miconazole
Fuentes regulatorias consultadas
Indicaciones aprobadas
- En España, la solución para pulverización cutánea está indicada para la tiña del pie en adultos.
- En Estados Unidos, el polvo tópico está indicado para la tiña del pie, corporal o inguinal.
Contraindicaciones
Absolutas
- Hipersensibilidad a miconazol, otros imidazoles o cualquier excipiente.
- Disfunción hepática para la solución para pulverización cutánea española.
- Asma alérgica susceptible de agravarse con un pulverizador.
Advertencias clínicas
- Suspender ante hipersensibilidad o irritación. No pulverizar en ojos, mucosas, heridas o áreas extensas; no ingerir ni combinar en la misma zona con otras preparaciones cutáneas. — CIMA registro 52875
- Advertencia mayor · Se han notificado anafilaxia y angioedema con miconazol tópico; interrumpir y solicitar atención inmediata ante signos de reacción grave. — CIMA registro 52875
- Se han comunicado muy raramente inflamación, hipopigmentación, eritema, urticaria, dermatitis de contacto, erupción, prurito, quemazón e irritación localizada con la solución cutánea. — CIMA registro 52875
- La solución contiene 737,8214 mg de etanol por ml; puede causar ardor en piel lesionada y, con aplicación frecuente, irritación y sequedad cutánea. — CIMA registro 52875
Interacciones medicamentosas
- SeveraWarfarina u otros antagonistas de la vitamina K
Mecanismo: Aunque la absorción tópica es limitada, miconazol puede inhibir CYP3A4/2C9 y potenciar o prolongar el efecto anticoagulante.
Recomendación: Usar con precaución, vigilar estrechamente el efecto anticoagulante y advertir sobre signos de hemorragia.
https://cima.aemps.es/cima/dochtml/ft/52875/FT_52875.html
- ModeradaHipoglucemiantes orales o fenitoína
Mecanismo: Miconazol puede potenciar la acción y los efectos adversos de estos fármacos, aunque las interacciones tópicas clínicamente relevantes son raras.
Recomendación: Usar con precaución y vigilar los efectos clínicos.
https://cima.aemps.es/cima/dochtml/ft/52875/FT_52875.html
Eventos adversos
Raros pero graves
Anafilaxia o angioedema · Hipersensibilidad grave
Embarazo y lactancia
Durante el embarazo, usar la solución cutánea solo si el beneficio supera el riesgo fetal. En lactancia, decidir si se interrumpe la lactancia o el tratamiento considerando el beneficio para el niño y la madre.
Bibliografía reciente (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