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Baytril Tablets 68mg Rx, 50ct |
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Baytril |
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BAYTRL-Tabs |
| Price: $117.47 |
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| What is Baytril?
Baytril (brand of enrofloxacin) Antibacterial tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin in dogs and cats. Prescription items are NON-RETURNABLE and NON-REFUNDABLE.
For:
Cats and Dogs (Baytril Taste Tabs) and Dogs only (Baytril Otic)
Benefits:
• Treats different types of bacterial infections
• Chewable tablets are flavored so your pet will enjoy eating them
Baytril is a fluoroquinolone antibiotic. Fluoroquinolones interfere with bacterial DNA metabolism to kill the bacteria. Enrofloxacin(Baytril) penetrates into all canine and feline tissues and body fluids. Concentrations of drug equal to or greater than the MIC for many pathogens (See tables I II and III) are reached in most tissues by two hours after dosing at 2.5 mg/kg and are maintained for 8-12 hours after dosing. Particularly high levels of enrofloxacin are found in urine. A summary of the body fluid/tissue drug levels at 2 to 12 hours after dosing at 2.5 mg/kg is given in table III.
Cautions:
Do not use in pregnant or nursing animals. Do not give Baytril within 2 hours of giving an antacid or sucralfate, a vitamin/mineral product, or dairy products. Tell your veterinarian about any other medications your pet is being given.
More Information:
Brand Name
Baytril (Bayer)
Generic Name
Enrofloxacin (en-row-flox’-a-sin)
What is the most important information I should know about Baytril:
Baytril is a prescription medication FDA-approved for veterinary use in dogs and cats. Baytril is available as 22.7mg, 68mg and 136mg scored chewable tablets for dogs and cats and as otic (ear) drops. The usual dose of Baytril for dogs is 2.27-9.07mg/pound every 24 hours. The usual dose of Baytril for cats is 2.27mg/pound every 24 hours. The dog and cat doses may be divided into two doses 12 hours apart. Always follow the dosage instructions provided by your veterinarian. Do not give Baytril to any pet other than the pet for whom it was prescribed. Baytril is not for use in animals allergic to it or other fluoroquinolone antibiotic drugs. It is advised that Baytril should not be used in younger dogs during their rapid growth phase, approximately 2 to 8 months in small to medium breeds, 2 to 12 months in large dogs, and 2 to 18 months in giant breeds.
What is Baytril:
Baytril is a fluoroquinolone antibiotic used for the treatment of bacterial infections of the urinary tract, skin, prostate, GI tract, liver, and lungs due to susceptible organisms. This medication may also be used for purposes other than those listed in this guide.
What should I discuss with my veterinarian before giving Baytril to my pet: Tell your veterinarian if your pet has had seizures, or is pregnant or lactating.
How should this medication be given:
Give Baytril Tablets exactly as directed by your veterinarian. Give all of the medication your veterinarian has prescribed. Symptoms may start to improve before the infection is completely treated. Allow plenty of water for your pet to drink. Do not exceed the maximum dose of 2.27mg/pound per day in cats because of an increased risk of altered vision or blindness. When using Baytril Otic, shake well before each use and administer 5-10 drops of Baytril Otic to coat the ear lesions and ear canal. Gently massage the ear so as to ensure complete and uniform distribution of the medication throughout the external ear canal. Administer Baytril Otic twice a day for up to 14 days or as directed by your veterinarian. If you do not understand the directions ask the pharmacist or veterinarian to explain them to you. Store Baytril at room temperature away from moisture and heat. Keep this medication away from children and pets.
What happens if I miss giving a dose:
Give the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose missed and give only the next regularly scheduled dose. Do not give a double dose of the medication.
What happens if I overdose the pet:
Seek emergency veterinary medical treatment. Symptoms of overdose may include loss of appetite, vomiting, and diarrhea.
What should I avoid while giving Baytril to my pet:
Do not use Baytril in animals allergic to it or other fluoroquinolone antibiotics. Do not give Baytril within 2 hours of giving an antacid or sucralfate, vitamin/mineral products, or dairy products. Use caution when using Baytril Otic in animals with a punctured ear drum.
What are the possible side effects of Baytril:
Stop giving the medication and seek emergency veterinary medical attention if your pet experiences an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue or face; or hives). Other less serious side effects may also occur. Continue to give the medication and talk to your veterinarian if your pet experiences loss of appetite, vomiting, diarrhea, dizziness, or drowsiness. Side effects other than those listed may occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to your pet.
