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Enromax
Enrofloxacin Injection 10%
Description
Enrofloxacin Injection 10% is a clear, colorless to pale yellow sterile solution intended for intramuscular administration. Each 100 mL contains 10 g of Enrofloxacin as the active ingredient. This formulation is specifically designed for veterinary use to treat a wide range of bacterial infections in livestock and companion animals.
Specification
100 ml: 10 g Enrofloxacin
Pharmacological Properties
Pharmacodynamics
Enrofloxacin belongs to the fluoroquinolone class of antibiotics and acts as a broad-spectrum bactericidal agent. It exhibits potent activity against a wide variety of pathogens, including Escherichia coli, Salmonella spp., Klebsiella spp., Brucella spp., Pasteurella spp., Actinobacillus pleuropneumoniae, Erysipelothrix spp., Proteus spp., Serratia marcescens, Corynebacterium pyogenes, Bordetella bronchiseptica, Staphylococcus aureus, Mycoplasma spp., and Chlamydia spp. Its activity against Pseudomonas aeruginosa and Streptococcus spp. is moderate, while it shows weak efficacy against anaerobic bacteria. A notable characteristic of Enrofloxacin is its significant Post-Antibiotic Effect (PAE) against susceptible organisms.
The mechanism of action involves the inhibition of bacterial DNA gyrase (topoisomerase II), a critical enzyme required for DNA replication, transcription, and repair. By interfering with these processes, Enrofloxacin prevents bacterial cell division and leads to cell death.
Pharmacokinetics
Following intramuscular injection, Enrofloxacin is rapidly and completely absorbed. Bioavailability is high, recorded at 91.9% in swine and 82% in dairy cattle. The drug is extensively distributed throughout the body, penetrating tissues and body fluids effectively. With the exception of cerebrospinal fluid, drug concentrations in almost all tissues exceed those in plasma.
Metabolism occurs primarily in the liver, where Enrofloxacin is de-ethylated at the 7-piperazine ring to form Ciprofloxacin, an active metabolite. Other metabolic pathways include oxidation and glucuronide conjugation. Excretion is mainly renal, via glomerular filtration and tubular secretion, with 15% to 50% of the drug excreted unchanged in the urine. The elimination half-life varies by species and route of administration: approximately 5.9 hours in dairy cattle, 1.5–4.5 hours in sheep, and 4.6 hours in swine.
Indications
Enrofloxacin is indicated for the treatment of bacterial diseases and mycoplasma infections in livestock and poultry susceptible to Enrofloxacin.
Dosage and Administration
Route of Administration: Intramuscular (IM) injection only.
Cattle, Sheep, Swine: Administer 0.025 mL per 1 kg of body weight.
Dogs, Cats, Rabbits: Administer 0.025 to 0.05 mL per 1 kg of body weight.
The treatment should be administered once or twice daily for 2 to 3 consecutive days.
Drug Interactions
Synergism: Concurrent use with Aminoglycosides or broad-spectrum Penicillins may result in a synergistic effect.
Chelation: Polyvalent cations such as Ca²⁺, Mg²⁺, Fe³⁺, and Al³⁺ can chelate with Enrofloxacin, potentially reducing its absorption and efficacy.
Xanthines: Concurrent administration with Theophylline or Caffeine may decrease plasma protein binding, leading to abnormally high serum concentrations of these xanthines and potential toxicity.
Hepatic Enzymes: Enrofloxacin inhibits hepatic enzymes, which may decrease the clearance and increase the serum concentration of other drugs metabolized by the liver.
Adverse Reactions
Musculoskeletal: In young growing animals, Enrofloxacin may cause degeneration of articular cartilage, leading to跛行 (lameness) and pain.
Gastrointestinal: Vomiting, anorexia, and diarrhea may occur.
Dermatological: Skin reactions such as erythema, pruritus, urticaria, and photosensitization have been observed.
Neurological: In dogs and cats, rare cases of allergic reactions, ataxia, and seizures have been reported.
Warnings and Precautions
CNS Effects: The drug has a potential excitatory effect on the central nervous system and may induce seizures; use with caution in dogs with a history of epilepsy.
Crystalluria: Use with caution in carnivores and animals with renal impairment, as crystalluria may rarely occur.
Age Restriction: This product is not recommended for use in dogs under 8 weeks of age.
Resistance: There is an increasing trend of bacterial resistance to fluoroquinolones. To minimize the development of resistance, this product should not be used at sub-therapeutic doses or for prolonged periods.
Withdrawal Periods
Cattle and Sheep: 14 days
Swine: 10 days
Rabbits: 14 days
Storage and Packaging
Storage: Store in a tight, light-resistant container.
Package Size: 100 mL per bottle.
R&A Technology Co., Limited
Address: Office 3A-9, 12/F.,Kaiser centre, No.18 CTR Street, Sai，Ying Pun, Hong Kong
Eastern Along Pharmaceutical Co., Ltd.
Address: No. 66, Taoyuan East Road, Songxia Industrial Park, Shilin Town, Nanhai District, Foshan City、
Ramical Pet Health Technology Com.,Ltd
Address: No.10, Hengbao Road, Datang Industrial Park, Sanshui District, Foshan City, Guangdong Province, P.R.C.
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