Endogenous androgens, mainly testosterone secreted by the testes and its major metabolite dihydrotestosterone responsible for the development of external and internal genitals and for maintaining secondary sexual characteristics (stimulating hair growth, deepening of the voice, libido development); for the overall impact on protein anabolism; for the development of skeletal muscles and the distribution of subcutaneous fat; for reducing the excretion of nitrogen, sodium, potassium, chlorides, phosphates and water.
Testosterone does not cause testicular development: it reduces the pituitary secretion of gonadotropins.
Effects of testosterone on some target organs are shown after peripheral conversion of testosterone to estradiol, which then binds to the estrogen receptor in the nuclei of cells of target organs (such as the pituitary, adipose tissue, brain, bone and testicular Leydig cells).
Bezen Menyufekchuring Beldzhium, Belgium
For adults prescribed by a doctor, for men
Gel for external application. 1 bag contains:
Active ingredient: Testosterone 0.050 g;
Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.
Replacement therapy in endogenous testosterone deficiency.
Hypersensitivity to testosterone or to other components of the formulation; presence of breast carcinoma, prostate cancer or suspected of having it; experience with Androgel in women and children is missing.
malignant neoplasms (due to the risk of hypercalcemia and hypercalciuria); severe cardiac, hepatic, or renal failure; coronary artery disease; arterial hypertension; epilepsy; migraine.
From the blood and lymphatic system: changes in the results of laboratory tests (polycythaemia, lipids level change).
With the genitourinary system: changes in the prostate gland, gynecomastia, mammalgia.
From the nervous system: dizziness, paraesthesia, amnesia, hyperaesthesia, mood changes.
Cardio-vascular system: increased blood pressure.
From the gastrointestinal tract: diarrhea.
On the part of the skin and its appendages: alopecia, rash.
General disorders: headache.
The drug contains alcohol, so when it is often applied to the skin may appear irritation and dryness.
How to accept, acceptance rate and dosage
The recommended dose of 5 grams of gel (i.e. 50 mg of testosterone) used 1 time per day at about the same time, preferably in the morning.
Individual daily dose may be adjusted by the physician according to clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. Correction dosing regimen should be performed in steps of 2.5 g of gel per day.
The gel is applied to the clean, dry intact skin shoulders, shoulder girdle and / or abdomen. After opening the bag should be immediately put on your skin and all of its contents spread a thin layer. Do not necessarily rub it into the skin. Give the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap and water after application.
Do not apply the gel on the genital area as a high content of ethanol in the product may cause local irritation. Permanent testosterone plasma concentration is achieved approximately at the second day of treatment with Androgel.
To adjust the testosterone dose necessary to determine the concentration of testosterone in the serum in the morning, before the use of the drug, from the third day after the start of treatment (within one week).
The dosage may be reduced if the testosterone plasma levels increased. If low concentrations, the dose can be increased, but no more than up to 10 g of gel per day.
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Androgel should be used with caution with oral anticoagulants, since it is possible potentiation of oral anticoagulants by synthesis modification hepatic coagulation factor and competitive inhibition of binding to plasma proteins. It is recommended to monitor the prothrombin time.
Patients receiving oral anticoagulants require frequent monitoring, particularly at the beginning and / or end of a course of treatment with androgens.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These drugs must be administered with caution, especially in patients suffering from heart diseases, kidney or liver.
Effects on laboratory tests: androgens may reduce levels of thyroxine binding globulin, resulting in a decrease in serum concentrations of T4 and increase sensitivity to T3 and T4.
Levels of free thyroid hormones, however, remain unchanged, while there are no clinical manifestations of hypothyroidism.
Androgel be used only with testosterone deficiency accompanied by such clinical manifestations as hypoplasia or regression of secondary sexual characteristics, change body structure, impaired carbohydrate and lipid metabolism, obesity, asthenia, sexual dysfunction (decreased libido, erectile dysfunction, etc.), decrease in bone mineral density, mood swings, depression, hot flashes, etc.
