Instruction for use: Kosilon

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

L65 Other nerubtsuyuschayasya hair loss

Cronkheta-Canada syndrome, Alopecia, Hair loss, Hair loss due to environmental factors, Diffuse hair loss non-hormonal etiology, Increased hair loss

Composition

Spray for external use 1 ml

active substance:

minoxidil 20 mg

auxiliary substances: ethanol 96% - 600 mg; propylene glycol 200 mg; purified water - up to 1 ml

Solution for external use 1 ml

active substance:

minoxidil 50 mg

auxiliary substances: propylene glycol 700 mg; ethanol 96% - 200 mg; water - up to 1 ml

Description of dosage form

Spray for external use: clear solution from pale yellow to orange.

Solution for external use: clear solution from light yellow to orange.

pharmachologic effect

Pharmacological action - stimulating hair growth.

Pharmacodynamics

Spray for external use

With external use, minoxidil stimulates hair growth in people with androgenic alopecia (hair thinning, baldness). Improves microcirculation, stimulates the transition of hair follicles to the active growing phase, changes the effect of androgens on hair follicles. Reduces the formation of 5-alpha-dehydrosterone (possibly, indirectly), which plays an important role in the formation of alopecia. The best effect is for a small prescription of the disease (no more than 10 years), young patients, the bald spot in the top of the head is no more than 10 cm, and there are more than 100 gun and terminal hair in the center of the bald head. The appearance of signs of hair growth is noted after 4 or more months of application of the drug. The onset and severity of the effect may vary in different patients. After the termination of the use of KosilonŽ, the growth of new hair is suspended, and within 3-4 months the restoration of the original appearance is possible. The precise mechanism of action of the drug KosilonŽ in the treatment of androgenic alopecia is unknown. Minoxidil is ineffective in case of baldness caused by taking a drug, improper nutrition (iron deficiency (Fe), vitamin A), as a result of hair styling in "tight" hairstyles.

Solution for external use

With external application of minoxidil, its stimulating effect on hair growth in persons with androgenic alopecia (hair thinning, baldness) was noted. It improves microcirculation, stimulates the transition of hair cells to the active growing phase, changes the effect of androgens on hair follicles. Reduces the formation of 5-alpha-dehydrotestosterone (possibly mediated), which plays a significant role in the formation of alopecia. The best effect is for a small prescription of the disease (no more than 10 years), young patients, the bald spot in the top of the head is no more than 10 cm, and there are more than 100 gun and terminal hair in the center of the bald head. The appearance of signs of hair growth is noted after 4 or more months of application of the drug.

The onset and severity of the effect may vary in different patients. After the cessation of the use of KosilonŽ, the growth of new hair is suspended, within 3-4 months the restoration of the original appearance is possible. The exact mechanism of action of the drug KosilonŽ in the treatment of androgenetic alopecia is unknown. Minoxidil is ineffective in case of baldness caused by taking drugs, malnutrition (iron deficiency (Fe), vitamin A), as a result of hair styling in "tight" hairstyles.

Pharmacokinetics

Spray for external use

With external use, minoxidil is poorly absorbed through normal intact skin: an average of 1.5% (0.3-4.5%) of the total applied dose enters the systemic circulation. The effect of concomitant skin diseases on the absorption of minoxidil is unknown.

After discontinuation of the drug, approximately 95% of minoxidil, which enters the systemic circulation, is excreted within 4 days. The profile of the metabolic biotransformation of minoxidil after the external use of the preparation KosilonŽ has not been fully studied to the present day.

Minoxidil does not bind to plasma proteins and is excreted by the kidneys through glomerular filtration. Minoxidil does not penetrate the BBB. Excreted mainly with urine. Minoxidil and its metabolites are excreted by hemodialysis.

Solution for external use

With external use, minoxidil is poorly absorbed through normal intact skin: an average of 1.5% (0.3-4.5%) of the total applied dose enters the systemic circulation. The effect of concomitant skin diseases on the absorption of minoxidil is unknown.

After discontinuation of the drug, approximately 95% of minoxidil, which enters the systemic circulation, is excreted within 4 days. The profile of the metabolic biotransformation of minoxidil after the external use of the preparation KosilonŽ has not been fully studied to the present day.

Minoxidil does not bind to plasma proteins and is excreted by the kidneys through glomerular filtration. Minoxidil does not penetrate the BBB. Excreted mainly with urine. Minoxidil and its metabolites are excreted by hemodialysis

Indications

Spray for external use

For the treatment of androgenic alopecia (hair restoration) and stabilization of hair loss in men and women.

