cap should be screwed back on tightly.
Experimental Design: Eighty cats were randomly selected for the study based upon inclusion criteria. The labeling for ITRAFUNGOL is written specifically for cats and includes all necessary information, including associated risks, so you can use the drug safely and effectively in cats. Liver enzyme concentrations should be monitored.If clinical signs suggestive of liver dysfunction develop, treatment should be discontinued immediately.In humans, itraconazole has been associated with cardiac adverse events due to its negative inotropic effect. After both a 3X and 5X overdose for 6 weeks, reversible changes in serum biochemical parameters occurred (increased ALT, ALP, AST and bilirubin) indicating liver involvement.Itraconazole is a cytochrome p-450 inhibitor and may therefore increase or prolong plasma concentrations of other drugs metabolized by this pathway.The solution should be administered directly into the mouth by means of the enclosed graduated dosing syringe.The daily dosage is 5 mg (0.5 mL)/kg body weight/day for 3 alternate periods of 7 consecutive days, each time with 7 days without treatment in between.The dosing syringe shows graduations per kg of body weight (e.g.
A 3X overdose for 6 weeks did not result in clinical side effects. Cats were sorted by … Vomiting, hepatic and renal disorders were seen after concomitant treatment of Itrafungol and cefovecin. Updated: 2020-09-02The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The U.S. Food and Drug Administration (FDA) recently approved ITRAFUNGOL, an itraconazole oral solution for treating dermatophytosis caused by Manufactured for Elanco US Inc., ITRAFUNGOL is a prescription animal drug and comes with a graduated dosing oral syringe. Adverse drug events reported for ITRAFUNGOL in cats include decreased appetite, vomiting, diarrhea, increased salivation, and elevated hepatic enzymes.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.FDA is aware that itraconazole is currently the treatment of choice for many systemic fungal infections in animals and alternative oral treatments are lacking.Itraconazole is highly lipophilic and practically insoluble in water.Because of the documented variations in drug absorption and poor bioavailability of oral formulations of itraconazole compounded from bulk drug substances, FDA recommends that you prescribe FDA-approved ITRAFUNGOL for cats that need to be treated with itraconazole. Prior to Itrafungol™ treatment, 13 cats were found to shed coccidia oocysts and were treated with sulfadimethoxine, and seven of these same cats received a second course of sulfadimethoxine treatment, after which the coccidiosis outbreak was considered resolved. Itrafungol should be administered orally using the enclosed graduated dosing syringe. These effects are usually mild and transient.After a 5X overdose of itraconazole administered for 6 consecutive weeks to adult cats, reversible clinical side effects were: rough hair coat, decreased food intake and reduced body weight. Each mL of Itrafungol contains 10 mg itraconazole (Ph.
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Eur.) swallow the product. For more information, please contact CVM’s Education & Outreach Staff at 240-402-7002 or Please refer to the FDA rigorously evaluates an animal drug before approving it. No related clinical signs were observed, and these values returned to normal by the end of the follow-up period. Oral formulations of itraconazole compounded from bulk drug substances are unapproved animal drugs and don’t have the same assurances of safety and effectiveness as ITRAFUNGOL.FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals.
The daily dosage is 5 mg (0.5 mL)/kg body weight/day for 3 alternate periods of 7 consecutive days, each time with 7 days without treatment in between. Do not use in pregnant or lactating queens.
Therefore, it is recommended to administer the product without food (before the meal).After dosing, the syringe should be removed from the bottle, washed and dried and the cap should be screwed back on tightly.Do not store above 25°C.
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