Instructions for use ANDRIOL TK™ (ANDRIOL TK)

Pharmacological properties of the drug Andriol tk™

Pharmacodynamics. Testosterone, the main androgenic hormone necessary for the normal development of male genital organs and secondary sexual characteristics, maintaining normal function of the testicles, prostate and seminal vesicles, to maintain libido and potency. Oral administration of Andriol TK provides physiological levels of testosterone in the blood serum in men with hypogonadism. In addition, the use of the drug leads to a clinically significant increase in plasma concentrations of dihydrotestosterone and estradiol, as well as a decrease in the level of sex hormone binding globulin (SHBG). Treatment with the drug in men with primary (hypergonadotropic) hypogonadism normalizes gonadotropin levels. Androgens influence the processes of anabolism in the body, the development of skeletal muscles and the distribution of subcutaneous fat on the body, are responsible for the end of linear growth of the body and stimulate erythropoiesis, increasing the production of erythropoietin. When taking them, salt and water retention may occur in the body. The effect of testosterone on target organs is enhanced after the peripheral conversion of testosterone to estradiol, which binds to estradiol receptors in the nucleus of the target cell. This process occurs in the pituitary gland, adipose tissue, brain, osteocytes and testicular granulocytes. The use of exogenous androgens, depending on the dose, delays the release of endogenous testosterone. The use of exogenous androgens in high doses can inhibit spermatogenesis. Pharmacokinetics. After oral administration, a significant portion of testosterone undecanoate, together with the lipophilic solvent, is absorbed in the small intestine and enters the lymphatic system, thus bypassing the initial passage through the liver. When testosterone is absorbed, undecanoate is partially reduced to form dihydrotestosterone undecanoate. From the lymphatic system it enters the blood plasma. As a result of hydrolysis in the blood plasma and tissues, testosterone undecanoate and dihydrotestosterone undecanoate are converted into natural androgens - testosterone and dihydrotestosterone. A single dose of 80–160 mg of Andriol TK leads to a clinically significant increase in the level of total plasma testosterone concentration, the maximum value of which, Cmax, is about 40 nmol/l and is achieved 4–5 hours after oral administration. The increased concentration of testosterone in the blood plasma persists for at least 8–12 hours. It is excreted mainly in the urine in the form of conjugates (ethiocholanolone and androsterone).

Andriol TK tablets No. 30

Dosage forms

capsules 40mg

Manufacturers

R.P.Sherer S.A., packed by N.V. Organon (France)

PharmGroup

Male sex hormones (androgens) and their analogues

International nonproprietary name

Testosterone

Leave procedure

Available with prescription

Compound

The active substance is testosterone.

pharmachologic effect

Androgenic, antitumor, anabolic. Regulates the development of male genital organs and secondary sexual characteristics, the growth of bone and muscle tissue; reduces fat deposition and excretion of microelements; inhibits the production and release of LH and FSH by the pituitary gland; increases anabolism and inhibits protein catabolism, increases the metabolism of nitrogenous substances with sufficiently high-calorie protein nutrition, stimulating the production of erythropoietin and erythropoiesis. Transdermal form "Androgel": Provides a constant transdermal supply of testosterone for 24 hours after a single application to intact, clean, dry skin. The concentration of testosterone in the serum increases from the first hour after using the drug Androgel, reaching a constant value from the second day of treatment. After treatment is stopped, testosterone concentrations begin to decrease approximately 24 hours after the last dose. Concentrations return to baseline approximately 72-96 hours after the last dose.

Indications for use

Androgen deficiency in men: delayed puberty, oligospermia, post-castration syndrome, underdevelopment of the genital organs, hypopituitrism, infertility due to impaired spermatogenesis, menopausal syndrome, impotence, osteoporosis. In women: hyperestrogenism, uterine fibroids, endometriosis, menopause (in combination with estrogens), premenstrual tension syndrome, breast cancer, osteoporosis. Androgel: Replacement therapy for testosterone deficiency.

Contraindications

Hypersensitivity, established or suspected carcinoma of the prostate and/or mammary glands, nephrosis or nephrotic phase of nephritis, hypercalcemia, edema, impaired liver and kidney function, diabetes mellitus, prostatic hypertrophy with symptoms of urinary disorders, heart and coronary failure, history of myocardial infarction, atherosclerosis in elderly men, pregnancy, breastfeeding. Androgel: There is no experience with the use of Androgel in women and children. Carefully. Malignant neoplasms (due to the danger of hypercalcemia and hypercalciuria); severe heart, liver or kidney failure; cardiac ischemia; arterial hypertension; epilepsy; migraine

Side effect

Premature puberty, prostate anomalies and cancer, increased sexual arousal and increased frequency of erections, penile enlargement, priapism, oligospermia, decreased ejaculate volume, sodium and water retention, premature closure of bone growth zones; headache, depression, anxiety, sleep disturbance, paresthesia, bleeding in the gastrointestinal tract, nausea, cholestatic jaundice, other androgenic effects (hirsutism, seborrhea, acne, etc.). Androgel: The most common adverse effects when using the recommended dose of 5 g of gel per day were skin reactions: erythema, acne, dry skin. In isolated cases, the following were noted: changes in laboratory test results (polycythemia, decreased lipid levels), headache; gynecomastia, mastodynia. From the central and peripheral nervous system - dizziness, paresthesia, hyperesthesia, mood changes; from the cardiovascular system - increased blood pressure; from the gastrointestinal tract - diarrhea; on the part of the skin and its appendages - alopecia. When high dosages are prescribed, irritability, nervousness, weight gain, and prolonged or frequent erections may develop.

