Trefostil 5% Minoxidil Alopecia Cutaneous Solution 60 Ml

Skin solution based on minoxidil.

Therapeutic indications

Trefostil 5% Cutaneous Solution is used in the symptomatic treatment of moderate intensity androgenetic alopecia in men. This medicinal product is not recommended for women, due to its limited efficacy and the high incidence of hypertrichosis (37% of cases) in areas far from that of application.

Dosage and Posology

A 1 ml dose should be applied to the scalp starting from the center of the affected area, twice a day. Respect the dosage regardless of the area to be treated. The total dosage should not exceed 2 ml.

Apply the product using your fingertips over the entire affected area. Before and after applying the solution, wash your hands thoroughly. Before application, the hair and scalp must be completely dry. Do not apply the product to other parts of the body.

A treatment of two daily applications is required for a period of two months before the stimulation of hair growth is evident. The onset and degree of hair regrowth vary depending on the individual. Although the trend of the data suggests that younger individuals, who have been developing baldness for a shorter time or who have a smaller area of baldness at the apex of the head are more likely to respond to treatment, individual response cannot be predicted. Some reports suggest that a return to baseline can be observed after 3 to 4 months if treatment is stopped. Trefostil 5% is not recommended in children under the age of 18 and in individuals over the age of 65 due to a lack of data on safety and efficacy.

A graduated pipette allows to dispense exactly 1 ml of solution, to be spread over the entire area to be treated.

Use of the pump with applicator: remove the lid of the bottle and unscrew the cap, screw the dosing pump to the bottle, for application: direct the pump towards the center of the area to be treated, press once and distribute the product with the fingertips all over the affected area. Repeat a total of 6 times to apply a 1ml dose. After each use, rinse the applicator with warm water.

Overdose

There is no evidence that locally applied minoxidil is absorbed in sufficient quantity to cause systemic effects. When used according to instructions, overdose is unlikely. If the product is applied to an area with reduced skin barrier integrity caused by trauma, inflammation, or a pathological process of the skin, there is the potential for a systemic overdose effect. Due to the systemic effects of minoxidil the following very rare adverse events may occur:

- Nervous system disorders

• Very rare: Dizziness

- General disorders and administration site conditions

• Very rare: Water retention resulting in weight gain

- Cardiac pathologies

• Very rare: Heart rate increased Hypotension

Accidental ingestion may cause systemic effects due to the vasodilating action of minoxidil (5 ml of solution contains 250 mg of minoxidil, which is 2.5 times the maximum dose used for oral administration in adults treated for hypertension).

Treatment of minoxidil overdose should be symptomatic and supportive. Hydro / sodium retention can be treated with appropriate diuretics, and tachycardia and angina with a beta-blocker or other sympathetic nervous system inhibitor. Symptomatic hypotension can be treated with intravenous physiological saline. The use of sympathomimetics such as norepinephrine and adrenaline should be avoided due to excessive cardiac stimulation.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Trefostil should not be used in the presence of coronary heart disease, arrhythmias, congestive heart failure or valvular heart disease.
• Do not use during pregnancy and lactation.

Side effects

The undesirable effects and their frequency were determined on the basis of a randomized, double-blind, placebo-controlled clinical study in 393 patients, comparing 5% minoxidil (157 patients), 2% minoxidil (158 patients) and placebo (78 patients). The frequencies of undesirable effects reported during marketing of minoxidil for cutaneous application are not known. Adverse reactions are listed below by MedDRA System Organ Class and frequency. Frequencies are defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (≥ 1 / 10,000, <1/1000), very rare (<1 / 10,000), not known (cannot be estimated from the available data).

