Instructions for use: Generolon 2% spray 60 ml
Composition
active ingredient: minoxidil;
1 ml of solution contains 20 mg or 50 mg of minoxidil;
excipients: ethanol 96%, propylene glycol, purified water.
Dosage form
The solution is topical.
Main physicochemical properties:
Aqueous-alcoholic transparent colorless or slightly yellowish solution with the smell of alcohol.
Pharmacotherapeutic group
Medicinal products used in dermatology. Other dermatological products. Minoxidil. ATX code D11A X01.
Pharmacological properties
Pharmacodynamics.
The mechanism by which minoxidil stimulates hair growth is not fully understood. Possible mechanisms for stopping hair loss include increasing the diameter of the hair shaft, stimulating the anagen phase of hair growth, prolonging the anagen phase, and stimulating the regrowth of anagen after the telogen phase. Minoxidil is a peripheral vasodilator that improves microcirculation in the hair follicles. It stimulates vascular endothelial growth factor, which promotes capillary growth, which is manifested by significant metabolic activity during the anagen phase of hair growth.
Pharmacokinetics.
Systemic absorption of minoxidil when applied topically to normal intact scalp is 1-2% of the total applied dose. Absorption of minoxidil through the skin increases with increasing dosage, frequency, or surface area of application.
Metabolism of absorbed minoxidil occurs in the liver, excretion of minoxidil and its metabolites is mainly by the kidneys. After cessation of topical application, approximately 95% of absorbed minoxidil is excreted from the body within 4 days.
Indication
Generolon (20 mg/ml), a cutaneous solution, is indicated for the treatment of male pattern alopecia in men and women aged 18 to 65 years.
Generolon (50 mg/ml), a cutaneous solution, is indicated for the treatment of male pattern alopecia in men aged 18 to 65 years.
Contraindication
Hypersensitivity to the components of the drug; pheochromocytoma, treated and untreated hypertension; scalp diseases (including psoriasis and sunburn); shaved scalp; simultaneous use of occlusive dressings or other topical medications on the scalp. Generolon (50 mg/ml), cutaneous solution, is contraindicated for use in women.
Interaction with other medicinal products and other types of interactions
Generolon should not be used simultaneously with other drugs for topical application to the scalp.
The simultaneous use of the drug Generolon and other topical preparations containing corticosteroids, tretinoin, dithranol or white soft paraffin and changing the protective functions of the skin may enhance the absorption of minoxidil.
It is possible that orthostatic hypotension may be increased during absorption of minoxidil in patients taking peripheral vasodilators, although this has not been clinically confirmed.
Guanethidine has been reported to interact with topical minoxidil preparations, resulting in a rapid and pronounced decrease in blood pressure. There is a theoretical possibility that topical minoxidil may interact with guanethidine.
Application features
Before you start using the drug Generolon, you must make sure that the scalp is healthy and not damaged.
You should not use Generolon if you have inflammation, infection, irritation, or soreness of the scalp.
Generolon 2%, cutaneous solution, is indicated for the treatment of male pattern alopecia in women and men. It should not be used for other causes of hair loss, for example, if there is no family history of hair loss, if there is sudden and/or patchy hair loss, if there is hair loss associated with childbirth, or if the cause of the hair loss is unknown.
Generolon 5%, cutaneous solution, is indicated for the treatment of male pattern alopecia in men. It should not be used for other causes of hair loss, for example, if there is no family history of hair loss, if there is sudden and/or patchy hair loss, or if the cause of hair loss is unknown.
You should stop using the drug and consult a doctor if you experience low blood pressure, chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of the hands and feet, persistent redness, scalp irritation, or other unexpected new symptoms.
If you have cardiovascular disease or arrhythmia, you should consult a doctor before starting to use the drug Generolon.
Generolon, a cutaneous solution, is for external use only. It should not be applied to any area of the body other than the head.
Increasing the dose or using the drug more often than recommended will not improve results.
Unwanted hair growth may be caused by applying the drug to areas other than the scalp.
