Treatment of male pattern baldness in men (androgenetic alopecia) to increase hair growth and prevent further loss. The drug is not intended for use in women, children and adolescents.
A competitive and specific Type II 5α-reductase inhibitor, an intracellular enzyme that converts testosterone to dihydrotestosterone (DHT). It has no affinity for the androgen receptor and has no androgenic, antiandrogenic, estrogenic, antiestrogenic or progestagenic effects. 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. Male pattern baldness does not occur in men with genetic deficiency of Type II 5α-reductase. Finasteride inhibits the process leading to the miniaturization of hair follicles on the head. In men with androgenetic alopecia, finasteride (in a dose of 1 mg per day) 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. Men who take finasteride 5 mg or another 5α-reductase inhibitor to treat benign prostatic hyperplasia or other diseases. Do not use in women.
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 who are suspected of pregnancy and women of childbearing age should not touch crushed or damaged tablets containing finasteride due to the possibility of absorption of finasteride through the skin and subsequent malformations in the 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. After the introduction of Finasteride, spontaneous reports of infertility were obtained. It is not known whether finasteride is excreted in human milk. The use of the drug in breast-feeding women is contraindicated.
Side effects:
Uncommon: decreased libido, depression, erectile dysfunction, ejaculation disorders (including decreased ejaculate volume). Not known: hypersensitivity reactions (including rash, pruritus, urticaria, angioneurotic edema - swelling of lips, tongue, throat and face), persistence of weakened libido after discontinuation of treatment, palpitations, increased liver enzymes, tenderness of mammary glands, enlarged mammary glands , testicular pain, infertility, persistence of erectile dysfunction and ejaculation after discontinuation of treatment, breast cancer in men. In addition, post-marketing reports of persistent sexual dysfunction (decreased libido, erectile dysfunction, ejaculation disorders) after discontinuation of finasteride treatment and cases of breast cancer in men.
Dosage:
Orally. 1 tabl once a day. To increase hair growth and / or prevent further loss of hair, it is necessary to use the drug on a daily basis for at least 3 months. In order to maintain the results of treatment, continuous use of the drug is recommended. Discontinuation of the drug results in the disappearance of its effects within 9-12 months.specialgroups of patients. There is no need to change the dosage in patients with renal insufficiency. 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 drug should be taken during or without meals.
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