Alerana - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspspray for external use

Composition:

1 ml of the preparation contains:

2 % solution

active substance: minoxidil - 20.0 mg;

Excipients: propylene glycol 0.3 ml, ethanol 95% (ethyl alcohol 95%) 0.5 ml, purified water 1.0 ml.

5% solution

active substance: minoxidil - 50.0 mg;

Excipients: propylene glycol 0.5 ml, ethanol 95% (ethyl alcohol 95%) 0.3 ml, purified water 1.0 ml.

Description:A clear, colorless or pale yellow solution.

Pharmacotherapeutic group:Alopecia remedy

ATX: & nbsp

D.11.A.X.01 Minoxidil

Pharmacodynamics:

Being a peripheral vasodilator, minoxidil with external application increases microcirculation in the area of hair follicles. Minoxidil stimulates the growth factor of the vascular endothelium (VEGF), which, it is supposed,is responsible for increasing the permeability of capillaries, 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 application minoxidil 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.

The average values of the area under the curve "concentration-time" (AUC) and maximum concentration (C_max) with a 5% solution of minoxidil are approximately 18.71 ng · h / ml and 2.13 ng / ml, respectively. Time to reach the maximum concentration (TC_m_Oh) 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 plasma proteins, later by ultrafiltration in vitro it was demonstrated its reversible binding to human plasma proteins in the range of 37-39%.

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

Metabolism

Approximately 60% of the minoxidil, absorbed after external application, is metabolized with the formation of minoxidil glucuronide mainly in the liver.

Excretion

The half-life of minoxidil for external application averages 22 hours, compared with 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 externally is excreted within 4 days.

Indications:

Treatment of androgenetic alopecia in men and women.

Contraindications:

Hypersensitivity to minoxidil or other components of the drug; age younger than 18 years and over 65; violation ofintegrity of skin; dermatosis of the scalp; simultaneous use of other drugs on the scalp; pregnancy; the period of breastfeeding.

Carefully:

Patients with cardiovascular diseases and arrhythmia, patients with renal and hepatic insufficiency, before starting treatment with the drug ALERANA®, it is necessary to consult a physician.

Pregnancy and lactation:

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

Dosing and Administration:

Outwardly.

Regardless of the size of the treated area, apply about 1 ml of the 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 using a 2% solution, and patients who require faster hair growth, a 5% solution can be used.

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

For the effectiveness of the drug and its achievement of hair follicles, it is important to apply the drug to the skin of the scalp, and ns to the hair. Apply the preparation ALERANA ® 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 achieved 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 application of the drug ALERANA® for 16 weeks, there is no increase in hair growth, then the drug should be discontinued. After the beginning of the use of the drug AERRANA®, increased hair loss can occur. This effect is caused by the influence of minoxidil.It is expressed in stimulating the hair transition from the resting phase (telogen) to the growth phase (anagen). Thus, there is a loss of old hair, on the site of which grow new. 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 patient groups

There are no recommendations for dosing of the drug AERRANA® for use 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 (Figure 1).

To apply the product to long hair or small areas of the scalp, it is more convenient to use an elongated spray nozzle (Figure 2).

To do this, remove the spray nozzle fixed on the bottle (Figure 3) and fix the elongated spray nozzle (Figure 4).

Side effects:

Classification of the incidence of adverse events according to recommendationsWorld Health Organization (WHO): 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; frequency is unknown - but it is not possible to establish the frequency of occurrence of available data.

Impaired nervous system: often - headache; very rarely - dizziness.

Disturbances from the skin and subcutaneous tissues: often - itchy skin, 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 extend to the ears and face, include: itching, irritation, pain, rash, edema, dry skin, erythema, but in some cases, the reactions may be more severe, including: exfoliation, dermatitis, blistering, bleeding, ulceration).

Immune system disorders: very rarely - angioedema (manifestations of angioedema may be: swelling of the lips, edema of the oral cavity, swelling of the oropharynx, swelling of the pharynx and swelling of the tongue), gynsensitivity (manifestations of hypersensitivity can be generalized erythema, generalized skin itch, face swelling and a feeling of tightness in the throat), allergic contact dermatitis.

Disorders from the side of the organ of vision: very rarely - eye irritation.

