Generolon, spray 5% 60 ml

Generolone – 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 Generolone® 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 androgenic alopecia is unknown. Minoxidil is ineffective in cases of alopecia caused by taking medications, improper diet (iron deficiency, vitamin A deficiency), as a result of hair styling in tight hairstyles.

Pharmacokinetics

When used topically, 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 50 mg;

Supplements:

ethanol (96%) – 243 mg;

propylene glycol – 520 mg;

water – up to 1 ml

How to take, the dosage

Actually.

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 it is necessary to wash hands. 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 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 midline.

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

The first signs of hair growth may appear after twice daily use 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 fill 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 topical minoxidil may interact with some topical medications. Concomitant use of minoxidil topical solution 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 applying the product before bathing (do not wash your head for more than 4 hours after applying the product).

Washing hair with Generolone® is recommended as usual. Hairspray and other hair care products can be used during the use of Generolone® . Before applying hair care products, first apply Generolone® and wait until the 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, you should ensure that the product is completely rinsed from the hair and scalp before using these chemical products.

Before treatment with Generolone® patients should have a general evaluation including collection and review of medical history. The physician must ensure that the scalp is healthy.

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

Generolone® contains ethyl alcohol, which can 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

Local 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, head itching, allergic contact dermatitis, folliculitis, hypertrichosis (unwanted body hair growth, 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 (if the drug is accidentally ingested)

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

Respiratory system: shortness of breath, allergic rhinitis.

Nervous system: headache, dizziness, vertigo, neuritis.

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

Overdose

Symptoms: fluid retention, decreased BP, tachycardia.

Treatment: diuretics may be prescribed to eliminate fluid retention, if necessary; beta-adrenoblockers may be used to treat tachycardia. To treat hypotension, 0.9% sodium chloride solution should be administered intravenously. Sympathomimetic agents such as norepinephrine and epinephrine with excessive cardiac stimulatory activity should not be administered.

Pregnancy use

The drug should not be used during pregnancy and lactation.

Similarities