Solution for external use

Treatment of androgenetic alopecia (hair restoration) and stabilization of the process of hair loss in men and women.

Contraindications

Spray for external use

increased sensitivity to minoxidil or other components of the drug;

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

age younger than 18 years and over 65 years.

With caution: patients with cardiovascular diseases and arrhythmia, renal and hepatic insufficiency, before starting treatment with KosilonŽ, should consult a doctor.

Solution for external use

increased sensitivity to minoxidil or other components of the drug;

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

old age (over 65 years);

age younger than 18 years.

pregnancy and lactation

Spray for external use

Do not use the drug during pregnancy and during breastfeeding.

Solution for external use

When pregnant and breast-feeding the drug should not be used.

Side effects

Spray for external use

Local side effects.

The use of minoxidil can cause an increase in hair loss during the transition from the resting phase to the growth phase, while the old hair falls out, and new ones grow in their place. This temporary phenomenon is usually observed after 2-6 weeks after the start of treatment and gradually stops within the next two weeks (the appearance of the first signs of the action of minoxidil).

Systemic side effects.

From the skin and subcutaneous fat: folliculitis, seborrhea, itching of the scalp, allergic contact dermatitis, hypertrichosis (unwanted growth of hair on the body, including hair growth on the face of women).

Dermatological diseases: nonspecific allergic reactions (skin rash, urticaria), edema of the face.

On the part of the respiratory system: dyspnea, allergic rhinitis.

From the nervous system: headache, dizziness, vertigo, neuritis.

On the part of the CAS: chest pain, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart, swelling.

If any of the side effects described in the description have worsened or any other side effects not listed in this description have occurred, you should inform your doctor.

Solution for external use

The use of minoxidil can cause an increase in hair loss during the transition from the resting phase to the growth phase, while the old hair falls out, and new ones grow in their place. This temporary phenomenon is usually observed after 2-6 weeks after the start of treatment and gradually stops within the next two weeks (the appearance of the first signs of the action of minoxidil).

Side effects with external application can occur in the form of skin itching at the site of application, contact dermatitis, folliculitis, hypertrichosis (unwanted hair growth on the body, including facial hair growth in women), seborrhea.

If the product is accidentally swallowed, the following symptoms may occur:

From the skin: nonspecific allergic reactions (skin rash, urticaria).

On the part of the respiratory system: dyspnea, allergic rhinitis.

From the nervous system: headache, dizziness, vertigo, neuritis.

On the part of the CAS: chest pain, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart, swelling.

Interaction

Spray for external use

There is a theoretical possibility (clinical confirmation is not available) of strengthening orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators. We can not rule out a very slight increase in minoxidil in the blood of patients suffering from arterial hypertension and taking minoxidil inwards in the case of the simultaneous use of KosilonŽ, although relevant clinical studies have not been carried out.

It was found that minoxidil for external use can interact with some other drugs for external use.

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

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

Solution for external use

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 small increase in minoxidil in the blood of patients suffering from hypertension and taking minoxidil inwards in the case of the simultaneous use of the drug KosilonŽ, although relevant clinical studies have not been conducted.

It was found that minoxidil, when applied externally, can interact with some other drugs for external use.

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.

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

Dosing and Administration

Outwardly.

Spray for external use

Regardless of the size of the treated area, apply 1 ml of solution with a nebulizer (7-8 clicks) 2 times a day to the affected areas of the scalp, starting from the center of the problem area. After application, wash hands.

The total daily dose should not exceed 2 ml (the dose does not depend on the size of the affected area). Patients who do not have satisfactory hair growth when using a 2% solution, and patients who want faster hair growth, can use a 5% solution.

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

Apply KosilonŽ only on the dry skin of the scalp. The solution does not require flushing.

The appearance of the first signs of stimulation of hair growth is possible after applying the drug 2 times a day for 4 months or more. The onset and severity of hair growth, as well as the quality of the hair, can fluctuate in different patients.

According to individual reports, recovery of the initial appearance can be expected within 3-4 months after cessation of treatment.

The duration of treatment on average is about 1 year.

Preparation for use: Before the first use, the solution should be sprayed 2-3 times until a uniform spraying is achieved. Next time, the nebulizer can be used immediately.

Solution for external use

KOSILONŽ is applied only to the scalp. Do not apply KosilonŽ to other parts of the body.

Before the first use of the spray gun, the solution should be sprayed 2-3 times until uniform spraying is achieved. Next time, the nebulizer can be used immediately.