Before treatment should be excluded other possible causes underlying the above symptoms. Currently, there is no clear age norms testosterone values. However, it should be taken into account that physiological levels of serum testosterone levels begin to decline from 30-40 years, and the level of globulin binding sex steroids increases. This, accordingly, leads to a decrease in the level of biologically active testosterone.
Due to variability in laboratory values, determination of the concentration of testosterone must be carried out in the same laboratory. Androgel not used to treat infertility or male erectile dysfunction, the cause of which is not associated with testosterone deficiency. Prior to the appointment of testosterone, all patients should be evaluated to rule out the risk of having prostate cancer, since androgens may accelerate the progression of sub-clinical prostate cancer and benign prostatic hyperplasia.
Should be careful and regular monitoring of the condition of the prostate (digital rectal examination, determination of prostate-specific antigen (PSA) in serum) and the breast at least once a year, and in elderly patients and patients at risk (clinical or family factors) – twice a year.
testosterone drugs should be used with caution in patients with malignancies at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. In these patients, it is recommended to control calcium concentration in the serum.
In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment with testosterone preparations can cause complications characterized by edema with congestive heart failure or without her. In this case, treatment should be discontinued immediately. In addition, you may need to diuretic therapy.
Patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentration is necessary periodically to check the following laboratory findings: hemoglobin, hematocrit (to detect polycythemia), liver function tests and lipid profile.
Data were published to increase the risk of sleep apnea in hypogonadal patients treated with testosterone esters, especially in those who had risk factors such as obesity and chronic respiratory disease.
In patients with diabetes receiving androgens, when the normal concentration of testosterone in the blood plasma can be observed an increase in insulin sensitivity. Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.
If the patient develops a severe local reaction, the treatment should be reviewed and, if necessary, discontinued. When using Androgel athletes need to take into account the fact that this drug contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests.
The potential transfer of testosterone
In appointing Androgel should inform the patient about the safety measures. To guarantee partner safety, the patient needs, for example, advised to conduct sexual intercourse before using the product, or to comply with the interval between Androgel application and sexual intercourse.
If intercourse is conducted in the range up to 6 hours after application Androgel preparation for a contact period is recommended to wear a T-shirt covering the application site to take a shower gel or before intercourse.
Preferably, to observe interval of at least 6 hours between each application of the gel and taking a bath or shower. However, taking a shower in a random period of from 1 to 6 hours after application of the gel does not significantly affect the treatment.
It is recommended to observe the following precautions for the patient: wash your hands with soap and water after applying the gel; close area deposition of clothing gel after the gel has dried; take a shower before contact with your partner. for persons not taking Androgel: in case of contact with the region of application of the gel, not pre-washed with water, rinse water needed as soon as possible with soap and skin, testosterone which could get; you must inform your doctor about the emergence and development of such features giperandrogenizatsii as acne or change your hair growth.
In the case of pregnant partners of the patient must pay more attention to the observance of safety measures. Pregnant women should avoid all contact with skin. In case of contact with the drug woman must quickly flushed into contact with soap and water.
Upon contact with children are recommended to wear a T-shirt covering the application site of the gel to avoid the risk of skin contact with the drug children.
Androgel should not be administered to patients who can not comply with safety instructions (eg severe alcoholism, drug abuse, severe psychiatric disorders).
Effects on ability to drive vehicles and other machines that require high concentration of attention
There is currently no data on the effect of Androgel on ability to drive the vehicle and management of machines and mechanisms.
Cases of overdose when using Androgel is not fixed.
Described only one case of overdose after application of testosterone administered by injection.
It had a stroke in a patient with a high concentration of testosterone in the plasma 114 ng / ml (395 nmol / L).
However, it is unlikely that such plasma testosterone concentrations can be achieved when applying the drug to the skin.