minoxidil
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Tratamiento de la alopecia androgénica moderada en adultos.
Contraindicaciones
Absolutas
- Hipersensibilidad a minoxidil o a los excipientes.
Advertencias clínicas
- Advertencia mayor · No aplicar si la caída es repentina, irregular, posparto o de causa desconocida, ni sobre cuero cabelludo lesionado. Controlar presión arterial y frecuencia cardiaca, especialmente si existe enfermedad cardiovascular. — CIMA/AEMPS, ficha técnica 84408
- Advertencia mayor · Suspender y consultar ante hipotensión, dolor torácico, palpitaciones, síncope, mareo, aumento de peso inexplicado o edema. Evitar ojos, sol o UVA y contacto de niños con la zona tratada. — CIMA/AEMPS, ficha técnica 84408
- La solución contiene etanol y es inflamable; mantener alejada de llamas, cigarrillos encendidos y secadores. — CIMA/AEMPS, ficha técnica 84408
- Advertencia mayor · Se han notificado reacciones alérgicas, incluido angioedema, con frecuencia no conocida; suspender y solicitar atención si aparecen hinchazón facial, labial o faríngea. — CIMA/AEMPS, ficha técnica 84408
- Advertencia mayor · La ingestión accidental puede causar efectos adversos cardiacos graves; mantener fuera de la vista y del alcance de los niños. — CIMA/AEMPS, ficha técnica 84408
Interacciones medicamentosas
- ModeradaVasodilatadores periféricos o antihipertensivos, como guanetidina
Mecanismo: Puede aumentar el riesgo de hipotensión ortostática.
Recomendación: Usar con precaución y monitorizar presión arterial.
CIMA/AEMPS, ficha técnica 84408https://cima.aemps.es/cima/dochtml/ft/84408/FT_84408.html
- ModeradaTretinoína, antralina, corticosteroides, retinoides o pomadas oclusivas tópicas
Mecanismo: Pueden alterar la barrera cutánea y aumentar la absorción de minoxidil.
Recomendación: No aplicar concomitantemente en la misma zona.
CIMA/AEMPS, ficha técnica 84408https://cima.aemps.es/cima/dochtml/ft/84408/FT_84408.html
Eventos adversos
Comunes (≥1%)
Reacciones dermatológicas notificadas con mayor frecuencia: prurito, dermatitis, sequedad, irritación cutánea, eczema e hipertricosis; generalmente leves o moderadas y reversibles al suspender
Raros pero graves
Taquicardia, palpitaciones o dolor torácico · Hipotensión · Alteraciones visuales
Embarazo y lactancia
Usar durante embarazo o lactancia solo si el beneficio para la madre supera el riesgo potencial para el feto o lactante.
Bibliografía reciente (PubMed)
Topical minoxidil (5% foam, 5% solution, and 2% solution) is FDA-approved for androgenetic alopecia (AGA) in men and women.Mechanism of action: Minoxidil acts through multiple pathways (vasodilator, anti-inflammatory agent, inducer of the Wnt/β-catenin signaling pathway, an antiandrogen), and may also affect the length of the anagen and telogen phases.Pharmacokinetics: Approximately 1.4% of topical minoxidil is absorbed through the skin. Minoxidil is a prodrug that is metabolized by follicular sulfotransferase to minoxidil sulfate (active form). Those with higher sulfotransferase activity may respond better than patients with lower sulfotransferase activity.Clinical efficacy (topical minoxidil): In a five-year study, 2% minoxidil exhibited peak hair growth in males at year one with a decline in subsequent years. Topical minoxidil causes hair regrowth in both frontotemporal and vertex areas. The 5% solution and foam were not significantly different in efficacy from the 2% solution.Oral and Sublingual minoxidil (not FDA approved; off-label): After 6 months of administration, minoxidil 5 mg/day was significantly more effective than topical 5% and 2% in male AGA. Low-dose 0.5-5 mg/day may also be safe and effective for female pattern hair loss and chronic telogen effluvium. Sublingual minoxidil may be safe and effective in male and female pattern hair loss.
Androgenetic alopecia (AGA) is the most common cause of hair loss, often challenging to treat. While oral finasteride (1 mg/d) is an FDA-approved treatment for male AGA, oral minoxidil and oral dutasteride are not approved yet. However, clinicians have been increasingly using these two drugs off-label for hair loss. Recently, Japan and South Korea have approved oral dutasteride (0.5 mg/d) for male AGA. A probable efficacy ranking, in decreasing order, is - dutasteride 0.5 mg/d, finasteride 5 mg/d, minoxidil 5 mg/d, finasteride 1 mg/d, followed by minoxidil 0.25 mg/d. Oral minoxidil predominantly causes hypertrichosis and cardiovascular system (CVS) symptoms/signs in a dose-dependent manner, whereas oral finasteride and dutasteride are associated with sexual dysfunction and neuropsychiatric side effects. The average plasma half-lives of minoxidil, finasteride, and dutasteride are ∼4 h, ∼4.5 h, and ∼5 weeks, respectively. Minoxidil acts through multiple pathways to promote hair growth. It has been shown as a vasodilator, an anti-inflammatory agent, a Wnt/β-catenin signaling inducer, and an antiandrogen. Finasteride inhibits 5α-reductase (5AR) type II isoenzyme, while dutasteride inhibits both type I and type II. Thus, dutasteride suppresses DHT levels more than finasteride in the serum and scalp.
