Action and mechanism

- [ANTI-ALOPECIC] with vasodilatory action.

- Mechanism of action: The exact mechanism by which cheminoxidil stimulates hair growth is unknown. It may alter androgen metabolism in the scalp, or due to its vasodilatory effect, it may increase microcirculation around the hair follicle.
Minoxidil, applied topically, stimulates keratocyte growth in vitro and in vivo. It does not increase the number of hair follicles, but it partially converts miniaturized and intermediate hairs into terminal hairs, delaying the progression of androgenetic alopecia in certain patients. This stimulation occurs after four or more months of treatment and varies between patients.
Discontinuing treatment stops hair growth, and alopecia may return in 3-4 months.
pretreatment. After 6–12 months of uninterrupted treatment, 1/3 of patients have shown positive responses.
In controlled clinical trials, cutaneous application of minoxidil in normotensive or hypertensive patients has not revealed any manifestations related to minoxidil absorption.

Pharmacokinetics

- Absorption: Minoxidil, administered cutaneously, is only slightly absorbed.
2% concentration: Approximately 1.4% (range: 0.3 to 4.5%) of the applied dose reaches the systemic circulation. From a 1 ml dose (20 mg of minoxidil) onwards, the amount of minoxidil absorbed is approximately 0.28 mg.
5% Concentration: An average of 1.7% (0.3-4.5%) of the applied dose would enter the general circulation. A 1 ml dose in solution form, corresponding to a cutaneous application of 50 mg of minoxidil, results in the absorption of 0.85 mg of minoxidil.
The lowest dose of IV minoxidil that produces clinically significant hemodynamic effects in patients with mild to moderate hypertension has been observed to be 6.86 mg.
The results of pharmacokinetic studies indicate that the three most important factors related to increased absorption of minoxidil into the skin are:

- quantitative increase in the applied dose.

- increase in the frequency of application.

- reduction of the barrier function of the stratum corneum of the epidermis.
After cutaneous application of minoxidil, absorption is not influenced by factors such as: sex, exposure to ultraviolet rays, simultaneous application of a moisturizer, 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 administration is discontinued, approximately 95% of the absorbed minoxidil is eliminated within 4 days.
Both minoxidil and its metabolite are excreted primarily in urine.

Indications

- [ANDROGENIC ALOPECIA]: Treatment of moderate intensity androgenetic alopecia in adult men.

Posology

Skin topical:

- Adults: 1 ml every 12 hours (equivalent to 10 sprays twice daily), applied to the scalp starting in the center of the area to be treated. The recommended daily dose should be maintained regardless of the extent of the alopecia.
1 ml is equivalent to 10 sprays from the dosing pump.
Maximum daily dose: 2 ml.

Rules for correct administration

Apply to a completely dry scalp, starting in the center of the area to be treated. Do not apply 5% minoxidil to other areas of the body.
Both the onset and degree of response to treatment with 5% minoxidil are individualized for each patient; therefore, a 4-month pretreatment course may be necessary before any signs of hair growth appear. When treatment with 5% minoxidil is discontinued, hair growth may cease and the initial stage of alopecia may return within 3-4 months.

It is recommended to wash your hands with plenty of water after applying 5% minoxidil.

- Children: Its use is not recommended in this age group since no studies have been conducted in this population.


- Elderly: Its use is not recommended in this age group since no studies have been conducted in this population.


- Instructions for correct administration: applied to the scalp starting from the center of the area to be treated.

Before applying the product, make sure your hair and scalp are completely dry. Apply to your 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 in breast milk) and minors under 18 years of age.

Precautions

- Dermatosis of the scalp:
In patients with dermatosis or skin lesions of the scalp, greater percutaneous absorption of the active ingredient may occur, so it should be ensured that these do not exist before application.

- Although studies with topical minoxidil have not shown significant systemic absorption, there is a possibility of small local absorption through the scalp, so regular monitoring of blood pressure and heart rate is recommended in patients with any cardiac or cardiovascular problems such as: potential risk of [EDEMA], [EDEMA], [PERIPHERAL ARTERY DISEASE], [HEART ARRHYTHMIA], [HEART FAILURE] or [VALVE DISEASE].

