Kosilon - instructions for use, doses, side effects, contraindications

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 is supposed to be responsible for increasing capillary permeability, which indicates a high metabolic activity observed in the anagen 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 intact skin: an average of 1.5% (1 - 2%) of the total applied dose enters the systemic circulation. Average values of the area under the curve "concentration-time" (AUC) and the maximum concentration (Cmax) are approximately 18.71 ng * h / ml and 2.13 ng / ml, respectively. The time to reach the maximum concentration (TCmax) is 5.79 hours. The effect of minoxidil on hemodynamics is not expressed until the average serum concentration of minoxidil reaches 21.7 mg / 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 blood proteins in the range of 37-39%. Since only 1-2% of the minoxidil applied externally is absorbed, the degree of its binding to plasma proteins is not clinically significant.

Metabolism. Approximately 60% of minoxidil is metabolized with the formation of minoxidil glucuronide mainly in the liver.

Excretion. The half-life of minoxidil for external application averages 22 hours. 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:

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

Carefully:

Patients with cardiovascular disease and arrhythmia, kidney and liver failure before starting treatment with the drug Cosilon® should consult with a doctor.

Pregnancy and lactation:

Do not use the drug during pregnancy and during breastfeeding.

Dosing and Administration:

For external use only.

Regardless of the size of the treated area, apply 1 ml of the solution with a nebulizer (8 strokes) 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, the drug Cosilon® is most effective at hair loss on the crown, for women - with hair loss in the middle part.

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

For the effectiveness of the drug and its achievement of hair follicles, it is important to apply the drug to the scalp, not to the hair. Do not apply Cosilon® to other parts of the body.

The appearance of the first signs of suspension of hair loss and restoration of hair growth is possible after applying the drug Cosilon® 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 applying the drug Cosilon® for 16 weeks, hair growth is not increased, then the drug should be discontinued. After the start of the use of the drug Cosilon®, 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 amplification 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 dosage of Cosilon® for use in patients with renal or hepatic insufficiency.

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.

Recommendations for using the nozzle: 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.

Side effects:

Classification of the incidence of adverse events according to recommendations World 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;
the frequency is unknown - it is not possible to establish the frequency of occurrence from the 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 spread to the ears and face include: itching, irritation, pain, rash, swelling, 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: edema of the lips, swelling of the tissues of the oral cavities, swelling of the oropharynx, swelling of the pharynx and swelling of the tongue), hypersensitivity (manifestations of hypersensitivity can be: generalized erythema, generalized skin itching, swelling of the face 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 exceeding the recommended levels are applied to larger areas of the body or other parts of the body other than the scalp, an increase in the systemic absorption of minoxidil is possible, which can lead to the development of undesirable events.

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

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

To normalize blood pressure should be administered intravenously 0.9% solution of sodium chloride. Do not prescribe sympathomimetic drugs, for example, norepinephrine and epinephrine, having excessive cardiostimulating activity.

Interaction:

There is a theoretical possibility (clinical confirmation is not available) of strengthening orthostatic hypotension in patients,receiving concomitant treatment with peripheral vasodilators. It is impossible to exclude a very small increase in the minoxidil content in the blood of patients suffering from arterial hypertension and host minoxidil In case of simultaneous application of Cosilon®, although relevant clinical studies have not been performed.

Determined that minoxidil for external use can interact with some other medicines for external use. The simultaneous use of a solution of minoxidil for external use and a 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 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.

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

During the period of using the drug Cosilon®, you can use hair spray and other hair care products. Before applying the hair care products, you must first apply the preparation of Cosilon® 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 flushed from the hair and scalp before using these chemicals.

Minoxidil in small amounts can be absorbed through the skin, so 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 agents, for example, guanethidine and its derivatives. The use of Cosilon® in patients with arterial 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 Cosilon® can cause an aggravation of these diseases.

Before starting treatment with Cosilon®, 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 Cosilon® 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.

The drug will not be effective when using: a hair dryer after applying the product to the scalp; hair care products that can cause scarring, as well as deep scalp burns; methods of hair care, requiring a strong pulling hair from the scalp (for example, braiding tight braids (brading) or the haircut "ponytail").

Applying the drug Cosilon® 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 the drug Cosilon® in cases of sudden hair loss, focal alopecia, when alopecia develops after birth, 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 not known.

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.

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 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.

Form release / dosage:

Solution for external use [alcohol] 5%.

Packaging:

For 60 ml in a round bottle of white polyethylene with a spray.Each vial with instructions for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-001149

Date of registration:11.11.2011 / 11.09.2012

Expiration Date:11.11.2016

The owner of the registration certificate:Boznalek, AOBoznalek, AO Bosnia and Herzegovina

Manufacturer: & nbsp

BOSNALIJEK, d.d. Bosnia and Herzegovina

Representation: & nbspBOSNALEK AO BOSNALEK AO Bosnia and Herzegovina

Information update date: & nbsp19.09.16

Illustrated instructions

Instructions

Cosilon® (Kosilon®)