Annotation of FDA Label for carisoprodol and CYP2C19

Summary

Carisoprodol (SOMA) should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol and a 50% decreased exposure to meprobamate (a metabolite of carisoprodol) compared to normal CYP2C19 metabolizers.

Prescribing

Excerpt from the carisoprodol drug label:

Patients with Reduced CYP2C19 Activity: SOMA should be used with caution in patients with reduced CYP2C19 activity.

Annotation

Carisoprodol (SOMA) is skeletal muscle relaxant. The FDA-approved drug label for carisoprodol (SOMA) highlights information regarding CYP2C19 poor metabolizers.

Excerpt from the carisoprodol drug label:

Patients with Reduced CYP2C19 Activity: SOMA should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3-5% and in Asians is approximately 15-20%.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the carisoprodol drug label.

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FDA PGx Associations

From the FDA Table of Pharmacogenetic Associations(opens in new window):
CategoryDrugGeneAffected SubgroupInteraction Description
PKCarisoprodolCYP2C19poor metabolizers

Results in higher systemic concentrations. Use with caution.

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Evidence for Clinical Annotations

This annotation has been used as evidence for the following clinical annotations.

    History

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