Itrafungol 10 mg/ml Oral Solution

Yellow to slightly amber, clear solution.
3. CLINICAL INFORMATION
3.1 Target Species
Cats.
3.2 Indications for use, for each target species
Treatment of dermatophytosis caused by Microsporum canis.
3.3 Contraindications
Do not use in cats with hypersensitivity to itraconazole or one of the other ingredients.
Do not use in cats with impaired liver or kidney function.
For use in pregnant and lactating queens: see section 3.7
3.4 Special warnings
Some cases of feline dermatophytosis can be difficult to cure, especially in catteries.
Cats treated with itraconazole can still infect other cats with M. canis as long as they are
not mycologically cured. It is therefore advised to minimise the risk of re-infection or
spread of infection by keeping healthy animals (including dogs as they can also be
infected by M. canis) separate from cats that are being treated. Cleaning and
disinfection of the environment with appropriate fungicidal products is highly
recommended – especially in case of group problems.
When clipping the hair of infected cats, the advice of the veterinarian should be sought
first.
Clipping of the hair coat is considered useful because it removes infected hairs,
stimulates new hair growth and hastens recovery. It is strongly recommended that
clipping is performed by a veterinarian. In cases with limited lesions, hair clipping can be
limited to the lesions only, whereas in cats with generalized dermatophytosis it is
recommended to clip the entire hair coat. Care should be taken not to cause trauma to
the underlying skin during clipping. It is recommended that disposable, protective clothing
and gloves are worn during the clipping of the affected animals. The clipping of the hair
should be performed in a well ventilated room which can be disinfected after clipping.
The hairs should be disposed of appropriately and all instruments, clippers etc. should be
disinfected.
Treatment of dermatophytosis should not be limited to treatment of the infected animal(s).
It should also include disinfection of the environment with appropriate fungicidal products,
since M. canis
measures such as frequent vacuuming, disinfection of grooming equipment and removal
of all potentially contaminated material that cannot be disinfected will minimize the risk of
re-infection or spread of infection. Disinfection and vacuuming should be continued for an
extended period after the cat is clinically cured, but vacuuming should be limited to
surfaces, which may not be cleaned with a damp cloth. All other surfaces should be
cleaned with a damp cloth. Any cloth used for cleaning should be washed and disinfected
or disposed of and the used vacuum cleaner bag should be disposed of.
Measures to prevent introduction of M.canis
new cats, isolation of cats returning from shows or breeding, exclusion of visitors and
periodic monitoring by Wood's lamp or by culturing for .
In refractory cases the possibility of an underlying disease should be considered.
Frequent and repeated use of an antimycotic may result in the induction of resistance to
antimycotics of the same class.
Refer to section 3.5 for Operator warnings.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Cats suffering from dermatophytosis, but also in poor general condition and/or suffering
from additional diseases or impaired immunological response should be monitored closely
during treatment. Because of their condition, this category of animals may be more
sensitive to the development of adverse effects. In case of a serious adverse effect,
treatment should be interrupted and supportive care therapy (fluid therapy) should be
initiated if necessary. If clinical signs suggestive of liver dysfunction develop, treatment
should be discontinued immediately. It is very important to monitor liver enzymes in
animals showing signs of liver dysfunction.
In humans, itraconazole has been associated with heart failure due to a negative inotropic
effect. Cats suffering from heart diseases should be carefully monitored and the treatment
should be withdrawn if the clinical signs deteriorate.
Use of the product should be based on identification and susceptibility testing of the target
pathogen(s). If this is not possible, therapy should be based on epidemiological
information and knowledge of susceptibility of the target pathogens at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
If a suspected lesion occurs on a human, consult a physician, since
dermatophytosis is a zoonotic disease. Therefore, wear latex gloves when clipping hair of
infected cats, when handling the animal during treatment or when cleaning the syringe.
