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Date: Tuesday, May 21, 2024 0:33

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.38
Baytril Flavour Tablets
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Enrofloxacin
Product:Baytril Flavour Tablets
Product index: Baytril Flavour Tablets
Incorporating:Baytril Flavour Tablets 15 mg
Baytril Flavour Tablets 50 mg
Baytril Flavour Tablets 150 mg
Qualitative and quantitative composition
Active Constituents
Relevant Constituents of the Excipients
Enrofloxacin mg per tablet
Artificial beef flavour Irradiated mg per tablet
Baytril Flavour Tablets 15 mg
15.0
6.0
Baytril Flavour Tablets 50 mg
50.0
12.0
Baytril Flavour Tablets 150 mg
150.0
42.0
For full list of excipients, see section 'Pharmaceutical Particulars'
Pharmaceutical form
Tablet.
Baytril Flavour Tablets 15 mg
A light brown to brown, slightly marbled, round, planar tablet for oral administration to dogs and cats.
Baytril Flavour Tablets 50 mg
Light brown to brown, slightly marbled, round, curved, scored tablets for oral administration to dogs.
Baytril Flavour Tablets 150 mg
Clinical particulars
Target species
Dogs and Cats.
Indications for use, specifying the target species
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Contraindications
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Not recommended for use in cats less than 8 weeks of age.
Baytril Flavour Tablets should not be used for prophylaxis.
Special warnings for each target species
Please refer to item 'Contraindications'.
Cats: Retinotoxic effects including blindness can occur when the recommended dose is exceeded.
Special precautions for use
i) Special precautions for use in animals
Do not exceed the recommended dosage
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing.
Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
Official and local antimicrobial policies should be taken into account when the product is used. In cases of pyoderma, possible underlying primary disease should be identified and treated.
Enrofloxacin is partially excreted via the kidneys; as with all fluoroquinolones, excretion may therefore be delayed in individuals with existing renal damage. The product should be used with caution in animals with severe renal or hepatic impairment. Retinotoxic effects including blindness can occur in cats when the recommended dose is exceeded.
Enrofloxacin-containing products should not be used in animals with persisting articular cartilage growth disorders, since disorders may worsen during treatment.
Do not use in cases of known resistance to quinolones or fluoroquinolones because of near-total cross-resistance to the former and complete crossresistance to the latter.
ii) Special precautions to be taken by the person administering the medicinal product to animals
Enrofloxacin may cause hypersensitivity (allergic reactions). People with known hypersensitivity to fluoroquinolones (e.g., enrofloxacin or ciprofloxacin) should avoid any contact with the product.
The product may be irritating to skin and eyes. In case of contact with skin or eyes, wash the affected area with clear running water. Wash hands after use.
iii) Other precautions
None.
Adverse reactions (frequency and seriousness)
On very rare occasions, mild and transient gastrointestinal disorders, such as hypersalivation, vomiting or diarrhoea, may be observed. As a result, anorexia may occur.
In very rare cases, neurological signs (seizures, tremors, ataxia, excitation) and anaphylactic reactions can also occur.
In dogs enrofloxacin may affect articular cartilage during the period of rapid growth.
The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals treated displaying adverse reaction(s)) common (more than 1 but less than 10 animals in 100 animals treated) uncommon (more than 1 but less than 10 animals in 1,000 animals treated) rare (more than 1 but less than 10 animals in 10,000 animals treated) very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The product may be used safely in pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction
Do not use enrofloxacin concomitantly with antimicrobial substances acting antagonistically to quinolones (e.g. macrolides, tetracyclines, or phenicols). Do not use concurrently with theophylline as the elimination of theophylline may be delayed.
Care should be taken during the concomitant use of flunixin and enrofloxacin in dogs to avoid adverse drug reactions. The decrease in drug clearances as a result of coadministration of flunixin and enrofloxacin indicates that these substances interact during the elimination phase. Thus, in dogs, the coadministration of enrofloxacin and flunixin increased the AUC and the elimination half-life of flunixin and increased the elimination half-life and reduced the Cmax of enrofloxacin.
Concurrent oral applications of substances containing calcium, aluminium or magnesium hydroxide (e.g. antacids), or multivitamins containing iron or zinc can interfere with intestinal absorption of fluoroquinolones. Enrofloxacin should therefore not be used concomitantly with those products.
The combined use of fluoroquinolones with digoxin should also be avoided because of potentially increased oral bioavailability of digoxin.
Amount(s) to be administered and administration route
The dosage rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Injection or Baytril 2.5% Injection and maintained with Baytril Flavour Tablets.
The daily dose is achieved as follows:-
Cats and small dogs: 1 Baytril Flavour Tablet 15 mg per 3 kg bodyweight.
Medium dogs: 1 tablet Baytril Flavour Tablets 50 mg per 10 kg bodyweight.
Large dogs: 1 tablet Baytril Flavour Tablets 150 mg per 30 kg bodyweight.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Do not exceed the recommended dose. In accidental overdose, vomiting, diarrhoea and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
Cats:
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days.
Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur.
Withdrawal period(s)
Not applicable
Pharmacological particulars
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics.
ATC Vet Code: QJ01MA90
Pharmacodynamics
Enrofloxacin is bactericidal in action with activity against Gram positive and Gram negative bacteria and mycoplasmas. The mechanism of action of the quinolones is unique among antimicrobials – they act primarily to inhibit bacterial DNA gyrase, an enzyme responsible for controlling the supercoiling of bacterial DNA during replication. Resealing of the double standard helix is inhibited resulting in irreversible degradation of the chromosomal DNA. The fluoroquinolones also possess activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
Pharmacokinetics
The pharmacokinetics of enrofloxacin in dogs and cats are such that oral and parenteral administration leads to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2-3 times higher than that found in the serum, have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone and lymphatic system. Enrofloxacin also distributes into the cerebrospinal fluid, the aqueous humour and the foetus in pregnant animals.
Pharmaceutical particulars
List of excipients
Lactose monohydrate
Maize starch
Microcrystalline cellulose
Polyvidone/Povidone
Magnesium stearate
Silica colloidal anhydrous
Artificial beef flavour Irradiated
Incompatibilities
None known
Shelf-life
Shelf-life of the product as packaged for sale: 5 years.
Special precautions for storage
Do not store above 25ºC. Store in a dry place.
Nature and composition of immediate packaging
Container material: Aluminium foil blister or plastic coated aluminium blister.
Container colour: Silver or white coloured.
Container volume: Strips of 10 light brown to brown tablets supplied in dispensing cartons containing 100 tablets.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Baytril Flavour Tablets 15 mg: Vm 00879/4120
Baytril Flavour Tablets 50 mg: Vm 00879/4122
Baytril Flavour Tablets 150 mg: Vm 00879/4121
Significant changes
Date of the first authorisation or date of renewal
Baytril Flavour Tablets 15 mg: 20 May 1992
Baytril Flavour Tablets 50 mg: 22 April 1992
Baytril Flavour Tablets 150 mg: 20 May 1992
Date of revision of the text
September 2023
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:Baytril Flavour Tablets 15 mg
GTIN:05032756180014
GTIN description:Baytril Flavour Tablets 50 mg
GTIN:05032756280011
GTIN description:Baytril Flavour Tablets 150 mg
GTIN:05032756380018