Ilium Enrotril Oral Solution
DESCRIPTION
Enrofloxacin is a fluoroquinolone antimicrobial which has the chemical name 1-cyclopropyl-7-(4-ethyl-1-piperazinyl)-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid. It has rapid bactericidal activity against a broad spectrum of aerobic bacteria. It is also effective against Gram positive bacteria and mycoplasmas. It is active at low concentrations compared with other classes of antimicrobial agents.
INDICATIONS
Primary indications for use in the dog and cat are:
• Urinary tract infections including infections with E.coli, Proteus spp., Klebsiella spp., Pseudomonas aeruginosa, Staph spp., and Group D Streptococcus.
• Respiratory infections, including infections with E.Coli, Streptococcus spp, Pasteurella spp, Klebsiella spp, Pseudomonas spp, Bordetella bronchiseptica, Staphylococcus spp.
• Deep pyodermas caused by Staph. Intermedius including those infected with secondary invaders.
• Wounds, abscesses and discharging sinuses
• Deep pyodermas, osteomyelitis and Gram negative septicaemias.
• Ilium Enrotril is useful for treating serious antibiotic resistant infections of the respiratory tract or genitor-urinary system, particularly chronic urinary tract infections in cats. Ilium Enrotril may also be used in exotic animals (small mammals, reptiles and avian species) for the treatment of bacterial infections of the alimentary and respiratory tracts where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates Enrofloxacin as the drug of choice.
DIRECTIONS FOR USE
Restraints
DO NOT USE in food producing species of animals.
FOR USE ONLY in companion animals where culture and sensitivity testing indicate no suitable alternative.
Contraindications
Dogs: The use of enrofloxacin is contraindicated in dogs during the rapid growth phase. Ilium Enrofloxacin should not be used in dogs under one (1) year of age. Giant breeds may be in the rapid growth phase for up to 18 months. Care should be used in treating individuals of these breeds with Ilium Enrofloxacin when they are younger than 18 months.
Cats: Ilium Enrofloxacin should not be used in cats less than 12 weeks of age. The safe use of enrofloxacin in breeding female cats has not been established.
Precautions
Although rare, it is prudent to consider that any fluoroquinolone may have the potential to induce retinal degeneration in cats, especially when used above label dose rates or in animals that may be elderly or suffering from renal or hepatic disease.
Dosage and Administration
Discard three months after initial use when stored at 30°C (Room Temperature).
Dogs & Cats:
For oral administration only
Administer 1mL/5kg bodyweight daily for up to five days.
For the treatment of simple infections, an enrofloxacin injection may be used as the initial dose, with continued daily oral Enrofloxacin dosage up to 2-3 days beyond the cessation of clinical signs. If no improvement is seen within five days, the diagnosis should be re-evaluated and a different course of therapy considered. In deep or complex infections, e.g. Pyodermas, discharging sinuses, extended courses may be required and progress should be regularly reviewed.
Dosing procedure using the measuring syringe.
Unscrew the tamper evident cap and attach the dosing syringe to the tube by gently pushing the syringe end into the insert at the top of the tube to ensure a good seal. Invert the tube and draw the plunger until the black line on the plunger corresponds to the volume required in mL. Turn the tube right way up and with a twisting motion, gently separate the dosing syringe from the tube. Position the syringe and gently press the plunger to dispense the dose.
Exotic Animals
In the absence of data, the following dosage and administration instructions may be suitable for exotic animals.
Treatment may be initiated with an enrofloxacin injection and should be maintained by oral enrofloxacin dosage forms as appropriate. In all cases, the use of tuberculin or insulin syringes and/or dilution of the enrofloxacin injection with sterile water for injection should be considered for administration of very small volumes. In all species vary the injection site when multiple injections are given.
Animal Safety
Dogs
Safety studies indicate enrofloxacin administered up to 5X the recommended oral dose is well tolerated in adult dogs. Incidences of vomiting, inappetance may be expected following repeated higher doses. Toxicity and mortality may be expected following administration of doses up to 25X the recommended dose.
In growing dogs, overextension of the carpal joint, and hind quarter weakness have been associated with administration of 5X doses of enrofloxacin for extended periods. Improvement of clinical signs should be evident following drug withdrawal.
Cats
In adult cats, inappetance, vomition, in-coordination and convulsions are clinical signs that can be associated with oral doses of enrofloxacin at 5x the recommended dose for six days. Vomition, in-coordination and death have been associated with higher enrofloxacin doses (25X recommended oral dose) for five consecutive days.
Administration of enrofloxacin doses at 5X recommended oral dose in growing cats has been associated with the prevalence of articular cartilage lesions.
Exotic Species
In the absence of data on its use in some exotic species, caution should be used when prescribing during pregnancy or lactation in some mammals and a careful risk/benefit assessment made.
Adverse Reactions
Dogs: The principle adverse reactions cited1 in adult dogs are vomiting and crystalluria. Two cases of vomiting recorded out of 270 dogs treated with oral Enrofloxacin have been reported in the literature. Subsequent studies involving treatment of 122 cases with injectable Enrofloxacin, followed by oral Enrofloxacin report no drug related side effects.
Cats: Side effects such as retinal degeneration, vomiting and anorexia may be observed in some cats following administration of oral Enrofloxacin at and above the recommended label dose.
Exotic Animals: Muscle bruising in reptiles and birds following injection has been reported occasionally.
First Aid
If poisoning occurs contact a doctor or Poisons Information Centre. Phone Australia 131 126.
TROY LABORATORIES PTY LIMITED
98 LONG STREET
SMITHFIELD NSW 2164 AUSTRALIA
W: www.troylab.com.au E: info@troylab.com.au
Dispose of empty container by wrapping in paper and placing in garbage.
Store below 30°C (Room Temperature). Protect from light.
Presentation
30/100mL tube
APVMA Approval Number: 62401/0609
REFERENCES
1Vancustem, P.M., Babish, J.G., Schwark, W.S. (1990) The fluoroquinolone antimicrobials: structure, antimicrobial activity, pharmacokinetics, clinical use in domestic animals and toxicity. Cornell Vet, 80, 173-186.
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