Instruction for use: Alerana

Active substance Minoxidil

ATX code D11AX01 Minoxidil

Pharmacological group

dermotropic means

Nosological classification (ICD-10)

L64 Androgenic alopecia

Alopecia androgenic, Androgenetic alopecia, Androgenic alopecia of moderate severity, Severe Androgen-Dependent Alopecia, Male pattern hair loss

Composition

Spray for external use (2% solution) 1 ml

active substance:

minoxidil 20 mg

auxiliary substances: propylene glycol - 0.3 ml; ethanol 95% (ethyl alcohol 95%) 0.5 ml; purified water - up to 1 ml

Spray for external use (5% solution) 1 ml

active substance:

minoxidil 50 mg

auxiliary substances: propylene glycol - 0.5 ml; ethanol 95% (ethyl alcohol 95%) - 0.3 ml; purified water - up to 1 ml

Description of dosage form

Transparent colorless or light yellow solution.

pharmachologic effect

Pharmacological action - promoting hair growth.

Pharmacodynamics

As a peripheral vasodilator, minoxidil, when applied topically, enhances microcirculation in the area of the hair follicles. Minoxidil stimulates the growth factor of the vascular endothelium, which is supposed to be responsible for increasing capillary permeability, which indicates a high metabolic activity observed in the anagen phase (growth phase). Minoxidil stimulates hair growth in patients with hereditary hair loss (androgenic alopecia) in the initial stage. The exact mechanism of action of minoxidil for external use in hair loss is not fully understood.

Pharmacokinetics

Suction. With external use, minoxidil is poorly absorbed through normal intact skin: an average of 1.5% (1-2%) of the total applied dose enters the systemic circulation. The effect of concomitant skin diseases on the absorption of minoxidil is unknown. AUC and Cmax using a 5% minoxidil solution are approximately 18.71 ng · h / ml and 2.13 ng / ml, respectively. Tmax with a 5% solution of minoxidil is 5.79 hours. The effect of minoxidil on hemodynamics is not expressed until the average serum concentration of minoxidil reaches 21.7 ng / ml.

Distribution. Although it was previously reported that minoxidil does not bind to blood plasma proteins, it was later demonstrated in vitro by its in vitro ultrafiltration that it reversibly binds to human plasma proteins in the 37-39% range.

Since only 1-2% of the topically applied minoxidil is absorbed, the degree of its binding to plasma proteins, noted in vivo after external application, will be clinically insignificant.

Metabolism. Approximately 60% of the minoxidil, absorbed after topical administration, is metabolized to form minoxidil glucuronide predominantly in the liver.

Excretion. T1 / 2 minoxidil for topical application is on average 22 hours and - 1.49 hours for oral administration. 97% of minoxidil and its metabolites are excreted by the kidneys and 3% by the intestine.

After discontinuation of the drug, approximately 95% of the minoxidil applied topically is excreted within 4 days.

Indications

For treatment of androgenic alopecia in men and women.

Contraindications

increased sensitivity to minoxidil or other components of the drug;

violation of the integrity of the skin or dermatosis of the scalp;

simultaneous application of other drugs applied to the scalp;

pregnancy;

the period of breastfeeding;

age younger than 18 years and over 65 years.

With caution: patients with cardiovascular disease and arrhythmia, renal and hepatic insufficiency - before starting treatment with Alaran®, consult a physician.

pregnancy and lactation

The drug Alerana® is contraindicated in women during pregnancy and during breastfeeding.

Side effects

Classification of the incidence of side effects according to WHO recommendations: very often -> 1/10; often from> 1/100 to <1/10; infrequently - from> 1/1000 to <1/100; rarely - from> 1/10000 to <1/1000; very rarely - <1/10000, including individual messages; the frequency is unknown - it is not possible to establish the frequency of occurrence from the available data.

From the nervous system: often - headache; very rarely - dizziness.

From the skin and subcutaneous tissues: often - skin itching, rash; rarely - dermatitis, manifested in the form of redness, flaking and inflammation; very rarely - temporary hair loss, hair color change, hair texture disorder, hypertrichosis (unwanted hair growth outside the site of application), reactions at the site of application (these reactions can spread to the ears and face, include pruritus, irritation, pain, rash, swelling , dry skin, erythema, but in some cases, the reactions may be more severe, including exfoliation, dermatitis, blistering, bleeding, ulceration).

