Itraskin®

Oral suspension.

Treatment of fungal infections.

Each mL of oral suspension contains:
Itraconazole……………………..20 mg
Excipients c.s.p……………..1 mL

Itraconazole is a synthetic antifungal agent, belonging to the family of azole derivatives. It was introduced in the 1990s in order to broaden the antifungal spectrum, increase potency compared to other azoles and reduce adverse effects at the digestive level, especially in prolonged therapies.
The antifungal action of itraconazole is generated through a multiple mechanism initiated by the inhibition of two cytochromes P450 involved in the biosynthesis of Ergosterol: CYP51 (sterol-14α demethylase) and CYP61 (Δ22-desnaturase). Ergosterol is an essential component of the plasma membrane of fungi.

Itraskin®, oral suspension, is indicated for the treatment of fungal infections caused by microorganisms susceptible to Itraconazole, such as cutaneous dermatophytoses caused by Microsporum canis in cats , dermatitis caused by Malassezia pachydermatis in dogs, and systemic infections of fungal origin, such as histoplasmosis, cryptococcosis, blastomycosis and sporotrichosis.

Dogs and cats.

Oral administration.

Cats:

Dogs:

Keep out of reach of children and pets.

• It is recommended to administer the drug in conjunction with the food, to increase its bioavailability.
• It is recommended to monitor the appetite of treated individuals.
• In prolonged treatment or in patients with particular risk conditions,
  recommends routine monitoring of liver enzymes (monthly ALT).

• Do not use in patients with hypersensitivity to Itraconazole or other azole agents.
• Do not use in patients with hepatic impairment or hypochlorhydria.
• Do not use in females during the gestation and lactation period.
• Do not use on dogs and cats under 2 months of age.

In dogs, the most common adverse effect is anorexia, especially at higher doses. Some cases may suffer from signs of hepatotoxicity, in which case treatment should be discontinued at least temporarily. Liver damage is determined by increased ALT activity. Anorexia is often a symptomatic marker of toxicity and usually occurs in the second month of treatment. Some dogs treated with doses of 10 mg/kg may develop vasculitis or ulcerative skin lesions and limb edema that may require dose reduction to 5 mg/kg. These problems usually resolve after the medication is stopped.
In cats, adverse effects are dose-related. Gastrointestinal effects (anorexia, weight loss, vomiting), hepatotoxicity (increased ALT, jaundice) and depression have been described. If adverse effects occur and ALT is increased, the drug should be discontinued. Enzyme hyperactivity in the absence of other signs does not necessarily necessitate dose reduction or discontinuation of medication. Once ALT levels normalize and other adverse effects subside, and if necessary, the drug can be restarted at half the dose initially used with closer clinical monitoring.

• Absorption of Itraconazole is reduced by co-administration with proton pump inhibitor antacids (omeprazole) and H2 blockers (Cimetidine, Ranitidine, etc.) or Didanosine.
• Itraconazole may increase prothrombin times in patients receiving warfarin or other coumarin anticoagulants. Rifamin may increase the metabolism of itraconazole.
• Itraconazole may increase serum levels of oral antidiabetic agents (e.g., chlorpropamide, glipizide, etc.), which may result in hypoglycemia.
• Do not use in conjunction with Cisapride, as it may cause ventricular arrhythmias.
• Itraconazole interacts with certain antihistamines (Terfenadine, Astemizole), benzodiazepines, calcium channel blockers, anticonvulsants, some antimicrobials, and cyclosporine.
• It is not recommended for use concomitantly with anticholinergics.

• Wash your hands after administering the product.
• In case of contact with the eyes, it is recommended to wash with plenty of water for 15 minutes.
• In case of accidental ingestion, do not induce vomiting. Get medical attention in case
  necessary.

Store at room temperature below 30°C. Do not freeze. Once opened, use within 8 weeks. Discard the unused product after that period of time.

Sale by prescription to the Veterinary Doctor.

Chile: Reg. SAG N° 2053
Costa Rica: Reg. No. MV-5639
Rep. Dominican: Reg. N° 9305
Bolivia: Reg. SENASAG PUV-F N°007252/16
Peru: Reg. SENASA F.33.36.I.0043

VETERINARY USE
INCLUDES DISPENSER
SHAKE BEFORE USE

Bottle with 120 mL

Laboratorio Drag Pharma Chile Invetec S.A.
Lautaro N° 300. Quilicura. Santiago. Chile.