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Action and mechanism - [ANTI-HAIR LOSS] with vasodilatory action. - Mechanism of action: The exact mechanism by which chemoxidil stimulates hair growth is not fully understood. It may alter androgen metabolism in the scalp, or, due to its vasodilatory effect, it may increase microcirculation around the hair follicle. Minoxidil, when applied topically, stimulates keratinocyte growth in vitro and in vivo. It does not increase the number of hair follicles but partially converts miniaturized and intermediate hairs into terminal hairs, thus slowing the progression of androgenetic alopecia in certain patients. This stimulation occurs after four or more months of treatment and varies among patients. Stopping treatment halts hair growth, and alopecia can return within 3-4 months pretreatment. After 6-12 months of uninterrupted treatment, 1/3 of the patients have shown positive responses. In controlled clinical trials, the cutaneous application of minoxidil in normotensive or hypertensive patients has not shown any manifestations related to the absorption of minoxidil. Pharmacokinetics - Absorption: Minoxidil, administered through the skin, is only slightly absorbed. At a 2% concentration: Approximately 1.4% (range: 0.3 to 4.5%) of the applied dose reaches the systemic circulation. From a 1 ml application (20 mg of minoxidil), the amount of minoxidil absorbed is approximately 0.28 mg. At a 5% concentration: An average of 1.7% (0.3-4.5%) of the applied dose would pass into the systemic circulation. A 1 ml dose of solution, corresponding to a cutaneous application of 50 mg of minoxidil, results in an absorption of 0.85 mg of minoxidil. It has been observed that the smallest dose of IV minoxidil that produces clinically significant hemodynamic effects in patients with mild to moderate hypertension is 6.86 mg. The results of pharmacokinetic studies indicate that the three most important factors related to increased absorption of minoxidil in the skin are the following: - quantitative increase of the applied dose. - increased frequency of application. - reduction of the barrier function of the stratum corneum of the epidermis. After application of minoxidil through the skin, its absorption is not influenced by factors such as: sex, exposure to ultraviolet rays, simultaneous application of a moisturizing product, occlusion (use of hairpieces), evaporation of the solvent (use of a hairdryer) or the surface of the application area. Plasma levels of minoxidil after cutaneous administration depend on the degree of absorption. When application is discontinued, approximately 95% of the absorbed minoxidil is eliminated within 4 days. Both minoxidil and its metabolite are primarily excreted in urine. Instructions - [ANDROGENIC ALOPECIA]: Treatment of moderate androgenetic alopecia in adult males. Posology Topical application to the skin: - Adults: 1 ml every 12 hours (corresponding to 10 sprays twice a day), applied to the scalp starting from the center of the area to be treated. The recommended daily dose should be respected regardless of the extent of the alopecia. 1 ml is equivalent to 10 sprays from the dosing pump. Maximum daily dose: 2 ml. Guidelines for proper administration Apply to a perfectly dry scalp, starting from the center of the area to be treated. Do not apply minoxidil 5% to other areas of the body. Both the onset and the degree of response to treatment with 5% minoxidil are individualized for each patient; therefore, a four-month course of treatment may be necessary before any signs of hair growth appear. When treatment with 5% minoxidil is discontinued, hair growth may cease and return to the initial stage of alopecia within three to four months. It is recommended to wash your hands thoroughly with water after applying minoxidil 5%. - Children: Its use is not recommended in this age group since no studies have been carried out in this population. - Elderly: Its use is not recommended in this age group since no studies have been carried out in this population. - Instructions for proper administration: applied to the scalp starting from the center of the area to be treated. Before applying the product, ensure that the hair and scalp are completely dry. Apply to the scalp, spreading the product (solution or gel) with your fingertips over the area to be treated, starting from the center. Wash your hands thoroughly before and after each application. Contraindications - Hypersensitivity to any of the components of the preparation. - Pregnancy, breastfeeding (in case of systemic absorption it is excreted with breast milk) and children under 18 years of age. Precautions - Scalp dermatosis: In patients with dermatosis or scalp lesions, increased percutaneous absorption of the active ingredient may occur; therefore, it should be ensured that these are not present before application. Although studies with topical minoxidil have not demonstrated significant systemic absorption, there is a possibility of minor local absorption through the scalp. Therefore, regular monitoring of blood pressure and heart rate is recommended in patients with any cardiac or cardiovascular problems such as: potential risk of edema, peripheral artery disease, cardiac arrhythmia, heart failure, or valvular heart disease. - Do not allow contact with broken skin, mucous membranes, or eyes. If accidental contact occurs, wash with plenty of cold water. - Wearing wigs is not recommended during treatment. Warnings about excipients: - This medicine contains propylene glycol, so it may cause skin irritation. Advice to the patient -Avoid use in case of scalp wounds. - This product is for application to the scalp, so avoid ingestion or inhalation. - For correct application, carefully