- Do not allow contact with broken skin, mucous membranes, or eyes. If accidental contact occurs, rinse thoroughly with cold water.

- The use of wigs is not recommended during treatment.

Warnings on excipients:

- This medicine contains propylene glycol, which may cause skin irritation.

Patient Advice

-Avoid use in case of scalp wounds.

- This product is for application to the scalp, so ingestion or inhalation should be avoided.

- For correct application, carefully read the instructions in the leaflet.

- Apply to a perfectly dry scalp, starting in the center of the area to be treated, and massage in with your fingertips. 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 the hot air can evaporate the product and reduce its effectiveness.

- After application, close the bottle tightly.

- The recommended daily dose should be observed regardless of the extent of the alopecia.

- The patient should be warned that a 4-month pretreatment may be necessary before any signs of hair growth are present.

- When treatment is discontinued, 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 application, a complete medical history and physical examination will be required.

- Do not use in the presence of wounds or dermatoses of the scalp until they have healed, as this may increase absorption and cause 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 recommended, one month after starting treatment and at least every 6 months thereafter.

- If systemic effects occur, such as rapid heartbeat or palpitations; rapid, 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 use of this medicine, discontinue treatment.

- Due to its content of ethanol and/or propylene glycol as excipients, frequent applications may cause skin irritation and dryness.

- 5% Minoxidil should not be used in women, given the possibility of hypertrichosis developing in other areas of the body.

- Avoid contact with eyes. In case of accidental contact with sensitive surfaces, it is recommended to rinse them thoroughly with water.

- It should not be applied concomitantly in the same area with other topical products such as corticosteroids, retinoids or occlusive ointments as they may increase absorption.

- It is advisable to consult a dermatologist if there is no hair growth in women at 8 months using the 2% concentration and in men at 12 months using the 2% concentration or at 4 months with the 5% concentration.

Interactions

- Antihypertensives: Although not clinically proven, 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 Category C. Animal studies have not demonstrated harmful effects on pregnancy, embryonal/fetal development, childbirth, or postnatal development. There are no clinical data available on the exposure of pregnant women to minoxidil, so its use during pregnancy is not recommended.

Lactation

Orally administered minoxidil is excreted in breast milk. No adverse effects have been observed in nursing infants. 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 in patients over 65 years of age have not been established.

Effects on driving

Although no side effects are expected, if the patient experiences vertigo or dizziness, they should not drive.

Adverse reactions

The most frequent adverse reactions are mild dermatological changes such as: peeling, erythema, dermatitis, hypertrichosis (in distal areas), stinging, itching and dryness of the skin (mainly due to the ethanol content).

- Cardiac: (0.1-1%): [TACHYCARDIA], [PALPITATIONS], [HYPOTENSION], increased or decreased pulse.

- Dematological/hypersensitivity: (1-10%): [PRURITUS], [SKIN IRRITATION], [CONTACT DERMATITIS], [DRY SKIN], [EXFOLIATIVE DERMATITIS]. (0.1-1%): [ALOPECIA] (especially at the start of treatment), patchy hair, [HIRSUTISM]. (<0.1%): [ACNE], allergic reactions (hypersensitivity, rhinitis, rash, generalised erythema, facial oedema).
-Nervous system: (0.1-1%): [HEADACHE], [PARESTHESIA]. (<0.1%): [DIZZINESS], [TASTE DISORDERS].

- Ocular: (<0.01%): [TEARING] altered, vision disturbances.

- Otorhinolaryngological: (<0.1%): [SINUSITIS], otitis (particularly otitis externa).

- Sexual: sexual dysfunction.

Overdose

- Symptoms: Accidental or deliberate overdose after topical application will result in increased dermatological adverse reactions, especially itching, dryness, skin irritation, and eczema. Systemic absorption will also be increased, with a consequent increase in the likelihood of systemic effects.
Accidental ingestion may cause systemic side 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 for symptoms resulting from accidental ingestion requires the use of diuretics for edema, beta-blockers or other sympathetic nervous system inhibitors 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.