Xeden 200 mg Tablet for Dogs

Composition

Each tablet contains:

Active substance:

Enrofloxacin 200.0 mg

Excipients:

Qualitative composition of excipients and other constituents

Pig liver powder

Yeast

Cellulose microcrystalline

Copovidone

Croscarmellose sodium

Silica colloidal anhydrous

Hydrogenated castor oil

Lactose monohydrate

Clover-shaped scored beige tablet

The tablet can be divided into four equal parts.

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Pharmacological properties

4.1 ATCvet code:

QJ01MA90

4.2 Pharmacodynamics

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.

According to the CLSI standard (CLSI July 2013), the veterinary breakpoints available for Enterobacteriaceae and Staphylococcus spp., are:

MICs values for Enrofloxacin in dogs (skin, soft tissue, respiratory and UTI), S ≤ 0.5 μg/mL; I: 1_2μg/mL; R ≥ 4μg/ml.

4.3 Pharmacokinetics

Enrofloxacin is rapidly metabolised to form an active compound, ciprofloxacin. After oral administration of XEDEN 200 (5 mg/kg) in dogs:

- The maximal plasma concentration of enrofloxacin of 1.72 µg/mL was observed one hour following administration.

- The maximal plasma concentration of ciprofloxacin (0.32 µg/mL) was observed two hours following administration.

Enrofloxacin is primarily excreted via the kidneys. A major portion of the parent drug and its metabolites is recovered in urine.

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 14% in dogs. The half-life in serum is 3-5 hours in dogs (5 mg/kg).

Approximately 60 % 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 in dogs.

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Target species

Dogs

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Indications

In dogs:

- Treatment of lower urinary tract infections (associated or not with prostatitis) and upper urinary tract infections caused by Escherichia Coli or Proteus mirabilis.

- Treatment of superficial and deep pyoderma.

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Dosage

Oral use 5 mg of enrofloxacin/kg/day as a single daily dosing, i.e. one tablet for 40 kg daily for:

- 10 days in lower urinary tract infections

- 15 days in upper urinary tract infections and lower urinary tract infections associated with prostatitis

- Up to 21 days in superficial pyoderma depending on clinical response

- Up to 49 days in deep pyoderma depending on clinical response

The treatment should be reconsidered in case of lack of clinical improvement at half of the treatment duration.

The tablets are flavoured, and are well accepted by dogs. The tablets may be administered directly in the mouth of the dog or simultaneously with food if necessary.

Instruction on how to divide the tablet: Put the tablet on an even surface, with its scored side facing down (convex face up). With the tip of the forefinger, exert slight vertical pressure on the middle of the tablet to break it along its width into halves. Then, in order to obtain quarters, exert slight pressure on the middle of one half with the forefinger to break it into two parts.

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Contraindications

Do not use in young or growing dogs (dogs aged less than 12 months (small breed) or less than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in growing puppies.

Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation.

Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product.

Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones.

Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects.

See also section 3.7.

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Adverse reactions

Dog:

1In this case, the administration of the product should be stopped.

2Possible alterations in growing puppies.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

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 dogs with severe renal or hepatic impairment. Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause and to treat the animal accordingly.

The chewable tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to (fluoro)quinolones should avoid contact with the veterinary medicinal product. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after handling the product. In case of contact with eyes, rinse immediately with plenty of water.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Use during pregnancy: Laboratory 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 maternal milk, the use is not recommended during lactation.

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Interactions

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.

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Overdose

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 methods and symptomatic treatment.

If necessary, administration of aluminium- or magnesium-containing antacids or activated carbon can be used to reduce absorption of enrofloxacin.

According to literature, signs of overdosage with enrofloxacin in dogs such as inappetence and gastrointestinal disturbance were observed at approximately 10 times the recommended dose when administered for two weeks. No signs of intolerance were observed in dogs administered 5 times the recommended dose for a month.

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Special warnings

None

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Withdrawal period

Not applicable

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Incompatibilities

Not applicable

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Immediate packaging

Blister complex: PVDC-TE-PVC/Aluminium heat-sealed blisters with 6 tablets / blister Cardboard box with 2 blisters of 6 tablets Cardboard box with 20 blisters of 6 tablets

Not all pack sizes may be marketed.

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Storage

Store in the original container. Protect from light.

Divided tablets should be stored in the blister pack. Any divided tablet portions remaining after 3 days should be discarded.

This medicinal product does not require any special temperature storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life of divided tablets: 3 days

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 15052/5091

8 DATE OF FIRST AUTHORISATION

12 October 2010

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 22 December 2025

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Registration holder

Ceva Animal Health Ltd

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