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Appropriateness of miconazole oral gel for patients taking statins

Miconazole is an azole antifungal that inhibits cytochrome P450 isoenzymes 2C9 and 3A4. The oral gel is absorbed systemically and has the potential to raise plasma levels of drugs metabolised by these isoenzymes, increasing the risk of adverse effects.

Tongue (Maksym Bondarchuk  Dreamstime.com)

The summary of product characteristics for miconazole oral gel contraindicates the co-administration of miconazole with drugs that are metabolised by CYP3A4, including some of the statins. However, there are no reports describing interactions between miconazole and any of the statins.

Patients taking pravastatin can use miconazole oral gel since pravastatin is not metabolised by cytochrome P450 isoenzymes. Because metabolism of fluvastatin and rosuvastatin via CYP3A4 is limited, a clinically significant interaction is unlikely. Therefore, miconazole oral gel can be used with caution for patients taking fluvastatin or rosuvastatin, provided they are monitored for adverse effects.

For patients taking atorvastatin or simvastatin, the lack of reports of an interaction with miconazole oral gel suggests that the antifungal may be used with caution if it is considered to be essential and there is no suitable alternative. However, cases of rhabdomyolysis have been reported with concomitant use of fluconazole with atorvastatin or simvastatin, and, because miconazole has the potential to interact in a similar way, prescribers should consider the benefits of treatment versus the risk of using the combination.

Prescribers should be aware that prescribing miconazole gel in combination with atorvastatin, fluvastatin, rosuvastatin or simvastatin is outside of the product licence of the gel.

Any patient taking a statin (other than pravastatin) who is given miconazole oral gel should be warned to watch for signs of myopathy (ie, dark coloured urine or unexplained muscle pain, tenderness or weakness). If myopathy does occur the statin should be stopped immediately.

Citation: Clinical Pharmacist URI: 11098644

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