This updated Medicines Q&A explores the evidence for the interaction between miconazole oral gel and statins.
- Miconazole is an azole antifungal which inhibits CYP450 isoenzymes CYP2C9 and CYP3A4. It is absorbed systemically from the oral gel preparation and has the potential to raise plasma levels of drugs metabolised by these isoenzymes, increasing the risk of adverse effects.
- The Summary of Product Characteristics for miconazole oral gel (Daktarin) contraindicates co-administration of miconazole with drugs that are metabolised by CYP3A4, including fluvastatin, rosuvastatin, atorvastatin and simvastatin.
- There are no reports describing interactions between miconazole and any of the statins.
- Pravastatin – patients taking pravastatin can use miconazole oral gel. Pravastatin is not metabolised by CYP450 isoenzymes therefore no interaction is expected.
- Fluvastatin and rosuvastatin – these undergo limited CYP450 metabolism therefore a clinically significant interaction is unlikely. Miconazole oral gel could be used with caution provided patients are monitored for adverse effects.
- Atorvastatin – the concomitant use of atorvastatin and miconazole should be avoided if possible. If miconazole oral gel must be used, it may be prudent to temporarily withhold atorvastatin to avoid possible adverse effects but the patient’s GP must be involved in this decision. If concurrent use is unavoidable then a lower dose of atorvastatin should be considered and the patient monitored for toxicity.
- Simvastatin – the SmPC for miconazole oral gel (Daktarin) contraindicates co-administration of miconazole oral gel and simvastatin due to the risk of myopathy and rhabdomyolysis. Simvastatin must be temporarily stopped if miconazole is prescribed; the patient’s GP must be involved in this decision.
- Any patient taking a statin (other than pravastatin) who is given miconazole oral gel should be warned to watch for signs of myopathy (i.e. unexplained muscle pain, tenderness or weakness or dark coloured urine). If myopathy does occur, the statin should be stopped immediately.