Regardless of the size of the area to be treated, 1 ml of solution should be applied with a dispenser (8 strokes) 2 times a day to the affected areas of the scalp beginning from the center of the affected area. After application, wash hands. The total daily dose should not exceed 2 ml.

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

Apply KosilonŽ only on the dry skin of the scalp. The solution does not require flushing.

The appearance of the first signs of stimulation of hair growth is possible after applying the drug 2 times a day for 4 months or more. The onset and severity of hair growth, as well as the quality of the hair, can fluctuate in different patients. According to individual reports, within 3-4 months after the cessation of treatment can be expected to restore the original appearance. The duration of treatment is about 1 year on average.

After clinical improvement, the dose is reduced to 1 ml of solution 1-2 times a week. If, after 4 months, a satisfactory result is not achieved, you should consult a dermatologist who may decide to prolong treatment.

Overdose

Spray for external use

Inadvertent ingestion of KosilonŽ may cause systemic side effects due to the vasodilator properties of minoxidil (5 ml of a 2% solution contain 100 mg of minoxidil, the maximum recommended dose for adults in the treatment of hypertension).

Symptoms: fluid retention, decreased blood pressure, tachycardia.

Treatment: diuretics may be prescribed to eliminate fluid retention if necessary; for the treatment of tachycardia - beta-blockers.

To normalize blood pressure, a 0.9% solution of sodium chloride should be administered. Do not prescribe sympathomimetic drugs, such as norepinephrine and epinephrine, which have excessive cardiostimulating activity.

Solution for external use

Inadvertent ingestion of KosilonŽ can cause systemic side effects due to the vasodilator properties of minoxidil (5 ml of KosilonŽ contains 250 mg of minoxidil, which is 2.5 times the maximum recommended dose for adults when ingested for the treatment of hypertension).

Symptoms: fluid retention, decreased blood pressure, tachycardia.

Treatment: diuretics may be prescribed to eliminate fluid retention if necessary; for the treatment of tachycardia - beta-blockers.

For the treatment of arterial hypotension, a 0.9% solution of sodium chloride should be administered. Do not prescribe symptomatic drugs, such as norepinephrine and epinephrine, which have excessive cardiostimulating activity.

special instructions

Spray for external use

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

The preparation of KosilonŽ is applied only to the dry skin of the scalp after bathing or should wait about 4 hours after applying the drug before bathing. Do not let your head get wet before 4 hours after application. Wash hair with the use of the drug KosilonŽ is recommended in the usual mode.

During the period of using the drug KosilonŽ, you can use hair spray and other hair care products. Before applying the hair care products, you must first apply the preparation of KosilonŽ and wait until the treated area of the skin dries completely. 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 washed off the hair and scalp before using these chemicals.

Minoxidil in small amounts can be absorbed through the skin, which is why 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 KosilonŽ 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. When systemic side effects occur, treatment should be discontinued. 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 cardiovascular disease in a history should be warned that treatment with the drug KosilonŽ can cause an aggravation of these diseases.

Before starting treatment with KosilonŽ, 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.

When systemic side effects or severe skin reactions occur, patients should cancel the drug and consult a doctor.

The composition of the drug KosilonŽ 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. Avoid inhalation during spraying. After applying the drug, you should wash your hands thoroughly.

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

Solution for external use

The drug KosilonŽ is applied only to the dry skin of the scalp after bathing or at least 4 hours before bathing. After applying the product on the scalp, the hands should be thoroughly washed. Wash hair with the use of the drug KosilonŽ is recommended in the usual mode. Hairspray and other hair care products can be used during the period of use of the drug KosilonŽ. Before applying hair care products, you must first apply the drug KosilonŽ 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 washed off the hair and skin of the scalp before applying these chemicals. Before starting treatment with KosilonŽ, 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.

When systemic side effects or severe skin reactions occur, patients should cancel the drug and consult a doctor.

The composition of the drug KosilonŽ includes ethyl alcohol. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the area with plenty of cold water.

Influence on the ability to drive and work on machines. The effect of the drug on psychomotor functions was not noted. The drug does not affect the ability to drive.

Form of issue

Spray for external use, 2%. For 60 ml in a PE bottle white with a nebulizer. 1 f. placed in a cardboard box.

Solution for external use [alcohol], 5%. For 60 ml in a round bottle of PE white with a nebulizer. 1 f. placed in a cardboard box.

Conditions of leave from pharmacies

Without recipe.

Storage conditions

At a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf Life

3 years.

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