CONTRAINDICATIONS:
Enrofloxacin is contraindicated in dogs and cats known to be hypersensitive to quinolones.
Dogs: Based on the studies discussed under the section on Animal Safety Summary, the use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds during the rapid growth phase. Large breeds may be in this phase for up to one year of age and the giant breeds for up to 18 months. In clinical field trials utilizing a daily oral dose of 5.0 mg/kg, there were no reports of lameness or joint problems in any breed. However, controlled studies with histological examination of the articular cartilage have not been conducted in the large or giant breeds.
ADVERSE REACTIONS:
Dogs: Two of the 270 (0.7%) dogs treated with enrofloxacin at 5.0 mg/kg per day in the clinical field studies exhibited side effects, which were apparently drug-related. These two cases of vomition were self-limiting.
Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system. Gastrointestinal: anorexia, diarrhea, vomiting, elevated liver enzymes
Neurologic: ataxia, seizures
Behavioral: depression, lethargy, nervousness
Cats: No drug-related side effects were reported in 124 cats treated with enrofloxacin at 5.0 mg/kg per day for 10 days in clinical field studies.
Post-Approval Experience: The following adverse experiences, although rare, are based on voluntary post-approval adverse drug experience reporting. The categories of reactions are listed in decreasing order of frequency by body system.
Ocular: Mydriasis, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. Mydriasis may be an indication of impending or existing retinal changes.
Gastrointestinal: vomiting, anorexia, elevated liver enzymes, diarrhea
Neurologic: ataxia, seizures
Behavioral: depression, lethargy, vocalization, aggression
To report adverse reactions, call 1-866-683-0660.
ANIMAL SAFETY SUMMARY
Dogs: Adult dogs receiving enrofloxacin orally at a daily dosage rate of 52 mg/kg for 13 weeks had only isolated incidences of vomition and inappetence. Adult dogs receiving the tablet formulation for 30 consecutive days at a daily treatment of 25 mg/kg did not exhibit significant clinical signs nor were there effects upon the clinical chemistry, hematological or histological parameters. Daily doses of 125 mg/kg for up to 11 days induced vomition, inappetence, depression, diffcult locomotion and death while adult dogs receiving 50 mg/kg/day for 14 days had clinical signs of vomition and inappetence.
Adult dogs dosed intramuscularly for three treatments at 12.5 mg/kg followed by 57 oral treatments at 12.5 mg/kg, all at 12 hour intervals, did not exhibit either significant clinical signs or effects upon the clinical chemistry, hematological or histological parameters.
Oral treatment of 15 to 28 week old growing puppies with daily dosage rates of 25 mg/kg has induced abnormal carriage of the carpal joint and weakness in the hindquarters. Significant improvement of clinical signs is observed following drug withdrawal. Microscopic studies have identified lesions of the articular cartilage following 30 day treatments at either 5, 15 or 25 mg/kg in this age group. Clinical signs of difficult ambulation or associated cartilage lesions have not been observed in 29 to 34 week old puppies following daily treatments of 25 mg/kg for 30 consecutive days nor in 2 week old puppies with the same treatment schedule.
Tests indicated no effect on circulating microfilariae or adult heartworms (Dirofilaria immitis) when dogs were treated at a daily dosage rate of 15 mg/kg for 30 days. No effect on cholinesterase values was observed.
No adverse effects were observed on reproductive parameters when male dogs received 10 consecutive daily treatments of 15 mg/kg/day at 3 intervals (90, 45 and 14 days) prior to breeding or when female dogs received 10 consecutive daily treatments of 15 mg/kg/day at 4 intervals: between 30 and 0 days prior to breeding, early pregnancy (between 10th & 30th days), late pregnancy (between 40th & 60th days), and during lactation (the first 28 days).
Cats: Cats in age ranges of 3 to 4 months and 7 to 10 months received daily treatments of 25 mg/kg for 30 consecutive days with no adverse effects upon the clinical chemistry, hematological or histological parameters. In cats 7-10 months of age treated daily for 30 consecutive days, 2 of 4 receiving 5 mg/kg, 3 of 4 receiving 15 mg/kg, 2 of 4 receiving 25 mg/kg and 1 of 4 nontreated controls experienced occasional vomition. Five to 7 month old cats had no side effects with daily treatments of 15 mg/kg for 30 days, but 2 of 4 animals had articular cartilage lesions when administered 25 mg/kg per day for 30 days.
Doses of 125 mg/kg for 5 consecutive days to adult cats induced vomition, depression, incoordination and death while those receiving 50 mg/kg for 6 days had clinical signs of vomition, inappetence, incoordination and convulsions, but they returned to normal.
Enrofloxacin was administered to thirty-two (8 per group), six- to eight-month-old cats at doses of 0, 5, 20, and 50 mg/kg of body weight once a day for 21 consecutive days. There were no adverse effects observed in cats that received 5 mg/kg body weight of enrofloxacin. The administration of enrofloxacin at 20 mg/kg body weight or greater caused salivation, vomition, and depression. Additionally, dosing at 20 mg/kg body weight or greater resulted in mild to severe fundic lesions on ophthalmologic examination (change in color of the fundus, central or generalized retinal degeneration), abnormal electroretinograms (including blindness), and diffuse light microscopic changes in the retina.
DRUG INTERACTIONS
Compounds that contain metal cations (e.g., aluminum, calcium, iron, magnesium) may reduce the absorption of some quinolone-class drugs from the intestinal tract.
Concomitant therapy with other drugs that are metabolized in the liver may reduce the clearance rates of the quinolone and the other drug.
Dogs: Enrofloxacin has been administered to dogs at a daily dosage rate of 10 mg/kg concurrently with a wide variety of other health products including anthelmintics (praziquantel, febantel, sodium disophenol), insecticides (fenthion, pyrethrins), heartworm preventatives (diethylcarbamazine) and other antibiotics (ampicillin, gentamicin sulfate, penicillin, dihydrostreptomycin). No incompatibilities with other drugs are known at this time.
Cats: Enrofloxacin was administered at a daily dosage rate of 5 mg/kg concurrently with anthelmintics (praziquantel, febantel), an insecticide (propoxur) and another antibacterial (ampicillin). No incompatibilities with other drugs are known at this time.
WARNINGS
For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children.
Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation persists following ocular or dermal exposure. Individuals with a history of hypersensitivity to quinolones should avoid this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.
For customer service or to obtain product information, including Material Safety Data Sheet, call 1-866-683-0660.
PRECAUTIONS:
Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.
Quinolone-class drugs have been associated with cartilage erosions in weight-bearing joints and other forms of arthropathy in immature animals of various species.
The use of fluoroquinolones in cats has been reported to adversely affect the retina. Such products should be used with caution in cats.
