Putney for Dogs & Cats - Enrofloxacin Flavored Tablets 68mg (1 tab) - [Bacterial Infections Treatment]

Enrofloxacin is used in the treatment of many types of bacterial infections including urinary tract, skin, prostate, GI tract, liver, and lungs. Enrofloxacin is the generic equivalent to Baytril and comes in a tasty chewable tablet, which most pets love. Enrofloxacin is sold per tablet and requires a prescription from your veterinarian.

Key Benefits

• Broad-spectrum antibiotic treats bacterial infections of the skin, respiratory system, and more
• Chewable flavored tablets
• Beef Flavored Tablets

How it works

Enrofloxacin is a fluoroquinolone antibiotic. Fluoroquinolones interfere with bacterial DNA metabolism to kill the bacteria.

Indications

Enrofloxacin Flavored Tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Enrofloxacin Flavored Tablets are indicated for use in dogs and cats.

Active Ingredients:

Enrofloxacin

Dogs:

Administer orally at a rate to provide 5-10 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 tablets may be offered in food or hand-administered (pilled) as with other oral tablet medications.

All tablet sizes are double score for accurate dosing.

Dogs:

Administer orally at 5 mg/kg (2.27 mg/lb) ob body weight. The dose for dogs and cats may be administered either as a single 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 administration, 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 reevaluated 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.

Caution:

Federal 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 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: Mydriasus, retinal degeneration (retinal atrophy, attenuated retinal vessels, and hyperreflective tapeta have been reported), loss of vision. Mydriases may be an indication of impending or existing retinal changes.
• Neurologic: ataxia, seizures
• Behavioral: depression, lethargy, vocalization, aggression

To report adverse reactions, 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.

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 inappentence. 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, inappentence, depression, difficult locomotion and death while adult dogs receiving 50 mg/kg/day for 14 days had clinical signs of vomition and inappetence.

Adult dogs doses intramuscularly for three treatments at 12.5 mg/kg followed by 57 oral treatments at 12.5 mg/kg, all at 12 hours 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 t 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, inappentence, 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 degeneraiton), abnormal electroretinogram (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 metabolizes in the liver may reduce the clearance rates of 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 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.

Storage:

Dispense tablets in tight containers only.

Store at controlled room temperature, 68-77°F (20-25°C).

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 with copius 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 information, including Material Safety Data Sheet, call 1-866-683-0660.

Efficacy Confirmation:

Dogs: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Staphyloccus intermedius; respiratory infections (pneumonia, tonsillitis, rhinitis) associated with susceptible strains of Escherichia coli and Staphylococcus aureus; and urinary cystitis associated with susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus aureus.

Cats: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Pasteurella multocida, Staphylococcus aureus, and Staphylococcus epidermidis.