Product Name: FENICZONE-23

Type: Oral Liquid Solution - Antibiotic Combination

COMPOSITION

Each 1000 ml contains:

• Florfenicol (innovator specs) ...... 230 mg
• Colistin Sulfate BP ...... 500 MIU (Million International Units)

DESCRIPTION

FENICZONE-23 is a 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 a valuable tool in poultry health management [citation:4].

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 [citation:2][citation:7].

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

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

Synergistic Combination:

• Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells [citation:2]
• The combination provides a "1+1>2" synergistic effect, enhancing bactericidal activity while expanding the antibacterial spectrum [citation:2]
• Simultaneous administration ensures both drugs reach target bacteria together, maximizing therapeutic efficacy [citation:7]

INDICATIONS

FENICZONE-23 is indicated for the treatment and control of diseases caused by bacteria sensitive to florfenicol and colistin sulfate in poultry [citation:4].

Target Pathogens:

• Escherichia coli - including avian pathogenic E. coli (APEC) causing colibacillosis [citation:2][citation:8]
• Salmonella spp. - including Salmonella Gallinarum (fowl typhoid) and Salmonella Pullorum (pullorum disease) [citation:2][citation:5]
• Clostridium perfringens - causing necrotic enteritis [citation:2]
• Shigella spp. and other susceptible gram-negative bacteria [citation:2]

Disease Conditions:

• Chronic Respiratory Disease (CRD) - complicated by bacterial infections [citation:4]
• Pneumonia - bacterial respiratory infections [citation:4]
• Fowl Cholera - caused by Pasteurella multocida [citation:4]
• Infectious Coryza - upper respiratory infection [citation:4]
• Fowl Typhoid - caused by Salmonella Gallinarum [citation:4]
• Paratyphoid - Salmonella infections [citation:4]
• Endocarditis and Yolk Sac Infections [citation:4]
• Necrotic Enteritis - intestinal bacterial infections with diarrhea, red/black stool [citation:2]

ANTIMICROBIAL SPECTRUM

• Gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Pasteurella multocida, Klebsiella spp., Pseudomonas spp. (colistin sensitive)
• Gram-positive bacteria: Staphylococcus aureus, Streptococcus spp., Clostridium perfringens
• Mycoplasma: Some activity against Mycoplasma species associated with CRD [citation:4]

DOSAGE & ADMINISTRATION

FENICZONE-23 is administered via drinking water. For optimal results, fresh solution should be prepared daily.

Recommended Dosage:

• Poultry (Broilers, Layers, Breeders): 1 ml per 2 liters of drinking water (or 0.5 ml per liter) [citation:5]
• Duration: 3-5 consecutive days [citation:5]
• Dosage Calculation: At 1 ml/2L, each ml treats 2 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

RESISTANCE CONSIDERATIONS

Antimicrobial resistance is an emerging concern in poultry production. Studies have documented resistance patterns among common poultry pathogens:

• In a study of 1,000 bacterial isolates from poultry, resistance rates were reported as: 55.5% to colistin, 34.5% to florfenicol, and 41.5% to enrofloxacin [citation:3][citation:6]
• The combination of florfenicol and colistin is recommended over single-agent therapy to overcome resistance and achieve synergistic effects [citation:2][citation:5]
• Florfenicol monotherapy may have reduced efficacy against multi-strain Salmonella due to resistance development; the combination with colistin is recommended for improved outcomes [citation:5]
• Veterinary consultation and susceptibility testing are recommended where available [citation:3]

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:2]
• The combination is particularly effective against intestinal bacterial infections including E. coli, Salmonella, and Clostridium perfringens [citation:2]

Colistin-Florfenicol Combination:

• Colistin increases cell membrane permeability, facilitating florfenicol entry into bacterial cells for enhanced efficacy [citation:2]
• Simultaneous administration in a single formulation ensures both drugs enter the body together, maximizing synergistic antibacterial action [citation:7]
• Florfenicol combined with other agents (e.g., doxycycline) has shown treatment efficacy of 73-80% against experimental E. coli infections in chickens [citation:8]

CONTRAINDICATIONS & PRECAUTIONS

• Not for use in birds producing eggs for human consumption during treatment period (withdrawal period required)
• Do not use in animals with known hypersensitivity to florfenicol, colistin, or polymyxin antibiotics
• Avoid concurrent use with other nephrotoxic drugs
• Not recommended for use in turkeys with fungal susceptibility concerns; antimicrobial treatment may predispose to fungal colonization, though colistin inclusion may reduce fungal overgrowth compared to beta-lactams [citation:1]
• 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): 5-7 days (consult local regulations for specific withdrawal period)
• Eggs: Not for use in laying hens producing eggs for human consumption

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)

Pack Sizes: 1 Liter HDPE bottle

PRODUCT SUMMARY
FENICZONE-23 Liquid Antibiotic Florfenicol innovator specs 230mg, Colistin sulphate BP 500 MIU per 1000ml Poultry 1 Liter

FOR VETERINARY USE ONLY