From the side of the immune system: very rarely - angioedema (manifestations of angioedema may be swelling of the lips, oral cavity, oropharynx, pharynx and tongue), hypersensitivity (generalized erythema, generalized itchy skin, face swelling and tightness in the throat ), allergic contact dermatitis.

From the side of the organ of vision: very rarely - irritation of the eyes.

From the heart: very rarely - tachycardia, a feeling of palpitations.

From the respiratory system, chest and mediastinum: very rarely - shortness of breath.

From the digestive tract: very rarely - nausea, vomiting.

General disorders and disorders at the injection site: very rarely - peripheral edema, pain in the chest.

From the side of the vessels: infrequently - a decrease in blood pressure.

If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions are noted, then it is necessary to inform the physician about it.

Interaction

There is a theoretical possibility of strengthening orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators, which, however, did not receive clinical confirmation.

We can not rule out a very slight increase in minoxidil in the blood of patients suffering from hypertension and taking minoxidil inwards in the case of simultaneous use of the drug Alerana®, although relevant clinical studies have not been conducted.

It was found that minoxidil for topical application can interact with some other drugs for topical application.

With topical application, minoxidil should not be used concomitantly with any other drugs (GCS, tretinoins, antralins) applied to the scalp.

The simultaneous use of a solution of minoxidil for external use and cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil.

Simultaneous use of cream containing tretinoin (0.05%) leads to increased absorption of minoxidil.

The simultaneous application of minoxidil to the skin and topical preparations such as tretinoin and dithranol, which cause a change in the protective functions of the skin, may lead to an increase in the absorption of minoxidil.

Dosing and Administration

Locally. Regardless of the size of the treated area, apply 1 ml of solution with a spray nozzle (7 strokes) 2 times a day to the affected areas of the scalp, starting from the center of the affected area. After application, wash hands.

The total daily dose should not exceed 2 ml (about 14 clicks) (the dose does not depend on the size of the affected area). Patients who do not have cosmetically satisfactory hair growth when applying a 2% solution, and patients for whom faster hair growth is desired, a 5% solution can be used.

For men, the drug Alerana® is most effective at hair loss on the crown, for women - with hair loss in the middle part.

To ensure the effectiveness of the drug and its impact on the hair follicles, it is important to apply the drug to the scalp, not to the hair. Apply Alaran® only on the dry skin of the scalp. Do not apply Alerana® to other parts of the body. The solution does not require flushing. The applied solution dries quickly.

The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after the application of the drug Alerana® 2 times a day for 2-4 months. To achieve and maintain the effect of restoring hair growth, the patient should not interrupt the use of the drug, otherwise hair loss will resume. An increase in the dose of the drug or its more frequent use will not lead to an improvement in the results of therapy. If after the application of the drug Alerana® for 16 weeks, hair growth is not increased, then therapy should be discontinued. After the beginning of the use of the drug Alerana®, increased hair loss can occur. This effect is expressed in stimulating the hair transition from the resting phase (telogen) to the growth phase (anagen) - there is a loss of old hair, in the place of which new ones grow. Temporary increase in hair loss usually lasts for 2-6 weeks from the start of treatment, and then decreases within 2 weeks. If the increased hair loss continues, then the drug should be discontinued and consult with a doctor.

Special groups of patients. There are no recommendations for dosing of Alaran® in patients with renal or hepatic insufficiency.

Recommendations on the use of nozzles

The spray nozzle attached to the bottle is better suited for applying the solution to large problem areas of the scalp.

To apply the product to long hair or small areas, it is more convenient to use an elongated spray nozzle.

To change the nozzle, it is necessary to remove the dispenser fixed on the bottle (I) and to strengthen the elongated spray nozzle (II).

Overdose

If doses in excess of those recommended are applied to extensive areas of the scalp or other areas of the body other than the scalp, an increase in the systemic absorption of minoxidil may be possible, which may lead to the development of undesirable events.

Symptoms: fluid retention, decreased blood pressure, tachycardia, dizziness.

