Xeden 50 mg for dogs 1 tablet
Treatment of lower urinary tract infections and upper urinary tract infections and treatment of superficial and deep pyoderma in dogs / Enrofloxacin
XEDEN 50 mg tablet for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF XEDEN
One tablet contains:
Enrofloxacin 50.0 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM OF XEDEN
Clover-shaped scored beige tablet
The tablet can be divided into four equal parts.
4. CLINICAL PARTICULARS OF XEDEN
4.1 Target species
4.2 Indications for use, specifying the target species
- 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.
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.
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 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.
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)
Possible joint cartilage alterations in growing puppies (see 4.3 contra-indications).
In rare cases vomiting and anorexia are observed.
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: 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 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/day as a single daily dosing, i.e. one tablet for 10 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.
Dog weight (kg): Number of tablets per day
≥ 2 - < 4: ¼ tablet of XEDEN 50 mg
≥ 4 - < 6.5: ½ tablet of XEDEN 50 mg
≥ 6.5 - < 8.5: ¾ tablet of XEDEN 50 mg and ¼ tablet of XEDEN 150 mg
≥ 8.5 - < 11: 1 tablet of XEDEN 50 mg and ¼ tablet of XEDEN 150 mg
≥ 11 - < 13.5: 1 ¼ tablet of XEDEN 50 mg and ½ tablet of XEDEN 150 mg
≥ 13.5 - < 17: 1 ½ tablet of XEDEN 50 mg and ½ tablet of XEDEN 150 mg
≥ 17 - < 25: ¾ tablet of XEDEN 150 mg
≥ 25 - < 35: 1 tablet of XEDEN 150 mg
≥ 35 - < 40: 1 ¼ tablet of XEDEN 150 mg
≥ 40 - < 50: 1 ½ tablet of XEDEN 150 mg
≥ 50 - < 55: 1 ¾ tablet of XEDEN 150 mg
≥ 55 - < 65: 2 tablets of XEDEN 150 mg
To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.
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.
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 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.
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 rapidly metabolised to form an active compound, ciprofloxacin.
After oral administration of XEDEN 50 (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.
6. PHARMACEUTICAL PARTICULARS OF XEDEN
6.1 List of excipients
Pig liver powder
Silica colloidal anhydrous
Hydrogenated castor oil
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
Shelf-life of divided 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 divided tablets should be returned to the original blister for storage.
Any divided tablets remaining after 72 hours should be discarded.