miconazole
Regulatory sources consulted
Approved indications
- In Spain, the cutaneous spray solution is indicated for tinea pedis in adults.
- In the United States, the topical powder is indicated for tinea pedis, corporis, or cruris.
Contraindications
Absolute
- Hypersensitivity to miconazole, other imidazoles, or any excipient.
- Hepatic dysfunction for the Spanish cutaneous spray solution.
- Allergic asthma that may be worsened by use of a spray.
Clinical warnings
- Discontinue for hypersensitivity or irritation. Do not spray into the eyes, on mucous membranes, wounds, or large areas; do not ingest or combine with other cutaneous preparations on the same site. — CIMA registro 52875
- Major warning · Anaphylaxis and angioedema have been reported with topical miconazole; discontinue and seek immediate care for signs of a severe reaction. — CIMA registro 52875
- Inflammation, hypopigmentation, erythema, urticaria, contact dermatitis, rash, itching, burning, and localized irritation have been reported very rarely with the cutaneous solution. — CIMA registro 52875
- The solution contains 737.8214 mg of ethanol per mL; it may cause burning on damaged skin and, with frequent application, skin irritation and dryness. — CIMA registro 52875
Drug interactions
- HighWarfarin or other vitamin K antagonists
Mechanism: Although topical absorption is limited, miconazole may inhibit CYP3A4/2C9 and enhance or prolong the anticoagulant effect.
Recommendation: Use cautiously, closely monitor the anticoagulant effect, and warn about signs of bleeding.
https://cima.aemps.es/cima/dochtml/ft/52875/FT_52875.html
- ModerateOral hypoglycemic drugs or phenytoin
Mechanism: Miconazole may enhance the action and adverse effects of these drugs, although clinically relevant topical interactions are rare.
Recommendation: Use cautiously and monitor clinical effects.
https://cima.aemps.es/cima/dochtml/ft/52875/FT_52875.html
Adverse events
Rare but serious
Anaphylaxis or angioedema · Severe hypersensitivity
Pregnancy and lactation
During pregnancy, use the cutaneous solution only if the benefit outweighs fetal risk. During breastfeeding, decide whether to discontinue nursing or treatment, considering the benefit to the child and mother.
Recent literature (PubMed)
Seborrheic dermatitis (SD) is a common chronic inflammatory skin disorder that mostly affects young adults in areas rich in sebaceous glands (scalp, face, and trunk). In adolescents and adults, SD clinical presentation may range from mild patches to diffuse scalp scaling. In infants, it mainly occurs on the scalp as yellowish, scaly patches ("cradle cap"). In adults, several environmental triggers are likely to promote SD development, along with fungal colonization by Malassezia spp., sebaceous gland activity, as well as immunosuppression, endocrine, neurogenic and iatrogenic factors. In children, early occurrence in the first trimester suggests the role of excessive sebaceous gland activity from maternal hormones, along with cutaneous microbiome alterations. The diagnosis of SD is usually clinical, and specific laboratory and/or instrumental investigations are seldom required. Treatment is aimed at modulating sebum production, reducing skin colonization by Malassezia spp., and controlling inflammation. In adults, mild-to-moderate scalp SD forms can be managed with topical antifungals (ketoconazole, ciclopirox, miconazole) or antiinflammatory (mild-to-moderate potency corticosteroids) or keratolytic/humectant (propylene glycol) agents. Recommended topical therapeutic options for mild-to-moderate facial or body areas SD include topical ketoconazole, ciclopirox, clotrimazole, mild-to-moderate potency corticosteroids, lithium succinate/gluconate, and topical calcineurin inihibitors (off-label use). In severe and/or resistant cases, the use of systemic antifungal drugs (terbinafine, itraconazole), as well as UVB phototherapy, may be considered. In children, scant scientific evidence supports the effectiveness and safety of topical drugs, and "cradle cap" is usually successfully managed with baby shampoos enriched with emollient agents and vegetable oils. Alternatively, similarly to adult scalp SD, medical device shampoos with antiinflammatory and antifungal properties,
Dandruff is a scalp disorder affecting the male populace predominantly. Topical agents and synthetic drugs used for dandruff treatment have specific side effects including burning at the application site, depression, dizziness, headache, itching or skin rash, nausea, stomach pain, vision change, vomiting, discoloration of hair, dryness or oiliness of the scalp and increased loss of hair. Thus, essential oils and extracts from plants could be valuable in the treatment and prevention of dandruff. This review aims to highlight current findings in dandruff occurrence, its etiology, promising plant essential oils/extracts, and novel treatment strategies. The main emphasis has been given on the anti-dandruff effect of essential oils and plant extracts to disrupt microbial growth. The proposed mechanism(s) of action, novel approaches used to perk up its biopharmaceutical properties, and topical application have been discussed. The literature survey was done, and bibliographic sources and research papers were retrieved from different search engines and databases, including SciFinder, PubMed, NCBI, Scopus, and Google Scholar. The selection of papers was accomplished based on exclusion and inclusion criteria. The scalp of diverse populations revealed an association of dandruff with microbial symbiosis, including Staphylococcus, Propionibacterium, Malassezia, and Candida as the pathogens responsible for the cause of dandruff. Topical antifungals are considered the first line of treatment for dandruff including azoles, with clotrimazole (1%), ketoconazole (2%), and miconazole (2%). Other commonly used therapies integrate benzoyl peroxide, coal tar, glycerin, zinc pyrithione, lithium succinate/gluconate, salicylic acid, selenium disulfide/sulfide, sodium sulfacetamide, etc. However, these medicaments and chemicals are known to cause specific side effects. Alternative therapies, including tea tree oil, thyme, Aloe vera, Mentha have been reported to demonstrate anti-dandruff activ