- Infections and infestations

• Frequency not known: Ear infections Otitis externa Rhinitis

- Disorders of the immune system

• Frequency not known: Hypersensitivity

- Psychiatric disorders

• Common: Depression

- Nervous system disorders

• Very common: Headache
• Frequency not known: Neuritis, Tingling sensation, Burning sensation

- Eye disorders

• Frequency not known: Visual disturbances Eye irritation

- Ear and labyrinth disorders

• Frequency not known: Dizziness

- Cardiac pathologies

• Frequency not known: Tachycardia, Chest pain, Palpitations

- Vascular pathologies

• Frequency not known: Hypotension

- Respiratory disorders

• Common: Dyspnoea

- Hepatobiliary disorders

• Frequency not known: Hepatitis

- Skin and subcutaneous tissue disorders

• Very common: Hypertrichosis (away from the application area)
• Common: Contact dermatitis (due to the presence of propylene glycol), Pruritus, Inflammatory skin disorders, Rash, Acneiform rash
• Frequency not known: Generalized erythema Alopecia, Uneven scalp coverage, Changes in hair structure, Changes in hair color

- Musculoskeletal system disorders

• Common: Musculoskeletal pain

- Renal and urinary disorders

• Frequency not known: Kidney stones

- General disorders and conditions

• Common: Local reactions at the administration site, application: irritation, peeling, dermatitis, erythema, dry skin, pruritus, peripheral edema, pain
• Frequency not known: Facial edema, Edema, Asthenia

Special warnings

In subjects suffering from dermatosis of the scalp, greater percutaneous absorption of minoxidil is possible. Although the occurrence of systemic effects related to minoxidil has not been observed during use of the solution, the possible occurrence of such effects cannot be excluded. As a precautionary measure, the possible appearance of symptoms indicating systemic effects, such as lowering of blood pressure, tachycardia, signs of hydro / sodium retention, should be regularly monitored. A medical history and clinical examination should be done before using the medicinal product. Patients with known cardiovascular disease or cardiac arrhythmias should contact a physician before using minoxidil. In particular, they should be warned of possible undesirable effects and informed of the possible occurrence of tachycardia, water / sodium retention or weight gain, or other systemic effects which require particular vigilance.

The control must be carried out at the beginning of the treatment and regularly thereafter. Treatment should be discontinued in case of systemic effects or severe dermatological reactions. Due to the risk of hypertrichosis in areas far from the application area, the use of this medicine cannot be justified in women. Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and / or patchy, hair loss is due to childbirth, or the reason for hair loss is unknown. The user should discontinue use of the product and consult a physician if hypotension is detected or if you experience chest pain, rapid heartbeat, fainting or dizziness, sudden unexplained weight gain, swollen hands or feet, or persistent redness or irritation of the scalp.

Minoxidil should only be used on normal, healthy scalp. Do not use if your scalp is red, inflamed, infected, irritated or sore or if you are using other medications on the scalp. In case of contact with the eyes, the solution (which contains ethanol in particular) can induce a burning sensation and irritation. In case of contact with sensitive areas (eyes, abraded skin, mucous membranes) rinse thoroughly with cold tap water. Inhalation of the mist spray should be avoided.

Accidental ingestion can cause serious cardiac adverse events. Therefore this product should be kept out of the reach of children. Some patients have observed a change in hair color and / or texture. During the application of the product, exposure to the sun is not recommended. Interactions with other medicinal products and other forms of interaction. Pharmacokinetic interaction studies in humans revealed that percutaneous absorption of minoxidil is increased by tretinoin and anthralin as a result of increased permeability of the stratum corneum; betamethasone dipropionate increases local tissue concentrations of minoxidil and decreases the systemic absorption of minoxidil.

Although not clinically tested, the risk of orthostatic hypotension in patients undergoing treatment with peripheral vasodilators cannot be excluded. The reabsorption of topically applied minoxidil is controlled and limited by the stratum corneum. Concomitant use of topically applied medicinal products impacting the stratum corneum barrier may lead to increased reabsorption of topically applied minoxidil. Therefore, the concomitant use of Trefostil and other topically applied medicinal products is not recommended.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. No special storage precautions. Before opening: 36 months. After first opening: 1 month.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

1 ml of Trefostil 5% Cutaneous Solution contain:

Active principle

50 mg of minoxidil.

Excipients

Propylene glycol, ethanol (96%), purified water.