XOLEGEL

Ketoconazole 2%, Topical gel

Marijuana

· Severity: Moderate

· Notes for Consumers: The effects of marijuana may be increased and side effects may get worse if it is combined with this medicine. Do not drive or operate machinery until you know how this combination will affect you. Contact your health care provider right away if you notice slurred speech, confusion, severe drowsiness, increased heart rate, or any other new or unusual side effects.

· Notes for Professionals: The incidence of marijuana associated adverse effects may change following coadministration with ketoconazole. Ketoconazole is an inhibitor of CYP2C9 and CYP3A4, two isoenzymes responsible for the metabolism of marijuana's most psychoactive compound, delta-9-tetrahydrocannabinol (Delta-9-THC). When given concurrently with ketoconazole the amount of Delta-9-THC converted to the active metabolite 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC) may be reduced. These changes in Delta-9-THC and 11-OH-THC plasma concentrations may result in an altered marijuana adverse event profile.

Ketoconazole 2%, Topical gel

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol-containing drinks or products while taking oral Ketoconazole and for 48 hours after completing Ketoconazole treatment. You may experience facial flushing, difficult breathing, slight fever, or chest tightness if you take Ketoconazole and alcohol together.

· Notes for Professionals: A disulfiram-like reaction has been reported when patients taking ketoconazole consume ethanol. 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. Due to the risk of hepatotoxicity, ethanol should be avoided during and for at least 48 hours following ketoconazole therapy.

Ketoconazole 2%, Topical gel

Caffeine-containing Foods/Beverages

· Severity: Moderate

· Notes for Consumers: Although an interaction is possible, these drugs are often used together. Side effects from Caffeine may get worse if you take Ketoconazole. Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. You may need to limit your Caffeine intake. Common foods and beverages containing caffeine include coffee, teas, colas and chocolate. Many non-prescription drugs and diet aids may also contain caffeine. Ketonconazole creams or shampoos do not interact.

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

<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>