Generolon, 2% spray 60 ml

Generolon – stimulates hair growth.

Pharmacodynamics

When applied topically, minoxidil stimulates hair growth in persons with androgenic alopecia (hair thinning, baldness). It improves microcirculation, stimulates the transition of hair cells into an active growing phase, changes the effect of androgens on the hair follicles. It reduces the formation of 5-alpha-dehydrotestosterone (possibly indirectly), which plays a significant role in the formation of baldness.

The best effect is achieved if the time of the disease is short (not more than 10 years), the patient is young, the baldness in the vertex is not more than 10 cm, the presence of more than 100 down and terminal hairs in the center of the baldness. The manifestation of signs of hair growth is observed after 4 months or more of using the drug.

The beginning and degree of the effect may vary from patient to patient. The 5% solution of the drug stimulates hair growth more strongly than the 2% solution, which has been noted in increased growth of downy hair.

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

Pharmacokinetics

In external application, minoxidil is poorly absorbed through normal intact skin: on average, 1.5% (0.3-4.5%) of the total dose applied enters the systemic bloodstream. The effect of concomitant skin diseases on the absorption of minoxidil is unknown. After discontinuation of the drug, approximately 95% of minoxidil entering the systemic bloodstream is eliminated within 4 days.

The metabolic biotransformation profile of minoxidil after external use of Generolone® has not yet been fully understood.

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

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

Indications

Treatment of androgenic alopecia (hair regrowth) and stabilization of hair loss in men and women.

Active ingredient

Composition

Active ingredient:

Minoxidil 20 mg;

Excipients:

Ethanol (96%) – 571 mg;

Propylene glycol – 104 mg;

Water – up to 1 ml

How to take, the dosage

Externally.

Independent of the size of the area to be treated, 1 ml of the solution should be applied using a dispenser (7 squeezes) twice a day to the affected areas of the scalp, starting from the center of the problem area. After application, you should wash your hands.

The total daily dose should not exceed 2 mg (the dose is independent of the size of the affected area). Patients who do not have satisfactory hair growth when using the 2% solution and patients for whom faster hair growth is desired may use the 5% solution.

For men, Generolone® is most effective for hair loss on the crown of the head; for women, it is most effective for hair loss in the middle partition.

Generolone® is applied only to dry scalp. The solution does not need to be rinsed off.

The first signs of hair growth may appear after application of the product twice daily for 4 months or longer. The onset and severity of hair growth, as well as hair quality, can vary from patient to patient.

Anecdotal reports indicate that within 3 to 4 months after discontinuation of treatment, one can expect to regain the original appearance. The duration of treatment is about 1 year on average.

Preparing for use. Remove the screw cap and attach the measuring pump. Attach the extended spray nozzle to the tube on top of the pump. Press the spray nozzle 3 to 4 times to prime the pump with the solution, after which the product can be applied.

Interaction

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

A very small increase in blood levels of minoxidil in patients with arterial hypertension receiving oral minoxidil cannot be excluded if Generolone® is used concomitantly, although appropriate clinical studies have not been performed.

It has been found that minoxidil for external use may interact with some drugs for external use. Simultaneous use of minoxidil solution for external use and cream containing betamethasone (0.05%) leads to decreased systemic absorption of minoxidil.

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

Special Instructions

Do not apply to other areas of the body.

Generolone® should only be applied to dry scalp after bathing, and you should wait about 4 hours after application before bathing (do not wash your scalp more than 4 hours after application).

Washing hair with Generolone® is recommended as usual. During the use of Generolone® it is possible to use hair spray and other hair care products. Before applying hair care products, first apply Generolone® and wait until the treated skin area is completely dry. There is no evidence that hair coloring, perming or the use of hair softeners may reduce the effectiveness of the product. However, to prevent possible scalp irritation, be sure to completely rinse the product from the hair and scalp before using these chemicals.

Patients should have a general assessment including a medical history and history check before starting treatment with Generolone®. The physician must ensure that the scalp is healthy.

If any systemic side effects or severe skin reactions occur, patients should discontinue the drug and see their physician.

Generolone® contains ethyl alcohol which may cause eye inflammation and irritation. In case of contact of the drug with sensitive surfaces (eyes, irritated skin, mucous membranes) the area should be rinsed with plenty of cold water. Avoid inhalation of the drug while spraying. After using the drug you should wash your hands thoroughly.

Contraindications

With caution: the elderly (over 65 years).

Side effects

Topical side effects

The most common side effect is dermatitis of the scalp. More severe cases of dermatitis, manifested by redness, peeling and inflammation, are less common. In rare cases, scalp itching, allergic contact dermatitis, folliculitis, hypertrichosis (unwanted growth of body hair, including facial hair growth in women), seborrhea are observed.

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

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.

Nervous system: headache, dizziness, vertigo, neuritis.

CPS: chest pain, BP fluctuations, palpitations, changes in heart rate, edema.

Overdose

Inadvertent ingestion of Generolone may cause systemic side effects due to the vasodilator properties of minoxidil (5 ml of 2% solution contains 100 mg of minoxidil – the maximum recommended dose for adults when taken orally for the treatment of arterial hypertension; 5 ml of 5% solution contains 250 mg of minoxidil, that is 2.5 times the maximum recommended daily dose for adults when taken orally in the treatment of arterial hypertension.)

Signs of overdose: fluid retention, decreased blood pressure, tachycardia.

Treatment: diuretics may be prescribed to eliminate fluid retention if necessary; beta-adreno locators to treat tachycardia. Intravenous 0.9% sodium chloride solution should be given to treat gynotension.

Simiatomimetics such as norepinephrine and epinephrine with excessive cardiac stimulatory activity should not be prescribed.

Pregnancy use

The drug should not be used during pregnancy and lactation.

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