Miconazole is a topical antifungal (creams, solutions, pessaries, oral gel) against skin, fold and genital fungal infections and, in gel form, oral candidiasis. It is widely available and well tolerated.
Also known as: Daktarin, Monistat
Oral miconazole (oral gel) can markedly increase the effect of warfarin, with risk of serious bleeding and a very high INR.
Miconazole is a potent CYP2C9 inhibitor, the main pathway of S-warfarin metabolism.
INR within 3–5 days of starting; bleeding signs (gums, dark urine, black stools).
Spontaneous bruising, nose or gum bleeding, dark urine, black stools.
Avoid oral miconazole gel in patients on warfarin; if unavoidable, prefer a non-azole topical antifungal and monitor INR closely (within days).
EMC-UK — Daktarin Oral Gel (miconazole) SmPC, warfarin interaction (INR >10 and bleeding cases): https://www.medicines.org.uk/emc/product/1508
Oral miconazol gel should be kept in the mouth as long as possible; avoid eating or drinking immediately after (not an adverse interaction, a use routine).
Avoid eating or drinking for ~30 min after applying the gel.
EMC-UK — Miconazol oral gel (Daktarin) PIL: "avoid eating and drinking for about 30 minutes".
Oral miconazol gel has partial systemic absorption — caution in liver disease.
Avoid long courses of oral gel in liver patients.
EMC-UK — miconazol oral gel SmPC 4.4 (hepatic).
Annex 1 records "Avoid, unless essential" (factor CM) — applies to oral systemic miconazol/oral gel, with partial absorption. Vaginal topical/cutaneous cream has negligible absorption and is the treatment of choice for vulvovaginal candidiasis in pregnancy.
Topical formulations (vaginal/cutaneous cream) are preferable and safe; avoid the oral gel/systemic form unless needed.
Annex 2 refers to "Benzodiazepines"? — no: the entry "Miconazole — See Benzodiazepines" (l. 42912) is another PDF cross-reference error (belongs to the previous line). Vaginal topical is compatible; oral gel at high doses — monitor the infant.
Prontuário Terapêutico INFARMED — Annex 1: "Miconazole — Avoid, unless essential" (l. 41014); Annex 2 l. 42912 (cross-reference error documented). EMC-UK (MHRA) — Miconazole SmPC (Daktarin) and Gyno-Daktar.
Clinical and educational support tool. The information does not replace a medical prescription or the opinion of a qualified healthcare professional.
Widely used imidazole topical antifungal (cutaneous, vaginal, oral) with direct fungicidal membrane action; the systemic exception is the buccal gel, with a real interaction with coumarin anticoagulants.
Two membrane actions: (1) inhibition of 14-α-demethylase (CYP51) → ergosterol depletion; (2) at high topical concentrations, direct interaction with membrane phospholipids → loss of integrity and cell death (fungicidal). Also inhibits fungal proteolytic acid production and has mild Gram+ antibacterial activity.
Cutaneous: < 1%. Vaginal: ~1–3% (miconazole nitrate); therapeutic local concentrations for > 24 h per application. Oral gel: partial mucosal absorption — enough for systemic interactions.
The absorbed fraction (significant only for oral gel) is hepatically metabolised; systemically inhibits CYP2C9 when absorbed — interaction with warfarin/acenocoumarol with described bleeding (raised INR). Renal and biliary excretion of metabolites.
Not clinically determinable by the topical route; by the oral route (gel), elimination half-life ~20–25 h (estimated from INR/interaction data).
Medicines from the same therapeutic group (ATC classification) or the same pharmacological class.
