Generolon 2% , 60 ml

Belupo, drugs and cosmetics dd, Croatia

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Product Overview

Composition

Active substance:

minoxidil 20 mg;

Excipients:

ethanol (96%) - 571 mg;

propylene glycol - 104 mg;

water - up to 1 ml

pharmachologic effect

Generolone - stimulates 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 the hair follicles. Reduces the formation of 5-alpha-dehydrotestosterone (possibly indirectly), which plays an essential role in the formation of hair loss.

It has the best effect when the disease is small (no more than 10 years), young age of patients, baldness in the vertex no more than 10 cm, the presence of more than 100 vellus and terminal hairs in the center of the bald spot. The manifestation 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 to increase the growth of vellus hair.

After the termination of the use of Generolon®, the growth of new hair stops, and within 3-4 months the original appearance can be restored. The exact mechanism of action of Generolon® in the treatment of androgenic alopecia is unknown. Minoxidil is ineffective in case of baldness caused by taking drugs, improper diet (iron deficiency, vitamin A), as a result of hair styling in tight hairstyles.

Pharmacokinetics

When applied topically, 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 the absorption of minoxidil is unknown. After discontinuation of the drug, approximately 95% of minoxidil that has entered the systemic circulation is excreted within 4 days.

The profile of the metabolic biotransformation of minoxidil after external use of Generolon® has not yet 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 excreted mainly in the urine. Minoxidil and its metabolites are excreted by hemodialysis.

Indications

Treatment of androgenic alopecia (hair restoration) and stabilization of the hair loss process in men and women.

Application during pregnancy and lactation

The drug should not be used during pregnancy and lactation.

Contraindications

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

With care: advanced age (over 65 years).

Side effects

Local side effects

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

The use of minoxidil can cause an increase in hair loss during the transition from the resting phase to the hair growth phase, with the 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 first signs of minoxidil action appear).

Systemic side effects (if the drug is accidentally swallowed)

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

Respiratory system: shortness of breath, allergic rhinitis.

Nervous system: headache, dizziness, vertigo, neuritis.

CVS: chest pain, fluctuations in blood pressure, heart palpitations, changes in heart rate, edema.

Interaction

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

A very slight increase in the content of minoxidil in the blood of patients suffering from arterial hypertension and taking minoxidil orally, in the case of the simultaneous use of Generolon®, cannot be ruled out, although the corresponding clinical studies have not been conducted.

It has been established that minoxidil for external use can interact with some drugs 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 the systemic absorption of minoxidil.

The simultaneous use of a cream containing tretinoin (0.05%) leads to increased absorption of minoxidil. The simultaneous application of minoxidil to the skin and topical preparations such as tretinoin and dithranol, which alter the protective functions of the skin, may lead to an increase in the absorption of minoxidil.

How to take, course of administration and dosage

Outwardly.

Regardless of the size of the treated area, it is necessary to apply 1 ml of the solution using a dispenser (7 clicks) 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 in whom satisfactory hair growth is not observed when using a 2% solution, and for patients for whom faster hair growth is desired, a 5% solution can be used.

For men, Generolon® is most effective for hair loss on the crown, for women - for hair loss in the middle part.

Generolon® is applied only to dry scalp. 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, can vary from patient to patient.

According to a few reports, within 3-4 months after the cessation of treatment, you can expect the restoration of the original appearance. The duration of treatment is on average about 1 year.

Preparation for use. Remove the screw cap and secure the metering pump. Attach the extended spray nozzle to the tube on top of the pump. 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, decreased blood pressure, tachycardia.

Treatment: to eliminate fluid retention, diuretics may be prescribed if necessary; for the treatment of tachycardia - beta-blockers. To treat hypotension, 0.9% sodium chloride solution should be administered intravenously. Do not prescribe sympathomimetic drugs such as norepinephrine and epinephrine, which have excessive cardiac stimulating activity.

Special instructions

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

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

It is recommended to wash your hair when using Generolon® as usual. During the period of use of the drug Generolon®, you can use hairspray and other hair care products. Before applying hair care products, you must first apply Generolon® and wait until the treated skin area 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 scalp irritation, make sure the product has been completely rinsed from the hair and scalp before using these chemicals.

Before starting treatment with Generolon®, 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.

The preparation Generolon® contains ethyl alcohol, which can cause inflammation and irritation of the eyes. In case of contact with sensitive surfaces (eyes, irritated skin, mucous membranes), rinse the area with plenty of cold water. Avoid inhalation of the drug when spraying. After using the drug, wash your hands thoroughly.

Release form

spray for external use

Storage conditions

At a temperature not exceeding 25 ° C

Shelf life

3 years

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