Itrafungol (Itraconazole) Oral Solution (Canada)

Oral antifungal solution for cats

DIN 02316811

Description

Each mL of ITRAFUNGOL Oral Solution contains 10 mg itraconazole (Ph. Eur.) in an oral solution with sweeteners and flavourings.

Pharmacology

ITRAFUNGOL Oral Solution contains itraconazole, a synthetic broad spectrum triazole antimycotic with activity against dermatophytes (Trichophyton spp., Microsporum spp.), yeasts (Candida spp., Malassezia spp.), various dimorphic fungi, zygomycetes and eumycetes (e.g., Aspergillus spp.). Antimycotic activity was demonstrated in in vitro systems and in vivo experimental models.

The mode of action of itraconazole is based on its 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.

Itrafungol (Itraconazole) Oral Solution Indications

For the treatment of feline dermatophytosis caused by Microsporum canis.

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. Itraconazole caused malformations and foetal resorptions when administered at high doses to rats and mice.

Warnings

Keep out of the reach of children. Wash hands after use.

Itrafungol (Itraconazole) Oral Solution Caution

When administering this product to kittens, be careful not to exceed the recommended dose.

Cats in general poor condition and/or suffering from another disease and/or which are immunocompromised should be monitored closely during treatment. Liver enzyme concentrations should be monitored.

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

In humans, itraconazole has been associated with cardiac adverse events due to its negative inotropic effect. Cats suffering from heart disease should be carefully monitored during treatment.

Adverse Reactions

Salivation, vomiting, diarrhea, anorexia, depression and apathy may occasionally occur. These effects are usually mild and transient.

After a 5X overdose of itraconazole administered for 6 consecutive weeks to adult cats, 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. After both a 3X and 5X overdose for 6 weeks, reversible changes in serum biochemical parameters occurred (increased ALT, ALP, AST and bilirubin) indicating liver involvement.

Drug Interactions

Itraconazole is a cytochrome p-450 inhibitor and may therefore increase or prolong plasma concentrations of other drugs metabolized by this pathway.

Itrafungol (Itraconazole) Oral Solution Dosage And Administration

The solution should be administered directly into the mouth by means of the enclosed graduated dosing syringe.

The daily dosage is 5 mg (0.5 mL)/kg body weight/day for 3 alternate periods of 7 consecutive days, each time with 7 days without treatment in between.

The dosing syringe shows graduations per kg of body weight (e.g. selecting 1 kg on the dosage syringe delivers 0.5 mL of itraconazole solution, selecting 2 kg on the dosage syringe delivers 1 mL of itraconazole solution).

Fill the syringe by pulling the plunger until it reaches the graduation corresponding to the correct body weight of the cat as indicated at the ring of the syringe (Figure 1). Treat the animal by slowly and gently injecting the liquid into the mouth, allowing the cat to swallow the product (Figure 2). 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.

Data in humans shows that food intake may result in lower drug absorption. Therefore, it is recommended to administer the product without food (before the meal).

After dosing, the syringe should be removed from the bottle, washed and dried and the cap should be screwed back on tightly.

Storage

Do not store above 25°C. Discard 5 weeks after opening. Avoid contamination of the solution.

How Supplied

ITRAFUNGOL Oral Solution is available in an individual box containing a 52 mL amber glass bottle and a graduated dosing syringe.

Veterinary Use Only

Imported/Distributed in Canada by: Virbac Canada Inc, 231, Shearson Crescent, Suite 209, Cambridge (Ontario) N1T 1J5.

1-800-338-3659

ITRAFUNGOL is a registered trademark of Virbac S. A.

© 2022 Virbac Corporation. All Rights Reserved.

11606

1608001D

1608000D

1608002C

CPN: 1177120.0