RECORLEV

Levoketoconazole 150mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication may cause severe discomfort that may last for hours. Contact your care team right away if you experience facial flushing or redness, severe headache, stomach cramps, nausea, or vomiting.

· Notes for Professionals: Advise patients to avoid alcohol consumption while taking ketoconazole. A disulfiram-like reaction has rarely been reported when alcohol was consumed concurrently with ketoconazole. Symptoms include facial flushing, difficult breathing, slight fever, and tightness of the chest. This reaction usually resolves spontaneously within 24 hours, with no lasting effects.

Levoketoconazole 150mg, Oral tablet

Caffeine-containing Foods/Beverages

· Severity: Mild

· Notes for Consumers: You may need to limit your caffeine intake while taking ketoconazole. Ketoconazole can increase the effects of caffeine. Too much caffeine can cause effects like nausea, nervousness, tremor, or difficulty sleeping.

· Notes for Professionals: Ketoconazole has been shown to inhibit the clearance of caffeine by 11 percent. The clinical significance of this interaction has not been determined.

Levoketoconazole 150mg, Oral tablet

Cannabis

· Severity: Major

· Notes for Consumers: Discuss cannabis use with your care team. The effects of cannabis may be altered if used with your medication. Call emergency services right away if you experience slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, or trouble staying awake.

· Notes for Professionals: Advise patients to avoid cannabis use during ketoconazole treatment. Concomitant use may alter the exposure of some cannabinoids and increase the risk for adverse reactions. The cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are CYP3A substrates and ketoconazole is a strong CYP3A inhibitor. Concomitant use of a cannabinoid product containing THC and CBD at an approximate 1:1 ratio with ketoconazole increased THC, 11-OH-THC, and CBD peak exposures by 1.3-, 3-, and 1.9-fold respectively.

Levoketoconazole 150mg, Oral tablet

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not drink grapefruit juice or eat grapefruit or grapefruit-containing foods while taking ketoconazole. Side effects from ketoconazole may get worse. Contact your care team right away if you experience any new or unusual side effects.

· Notes for Professionals: Advise patients to avoid grapefruit and grapefruit juice during ketoconazole treatment due to the risk of increased ketoconazole exposure and adverse reactions. Ketoconazole is a CYP3A substrate and grapefruit juice is a strong CYP3A inhibitor.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>