Xeden 15 mg for cats 1 tablet
Treatment of upper respiratory tract infections in cats / Enrofloxacin
XEDEN 15 mg tablet for cats
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF XEDEN
One tablet contains:
Enrofloxacin 15.0 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF XEDEN
Oblong scored beige tablet
The tablet can be divided into two equal parts.
4. CLINICAL PARTICULARS OF XEDEN
4.1 Target species
4.2 Indications for use, specifying the target species
In cats: treatment of upper respiratory tract infections
Do not use in young, growing cats, because of the possibility of the development of cartilage lesions. (cats aged less than 3 months or weighing less than 1kg)
Do not use in the case that there is resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoquinolones.
Do not use in cats having seizure disorders, since enrofloxacin may cause CNS stimulation.
See also section 4.7 and 4.8.
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precautions for use in animals
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.
Wherever possible, fluoroquinolones should 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.
Use the product with caution in cats with severe renal or hepatic impairment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the physician.
Wash hands after handling the product.
In case of contact with eyes, rinse immediately with plenty of water.
4.6 Adverse reactions (frequency and seriousness)
Vomiting or diarrhoea may appear during the treatment. These signs regress spontaneously and generally do not require treatment discontinuation.
In rare case, hypersensitive reactions may occur. In this case, the administration of the product should be stopped.
Neurological signs (seizures, tremors, ataxia, excitation) can occur.
4.7 Use during pregnancy, lactation or lay
Use during pregnancy :
Studies in laboratory animals (rat, chinchilla) have not produced any evidence of a teratogenic, foetotoxic, maternototoxic effect. Use only according to the benefit/risk assessment by the responsible veterinarian.
Use during lactation:
As enrofloxacin passes into the maternal milk, the use is not recommended during lactation
4.8 Interaction with other medicinal products and other forms of interaction
Concurrent use of flunixin should be under careful veterinary monitoring, as the interactions between these drugs may lead to adverse events related to delayed elimination.
Concomitant administration of theophylline requires careful monitoring as serum levels of theophylline may increase.
Concurrent use of magnesium or aluminum containing substances (such as antacids or sucralfate) may reduce absorption of enrofloxacin. These drugs should be administered two hours apart.
Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects.
4.9 Amounts to be administered and administration route
5 mg of enrofloxacin/kg body weight once daily for 5 to 10 consecutive days:
either 1 tablet for 3 kg body weight as a single daily dosing.
or ½ tablet for 1.5 kg body weight as a single daily dosing.
The treatment should be reconsidered in case of lack of clinical improvement at half of the treatment duration.
Cat weight (kg): Number of tablets per day
≥ 1.1 - < 2: ½
≥ 2 - < 4: 1
≥ 4 - < 5: 1 ½
≥ 5 - < 6.5: 2
≥ 6.5 - < 8.5: 2 ½
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing
The tablets are flavoured. They may be administered directly in the mouth of the cat or added to food if necessary.
Do not exceed the recommended treatment dose.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosing can cause vomiting and nervous signs (muscle tremor, incoordination and convulsions) which may require treatment discontinuation.
In the absence of any known antidote, apply drug elimination and symptomatic treatment.
If necessary, administration of aluminium or magnesium containing antacids or activated carbon can be used to reduce absorption of enrofloxacin.
In laboratory studies, ocular adverse effects have been observed from 20 mg/kg.
The toxic effects on the retina caused by overdosing may be such that they lead to irreversible blindness in the cat.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES OF XEDEN
ATCvet code: QJ01MA90
Pharmacotherapeutic group: Fluoroquinolones
5.1 Pharmacodynamic properties
Enrofloxacin is a synthetic fluoroquinolone antibiotic that exerts its activity by inhibiting topoisomerase II, an enzyme involved in the mechanism of bacterial replication.
Enrofloxacin exerts bactericidal activity concentration-dependant with similar values of minimal inhibit concentration and minimal bactericide concentrations. It also possesses activity against bacteria in the stationary phase by an alteration of the permeability of the outer membrane phospholipid cell wall.
In general, enrofloxacin exhibits good activity against most gram-negative bacteria, especially those of the Enterobacteriacea. Escherichia coli, Klebsiella spp., Proteus spp., and Enterobacter spp. are generally susceptible.
Pseudomonas aeruginosa is variably susceptible and, when it is susceptible, usually has a higher MIC than other susceptible organisms.
Staphylococcus aureus and Staphylococcus intermedius usually are susceptible.
Streptococci, enterococci, anaerobic bacteria can generally be considered resistant.
Induction of resistance against quinolones can develop by mutations in the gyrase gene of bacteria and by changes in cell permeability towards quinolones.
5.2 Pharmacokinetic particulars
Enrofloxacin is approximately 100% bioavailable after oral administration. It is unaffected by food. Enrofloxacin is rapidly metabolised to form an active compound, ciprofloxacin.
After oral administration of XEDEN 15 (5 mg/kg) in cats:
The maximal plasma concentration of enrofloxacin of 2.9µg/mL was observed one hour following administration.
The maximal plasma concentration of ciprofloxacin (0.18 µg/ml) was observed 5 hours following administration.
Enrofloxacin is widely distributed in the body. The tissue concentrations are often higher than the serum concentrations. Enrofloxacin crosses the blood-brain barrier. The degree of protein binding in serum is 8% in cats. The half-life in serum is 3-4 hours in cats (5 mg/kg). Approximately 25 % of the dose of enrofloxacin is excreted in the urine and 75 % via faeces. Approximately 15 % of the dose is excreted as unchanged enrofloxacin and the remainder as metabolites, amongst others ciprofloxacin. The total clearance is approximately 9 ml/minute/kg bodyweight.
6. PHARMACEUTICAL PARTICULARS OF XEDEN
6.1 List of excipients
Pig liver powder
Silica colloidal anhydrous
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
Shelf-life of half tablets:
6.4. Special precautions for storage
Store in the original container.
Protect from light.
This medicinal product does not require any special temperature storage conditions.
Any half tablets should be returned to the original blister for storage.
Any half tablets remaining after 24 hours should be discarded.