read the instructions in the leaflet. Apply to a perfectly dry scalp, starting from the center of the area to be treated, and massage with your fingertips to spread the product over the area. If using the solution, it is recommended to wash your hands thoroughly with water before and after application. - Do not use a hairdryer to speed up hair drying because hot air can evaporate the product and decrease its effectiveness. - After application, seal the bottle tightly. - The recommended daily dose must be respected regardless of the extent of the alopecia. - The patient should be advised that a 4-month pre-treatment may be necessary before any signs of hair growth are seen. - When treatment is stopped, growth may cease and return to the initial stage of alopecia within 3-4 months. - Rinse thoroughly with water in case of accidental contact with eyes, broken skin or mucous membranes. Special warnings - Prior to its application, a medical history and a complete physical examination will be necessary. - Do not use in the presence of wounds or scalp dermatosis until these have healed, as there may be an increase in absorption and systemic adverse effects. - There is a possibility of minor local absorption through the scalp, so regular monitoring of blood pressure and heart rate is recommended. - Regular monitoring of the patient is advised, one month after starting treatment and at least every 6 months thereafter. - If systemic effects such as rapid heartbeat or palpitations occur; rapid and unexplained weight gain; swelling of the hands, elbows and face; lightheadedness, dizziness or fainting; blurred vision; If you experience chest, hand or shoulder pain, scalp irritation, or any other reaction that you suspect may be due to the application of this medication, discontinue treatment. - Due to its content of ethanol and/or propylene glycol as excipients, frequent applications may cause skin irritation and dryness. - Minoxidil 5% should not be used in women, given the possibility of hypertrichosis appearing in other body areas. - Avoid contact with eyes. In case of accidental contact with sensitive surfaces, wash them thoroughly with water. - It should not be applied concomitantly to the same area with other topical products such as corticosteroids, retinoids or occlusive ointments as they may increase its absorption. - It is advisable to consult a dermatologist if there is no hair growth in women after 8 months using the 2% concentration and in men after 12 months using the 2% concentration or after 4 months with the 5% concentration. Interactions - Antihypertensives: Although not clinically proven, there is a possibility that minoxidil may increase the risk of orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators and antihypertensive drugs such as guanethidine and derivatives. Pregnancy FDA Pregnancy Category C. Animal studies have not shown harmful effects on pregnancy, embryonal/fetal development, parturition, or postnatal development. Clinical data on the exposure of pregnant women to minoxidil are not available; therefore, its use during pregnancy is not recommended. Lactation Orally administered minoxidil is excreted in breast milk. No adverse effects have been observed in the infant. The American Academy of Pediatrics considers the use of minoxidil compatible with breastfeeding. Children The safety and efficacy of topical minoxidil in children under 18 years of age have not been established. Seniors The safety and efficacy of topical minoxidil have not been established in patients over 65 years of age. Effects on driving Although no such effects are expected, if the patient experiences dizziness or lightheadedness, they should not drive. Adverse reactions The most frequent adverse reactions are mild dermatological alterations such as: peeling, erythema, dermatitis, hypertrichosis (in distal areas), stinging, itching and dry skin (mainly due to the ethanol content). - Cardiac: (0.1-1%): [TACHYCARDIA], [PALPITATIONS], [HYPOTENSION], increase or decrease in pulse. - Dermatological/hypersensitivity: (1-10%): [PRURITUS], [SKIN IRRITATION], [CONTACT DERMATITIS], [DRY SKIN], [EXFOLIATIVE DERMATITIS]. (0.1-1%): [ALOPECIA] (especially at the start of treatment), uneven hair growth, [HIRSUTISM]. (<0.1%): [ACNE], allergic reactions (hypersensitivity, rhinitis, rash, generalized erythema, facial edema). -Nervous system: (0.1-1%): [HEADACHE], [PARESTHESIA]. (<0.1%): [DIZZINESS], [TASTE DISTURBANCES]. - Ocular: (<0.01%): [TEARING] altered, vision alterations. - Otorhinolaryngological: (<0.1%): [SINUSITIS], otitis (particularly, otitis externa). - Sexual: sexual dysfunction. Overdose - Symptoms: Accidental or intentional overdose following topical application will increase the intensity of dermatological adverse reactions, especially itching, dryness, skin irritation, and eczema. Systemic absorption will also be greater, with a consequent increase in the likelihood of systemic effects. Accidental ingestion could cause systemic effects due to the vasodilatory action of minoxidil (5 ml of 2% solution contains 100 mg of minoxidil, which is the maximum oral dose used in adults for the treatment of high blood pressure). These signs and symptoms include hypotension, tachycardia, fluid retention with edema, pleural effusion, or congestive heart failure. - Treatment: Treatment of the condition resulting from accidental ingestion requires the use of diuretics for edema, beta-blockers or other inhibitors of the sympathetic nervous system for tachycardia, and intravenous isotonic sodium chloride solution for hypotension. Sympathomimetics, such as adrenaline and noradrenaline, should be avoided due to the cardiac overstimulation they produce.
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