Generolon® (Generolon)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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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 or 50.00 mg; Excipients: Ethanol (96%) - 571.00 / 243.00 mg, propylene glycol - 104.00 / 520.00 mg, water - up to 1 ml.

    Description:

    Colorless or slightly colored with a yellowish hue, a clear aqueous alcohol solution with the smell of alcohol.

    Pharmacotherapeutic group:A treatment for alopecia
    ATX: & nbsp

    D.11.A.X.01   Minoxidil

    Pharmacodynamics:

    With topical application of minoxidil stimulates hair growth in people with androgenic alopecia (hair thinning, baldness). Improves microcirculation, stimulates the transition hair cells in 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. A 5% solution of the drug stimulates hair growth more than 2% of the solution, which was noted for increasing hair growth hair: After stopping the use of Generrolon®, the growth of new hair is suspended, and within 3-4 months, it is possible to restore the original outer species. The exact mechanism of action of the drug Generrolon® 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 % (0.3-4.5%) 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 external application of the generolon® preparation 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:Treatment of androgenic alopecia (hair restoration) and stabilization of the process of hair loss in men and women.
    Contraindications:

    Hypersensitivity to minoxidil or other components of the drug; age younger than 18 years; violation of the integrity of the skin, dermatosis of the scalp.

    Carefully:The elderly are older than 65 years.
    Pregnancy and lactation:Do not use the drug during pregnancy and lactation.
    Dosing and Administration:

    Outwardly.

    Regardless of the size of the treated area, 1 ml of solution should be applied with a metering device (7 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 mg (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 Generolon® is most effective at hair loss on the crown, for women - with hair loss in the middle part.

    The drug Generrolon® is applied only to 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 on average is about 1 year.

    Preparation for use: Remove the screw cap and fix the measuring pump. On the tube on top of the pump, strengthen the elongated nozzle for spraying. Press the spray nozzle 3-4 times to ensure that the pump is filled with the solution, after which the preparation can be used.
    Side effects:
    Local side effects:

    The most common side effect is dermatitis of the scalp. Less pronounced cases of dermatitis, manifested in the form of redness, flaking and inflammation. In rare cases, itching of the head, allergic contact dermatitis, folliculitis, hypertrichosis (unwanted hair growth on the body, including facial hair growth in women), seborrhea.

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

    Systemic side effects (with accidental ingestion):

    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.

    Overdose:

    Accidental ingestion of the drug Generolon® can cause systemic side effects due to the vasodilating properties of minoxidil (5 ml of a 2% solution contains 100 mg of minoxidil, the maximum recommended dose for adults when ingested for the treatment of hypertension, (5 ml of a 5% solution contains 250 mg of minoxidil, that is, a dose 2.5 times greater than the recommended maximum daily intake for adults for oral administration in the treatment of hypertension.) Signs of an overdose: fluid retention, decrease arterial pressure, tachycardia Treatment: to eliminate fluid retention if necessary, diuretics can be prescribed;tachycardia - beta-blockers. To treat hypotension 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 the minoxidil content in the blood of patients suffering from arterial hypertension and host minoxidil In case of concomitant use of Generolon®, although relevant clinical studies have not been performed. Determined that minoxidil for external use can, interact with certain 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 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 a change in the protective fictions of the skin, may lead to an increase in the absorption of minoxidil.
    Special instructions:

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

    The drug Generrolon® 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 earlier than 4 hours after application. Wash hair with the drug Generolon® is recommended in the usual mode.

    During the period of application of the drug Generrolon®, you can use hair spray and other hair care products. Before applying hair care products, first apply Generrolon® and wait until the treated area of ​​the skin is completely dry. There is no evidence that dyeing hair, perming or using hair softeners can reduce the effectiveness of the drug.However, to prevent possible irritation of the scalp, you need to make sure that the drug was completely washed off hair and scalp before using these chemicals.

    Before starting treatment with Generrolon®, patients should undergo a general examination, including the collection and study of medical history. The doctor should be convinced of that the skin of the scalp is healthy.

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

    The preparation generolon® 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.

    Form release / dosage:

    Spray for external use 2% and 5%.

    Packaging:

    60 ml of solution in a white bottle of high-density polyethylene (HDPE) with a screw cap polypropylene (PP) white,equipped with a plastic ring control the first opening.

    1 or 2 bottles complete with 1 plasticdimensional measuring pump and 1 nozzle for spraying in a protective bag and instructions for use are placed in a cardboard box.

    3 bottles complete with 2 plastic measuring pumps and 2 nozzles for spraying in a protective bag and instructions for use are placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    Spray for external use 2% - 3 of the year.

    Spray for external use 5% - 4 of the year.

    Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001609
    Date of registration:23.03.2012 / 19.04.2016
    Expiration Date:23.03.2017
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp22.03.2017
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