram-negative and gram-positive bacteria, particularly effective against E. coli, Salmonella, and Clostridium infections.
Product Name: FENICZONE-12
Type: Oral Liquid Solution - Antibiotic Combination
COMPOSITION
Each 100 ml contains:
- Florfenicol (innovator specs) ...... 10 g (10% w/v, 100 mg/ml)
- Colistin Sulfate BP ...... 2.50 g (2.5% w/v, 25 mg/ml)
DESCRIPTION
FENICZONE-12 is a concentrated, broad-spectrum antibiotic oral solution combining florfenicol (10%) and colistin sulfate (2.5%) 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
Florfenicol is a synthetic broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. Florfenicol does not carry the risk of inducing human aplastic anemia associated with chloramphenicol and also has activity against some chloramphenicol-resistant strains of bacteria . Colistin sulfate (polymyxin E) is a polypeptide antibiotic that increases bacterial cell membrane permeability by interacting with phospholipids, leading to cell death . 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
MECHANISM OF ACTION
Florfenicol:
- Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit
- Blocks peptidyl transferase activity, preventing peptide bond formation
- Exhibits time-dependent bactericidal activity; low concentration bacteriostasis, high concentration bactericidal
- Active against some chloramphenicol-resistant strains of bacteria
Colistin Sulfate:
- Acts as a surface-active agent, disrupting bacterial cell membrane integrity
- Increases membrane permeability, leading to leakage of cellular contents
- Exhibits concentration-dependent bactericidal activity; promotes digestion and aids growth
- Improves feed utilization and reduces feed-to-egg ratio
Synergistic Combination:
- Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells
- The combination provides a "1+1>2" synergistic effect, enhancing bactericidal activity while expanding the antibacterial spectrum
- Simultaneous administration in a single formulation ensures both drugs reach target bacteria together, maximizing therapeutic efficacy
- Internal and external combination provides enhanced bactericidal action
INDICATIONS
FENICZONE-12 is indicated for the treatment and control of diseases caused by bacteria sensitive to florfenicol and colistin sulfate in poultry
Target Pathogens:
- Escherichia coli - including avian pathogenic E. coli (APEC) causing colibacillosis
- Salmonella spp. - including Salmonella Gallinarum (fowl typhoid) and Salmonella Pullorum (pullorum disease)
- Clostridium perfringens - causing necrotic enteritis and enterotoxic syndrome
- Pasteurella multocida - causing fowl cholera
- Shigella spp., Klebsiella spp. and other susceptible gram-negative bacteria
- Staphylococcus aureus and Streptococcus spp.
- Haemophilus paragallinarum - causing infectious coryza
Disease Conditions:
- Necrotic Enteritis and Enterotoxic Syndrome - intractable diarrhea, red or black stool, undigested feed particles in stool, thinned intestinal wall with mucosal detachment
- Colibacillosis - E. coli infections causing airsacculitis, pericarditis, and perihepatitis
- Fowl Cholera - caused by Pasteurella multocida
- Fowl Typhoid and Pullorum Disease - Salmonella infections
- Chronic Respiratory Disease (CRD) - complicated by bacterial infections
- White Dysentery - caused by Salmonella Pullorum
- Endocarditis and Yolk Sac Infections
PHARMACOKINETIC PROPERTIES
- Absorption: Florfenicol is rapidly absorbed after oral administration, reaching therapeutic blood concentrations within 1 hour and peak concentrations at 1-3 hours
- Bioavailability: Approximately 80% or higher
- Distribution: Widely distributed throughout the body; can cross the blood-brain barrier
- Elimination: Primarily excreted unchanged in urine, with small amounts excreted in feces
DOSAGE & ADMINISTRATION
FENICZONE-12 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 2-4 liters of drinking water
- Alternative Dose: 0.25-0.5 ml per liter of drinking water
- Duration: 3-5 consecutive days
- Dosage based on florfenicol: 20-30 mg florfenicol per kg body weight per day
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 consult veterinary guidance
EFFICACY AND RESISTANCE CONSIDERATIONS
Synergistic Activity:
- Research confirms that the combination of florfenicol and colistin provides superior bactericidal activity compared to either agent alone, achieving a "1+1>2" synergistic effect
- The combination is particularly effective against intestinal bacterial infections including E. coli, Salmonella, and Clostridium perfringens
- Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells for enhanced efficacy
Antimicrobial Resistance Data:
- A recent study of 410 E. coli isolates from Hungarian poultry farms (2022-2023) found resistance rates of 62.7% to florfenicol, 30.7% to colistin, and 52.9% to enrofloxacin
- The combination of florfenicol and colistin is recommended over single-agent therapy to overcome resistance and achieve synergistic effects
- Florfenicol monotherapy may have reduced efficacy against multi-strain Salmonella due to resistance development; the combination with colistin is recommended for improved outcomes
- Veterinary consultation and susceptibility testing are recommended where available
DRUG INTERACTIONS
- Antagonistic: Macrolides and lincosamides share the same binding site (50S ribosomal subunit) and may produce antagonistic effects when used concurrently
- Potential antagonism: May antagonize the bactericidal activity of penicillins or aminoglycosides, though this has not been demonstrated in vivo
- Synergistic: Colistin enhances the efficacy of florfenicol by increasing bacterial cell membrane permeability
CONTRAINDICATIONS & PRECAUTIONS
- Egg production: Do not use in birds producing eggs for human consumption. Research indicates that after oral administration, florfenicol residues in eggs peak at 307.64 μg/kg at day 1 post-treatment. For laying hens prior to egg production, a 10-day safety interval is recommended, with a 42-day withdrawal period recommended before the theoretical laying time due to irregularity of early egg production
- 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. Above recommended doses may have immunosuppressive effects
- Renal impairment: Dose reduction or extended dosing intervals may be necessary in animals with renal impairment
- Embryotoxicity: Has embryotoxic effects; use with caution in breeding animals and during early pregnancy
- 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
- Eggs: Not for use in laying hens producing eggs for human consumption
- Fish: 375 degree-days
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-12 Liquid Antibiotic Florfenicol innovator specs 10g, Colistin sulphate BP 2.50g per 100ml Poultry 1 Liter
FOR VETERINARY USE ONLY
