Treatment of the first stage of hair loss in men (androgenetic alopecia). The product stabilizes the androgenetic alopecia in men from 18 to 41 years old. The efficacy of Finasteride in the treatment of bilateral recession and hair loss has not been established.
A competitive and specific Type II 5α-reductase inhibitor, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT). Finasteride reduces plasma DHT concentrations within 24 hours after administration. Hair follicles contain Type II 5α-reductase. In men with androgenetic alopecia, in balding scalp, there is a presence of miniaturized hair follicles and an increase in DHT. The use of finasteride contributes to the reduction of DHT in the scalp and plasma in men. Finasteride inhibits the process leading to the miniaturization of hair follicles on the head. In men with androgenetic alopecia, finasteride increases hair growth and prevents their further loss. Finasteride is not effective in the treatment of androgenetic alopecia in women. The oral bioavailability of finasteride is approximately 80%. Food does not affect bioavailability. Cmax in plasma occurs about 2 hours after administration. Finasteride is completely absorbed after 6-8 hours. It binds plasma proteins in approximately 93%. Finasteride crosses the blood-brain barrier but does not appear to have an affinity for cerebrospinal fluid. It is metabolised mainly by CYP3A4. 39% of the dose is excreted in the urine as metabolites and 57% in the faeces. Medium T0,5 in the final phase of elimination is dependent on age and amounts to 5-6 h in men aged 18-60 and 8 h in men over 70 years of age.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. It should not be used in men taking finasteride 5 mg tablets or any other 5α-reductase inhibitors used to treat benign prostatic hyperplasia or other diseases. Do not use in women, adolescents and children.
Precautions:
Finasteride should not be used in children and adolescents. There are no data on the efficacy or safety of finasteride in children under 18 years of age. Finasteride causes a reduction in prostate antigen (PSA) levels - this should be taken into account if it is necessary to determine the patient's PSA value during treatment. In this case, the doubling of the PSA value should be considered before comparing the results with the results obtained from untreated men. Because of the risk of breast cancer in men, patients should be advised to immediately report any changes in breast tissue such as nodules, soreness, enlarged mammary glands, or nipple leakage. The effects of hepatic failure on the pharmacokinetics of finasteride have not been studied. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is not indicated for use in women. The use of the drug is contraindicated in pregnant women and women of childbearing age. Pregnant women and women of childbearing age should not touch broken or broken tablets containing finasteride due to the possibility of absorbing finasteride and, consequently, the risk of malformation of the male fetus. In patients receiving finasteride 5 mg daily, small amounts of the drug were detected in the semen. It is not known whether the male fetus may have an undesired effect on the contact of his mother with the semen of a patient treated with finasteride. If the sexual partner of a patient treated with finasteride is pregnant or is presumed to be pregnant, it is recommended that the patient minimize exposure of his partner to contact with semen. Spontaneous reports of infertility and / or poor sperm quality were obtained after placing finasteride on the market.Some reports related to patients who also had other risk factors for infertility. After finishing treatment with Finasteride, the semen is normalized or improved.
Side effects:
Uncommon: reduced libido, mood disorders with symptoms of depression, erectile dysfunction, ejaculation disorders (including decreased ejaculate volume). Not known: hypersensitivity reactions including rash, pruritus, urticaria and swelling of the lips and face, palpitations, increased liver enzymes, tenderness and enlargement of the mammary glands, testicular pain, infertility. In addition: persistence of erectile dysfunction after discontinuation of treatment, cancer of mammary glands in men.
Dosage:
Orally. 1 tabl per day. The effectiveness and duration of treatment should be regularly evaluated by a physician. In general, to see stabilization in hair loss, it is necessary to use the drug for 3-6 months. For the best treatment results, continuous use of the drug is recommended. After discontinuation of treatment, the beneficial effect of the drug gradually disappears after the sixth month, and completely disappears after 9 to 12 months.Special groups of patients. No dosage adjustment is necessary for patients with renal insufficiency. There are no data on use in patients with hepatic impairment and concomitant use of finasteride and topical minoxidil in male pattern baldness. Finasteride should not be used in children and adolescents. There are no data on the efficacy or safety of finasteride in children under 18 years of age.Way of giving. The tablet should be swallowed whole, it must not be divided or crushed. The tablets can be taken regardless of meals.
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