What other drugs will affect Baytril:
Before giving Baytril, tell your veterinarian if your pet is being given warfarin, theophylline, probenecid, or phenytoin. When given with cyclosporine, Baytril can increase the risk of kidney damage from the cyclosporine. Drugs other than those listed may also interact with Baytril. Talk to your veterinarian or pharmacist before giving any prescription or over-the-counter medications.
Where can I get more information:
Your pharmacist has additional information about Baytril written for health professionals that you may read.
Microbiology:
Quinolone carboxylic acid derivatives are classified as DNA gyrase inhibitors. The mechanism of action of these compounds is very complex and not yet fully understood. The site of action is bacterial gyrase a synthesis promoting enzyme. The effect on Escherichia coli is the inhibition of DNA synthesis through prevention of DNA supercoiling. Among other things such compounds lead to the cessation of cell respiration and division. They may also interrupt bacterial membrane integrity.1
Enrofloxacin is bactericidal with activity against both Gram negative and Gram positive bacteria. The minimum inhibitory concentrations (MICs) were determined for a series of 39 isolates representing 9 genera of bacteria from natural infections in dogs and cats selected principally because of resistance to one or more of the following antibiotics: ampicillin cephalothin colistin chloramphenicol erythromycin gentamicin kanamycin penicillin streptomycin tetracycline triple sulfa and sulfa/trimethoprim. The MIC values for enrofloxacin against these isolates are presented in table I. Most strains of these organisms were found to be susceptible to enrofloxacin in vitro but the clinical significance has not been determined for some of the isolates.
The susceptibility of organisms to enrofloxacin should be determined using enrofloxacin 5 mcg disks. Specimens for susceptibility testing should be collected prior to the initiation of enrofloxacin therapy.
Pharmacokinetics:
In dogs the absorption and elimination characteristics of the oral formulation are linear (plasma concentrations increase proportionally with dose) when enrofloxacin is administered at up to 11.5 mg/kg twice daily.2 Approximately 80% of the orally administered dose enters the systemic circulation unchanged. The eliminating organs based on the drug's body clearance time can readily remove the drug with no indication that the eliminating mechanisms are saturated. The primary route of excretion is via the urine. The absorption and elimination characteristics beyond this point are unknown. In cats no oral absorption information is available at other than 2.5 mg/kg administered orally as a single dose. Saturable absorption and/or elimination processes may occur at greater doses. When saturation of the absorption process occurs the plasma concentration of the active moiety will be less than predicted based on the concept of dose proportionality.
Following an oral dose in dogs of 2.5 mg/kg (1.13 mg/lb) enrofloxacin reached 50% of its maximum serum concentration in 15 minutes and peak serum level was reached in one hour. The elimination half-life in dogs is approximately 2 1/2-3 hours at that dose while in cats it is greater than 4 hours. In a study comparing dogs and cats the peak concentration and the time to peak concentration were not different.
INDICATIONS:
Baytril® (brand of enrofloxacin) Antibacterial tablets are indicated for the management of diseases associated with bacteria susceptible to enrofloxacin. Baytril Antibacterial tablets are indicated for use in dogs and cats.
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 Staphylococcus 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.
Palatability: Free choice palatability in dogs was confirmed in a study in which 350 individual dosings resulted in a voluntary ingestion rate of 73%.
Cats: Clinical efficacy was established in dermal infections (wounds and abscesses) associated with susceptible strains of Pasteurella multocida Staphylococcus aureus and Staphylococcus epidermidis.
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 Baytril® (brand of enrofloxacin) tablets 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 Baytril® (brand of enrofloxacin) tablets 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
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 difficult 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/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.
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 effect the retina. Such products should be used with caution in cats.
DOSAGE AND ADMINISTRATION:
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 this 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.
Palatability:
Most dogs will consume Baytril® Taste Tabs® tablets willingly when offered by hand. Alternatively the tablet(s) may be offered in food or hand-administered (pilled) as with other oral tablet medications. In cats Baytril® Taste Tabs® tablets should be pilled. After administration watch the animal closely to be certain the entire dose has been consumed.
Dogs Cats:
The duration of treatment should be selected based on clinical evidence. Generally administration of Baytril 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.
STORAGE:
Dispense tablets in tight containers only. |
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