Androgenetic alopecia (AGA), also known as male pattern hair loss (MPHL) or female pattern hair loss (FPHL), is the most common form of alopecia worldwide, and arises from an excessive response to androgens. AGA presents itself in a characteristic distribution unique to both sexes. Despite its prevalence, AGA can be quite challenging to treat. The condition is chronic in nature and stems from an interplay of genetic and environmental factors. There are only two US Food and Drug Administration (FDA)-approved drugs for the condition: topical minoxidil and oral finasteride. However, numerous non-FDA-approved treatments have been shown to be effective in treating AGA in various studies. Some of these treatments are relatively new and still to be explored, thus emphasizing the need for an updated review of the literature. In this comprehensive review, we discuss the evaluation of AGA and the mechanisms of action, costs, efficacies, and safety profiles of existing, alternative, and upcoming therapeutics for this widespread condition.
There has been increased interest in low-dose oral minoxidil for androgenetic alopecia (AGA) treatment. However, the efficacy of oral minoxidil for male AGA is yet to be evaluated in comparative therapeutic trials. To compare the efficacy, safety, and tolerability of daily oral minoxidil, 5 mg, vs twice-daily topical minoxidil, 5%, for 24 weeks in the treatment of male AGA. This double-blind, placebo-controlled randomized clinical trial was conducted at a single specialized clinic in Brazil. Eligible men with AGA aged 18 to 55 years classified using the Norwood-Hamilton scale as 3V, 4V, or 5V were included and randomized. Data were collected from January to December 2021, and data were analyzed from September 2022 to February 2023. Participants were randomized 1:1 into 2 groups: oral minoxidil, 5 mg, daily and topical placebo solution; or 1 mL of topical minoxidil, 5%, twice daily and oral placebo for 24 weeks. The primary outcome was change in terminal hair density on the frontal and vertex regions of the scalp. The secondary outcomes were change in total hair density and photographic evaluation. Among 90 enrolled participants, 68 completed the study; of these, the mean (SD) age was 36.6 (7.8) years. A total of 33 participants were enrolled in the oral minoxidil group and 35 in the topical treatment group. Both groups were homogenous in terms of demographic data and AGA severity. For the frontal area, the mean change from baseline to week 24 between groups was 3.1 hairs per cm2 (95% CI, -18.2 to 21.5; P = .27) for terminal hair density and 2.6 hairs per cm2 (95% CI, -10.3 to 15.8; P = .32) for total hair density. For the vertex area, the mean change from baseline to week 24 was 23.4 hairs per cm2 (95% CI, -0.3 to 43.0; P = .09) for terminal density and 5.5 hairs per cm2 (95% CI, -12.5 to 23.5; P = .32) for total hair density. According to the photographic analysis, oral minoxidil was superior to topical minoxidil on the vertex (24%; 95% CI, 0 to 48; P = .04) but no
Alopecia areata is an autoimmune form of non-scarring hair loss. It is usually characterized by limited areas of hair loss. However, the disease may progress to complete scalp and body hair loss (alopecia totalis, alopecia universalis). In patients with alopecia areata hair loss significantly impacts the quality of life. Children and adolescents with alopecia areata often experience bullying, including physical aggression. The disease severity evaluation tools used in clinical practice are: the Severity of Alopecia Tool (SALT) score and the Alopecia Areata Scale (AAS). A SALT score equal to or greater than 20 constitutes a commonly accepted indication for systemic therapy in alopecia areata. When using the AAS, moderate to severe alopecia areata should be considered a medical indication for systemic treatment. Currently, the only two EMA-approved medications for alopecia areata are baricitinib (JAK 1/2 inhibitor) for adults and ritlecitinib (JAK 3/TEC inhibitor) for individuals aged 12 and older. Both are EMA-approved for patients with severe alopecia areata. Other systemic medications used off-label in alopecia areata include glucocorticosteroids, cyclosporine, methotrexate and azathioprine. Oral minoxidil is considered an adjuvant therapy with limited data confirming its possible efficacy. This consensus statement is to outline a systemic treatment algorithm for alopecia areata, indications for systemic treatment, available therapeutic options, their efficacy and safety, as well as the duration of the therapy.