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Chunk #11 — Current Status of Drug Labeling and Pharmacogenomic Testing Guidelines — Guidelines and Labeling for Tricyclic Antidepressants

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Pharmacogenomic testing for neuropsychiatric drugs: current status of drug labeling, guidelines for using genetic information, and test options.
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Tricyclic antidepressants are used for a variety of conditions including depression and neuropathic pain. Language regarding the pharmacokinetic effects of PM status for CYP2D6 and/or CYP2C19 is included in the product labeling for clomipramine, desipramine, doxepin, imipramine, nortriptyline, protryptyline, and trimipramine.23 Although the details of the labeling may differ slightly across medications, the wealth of evidence linking metabolizer status to serum concentrations and drug outcomes provided the basis for guidelines that now outline how to use available pharmacogenomic test information in clinical scenarios.24 The recommendations are based on a comprehensive literature review with a focus on the pertinent genotypes and available pharmacokinetic data based on the genotype and phenotype characteristics.