Description
DESCRIPTION OF THE PREPARATION: Tablets green, square, flat on both sides and chamfered, with a line and engraved "BP" on one side, and on the other – "50", with rounded edges. Dosage form Tablets. PHARMACOTHERAPEUTIC GROUP and ATC code: Androgenic hormone, G03B B01. PHARMACOLOGICAL PROPERTIES: Pharmacodynamic properties Compensates for androgen deficiency, stimulates the development of male genital organs and secondary sexual characteristics, improves libido and potency, exhibits anabolic properties, increases the amount of proteins accumulating in tissues, especially in muscle, accelerates bone growth and the speed of epiphyseal closure, activates erythropoiesis . In recommended doses, it does not reduce spermatogenesis. The drug does not have hepatotoxicity. pharmacokinetic properties. After oral administration, mesterolone is rapidly and almost completely absorbed in the dose range of 25–100 mg. The maximum serum concentration is 3.1 ± 1.1 ng / ml, it is reached 1.6 ± 0.6 hours after taking the drug. The half-life is 12-13 hours. 98% of mesterolone binds to serum proteins, 40% of mesterolone binds to albumin and 58% to globulin. Mesterolone is rapidly metabolized. It is excreted by the kidneys only as metabolites. The main metabolite is 1b-methyl-androsterone, in conjugated form, accounting for 55-70% of metabolites excreted by the kidneys. Another metabolite is 1α-methyl-5α-androstane-3α,17β-diol, accounting for about 3% of metabolites excreted by the kidneys.About 80% of the dose of mesterolone is excreted as metabolites in the urine, and about 13% of the dose is excreted in the faeces. INDICATIONS: Hypogonadism, psycho-vegetative disorders and decreased performance in violation of potency, infertility (with oligospermia and insufficiency of Leydig cells), aplastic anemia. METHOD OF APPLICATION AND DOSES: tablets are taken whole without chewing, with a sufficient amount of liquid. Psycho-vegetative disorders and decreased performance in violation of potency: 75 mg / day until a noticeable improvement, then 25-50 mg daily for many months. Hypogonadism: for the formation of secondary sexual characteristics, 50-100 mg 3 times a day for many months, as maintenance therapy, 50 mg 2-3 times a day. Male infertility (to improve the quality and quantity of spermatozoa): 50 mg 2-3 times a day for 1 cycle of spermatogenesis (90 days), after a break for several weeks – again. with post-pubertal insufficiency of Leydig cells: 50 mg 2 times a day, the course is several months. Aplastic anemia (to stimulate erythropoiesis): 50-100 mg 3 times a day. SIDE EFFECTS: In some cases – frequent and prolonged erection (passes when the dose is reduced or the drug is discontinued), rarely benign or malignant changes in the liver. CONTRAINDICATIONS: Hypersensitivity to the active substance or any component of the drug, prostate cancer, liver tumors (including history), children's age. OVERDOSE: In acute overdose, the toxicity of the drug is extremely low. In chronic overdose, priapism may develop.In this case, treatment should be stopped, and after the disappearance of symptoms – start in smaller doses. PRECAUTIONS AND PECULIARITIES OF APPLICATION: Mesterolone is intended exclusively for use by male patients. androgens should not be taken by healthy individuals to strengthen muscles or increase general physical abilities. For the purpose of prevention, periodic examinations of the prostate gland are recommended. After taking mesterolone, the formation of benign, and even more rarely, malignant liver tumors was very rarely observed. In some cases, intra-abdominal bleeding caused by such tumors was life-threatening. Therefore, if you experience pain in the upper abdomen, you should consult a doctor about the possibility of further use of the drug. In prepubertal boys, androgens should be used with caution to avoid premature closure of the epiphyses and accelerated sexual development. INTERACTION WITH OTHER DRUGS: Increases the effectiveness of anticoagulants and hypoglycemic agents (you need to change doses), inhibits the excretion of cyclosporine. Liver enzyme inducers (barbiturates, rifampicin, carbamazepine, phenylbutazone, phenytoin) reduce the effect of the drug. NAME AND ADDRESS of the manufacturer: SC Balkan Pharmaceuticals SRL st. Gradescu, 4 mun. Chisinau, Republic of Moldova
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