Peer-reviewed veterinary case report
Comparison of Compounded, Generic, and Innovator-Formulated Itraconazole in Dogs and Cats.
- Journal:
- Journal of the American Animal Hospital Association
- Year:
- 2018
- Authors:
- Renschler, Janelle et al.
- Affiliation:
- From MiraVista Diagnostics
Plain-English summary
This study looked at different forms of the antifungal medication itraconazole, which is used to treat fungal infections in dogs and cats. Researchers tested blood samples from 95 dogs and 20 cats who were receiving either compounded itraconazole (made from bulk powder), generic itraconazole, or the brand name version. They found that the blood levels of itraconazole were much lower in the compounded group, with 95% of those animals having levels that were not high enough to be effective. In contrast, the generic and brand name versions had similar and more effective blood levels, although some animals in those groups also had levels that were too low or potentially too high. Overall, the study suggests that compounded itraconazole should be avoided, while generic itraconazole is a good alternative to the brand name version.
Abstract
The triazole antifungal itraconazole may be cost prohibitive in brand name form; therefore, compounded and generic products are often used as alternatives. Itraconazole blood concentrations have not been studied in clinical patients receiving these formulations. Itraconazole bioassay was performed on serum/plasma from 95 dogs and 20 cats receiving itraconazole (compounded from bulk powder, generic pelletized, or brand name) for systemic mycosis treatment. Mean itraconazole concentration was lower in the compounded group (n = 42) as compared with the generic (n = 40) or brand name (n = 33) groups (0.5 µg/mL versus 8.3 µg/mL and 6.5 µg/mL, respectively; P < .001). No statistical difference was observed between itraconazole concentrations in the generic and brand name groups. Forty animals (95.2%) in the compounded group had subtherapeutic (<1.0 µg/mL) values. All cats in this group (n = 10) had undetectable itraconazole concentrations. Some animals in the generic and brand name groups had subtherapeutic values (12.5 and 12.1%, respectively) or potentially toxic values (>10 µg/mL; 37.5 and 24%, respectively). Compounded itraconazole should be avoided, but generic itraconazole appears to serve as a reasonable alternative to brand name itraconazole. Therapeutic drug monitoring may be beneficial in all cases.
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Search related cases →Original publication: https://pubmed.ncbi.nlm.nih.gov/29757665/