Some patients may experience changes in hair color and/or texture.
Some patients have reported increased hair loss after starting treatment with minoxidil cutaneous solution. This is most likely due to the transition from the resting phase (telogen phase) to the growing phase (anagen phase). This is when old hair falls out and new hair grows in its place. This temporary increase in hair loss usually occurs 2–6 weeks after starting treatment and resolves within a few weeks. If hair loss persists for >2 weeks, minoxidil cutaneous solution should be discontinued and a doctor should be consulted.
It should be used with caution in patients with ischemic heart disease, angina, arrhythmia, patients with arterial hypotension; patients with individual variability, unusual sensitivity, impaired skin integrity caused by inflammation or skin disease processes (for example, scalp damage or scalp psoriasis), which may lead to systemic effects of minoxidil.
Accidental ingestion of the drug into the digestive tract may lead to serious adverse cardiac events. Therefore, this drug should be stored out of the reach of children.
Generolon, a cutaneous solution, contains ethanol, which may cause eye irritation. If the drug gets on mucous membranes, damaged skin, or eyes, these areas should be thoroughly rinsed with running water.
Generolon, a cutaneous solution, contains propylene glycol, which may cause skin irritation.
It is not recommended to use a hairdryer during treatment, as this may cause accelerated evaporation of the active substance.
The drug is flammable, after opening the original packaging, the drug should be protected from open fire and high temperatures.
Do not use while using an occlusive dressing, or after shaving the head.
If there is no satisfactory result after 4 months, a dermatologist's consultation is necessary. Continuation of the course or repeated treatment is recommended after consultation with a dermatologist.
Use during pregnancy or breastfeeding
The drug is contraindicated for women during pregnancy or breastfeeding.
There are no adequate and well-controlled studies of minoxidil in pregnant women. Animal studies have shown a risk to the fetus at very high exposure levels compared to human exposure levels. There is a potential risk of fetal harm when administered to pregnant women.
Systemically absorbed minoxidil is excreted in breast milk. The effects of minoxidil on newborns and/or infants are unknown.
Ability to influence reaction speed when driving vehicles or other mechanisms
Due to the possible development of dizziness or a decrease in blood pressure, caution should be exercised when driving or operating machinery. If the described undesirable effects occur, one should refrain from performing these types of activities.
Method of administration and doses
Generolon 2%, cutaneous solution, is intended for external use only for men and women aged 18 to 65 years.
Generolon 5%, cutaneous solution, is intended for external use only for men aged 18 to 65 years.
Before first use, you must prime the sprayer by pressing it several times to achieve a uniform flow of solution. After that, the device is ready for use.
Before applying the solution, you need to thoroughly dry your scalp and hair.
Using a sprayer, apply 1 ml of the solution to dry skin in the bald area 2 times a day and rub in lightly, moving from the center to the periphery of the area. With each application, the sprayer should be pressed 10 times to apply 1 ml of the solution. The daily dose should not exceed 2 ml. After each application of the solution, hands should be washed.
To achieve a therapeutic effect, a 2% cutaneous solution should be applied twice a day for at least 4 months. To achieve a therapeutic effect, a 5% cutaneous solution should be applied twice a day for at least 2 months. After achieving clinical improvement, the drug should be continued to support hair growth. There are reports of resumption of hair loss 3–4 months after discontinuation of minoxidil treatment. Treatment should be discontinued if there is no effect within 1 year of use.
Elderly patients.
Not recommended for use in the elderly. The safety and effectiveness of minoxidil in people over 65 years of age have not been established.
Special populations.
There are no special recommendations for the use of minoxidil in patients with impaired renal and hepatic function.
Children.
Do not prescribe the drug to children under 18 years of age.
