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:

Elanco US Inc.

INN (International Name):

itraconazole

Composition:

itraconazole 10 mg in 1 mL

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 handing the animal. ITRAFUNGOL 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 u

Product summary:

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 ™

Authorization status:

New Animal Drug Application

Summary of Product characteristics

ITRAFUNGOL- ITRACONAZOLE INJECTION, SOLUTION
ELANCO US INC.
----------
ITRAFUNGOL™
(ITRACONAZOLE ORAL SOLUTION)
10 mg/ml
Antifungal for oral use in cats only
CAUTION:
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION:
ITRAFUNGOL 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 soluti