Treatment: symptomatic and supportive. To eliminate fluid retention if necessary, diuretics can be prescribed; for treatment of tachycardia - β-adrenoblockers. To treat hypotension, you should inject a 0.9% solution of sodium chloride in / in. Do not prescribe sympathomimetic drugs, such as norepinephrine (noradrenaline) and epinephrine (epinephrine), which have excessive cardiostimulating activity.

special instructions

It should be applied only to the scalp.

If the drug is applied with the fingertips, then after the treatment of the head, hands should be thoroughly washed. Apply Alerana® only on the dry skin of the scalp. Before applying the drug, there is no need to wash the head. In the case of washing the head before applying the drug, it is necessary to dry hair and scalp. Washing of the head is allowed no less than 4 hours after the application of the drug.

Hairspray and hair care products can be used during the period of application of the drug Alerana®. Before applying hair care products, first apply the Alerana® preparation and wait until the treated area of the skin is completely dry. There is no evidence that hair coloring, perming, or use of hair care products can somehow reduce the effectiveness of the drug. However, to prevent possible irritation of the scalp, you need to make sure that the product has been completely flushed from the hair and scalp before using these chemicals. Do not apply the drug within 24 hours after using any chemicals (including after a chemical wave and / or staining, including staining with natural dyes - henna / basma).

When using a hair dryer after applying the product on the scalp, hair care products that can cause scarring or deep burns of the scalp, strong pulling of the hair from the scalp (for example, tight braids (brady) or horse-tail hair). The drug loses its effectiveness.

Applying the drug Alerana® should only be on the healthy scalp skin. You can not use it for inflammation, infection, irritation, soreness of the skin, and also at the same time as other medicinal products applied to the scalp.

Do not use Alerana® in cases of sudden hair loss, focal alopecia, when alopecia develops after birth, in case of baldness caused by taking drugs, malnutrition (iron deficiency, vitamin A), tight styling of hair, and also when the cause of hair loss is unknown.

Accidental ingestion of the drug inside can lead to the development of serious adverse events from the heart. Therefore, this product should be stored in places inaccessible to children.

Before starting treatment with Alaran®, patients should undergo a general examination, which includes the collection of anamnesis. The physician should make sure that the scalp skin is healthy.

Minoxidil in small amounts can be absorbed through the skin, and there is a risk of systemic side effects such as water and salt retention, generalized and local edema, pericardial effusion, pericarditis, cardiac tamponade, tachycardia, angina pectoris, increased orthostatic hypotension caused by some antihypertensive agents, for example, guanethidine and its derivatives. The use of Alaran® in patients with hypertension receiving treatment with guanethidine or derivatives of guanethidine, or minoxidil, is possible only under conditions of medical observation. Patients should undergo periodic examinations to identify possible signs of systemic side effects of minoxidil. If systemic side effects such as a decrease in blood pressure or chest pain, rapid heart rate, weakness or dizziness, sudden unexplained weight gain, swelling of the hands or feet, and severe skin reactions, stop using Alaran® and consult a doctor. To treat edema and fluid retention in the body if necessary, diuretics can be prescribed. To eliminate tachycardia and angina, β-blockers can be prescribed. Patients with a history of cardiovascular disease should be warned that treatment with Alaran® can affect the course of these diseases.

The composition of the drug Alerana® includes ethyl alcohol, which can cause inflammation and eye irritation. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse with plenty of cold water.

Influence on the ability to drive vehicles and mechanisms. In connection with the possible development of headache, dizziness, eye irritation, care should be taken when driving vehicles and doing certain activities that require increased concentration of attention and quick motor reaction. When these undesirable phenomena appear, one should refrain from performing these activities.

Form of issue

Spray for external use, 2% and 5%. For 50 or 60 ml in glass bottles with plastic coating, sealed with dispensers made of HDPE with spray nozzles made of HDPE and caps made of polypropylene. The bottle is completed with an elongated spray nozzle made of HDPE. A bottle and an elongated spray nozzle are put in a cardboard or plastic pallet in a pack of cardboard.

Conditions of leave from pharmacies

Without recipe.

Storage conditions

In the dark place at a temperature of 0-25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.