10 mg/ml

Antifungal for oral use in cats only

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

ITRAFUNGOL oral solution is a yellow to slightly amber, clear solution containing the active ingredient, itraconazole, at 10 mg/mL.

ITRAFUNGOL oral solution is indicated for the treatment of dermatophytosis caused by Microsporum canis in cats.

The solution should be administered orally using the enclosed graduated dosing syringe.

The daily dosage is 5 mg/kg (0.5 mL/kg) body weight administered once daily on alternating weeks for 3 treatment cycles. Cats are treated during weeks 1, 3, and 5, and left untreated during weeks 2 and 4.

Each line on the dosing syringe represents 0.05 mL of oral solution.

The solution should be administered orally using the enclosed graduated dosing syringe. Keep the bottle upright and insert the dosing syringe through the opening of the top of the bottle (Figure 1). Do not invert the bottle (Figure 2). Fill the syringe by pulling the plunger until it reaches the graduation corresponding to the correct mL dose as indicated at the top of the syringe ring (Figure 3). Treat the cat by slowly and gently administering the liquid into the mouth, allowing the cat to swallow the product (Figure 4). For cats weighing more than 13.0 lbs, the total dose will need to be calculated and given over two doses as the dosing syringe only holds 3.0 mL of solution.

Fig. 1

Fig. 2

Fig. 3

Fig. 4

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

Do not administer to cats with hypersensitivity to itraconazole.

ITRAFUNGOL (itraconazole oral solution) has not been shown to be safe in pregnant cats (see Animal Safety section). ITRAFUNGOL should only be used in pregnant or lactating cats when the benefits outweigh the potential risks.

Not for use in humans. Keep this and all medications out of reach of children. 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 and seek medical advice.

ITRAFUNGOL has been associated with renal changes found on histopathology that were not noted after an eight week recovery period (see Animal Safety). Use with caution in cats with renal dysfunction.

ITRAFUNGOL is metabolized by the liver (mainly CYP3A) and can cause elevated liver enzymes (see Animal Safety section). Use with caution in cats with impaired liver function. If clinical signs suggestive of liver dysfunction develop, treatment should be discontinued.

ITRAFUNGOL is a cytochrome p-450 inhibitor and may increase or prolong plasma concentrations of other drugs metabolized by this pathway, such as amitriptyline, amlodipine, benzodiazepines, buspirone, cisapride, corticosteroids, cyclosporine, ivermectin, and macrolide antibiotics.

Negative inotropic effects have been reported in literature when itraconazole was administered intravenously to dogs and healthy human volunteers. Cats suffering from heart disease should be carefully monitored during treatment.

In the laboratory effectiveness study, adverse reactions related to exposure to ITRAFUNGOL were primarily related to the gastrointestinal tract. Two ITRAFUNGOL-treated cats experienced transient hypersalivation during the dosing period. Vomiting was observed in 5 ITRAFUNGOL-treated cats (12.5%) during the dosing period compared to four cats (10%) in the control group. Diarrhea was observed in 9 ITRAFUNGOL-treated cats (22.5%) during the dosing period as compared to 7 cats (17.5%) in the control group. One ITRAFUNGOL-treated cat showed mild increases in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at the end of the dosing period. No related clinical signs were observed, and these values returned to normal by the end of the follow-up period. One cat in the ITRAFUNGOL-treated group was noted to have lip erythema and lip induration once during the study.

Field safety was evaluated in 266 cats randomized to receive itraconazole oral solution. Of the 266 cats that received at least one dose of itraconazole oral solution, adverse reactions included 35 cases (13%) of one or more elevated hepatic enzymes and 8 cases (3%) of gastrointestinal upset, including decreased appetite, vomiting and/or diarrhea. Other infrequent adverse reactions included less than 3 cases each of somnolence, depression, and increased salivation.

For technical assistance or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or on line at www.fda.gov/reportanimalae

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 of the fungal organism.

Itraconazole was absorbed rapidly following oral administration of ITRAFUNGOL (itraconazole oral solution) to laboratory cats. Compared to the fasted state, administration of ITRAFUNGOL with food results in slightly higher (1.3 fold) mean total itraconazole exposure (AUC), delay in median Tmax (Fed 4 hours vs. Fasted 2 hours) and significant decrease (approximately 0.55 fold) in maximum plasma concentration (Cmax). ITRAFUNGOL can be administered with or without food. Itraconazole oral solution binds extensively to plasma proteins (> 99%), and distributes well to tissues. More than 30 metabolites are formed. Hydroxy-itraconazole is the parent metabolite and has antifungal activity. Excretion is rapid and primarily via the feces.

In cats, a single oral dose of 5 mg/kg results in a Cmax of 0.525 μ/ml post dose at 2 hours (Tmax). The AUC0-24h is 5.09 μg.h/ml and the half-life in plasma is 12.1 hours. After repeated daily administration for seven days at 5 mg/kg/day, the Cmax is doubled (1.05 μg/ml), the AUC0-24h is increased 3-fold (15.4 μg.h/ml) and the plasma half-life is increased to 36 hours.

In the therapeutic treatment schedule, itraconazole is almost completely cleared from plasma after each wash-out period. The hydroxy-itraconazole remains near or below the quantification limit in feline plasma after a single dose of itraconazole oral solution at 5 mg/kg. However, after repeated daily doses of itraconazole oral solution at 5 mg/kg for one week, the hydroxy-itraconazole Cmax of 0.059 μg/ml was reached at 2 hours (Tmax). Itraconazole 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 final dosing. Concentrations of hydroxy-itraconazole in hair are insignificant.

Store at 68-77°F (20-25°C). Excursions permitted between 59-86°F (15-30°C).

ITRAFUNGOL (itraconazole oral solution) is available in a glass bottle containing 52 mL of oral solution, closed with a child resistant screw cap and packaged in a cardboard box that includes a package insert and a graduated dosing syringe.

Approved by FDA under NADA # 141-474

Manufactured for Elanco US Inc.
Greenfield, IN 46140
Version Date: September 2019

Itrafungol, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Elanco™

NDC 58198-0796-4

52 ml

Itrafungol™

(itraconazole
oral solution)

Antifungal for oral
use in cats only

For the treatment of dermatophytosis
caused by Microsporum canis in cats

Oral dosing syringe included

10 mg/ml

Caution:

Federal (USA) law restricts this
drug to use by or on the order
of a licensed veterinarian.

Approved by FDA under NADA # 141-474

52 ml

Itrafungol™

(itraconazole oral solution)

Antifungal for oral use in cats only

For the treatment of dermatophytosis caused by Microsporum canis in cats

Oral dosing syringe included

Caution:

Federal (USA) law restricts this drug to use
by or on the order of a licensed veterinarian.

10 mg/ml

Elanco