Enrosite for Dogs & Cats - (Enrofloxacin) Flavored Tablets 68mg (250 count) - [Antibacterial Treatment] (2024)

Dogs:

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. If dogs do not consume Enrofloxacin Flavored Tablets willingly when offered by hand, then alternatively the tablet(s) may be offered in the food or hand- administered (pilled) as with other oral tablet medications.

All tablet sizes are double scored for accurate dosing.

Cats:

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. In cats, Enrofloxacin Flavored Tablets should be pilled. After adminsitration, watch the animal closely to be certain the entire dose has been consumed.

All tablet sizes are double scored for accurate dosing.

Dogs & Cats:

The duration of treatment should be selected based on clinical evidence.

Generally, administration of Enrofloxacin Flavored Tablets should continue for at least 2-3 days beyond cessation of clinical signs. For severe and/or complicated infections, more prolonged therapy, up to 30 days, may be required. If no improvement is seen within five days, the diagnosis should be re-evaluated and a different course of therapy considered.

The lower limit of the dose range in dogs and the daily dose for cats was based on efficacy studies in dogs and cats where enrofloxacin was administered at 2.5 mg/kg twice daily. Target animal safety and toxicology were used to establish the upper limit of the dose range for dogs and treatment duration for dogs and cats.

Cautions:

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals.

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 postapproval 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 postapproval 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 suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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 1-833-571-1525.

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.

Storage:

Dispense tablets in tight containers only.

Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [see USP Controlled Room Temperature].