Active substanceMinoxidilMinoxidil
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  • Dosage form: & nbspspray for external use
    Composition:

    1 ml of the solution contains:

    Active substance minoxidil 20.00 mg;

    Excipients: ethanol 96% - 600.00 mg, propylene glycol - 200.00 mg, water purified to 1.00 ml.

    Description:Transparent solution from pale yellow to orange.
    Pharmacotherapeutic group:A treatment for alopecia
    ATX: & nbsp

    D.11.A.X.01   Minoxidil

    Pharmacodynamics:

    With external application 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 a significant role in the formation of baldness.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 application of Cosilon®, 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 Cosilon® in the treatment of androgenic alopecia is unknown. Minoxidil Ineffective in case of baldness caused by taking a drug, malnutrition (iron deficiency (Fe), vitamin A), as a result of hair styling in "tight" hairstyles.

    Pharmacokinetics:

    With external application minoxidil poorly absorbed through normal intact skin: an average of 1.5% (0.3 to 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 Cosilon® 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 blood-brain barrier. Excreted mainly with urine. Minoxidil and its metabolites are excreted by hemodialysis.

    Indications:

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

    Contraindications:
    • Hypersensitivity 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.
    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 sprayer (7-8 pressing) 2 times a day on 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, Cosilon® is most effective in hair loss on the vertex, 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.

    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 discontinuation 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.

    Side effects:

    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 in their place grows new. 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:

    Skin and UndercutknifeFiber: folliculitis, seborrhea, itchy scalp, allergic contact dermatitis, hypertrichosis (unwanted body hair growth, including facial hair growth in women);

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

    Respiratory system: shortness of breath, allergic rhinitis.

    Nervous system: headache, dizziness, vertigo, neuritis.

    The cardiovascular system: pain in the chest, fluctuations in blood pressure, palpitations, changes in the rhythm of the heart beat, swelling.

    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:

    Inadvertent ingestion of Cosilon® 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).

    Signs of an overdose: fluid retention, lowering 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 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 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 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 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 preparation of Cosilon® is applied only to the dry skin of the scalp after bathing or should wait about 4 hours after application of 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 washed off 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 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.

    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:

    Spray for external use 1 %.

    Packaging:

    To 60 ml in a polyethylene bottle of white color 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:LSR-005921/08
    Date of registration:28.07.2008 / 16.07.2014
    Expiration Date:Unlimited
    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: & nbsp05.02.2018
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