Fugasol 10 mg/ml Oral Solution for Cats

Composition

Each ml contains:

Active substance:

Itraconazole 10 mg

Excipients:

Slight yellow to brownish, clear to slight opalescent solution.

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Pharmacological properties

4.1 ATCvet code: QJ02AC02

4.2 Pharmacodynamics

The veterinary medicinal product contains itraconazole, a synthetic broad spectrum triazole antimycotic with a high activity against the dermatophyte Microsporum canis. The mode of action of itraconazole is based on its highly selective binding ability to fungal Cytochrome P-450 iso-enzymes. This inhibits the synthesis of ergosterol and affects membrane-bound enzyme function and membrane permeability. This effect is irreversible and causes structural degeneration.

4.3 Pharmacokinetics

Laboratory animals rapidly absorb orally administered itraconazole. It binds very extensively to plasma proteins (>99 %) and distributes to tissues. More than 30 metabolites are formed, from which hydroxy-itraconazole has an antifungal activity as the parent. Excretion is rapid and mainly via the faeces.

In cats a single oral dose of 5 mg/kg results in maximum plasma concentrations of on average 0.847 µg/ml attained 1.4 hours after dosing. The AUC0-24h is 9.8 µg.h/ml. The half‑life in plasma is about 21 hours. After repeated administration for one week at 5 mg/kg/day, the maximum plasma concentration is more than doubled. The AUC0-24h is increased 3 times and the plasma half‑life is also increased 3 times.

In the therapeutic treatment schedule, itraconazole is almost completely cleared from plasma after each wash-out. In contrast to what happens in other animals, hydroxy- itraconazole remains near or below the quantification limit in plasma after a single dose of itraconazole at 5 mg/kg. Concentrations in cat’s hair vary; an increase occurs during treatment to a median value of 3.0 μg/g (mean 5.2 μg/g) at the end of the third dosing week and concentrations drop slowly to 1.5 μg/g (mean 1.9 μg/g) at 14 days after the end of treatment. Concentrations of hydroxy-itraconazole in hair are insignificant.

Bioavailability of the oral solution of itraconazole in humans is higher when administered in fasted conditions.

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Target species

Cats.

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Indications

Treatment of dermatophytosis caused by Microsporum canis.

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Dosage

Oral use.

Administer 5 mg of itraconazole per kg body weight once daily, equivalent to 0.5 ml of the veterinary medicinal product per kg body weight once daily. The solution should be administered directly into the mouth by means of a dosing syringe.

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.

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 veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal 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.

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Contraindications

Do not use

- in cases of hypersensitivity to itraconazole, to other azoles or any of the excipients.

- in cases of impaired liver or kidney function.

- in pregnant and lactating queens: see section 3.7.

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Adverse reactions

Cats:

1 These effects are usually mild and transient.

2 Transient

3 Associated with elevated liver enzymes

4 If clinical signs suggestive of liver dysfunction develop, treatment should be discontinued immediately.

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:

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 farm level, or 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:

M. canis 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. If a suspected lesion occurs on a human, consult a physician.

This veterinary medicinal product may cause skin and/or eye irritation. Avoid contact with skin and eyes. Wash hands and exposed skin after use. In case of accidental contact with eyes, rinse thoroughly with water. In case of persistent pain or irritation, seek medical advice and show the label or package leaflet to the physician. This veterinary medicinal product may be harmful after accidental ingestion by children. Do not leave the filled syringe unattended. In case of accidental ingestion, rinse mouth with water, seek medical advice immediately and show the package leaflet or the label to the physician.

This veterinary medicinal product may cause hypersensitivity reactions. People with known hypersensitivity to itraconazole or propylene glycol should avoid contact with the veterinary medicinal product. Wash hands after use.

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

Pregnancy and lactation:

Do not use in pregnant or lactating queens.

Malformations and foetal resorptions were seen in overdose studies in laboratory animals. Laboratory studies in rats have shown evidence of dose-related teratogenic, foetotoxic and maternotoxic effects at high dosages (40 and 160 mg/kg bw/day for 10 days during their gestational period).

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Interactions

Vomiting, hepatic and renal disorders were seen after concomitant treatment of itraconazole and cefovecin. Symptoms like motor incoordination, faecal retention and dehydration are observed when tolfenamic acid and itraconazole are given simultaneously. Co-administration of the veterinary medicinal 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 veterinary medicinal product and these drugs should be avoided.

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Overdose

After a 5 times overdose of itraconazole administered for 6 consecutive weeks, reversible clinical side effects were: rough hair coat, decreased food intake and reduced body weight. A 3 times overdose for 6 weeks did not result in clinical side effects. Both after a 3 times and a 5 times overdose for 6 weeks, reversible change in serum biochemical parameters indicating liver involvement occur (increased ALT, ALP, bilirubin and AST). At 5 times overdose a slight increase in segmented neutrophils and a slight decrease in lymphocytes were observed.

No studies on overdose in kittens have been performed.

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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 generalised 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 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 minimise 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 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.

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.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Amber glass or white high density polyethylene (HDPE) bottles with child resistant polypropylene screw cap and low density polyethylene (LDPE) syringe in-lay. Measuring device: Syringe (3 ml) with low density polyethylene (LDPE) body and polystyrene (PS) plunger.

Each bottle contains: 25 ml, 50 or 100 ml

Package size:

Cardboard box with 1 bottle of 25, 50 or 100 ml and an oral syringe of 3 ml as dosing device.

Not all pack sizes may be marketed.

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Storage

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

Keep the container tightly closed.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months Shelf life after first opening the immediate packaging: 90 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 20916/3003 (NI) Vm 20916/5006 (GB)

8 DATE OF FIRST AUTHORISATION

15 December 2022

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

February 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

Gavin Hall Approved: 08 April 2025

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Registration holder

CP Pharma Handelsgesellschaft mbH

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