Overdose
Accidental or intentional overdose of the drug Generolon, a solution for topical application, will lead to an increase in the intensity of adverse dermatological reactions, especially itching, dry skin, irritation. Increased systemic absorption of minoxidil is possible when applied to large body surfaces or to areas other than the scalp, in doses exceeding the recommended ones. Accidental ingestion of the solution into the digestive tract may cause systemic effects due to the vasodilatory effect of minoxidil (5 ml of the drug Generolon 2% contain 100 mg of minoxidil, which is the maximum recommended dose in the treatment of hypertension. 2 ml of the drug Generolon 5% contain 100 mg of minoxidil, which is the maximum recommended dose in the treatment of hypertension). Symptoms of minoxidil overdose are primarily cardiovascular disorders associated with sodium and fluid retention. Tachycardia, hypotension, dizziness and drowsiness may also occur. Treatment Treatment of minoxidil overdose should be symptomatic and supportive. Beta-blockers are prescribed for tachycardia. Diuretics are used to correct fluid retention.
Side effects
In placebo-controlled studies, the overall incidence of adverse reactions by system organ class in women was approximately five times higher than in men. In clinical studies involving several thousand patients, minoxidil topical solution was compared with a topical solution without active substance. Dermatological reactions, such as irritation and itching, occurred in patients after application of both solutions, which is explained by the presence of propylene glycol in both solutions. Data from 7 placebo-controlled studies involving 1197 men and women using minoxidil topical solution (20 mg/ml and 50 mg/ml combined), indicate the occurrence of adverse reactions. In addition, cases of adverse reactions have been reported in the post-marketing period of use of this medicinal product.
The following frequency categories are used in this section: very common (≥10%); common (≥1% and <10%); uncommon (≥0.1% and <1%); rare (≥0.01% and <0.1%); very rare (<0.01%); frequency not known (cannot be estimated from the available data).
From the immune system.
Common: hypersensitivity reactions (including facial swelling, generalised erythema, generalised pruritus, facial swelling and throat tightness).
Frequency unknown - angioedema (including lip swelling, lip swelling, oral swelling, oropharyngeal swelling, pharyngeal swelling, tongue swelling and tongue swelling).
From the psychological side.
Frequency unknown – depressed mood.
From the nervous system.
Very common is headache.
Uncommon: dizziness.
From the organs of vision.
Frequency unknown – eye irritation.
From the heart.
Common – chest pain.
Uncommon – rapid heartbeat.
Frequency unknown - increased heart rate.
From the side of the vessels.
Frequency unknown - decreased blood pressure.
On the part of the respiratory system, chest organs and mediastinum.
Uncommon: shortness of breath.
From the gastrointestinal tract.
Uncommon – nausea.
Frequency unknown – vomiting.
On the skin and subcutaneous tissue.
Common: hypertrichosis (unwanted hair growth in areas other than the scalp, including facial hair growth in women), pruritus (including generalized itchy rash and pruritus of the eyes), rash (including pustular, papular, generalized, vestibular and macular rash), dermatitis (including application site contact, allergic, atopic, seborrheic).
Rarely - change in hair texture. Frequency not known - dry skin, skin peeling (including exfoliative rash and exfoliative dermatitis), acne (acne-like rash), temporary hair loss, hair color change. General disorders and administration site conditions. Common - peripheral edema. Frequency not known - application site reactions (sometimes extending to adjacent areas of the body, including the ears and face), namely itching, irritation, pain, rash, edema, dry skin, erythema and erythematous rash, which can sometimes be more serious and include peeling, dermatitis, blistering, bleeding and ulceration.
Research results.
Common – weight gain.
You should stop using the drug and consult a doctor if you experience chest pain, rapid heartbeat, weakness, dizziness, unexpected weight gain, swelling of the hands and feet, persistent redness or irritation of the scalp.
Expiration date
3 years.
30 days after first opening the bottle.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
60 ml in a bottle, 1 bottle complete with a measuring pump and spray nozzle in a cardboard box.
Vacation category
Without a prescription.
Producer
Belupo, pharmaceuticals and cosmetics, Inc., Croatia.
Address
Danica Street 5, 48000 Koprivnica, Croatia / Ulica Danica 5, 48 000 Koprivnica, Croatia.
