Dosage and administration

The solution is administered orally, directly into the mouth by means of the enclosed graduated dosing syringe.

Dose

5 mg/kg bodyweight per day (or 0.5 ml/kg).

Administration

Pulse dosing schedule: Treat for 7 days and then stop treatment for 7 days. Repeat 3 times. Cats must be treated during weeks 1,3 and 5 and left untreated during weeks 2 and 4.

5 mg/kg per day for 3 alternating weeks
PULSE 1	No Rx	PULSE 2	No Rx	PULSE 3
7 days treatment	7 days no treatment	7 days treatment	7 days no treatment	7 days treatment

The dosing syringe provided shows graduations for 100 grams of body weight. Fill the syringe by pulling the plunger until the correct body weight of the cat is indicated on the syringe. Treat the animal by slowly and gently injecting the liquid into the back of the mouth, allowing the cat to swallow the product.

When administering the product to kittens, be careful not to administer more than the recommended dose/weight. For kittens weighing less than 0.5kg, a 1 ml syringe which allows proper dosing should be used.

Contra-indications, warnings, etc

Contraindications

Do not administer to cats with hypersensitivity to itraconazole or one of the other ingredients. Do not administer to cats with impaired liver or kidney function. Do not use in pregnant or lactating queens.

Warnings

For animal use only. Keep out of reach of children. Wear latex gloves when handling the animal during treatment. 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. In case of accidental ingestion, rinse mouth with water.

Special Warnings

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 spores can survive in the environment for up to 18 months. Other 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.

Clipping of the hair coat is considered useful because it removes infected hairs, stimulates new hair growth and hastens recovery. 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 hair clipping. Furthermore it is recommended that disposable gloves are worn during treatment or clipping of the affected animals. The hairs should be disposed of appropriately and all instruments, clippers etc. should be disinfected. Measures to prevent introduction of M. canis into groups of cats may include isolation of new cats, isolation of cats returning from shows or breeding, exclusion of visitors and periodic monitoring by Wood’s lamp or by culturing for M. canis.

Undesirable effects

Salivation, vomiting, diarrhoea and anorexia may occasionally occur. These effects are usually mild and transient. A transient increase in liver enzymes may occur. In very rare cases this was associated with icterus. In such cases, treatment should be interrupted.

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. Serum ALT and AST levels can be monitored.

In humans, itraconazole has been associated with heart failure due to a negative inotropic effect. Cats suffering form heart diseases should be carefully monitored and the treatment should be withdrawn if the clinical signs deteriorate.

Pharmaceutical precautions

Do not store above 25 °C. In-use shelf life: 5 weeks. When the container is opened for the first time, the date on which any product remaining in the container must be discarded should be calculated. This discard date should be written in the space provided on the label. After each dose, the syringe should be washed and dried and the bottle cap screwed back on tightly.

Legal category

POM-V

Packaging Quantities

Amber glass bottle containing 52 ml oral solution, packed in a cardboard box with a graduated dosing syringe.

Further information

Clinical studies have indicated that the time period between clinical and mycological cure may vary. It is therefore advised to minimize the risk of re-infection or spread of infection by keeping healthy animals separate from animals that are being treated. Cleansing and disinfection of the environment with appropriate products is highly recommended – especially in cases of multiple cat infections. In exceptional cases, a prolonged time between clinical and mycological cure may be observed. In such cases, a repeated treatment may be necessary. Some cases of dermatophytosis may never be completely cured.

Interactions with other drugs

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 anti-diabetic 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 Itrafungol and these drugs should be avoided.