Wash hands and exposed skin after use. In case of accidental contact with eyes, rinse
thoroughly with water. In case of pain or irritation, seek medical advice immediately and
show the package leaflet or the label to the physician. In case of accidental ingestion, rinse
mouth with water.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Common
(1 to 10 animals / 100
animals treated):
Vomiting, Diarrhoea, Increased salivation
Anorexia, Depression, Apathy
Rare
(1 to 10 animals / 10,000
animals treated):
Elevated liver enzymes
2,3,4
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Weight loss
Elevated total bilirubin
3,4
(may be associated with
icterus)
These effects are usually mild and transient.
Transient.
If clinical signs suggestive of liver dysfunction develop, treatment should be discontinued
immediately.
Sometimes fatal.
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 also section 16 of the package leaflet for respective contact
details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use in pregnant or lactating queens. Malformations and foetal resorptions were
seen in overdose studies in laboratory animals.
3.8 Interaction with other medicinal products and other forms of interactions
Vomiting, hepatic and renal disorders were seen after concomitant treatment of Itrafungol
and cefovecin. Symptoms like motor incoordination, faecal retention and dehydration are
observed when tolfenamic acid and Itrafungol are given simultaneously. Co-administration
of the product and these drugs, in absence of data in cats, should be avoided.
In human medicine, interactions between itraconazole and certain other drugs have been
described, resulting from interactions with cytochrome P450 3A4 (CYP3A4) and P-
glycoproteins (PgP). This may result in increased plasma concentrations of e.g. oral
midazolam, cyclosporin, digoxin, chloramphenicol, ivermectin, or methylprednisolone. The
increased plasma levels can prolong the duration of effects as well as side effects.
Itraconazole may also increase the serum level of oral antidiabetic agents, which may
result in hypoglycaemia.
On the other hand, some drugs, e.g. barbiturates or phenytoin can increase the rate of
metabolism of itraconazole, resulting in a decreased bioavailability, hence a decreased
efficacy. As itraconazole requires an acidic environment for maximal absorption, antacids
cause a marked reduction in absorption. Concomitant use of erythromycin can increase
the plasma concentration of itraconazole.
Interactions in humans between itraconazole and calcium antagonists have also been
reported. These drugs might have additive negative inotropic effects to the heart.
It is not known to what extent these interactions are relevant for cats, but in the absence
of data, co-administration of the product and these drugs should be avoided.
3.9 Administration routes and dosage
Oral use.
The solution is administered orally directly into the mouth by means of a dosing syringe.
The daily dosage is 5 mg/kg or 0.5 ml/kg/day.
The dosage regime is 0.5 ml/kg/day for 3 alternate periods of 7 consecutive days, each
time with 7 days without treatment in between.
7 Days7 Days7 Days7 Days7 DaysTreatmentNo treatmentTreatmentNo treatmentTreatment
The dosing syringe shows graduations per 100 gram of body weight. Fill the syringe by
pulling the plunger until it reaches the graduation corresponding to the correct body
weight of the cat.
When administering the product to kittens, the administrator should be careful not to
administer more than the recommended dose/weight. For kittens weighing less than 0.5
kg, a 1 ml syringe which allows proper dosing should be used.
Treat the animal by slowly and gently injecting the liquid into the mouth, allowing the cat
to swallow the product.
After dosing, the syringe should be removed from the bottle, washed and dried and the
cap should be screwed back on tightly.
Data in humans shows that food intake may result in lower drug absorption. Therefore, it
is recommended to administer the product by preference between meals.
In some cases, a prolonged time between clinical and mycological cure may be
observed. In cases where a positive culture is obtained 4 weeks after the end of
administration, the treatment should be repeated once at the same dosage regimen. In
such cases where the cat is also immunosuppressed, treatment should be repeated and
the underlying disease addressed.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
After a 5x overdose of itraconazole administered for 6 consecutive weeks, reversible
clinical side effects were: rough hair coat, decreased food intake and reduced body
weight . A 3x overdose for 6 weeks did not result in clinical side effects. Both after a 3x
and a 5x overdose for 6 weeks, reversible change in serum biochemical

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