Generolone spray for external use 2% 60 ml
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Active ingredients
Minoxidil
The brand
Generolon
Release form
Spray
Composition
Active ingredient: in 1 ml - minoxidil 50 mg. Excipients: ethanol 96% - 243 mg, propylene glycol - 520 mg, water - up to 1 ml.
Pharmacological effect
When applied topically, Minoxidil stimulates hair growth in individuals with androgenic alopecia (hair thinning, baldness). It 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 dehydrosterone (possibly indirectly), which plays a significant role in the formation of baldness. The best effect has a small duration of the disease (no more than 10 years), young patients, a bald spot in the region of the crown not more than 10 cm, the presence in the center of the baldness more than 100 vellus and terminal hair. The manifestation of signs of hair growth is noted after 4 months or more of the drug. The onset and severity of the effect may vary in different patients. A 5% solution of the drug stimulates hair growth more than a 2% solution, which was noted for an increase in the growth of fluff hair: After discontinuation of the use of the drug Generolon, the growth of new hair stops, and within 3-4 months it is possible to restore the original appearance. The exact mechanism of action of the drug Generolon in the treatment of androgenic alopecia is unknown. Minoxidil is ineffective in the case of baldness caused by taking the drug, malnutrition (iron deficiency (Fe), vitamin A), as a result of hair styling in tight hairstyles.
Pharmacokinetics
When applied externally, Minoxidil is poorly absorbed through normal, intact skin: an average of 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 eliminated within 4 days. The profile of metabolic biotransformation of minoxidil after external use of the drug 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 blood-brain barrier. Excreted mainly with urine. Minoxidil and its metabolites are excreted by hemodialysis.
Indications
Treatment of androgenic alopecia (hair restoration) and stabilization of hair loss in men and women.
Contraindications
- Hypersensitivity to Minoxidil or other components of the drug; - age under 18; - violation of the integrity of the skin, dermatosis of the scalp. With care: advanced age - over 65 years.
Precautionary measures
Older age - over 65 years.
Use during pregnancy and lactation
Do not use the drug during pregnancy and breastfeeding.
Dosage and administration
Outwardly. Regardless of the size of the treated area, it is necessary to apply 1 ml of solution using a dispenser (7 taps) 2 times / day to the affected areas of the scalp, starting from the center of the problem area. Wash 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 for whom satisfactory hair growth is not observed when using a 2% solution, and patients for whom faster hair growth is desired, can use a 5% solution. For men, the drug Generolon is most effective for hair loss on the crown, for women with hair loss in the middle parting. The preparation Generolon is applied only on the dry skin of the 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 / day for 4 months or more. The beginning and severity of hair growth, as well as the quality of hair can vary in different patients. According to single reports, within 3-4 months after cessation of treatment, the initial appearance can be restored. The average duration of treatment is about 1 year. Preparation for use: Remove the screw cap and fasten the measuring pump. Strengthen the elongated spray nozzle onto the tube on top of the pump. Press the spray nozzle 3-4 times to fill the pump with a solution, after which the preparation can be applied.
Side effects
Local side effects: The most common side effect is dermatitis of the scalp. More rarely there are more pronounced cases of dermatitis, manifested in the form of redness, peeling and inflammation. In rare cases, itchy head, allergic contact dermatitis, folliculitis, hypertrichosis (unwanted hair growth on the body, 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, while old hair fall out and new ones grow in their place. This temporary phenomenon is usually observed after 2-6 weeks after the start of treatment and gradually, over the next 2 weeks, stops (the appearance of the first signs of the action of minoxidil). Systemic side effects (in case of accidental ingestion of the drug): Dermatological diseases: nonspecific allergic reactions (skin rash, urticaria), swelling of the face. Respiratory system: shortness of breath, allergic rhinitis. Nervous system: headache, dizziness, vertigo, neuritis. Cardiovascular system: chest pain, fluctuations in blood pressure, rapid heartbeat, changes in the rhythm of heart contractions, edema.
Overdose
Accidental ingestion of Generolon may cause systemic side effects due to the vasodilator properties of minoxidil (5 ml of a 2% solution contains 100 mg of minoxidil - the maximum recommended dose for adults when taken orally in the treatment of hypertension; 5 ml of a 5% solution contains 250 mg of Minoxidil, that is, a dose 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, lower blood pressure, tachycardia. Treatment: to eliminate fluid retention, diuretics can be prescribed if necessary; for the treatment of tachycardia - beta-blockers. For the treatment of hypotension should be introduced into / in a 0.9% solution of sodium chloride. You should not appoint sympathomimetic agents, for example, norepinephrine and epinephrine, which have excessive cardiac stimulating activity.
Interaction with other drugs
There is a theoretical possibility (there is no clinical confirmation) of increasing orthostatic hypotension in patients receiving concomitant treatment with peripheral vasodilators. We can not exclude a very slight increase in the content of minoxidil in the blood of patients suffering from: hypertension and taking minoxidil orally in the case of simultaneous use of the drug Generolon, although the corresponding clinical studies have not been conducted. It has been found that minoxidil for topical use may interact with certain topical drugs. The simultaneous use of a solution of minoxidil for external use and a cream containing betamethasone (0.05%) leads to a decrease in systemic absorption of minoxidil. The simultaneous use of tretinoin containing cream (0.05%) leads to an increased absorption of minoxidil. The simultaneous application to the skin of minoxidil and topical preparations, such as tretinoin and dithranol, which cause a change in the protective functions of the skin, can lead to an increase in the absorption of minoxidil.
special instructions
Do not apply the drug to other areas of the body. The drug Generolon is applied only on the dry skin of the scalp after bathing or you should wait about 4 hours after applying the drug before bathing. Do not let your head get wet earlier than 4 hours after applying the drug. Wash your hair when using the drug Generolon is recommended in the usual way. 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 area of the skin is completely dry. There is no evidence that dyeing hair, performing a perm or using hair softeners can reduce the effectiveness of the drug. However, to prevent possible irritation of the scalp, it is necessary to make sure that the drug was completely washed off 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 medical history. The physician must ensure that the scalp is healthy. When a systemic side. effects or severe skin reactions, patients should discontinue the drug and consult a doctor. The preparation Generolon is ethyl alcohol, which can cause inflammation and irritation of the eyes. In case of contact with the drug on sensitive surfaces (eyes, irritated skin, mucous membranes) it is necessary to wash the area with plenty of cold water. Inhalation of the drug should be avoided when spraying. Wash hands thoroughly after using the product.