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Clinical particulars
Target species
Dogs
Indications for use, specifying the target species
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.
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 Use during pregnancy, lactation and lay and Interactions
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.
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
Persons with a known hypersensitivity to (fluoro)quinolones should avoid any contact with the product.
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.
Adverse reactions (frequency and seriousness)
Possible joint cartilage alterations in growing puppies (see Contraindications)
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.
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.
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. Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects.
Amounts to be administered and administration route
Oral use.
5 mg of enrofloxacin/kg/day as a single daily dosing, i.e. one Xeden 50 mg tablet for 10 kg body weight, one Xeden 150 mg tablet for 30 kg body weight, one Xeden 200 mg for 40 kg daily body weight 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.
Xeden 50 mg
Number of tablets per day
Xeden 150 mg
Number of tablets per day
Xeden 200 mg
Number of tablets per day
Weight of dog (kg)
1/4
2 - < 4
1/2
4 - < 6.5
3/4
1/4
6.5 - < 8.5
1
1/4
8.5 - < 11
1 ¼
1/2
11 - < 13.5
1 ½
1/2
13.5 - < 17
3/4
1/2
17 - < 25
1
3/4
25 - < 35
1 ¼
1
35 - < 40
1 ½
1
40 - < 45
1 ½
1 ¼
45 - < 50
1 ¾
1 ¼
50 - < 55
2
1 ½
55 - < 65
1 ¾
65 - < 80
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.
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.
Withdrawal period(s)
Not applicable