special instructions

If androgen-dependent adverse reactions occur, treatment is stopped until they disappear and resumed with reduced doses. Androgel: Used only for testosterone deficiency, accompanied by regression of secondary sexual characteristics, changes in body structure, asthenia, decreased libido, erectile dysfunction, etc. Other possible causes underlying the symptoms described above must be excluded. Androgel is not used to treat male infertility or erectile dysfunction. Before prescribing testosterone, it is necessary to exclude the risk of prostate cancer. Regular monitoring of the condition of the prostate and mammary glands should be carried out. In patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, the following laboratory parameters should be checked: hemoglobin, hematocrit and liver function tests. Data have been published showing an increased risk of developing sleep apnea in patients with hypogonadism receiving treatment with testosterone esters. In patients receiving androgens, when plasma testosterone concentrations reach normal levels, an increase in insulin sensitivity may occur. If a severe local reaction develops, treatment should be reconsidered. It is preferable to maintain an interval of at least 6 hours between applying the gel and taking a bath or shower. For persons not taking Androgel: in case of contact with the area where the gel was applied that was not previously washed with water, it is necessary to wash the area of ​​skin on which testosterone may have come into contact with soap and water as soon as possible; You should inform your doctor about the appearance and development of signs of hyperandrogenization, such as acne or changes in normal hair growth. Pregnant women should avoid any contact of the drug with the skin. Androgel should not be prescribed to patients who are unable to comply with safety instructions (for example, severe chronic alcoholism, substance abuse, severe mental disorders).

Storage conditions

List B. In a place protected from light, at room temperature.

Literature

Encyclopedia of Medicines, 2006.

Interaction

Increases the effect of indirect anticoagulants (warfarin, nicumalon, phenylin) and hypoglycemic agents, inhibits the excretion of cyclosporine. Barbiturates and alcohol reduce the effect. Androgel: In patients with diabetes, the metabolic effect of using Androgel may lead to a decrease in blood glucose levels and, therefore, require a reduction in the insulin dose. It is recommended to monitor prothrombin time. Coadministration of testosterone and ACTH or corticosteroids may increase the risk of edema. Effect on Laboratory Tests: Androgens may decrease thyroxine-binding globulin levels, resulting in decreased serum T4 concentrations and increased sensitivity to T3 and T4.

Synonyms

Andriol, Androgel, Nebido, Nuvir, Testosterone propionate

Use of the drug Andriol tk™

The dose is selected individually depending on the clinical effect. Typically, an initial dose of 120–160 mg/day for 2–3 weeks, followed by a maintenance dose of 40–120 mg/day, is adequate. Andriol TK capsules are taken orally during meals without chewing, if necessary, with a small amount of liquid. It is advisable to take half the daily dose in the morning and the rest in the evening. If an odd number of capsules is taken, the higher dose is taken in the morning.

Drug interactions

When taking certain other drugs at the same time, the following effects may occur:

• inducers of microsomal oxidation enzymes: decreased concentration of testosterone in the body (dosage adjustment of testosterone undecanoate is necessary);
• inhibitors of microsomal oxidation enzymes: increasing the concentration of testosterone in the body (dosage adjustment of testosterone undecanoate is necessary);
• adrenocorticotropic hormones, glucocorticosteroids: increased formation of edema;
• insulin and other hypoglycemic drugs: increasing glucose tolerance and reducing the need for insulin or other hypoglycemic drugs in patients with diabetes (special monitoring is recommended before, during and after treatment with Andriol);
• coumarin-type anticoagulants: enhance the effect of the latter while taking high doses of testosterone undecanoate (prothrombin time should be carefully monitored and, if necessary, reduce the dose of the anticoagulant).

According to the instructions, Andriol is able to reduce the content of thyroxine-binding globulin, as a result of which the level of total T4 in the serum decreases and the binding of T3 and T4 increases. In this case, the level of free thyroid hormones does not change, and there are no clinical symptoms of thyroid dysfunction.

Special instructions for the use of the drug Andriol tk™

In prepubertal boys, androgens should be used with caution to avoid premature closure of the epiphyses and accelerated sexual development. Regular monitoring of skeletal development is necessary. Patients with latent or severe heart failure, impaired renal function, hypertension (arterial hypertension), epilepsy or migraine (either currently or in history) should be under constant medical supervision, since sometimes deterioration or exacerbation of these diseases is possible. Androgens should be prescribed with caution to patients with benign prostatic hyperplasia. If androgen-dependent adverse reactions develop, treatment should be discontinued. After the disappearance of side effects, treatment with the drug should be resumed at lower doses. Taking steroids may affect the results of certain laboratory tests.

Indications for use

Andriol is prescribed as hormone replacement therapy for diseases and conditions caused by testosterone deficiency:

• Endocrine impotence;
• Eunuchoidism;
• Post-castration syndrome;
• Hypopituitarism;
• Infertility associated with impaired spermatogenesis;
• Menopausal phenomena in men (decreased libido, deterioration in general well-being);
• Masculinization in transsexuals;
• Osteoporosis caused by androgen deficiency.

Reviews about Andriol

According to reviews, Andriol has proven itself well when used in bodybuilding to strengthen muscles and increase their volume. Patients confirm the effectiveness of this expensive drug in the treatment of conditions caused by low testosterone levels, as well as as a prophylactic agent. However, it is noted that Andriol should be taken only after consultation with a specialist, confirmation of insufficient production of this steroid and identification of the causes of the disorder. In some cases, weakness, drowsiness and other side effects associated with changes in hormonal levels in the body are observed.