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Itrafungol Oral Solution for Cats

Itrafungol Oral Solution for Cats

Itrafungol is used to treat ringworm (a fungal infection of the skin usually causing scaling and hair loss). It is supplied as a liquid to be given directly into the back of the mouth using the syringe provided. Accurate dosing is possible as long as the cat has been weighed first. A dose is given once daily for 7 days. This treatment is then repeated on alternate weeks so that treatment is given on week1, week 3 and week 5. No treatment is given on week 2 or week 4. Ideally medication is given on an empty stomach to improve absorption.

Ringworm produces spores which can persist in the environment for 18 months, so it is important to sterilise grooming equipment and bedding as much as possible. Ringworm can sometimes affect humans too, so operators should wear gloves and wash hands after handling infected cats. Clipping the hair on cats improves the chances of successful treatment.

Description

Presentation

Yellow to slightly amber, clear oral solution containing 10 mg itraconazole per ml. Other ingredients include propylene glycol, sorbitol and caramel (E150).

Uses

Treatment of dermatophytosis in cats caused by Microsporum canis.

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/day).

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 per 100 gram of body weight. Fill the syringe by pulling the plunger until it reaches the graduation corresponding the correct body weight of the cat. 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.

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.

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. Malformations and foetal resorptions were seen in overdose studies in laboratory animals.

Operator Warnings

If a suspected lesion occurs on a human, consult a physician, since 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. 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

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.

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. 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.

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 hair clipping. Furthermore it is recommended that disposable protective clothing and gloves are worn during 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.

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.

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 (such as serum ALT and AST levels) in animals showing signs of liver dysfunction.

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.

Frequent and repeated use of an antimycotic may result in the induction of resistance to antimycotics of the same class.

Undesirable effects

In clinical studies, some form of adverse reaction possibly related to the administration of the product were noted. Common adverse reactions were vomiting, diarrhoea, anorexia, salivation, depression and apathy. These effects are usually mild and transient. A transient increase in liver enzymes may occur; in very rare cases this was associated with icterus. If clinical signs suggestive of liver dysfunction develop, treatment should be discontinued immediately.

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.

For animal use only. Keep out of the reach and sight of children.

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 box. 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, closed with a child resistant screw cap, packed in a cardboard box with a graduated dosing syringe.

Further information

Itrafungol containts itraconazole, a synthetic broad spectrum triazole antimycotic with a high activity against dermatophytes (Trichophyton spp., Microsporum spp.), yeasts (Candida spp., Malassezia spp.), various dimorphic fungi, zygomycetes and eumycetes (eg Apsergillus spp.).

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.

Overdose

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 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.

Disposal

Any unused product or waste material should be disposed of in accordance with national requirements.

Marketing Authorisation Number

Vm 00006/4148

GTIN (Global Trade Item No)

Itrafungol 10mg/ml Oral Solution 52ml bottle

05420036901785

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Dosage

3rd Jul 2014
Val

I have a question about the dosage. I have two kittens weighing 5kg and 2.5kg respectively. I am drawing up Itrafungol to 5 and 2.5 for each as instructed to by the vet. Is this the correct dosage? The part that confuses me is the instructions stating 5mg / kg body weight. The bottle contains 10mg per ml so does that mean I am giving them twice the amount or is it already worked out based on the syringe corresponding to their weight? Confused :( Thanks in advance.

John Cousins
  • Veterinary Surgeon at VioVet

The syringe is calibrated according to bodyweight of cat. This might seem a bit odd, but is designed to make it easy. The syringe provided 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. If you are doing this, all will be well. (You normally treat on weeks 1, 3 and 5, missing out weeks 2 and 4.

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