Itrafungol: Product Information

ITRAFUNGOL- itraconazole injection, solution
Virbac AH, Inc

10 mg/mLAntifungal for oral use in cats only

Caution

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

Description

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

Indication

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

Dosage and Administration

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.

7 days	7 days	7 days	7 days	7 days
Daily treatment	No treatment	Daily treatment	No treatment	Daily treatment

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

Table 1: Dose Table for ITRAFUNGOL

Weight of Cat	Volume of ITRAFUNGOL
0.5 lb	0.1 mL
1.0 lb	0.2 mL
1.5 lb	0.35 mL
2.0 lb	0.45 mL
2.5 lb	0.55 mL
3.0 lb	0.7 mL
3.5 lb	0.8 mL
4.0 lb	0.9 mL
4.5 lb	1.0 mL
5.0 lb	1.15 mL
6.0 lb	1.35 mL
7.0 lb	1.6 mL
8.0 lb	1.8 mL
9.0 lb	2.0 mL
10.0 lb	2.25 mL
11.0 lb	2.5 mL
12.0 lb	2.7 mL
13.0 lb	3.0 mL

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.

After dosing, do not replace syringe in the bottle. Rinse and dry the syringe. The bottle cap should be screwed back on tightly.

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Contraindications

Do not administer to cats with hypersensitivity to itraconazole.

Warnings User Safety Warnings

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.

Special precautions for person administering the veterinary product to the animal:

Microsporum canis dermatophytosis is a zoonotic disease (a disease that can be transmitted from animals to humans); therefore consult a physician if a suspected lesion occurs on a human. Wear protective gloves when handling the animal during treatment or when cleaning the syringe. Wash hands and exposed skin after handling the animal.

ITRAFUNGOL (itraconazole oral solution) has not been shown to be sporicidal; therefore in order to reduce zoonotic potential, environmental contamination, and to decrease course of the disease, topical and environmental treatment should also be utilized.

Animal Safety Warnings

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

Keep ITRAFUNGOL oral solution in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions

In the laboratory effectiveness study, adverse reactions related to exposure to ITRAFUNGOL oral solution 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.

Adverse Reactions

Post-Approval Experience (2021)
The following adverse events are based on post-approval adverse drug experience reporting for ITRAFUNGOL (itraconazole oral solution). Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.
The following adverse events reported in cats are listed in decreasing order of reporting frequency:
Anorexia, emesis, elevated liver enzymes, lethargy, weight loss, icterus, elevated total bilirubin, and diarrhea.
Death (including euthanasia) has been reported. Some of these deaths were associated with the adverse events reported above.