Instructions for use ANDRIOL TK™ (ANDRIOL TK)

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Andriol TK® (Andriol TK®)

The following parameters should be monitored in people taking

Andriol TK® (in the first year of admission - quarterly, then once a year):

- digital rectal examination of the prostate to exclude benign prostatic hyperplasia or asymptomatic prostate cancer;

- determination of hematocrit and hemoglobin to exclude polycythemia.

In prepubertal boys, growth and sexual development should be monitored as Andriol TK® in high doses may accelerate epiphyseal closure and puberty.

Sunset yellow dye (E110), which is part of the capsule shell of the drug Andriol TK®, can cause allergic reactions.

Conditions requiring observation

Patients, especially the elderly, with the following conditions should be monitored.

Tumors: breast cancer, hypernephroma, bronchial cancer and bone metastases. These patients may experience spontaneous hypercalcemia, including during androgen therapy. Hypercalcemia may indicate a positive tumor response to hormonal treatment. However, hypercalcemia should be treated first, and hormonal therapy can be resumed once calcium concentrations have returned to normal.

Pre-existing medical conditions: In patients with existing cardiac, renal, or hepatic disease, or cardiac, renal, or hepatic insufficiency, androgen treatment may result in the development of edema with or without congestive heart failure. In such cases, treatment should be stopped immediately.

Patients with myocardial infarction, cardiac, hepatic or renal failure, hypertension, epilepsy and migraine should be monitored due to the risk of worsening or relapse. In such cases, treatment should be stopped immediately.

Diabetes mellitus: androgens in general and Andriol TK® in particular can increase glucose tolerance in patients with diabetes mellitus (see section “Interaction with other drugs”).

Anticoagulant therapy: androgens in general and Andriol TK® in particular can enhance the effect of coumarin-type anticoagulants (see section “Interaction with other drugs”).

Use of the drug in athletes

Patients participating in competitions under the control of the World Anti-Doping Agency (WADA) should familiarize themselves with the WADA rules before starting treatment with the drug, as its use may affect the results of doping control. Androgens should not be used to enhance athletic performance as this poses serious health risks.

Release form and composition

Andriol is available in the form of capsules and oil solutions for intramuscular administration of three types:

  • Oil;
  • Oil – olive oil;
  • Oily – peach oil.

Andriol capsules are gelatinous and soft. They are oval in shape and red-orange in color.

The active ingredient of this product is testosterone undecanoate, and the auxiliary components are:

  • Propylene glycol monolaurate;
  • Lecithin;
  • Glycerol;
  • Medium chain triglycerides;
  • Gelatin;
  • Castor oil;
  • Sunset yellow dye (E110).

Directions for use and dosage

The dosage of Andriol directly depends on the nature of the disease and its clinical manifestations. The duration of treatment is determined by the effectiveness of the therapy. Along with this, you can give a standard dosage for specific diseases:

  • For men with eunuchoidism, removal of the gonads as a result of injury or through surgery, as well as in cases of congenital underdevelopment, Andriol is prescribed 25 mg per day, 50 mg every 1-2 days or 100-200 mg once every 15 days . The duration of the course depends on the form of the disease and the effectiveness of treatment. When the clinical picture improves, switch to maintenance doses - 5-10 mg per day or every second day;
  • For men in cases of impotence with functional deficiency of the gonads, male menopausal syndrome, nervous exhaustion and fatigue, Andriol is prescribed 10 mg every day or 25 mg 2-3 times every 7 days for 1-2 months;
  • For men in the initial stages of prostate hypertrophy, 10 mg of the drug is prescribed every second day for 1-2 months;
  • Women with vascular and nervous disorders of menopausal origin and in cases of contraindications to the use of estrogens are prescribed 10 mg of Andriol every second day or 100 mg once every 2-3 weeks for several months;
  • Women over 45 years of age in cases of dysfunctional uterine bleeding are prescribed 10-25 mg every second day for 20-30 days. It is important to note that it is first necessary to completely exclude the presence of malignant neoplasms of the uterus;
  • For women with malignant tumors of the ovaries or breast, the dosage is as follows: 50-100 mg of Andriol every day for several months. Depending on the results of therapy, the amount of the drug is reduced and switched to maintenance doses. In this case, they amount to 100-200 mg of the drug after 1-2 weeks.

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.

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).

Side effects

The use of Andriol in prepubertal boys can cause the following side effects:

  • Premature closure of bone growth zones;
  • Premature puberty;
  • Increasing the frequency of erections and increasing the size of the penis.

In male patients, the use of Andriol can cause increased sexual arousal, decreased ejaculate volume, priapism and oligospermia.

The use of Andriol by women can cause the following side effects:

  • Deepening of the voice;
  • Breast atrophy;
  • Excessive hair growth on the body and face;
  • Amenorrhea.

In patients of both sexes, Andriol in some cases can cause side effects such as:

  • Allergic reactions;
  • Edema;
  • Pain and itching at injection sites;
  • Cholestatic jaundice;
  • Nausea and dizziness;
  • Retention of sodium and water in the body;
  • Bleeding from the gastrointestinal tract.

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.

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.

Contraindications

This drug is contraindicated in men with breast or prostate cancer and gynecomastia.

The product should not be used in the following cases:

  • Kidney failure;
  • Liver failure;
  • Diabetes mellitus;
  • Nephrosis and nephrotic stage of nephritis;
  • Hypercalcemia;
  • Myocardial infarction;
  • Edema;
  • Prostate hypertrophy;
  • Pregnancy and lactation.

The use of Andriol should be prescribed with extreme caution to male adolescents during puberty, as well as to patients with an asthenic physique and elderly men.

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