Heart Disease: very rarely: tachycardia, palpitation.

Disturbances from the respiratory system, chest and mediastinal organs: very rarely - dyspnea.

Disorders from the gastrointestinal tract: very rarely - nausea, vomiting.

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

Violation from the vessels: infrequently - lowering blood pressure.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

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

Symptoms

Fluid retention, lowering blood pressure, tachycardia, dizziness.

Treatment

Treatment is symptomatic and supportive.

To eliminate fluid retention if necessary, diuretics can be prescribed; for the treatment of tachycardia - beta-blockers.

To treat hypotension should be administered intravenously 0.9% solution of sodium chloride. Investigates to appoint sympathomimetic agents, for example, norepinephrine (norepinephrine) and epinephrine (adrenaline), having excessive cardiostimulating activity.

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. It can not be ruled out that there is a very slight increase in minoxidil in the blood of patients suffering from hypertension and taking minoxidil In case of simultaneous use of the drug ALERANA, although relevant clinical studies have not been conducted.

Determined that minoxidil for external use can interact with some other medicines for external use.

With external application minoxidil should not be used simultaneously with any other drugs (glucocorticosteroids, tretinoin, anthralin) applied to the scalp.

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

Simultaneous application to the skin minoxidil and preparations for external use, such as tretinoin and dithranol, which cause changes in the protective functions of the skin, can lead to an increase in the absorption of minoxidil.

Special instructions:

Do not apply the drug to other parts of the body.

If you applied the drug with your fingertips, after handling the head, your hands should be thoroughly washed. Apply the preparation ALERANA ® only on the dry skin of the scalp. Before applying the drug, there is no need to wash the head. In 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 medicinal product.

Hairspray and other hair care products can be used during the period of application of the drug ALERANA®. Before applying hair care products, first apply the drug ALERANA® and wait until the treated area of the skin is completely dry. There is no evidence that hair coloring, perming, or the use of hair softeners 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 (after a chemical wave and / or staining, including staining with natural dyes - henna / basma, etc.). The drug will not be effective when using: a hair dryer after applying the product to the scalp; means but hair care,which can cause the formation of scars, as well as deep burns of the scalp; methods of hair care, requiring a strong pulling hair from the scalp (for example, braiding tight braid (branding) or the haircut "ponytail").

Applying the drug ALERANA ® should only be on the healthy skin of the scalp. 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 the drug ALERANA in cases of sudden hair loss, focal alopecia, when alopecia develops after childbirth, in case of baldness caused by medication, malnutrition (iron deficiency, vitamin A), as a result of hair styling in "tight" hairstyles , and also in the case 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 the drug ALERANA, patients should undergo a general examination, including the collection and study of medical history.The physician should make sure that the scalp skin is healthy.

Minoxidil can be absorbed in small amounts in small amounts, and there is a risk of systemic side effects such as water and salt retention, generalized and local edema, pericardial effusion, pericarditis, pericardial tamponade, tachycardia, angina pectoris, increased orthostatic hypotension, caused by some antihypertensive drugs, for example, guanethidine and its derivatives. The use of the drug AERANA® by 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. When systemic side effects, such as lowering 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, discontinue the use of the drug AERANA® and consult a doctor .To treat edema and fluid retention in the body if necessary, diuretics can be prescribed. To eliminate tachycardia and angina, beta-blockers can be prescribed. Patients with a history of cardiovascular disease should be warned that treatment with ALERANA® can cause an aggravation 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 the area with plenty of cold water.

Effect on the ability to drive transp. cf. and fur:

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 release / dosage:

Spray for external use 2% and 5%.

Packaging:

50 ml or 60 ml in glass bottles with plastic coating, sealed with high-density polyethylene (HDPE) dispensers with HDPE spray nozzles and polypropylene caps. The bottle is completed with an elongated spray nozzle made of HDPE. The bottle and an extended spray nozzle are put in a cardboard or plastic pallet and, together with the instruction for use, are placed in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature above 25 ° C.

Keep out of the reach of children.

Shelf life:

Shelf life 2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000224

Date of registration:16.02.2011 / 17.03.2016

Expiration Date:Unlimited

The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia

Manufacturer: & nbsp