ITRAFUNGOL- itraconazole injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

itraconazole (UNII: 304NUG5GF4) (itraconazole - UNII:304NUG5GF4)

Available from:

Virbac AH, Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Do not administer to cats with hypersensitivity to itraconazole. 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 environment

Product summary:

ITRAFUNGOL 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.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ITRAFUNGOL- ITRACONAZOLE INJECTION, SOLUTION
VIRBAC AH, INC
----------
ITRAFUNGOL®
(ITRACONAZOLE ORAL SOLUTION)
10 mg/mL
Antifungal 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
sol