Product Name: FENICZONE-10

Type: Oral Liquid Solution - Antibiotic Combination

COMPOSITION

Each 100 ml contains:

• Florfenicol (innovator specs) ...... 10 g (10% w/v)
• Colistin Sulfate BP ...... 50 MIU (Million International Units)

DESCRIPTION

FENICZONE-10 is a concentrated, broad-spectrum antibiotic oral solution combining florfenicol (10%) 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

Florfenicol is a synthetic broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit . 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

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

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
• Promotes feed utilization and reduces feed-to-egg ratio

INDICATIONS

FENICZONE-10 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-10 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 (based on 10% florfenicol concentration)
• Alternative Dose: 0.25-0.5 ml per liter of drinking water
• Duration: 3-5 consecutive days
• Note: For young chicks under 20 days of age, use with caution or consult veterinary guidance

Alternative Dosage Based on Body Weight:

• Florfenicol: 20-30 mg per kg body weight per day (based on 10% concentration)
• Equivalent to 0.2-0.3 g of florfenicol powder per kg body weight

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
• Broiler Treatment Protocol: For Salmonella treatment, 1 g per 2 liters of water for 12 hours, up to 5 days

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 study of 1,000 bacterial isolates from poultry (primarily E. coli and Salmonella) found resistance rates of 55.5% to colistin, 34.5% to florfenicol, and 41.5% 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 during treatment period. Research indicates that after oral administration, florfenicol residues in eggs peak at 307.64 μg/kg at day 1 post-treatment, dropping below 10 μg/kg by day 10 . 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
• 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
• 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-10 Liquid Antibiotic Florfenicol innovator specs 10g, Colistin sulphate BP 50 MIU per 100ml Poultry 1 Liter

FOR VETERINARY USE ONLY