Generolone spray for external use 2% vials, 60ml

Composition

Active ingredient:

minoxidil 20 mg;

Auxiliary substances:

ethanol (96%) – 571 mg;

propylene glycol-104 mg;

water-up to 1 ml

Pharmacological action

Generolone-stimulating hair growth.

Pharmacodynamics

When applied topically, minoxidil stimulates hair growth in individuals with androgenic alopecia (thinning hair, baldness). Improves microcirculation, stimulates the transition of hair cells to the active growing phase, changes the effect of androgens on hair sacs. Reduces the formation of 5-alpha-dehydrotestosterone (possibly indirectly), which plays a significant role in the formation of baldness.

It has the best effect when the disease is not very old (no more than 10 years), patients are young, bald spots in the crown of the head are no more than 10 cm, and there are more than 100 downy and terminal hairs in the center of the bald spot. The appearance of signs of hair growth is noted after 4 or more months of using the drug.

The onset and severity of the effect may vary from patient to patient. A 5% solution of the drug stimulates hair growth more strongly than a 2% solution, which was noted for an increase in the growth of fluffy hair.

After discontinuation of Generolon® the growth of new hair is suspended, and within 3-4 months it is possible to restore the original appearance. The exact mechanism of action of Generolone in the treatment of androgenetic alopecia is unknown. Minoxidil is ineffective in the case of baldness caused by taking drugs, improper nutrition (iron deficiency, vitamin A), as a result of styling hair in tight hairstyles.

Pharmacokinetics

When applied externally, minoxidil is poorly absorbed through normal intact skin: on average,1.5% (0.3–4.5%) of the total applied dose enters the systemic circulation. The effect of concomitant skin diseases on minoxidil absorption is unknown. After discontinuation of the drug, approximately 95% of minoxidil released into the systemic circulation is eliminated within 4 days.

Profile of metabolic biotransformation of minoxidil after external use of Generolone® until now, it has not been fully studied.

Minoxidil does not bind to plasma proteins and is excreted by the kidneys through glomerular filtration. Minoxidil does not penetrate the BBB.

It is mainly excreted in the urine. Minoxidil and its metabolites are eliminated by hemodialysis.

Indications

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

Use during pregnancy and lactation

Do not use the drug during pregnancy and lactation.

Contraindications

• Hypersensitivity to minoxidil or other components of the drug;
• age under 18 years;
• violation of the integrity of the skin;
• dermatosis of the scalp.

With caution:  older age (over 65 years).

Side effects

Local side effects

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

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

Systemic side effects (in case of accidental ingestion of the drug)

Skin and subcutaneous tissue:  non-specific allergic reactions (skin rash, urticaria), facial edema.

Respiratory system:  shortness of breath, allergic rhinitis.

The nervous system:  headache, dizziness, vertigo, neuritis.

CCC:  chest pain, blood pressure fluctuations, rapid heartbeat, changes in heart rate, edema.

Interaction

There is a theoretical possibility (no clinical confirmation) increased orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators.

A very slight increase in the blood content of minoxidil in patients suffering from arterial hypertension and taking minoxidil orally cannot be excluded in the case of simultaneous use of Generolone®, although no relevant clinical studies have been conducted.

It has been established that minoxidil for external use can interact with some drugs for external use. Simultaneous use of a minoxidil solution for external use and a cream containing betamethasone (0.05%) leads to a decrease in the systemic absorption of minoxidil.

Simultaneous use of a cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. Concomitant application of minoxidil to the skin and topical preparations such as tretinoin and ditranol, which cause changes in the protective functions of the skin, may lead to increased absorption of minoxidil.

How to take, course of use and dosage

Externally.

Regardless of the size of the treated area, it is necessary to apply 1 ml of the solution using a dispenser (7 taps) 2 times a day to the affected areas of the scalp, starting from the center of the problem area. Wash your hands after use.

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 experience satisfactory hair growth when using a 2% solution, and patients who want faster hair growth, can use a 5% solution.

For men, the drug Generolone® is most effective for hair loss on the top of the head, for women – for hair loss in the middle parting area.

Generolon® should only be applied to dry scalp skin. The solution does not require rinsing.

The appearance of the first signs of hair growth stimulation is possible after using the drug 2 times a day for 4 months or more. The onset and severity of hair growth, as well as the quality of hair, may vary from patient to patient.

According to isolated reports, recovery of the original appearance can be expected within 3-4 months after discontinuation of treatment. The average duration of treatment is about 1 year.

Preparation for use. Remove the screw-on cover and secure the measuring pump. Attach an extended spray nozzle to the top of the pump tube. Press the spray nozzle 3-4 times to fill the pump with the solution, after which the drug can be applied.

Overdose

Symptoms:  fluid retention, reduction Blood pressure, tachycardia. Treatment:  If necessary, diuretics can be prescribed to eliminate fluid retention; beta — blockers can be used to treat tachycardia. For the treatment of hypotension, an intravenous 0.9% sodium chloride solution should be administered. Do not prescribe sympathomimetic agents, such as norepinephrine and epinephrine, which have excessive pacing activity.

Special instructions

Do not apply the product to other areas of the body.

Generolon® should only be applied to dry scalp skin after bathing, and after applying the drug, wait about 4 hours before bathing (do not wet your head earlier than 4 hours after applying the drug).

Wash your hair when using Generolone® is recommended in the usual mode. During the period of use of Generolone®, you can use hairspray and other hair care products. Before applying hair care products, you must first apply Generolone® and wait until the treated area of the skin is completely dry. There is no evidence that hair coloring, perming, or using hair softeners can reduce the effectiveness of the drug. However, to prevent possible irritation of the scalp, make sure that the product has been completely washed off the hair and scalp before using these chemicals.

Before starting treatment with Generolone®, patients should undergo a general examination, including the collection and study of a medical history. The doctor should make sure that the scalp is healthy.

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

Generolon® contains ethyl alcohol, which can cause inflammation and irritation of the eyes. If the drug gets on sensitive surfaces (eyes, irritated skin, mucous membranes), it is necessary to rinse the area with plenty of cold water. Inhalation of the drug during spraying should be avoided. After using the drug, wash your hands thoroughly.

Product form

spray for external use

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Minoxidil

Dosage form

spray for external use

Purpose

For adults

Indications

Alopecia