Androgel® (Androgel)
Androgel should be used only in case of testosterone deficiency, accompanied by such clinical manifestations as: underdevelopment or regression of secondary sexual characteristics, changes in body structure, disturbances of carbohydrate and lipid metabolism, obesity, asthenia, sexual dysfunction (decreased libido, erectile dysfunction, etc.), decreased bone mineral density, mood swings, depression, hot flashes, etc. Before starting treatment, other possible causes underlying the symptoms described above must be excluded.
Currently, there are no clear age standards for testosterone levels. However, it must be taken into account that physiological levels of serum testosterone begin to decline from the age of 30-40 years, and the level of sex steroid binding globulin increases. This, accordingly, leads to a decrease in the level of biologically active testosterone.
Due to the variability of laboratory values, testosterone concentrations should be determined in the same laboratory.
Androgel® is not used to treat male infertility or erectile dysfunction, the cause of which is not related to testosterone deficiency.
Before prescribing testosterone, all patients should be screened to rule out the risk of prostate cancer, as androgens may accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia. Careful and regular monitoring of the prostate gland (digital rectal examination, serum prostate-specific antigen (PSA) determination) and breast glands should be carried out at least once a year, and in elderly patients and patients at risk (with clinical or family factors) - twice a year.
Testosterone preparations should be used with caution in patients with malignant neoplasms due to the risk of hypercalcemia (and concomitant hypercalciuria) due to bone metastases. It is recommended to monitor serum calcium concentrations in these patients.
In patients suffering from severe heart, liver or kidney failure, treatment with testosterone preparations may cause complications characterized by edema with or without congestive heart failure. In this case, treatment should be stopped immediately. In addition, diuretic therapy may be required.
In patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, the following laboratory parameters should be periodically checked: hemoglobin, hematocrit (to detect polycythemia), liver function tests, and lipid profile.
Evidence has been published of an increased risk of sleep apnea in hypogonadal patients treated with testosterone esters, especially those with risk factors such as obesity and chronic respiratory disease.
In patients with diabetes mellitus receiving androgens, when normal plasma testosterone concentrations are achieved, an increase in insulin sensitivity may be observed.
Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure, requiring dosage adjustment.
If the patient develops a severe local reaction, treatment should be reconsidered and, if necessary, discontinued.
When using Androgel in athletes, it is necessary to take into account the fact that this drug contains an active substance (testosterone), which can give a positive reaction in anti-doping tests.
Potential testosterone transfer
When prescribing Androgel, it is necessary to inform the patient about safety measures. To ensure the safety of the partner, the patient should, for example, be advised to have sexual intercourse before using the drug or to observe the interval between the use of Androgel and sexual intercourse. If sexual intercourse is carried out within 6 hours after applying Androgel®, during the period of contact it is recommended to wear a T-shirt covering the area where the gel was applied or take a shower before sexual intercourse.
It is preferable to maintain an interval of at least 6 hours between applying the gel and taking a bath or shower. However, occasional showering within 1 to 6 hours of applying the gel does not have a significant effect on treatment.
The following precautions are recommended:
- for the patient:
— wash your hands with soap after applying the gel;
- cover the area where the gel is applied with clothing after the gel has dried;
- take a shower before contacting your partner.
— for persons not taking Androgel®:
- in case of contact with the area of application of the gel that has not been 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 must inform your doctor about the appearance and development of signs of hyperandrogenization such as acne or changes in normal hair growth.
If the partner is pregnant, the patient needs to be more careful about taking precautions. Pregnant women should avoid any contact of the drug with the skin. In case of contact with the drug, a woman should wash the contacted area with soap and water as quickly as possible.
When in contact with children, it is recommended to wear a T-shirt covering the area where the gel is applied to avoid the risk of children's skin coming into contact with the drug.
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).
Androgel, 30 pcs., 5 g, 10 mg/g, gel for external use
Androgel® should be used only in case of testosterone deficiency, accompanied by such clinical manifestations as: underdevelopment or regression of secondary sexual characteristics, changes in body structure, disorders of carbohydrate and lipid metabolism, obesity, asthenia, sexual dysfunction (decreased libido, erectile dysfunction, etc. ), decreased bone mineral density, mood swings, depression, hot flashes, etc. Before starting treatment, other possible causes underlying the symptoms described above must be excluded. Currently, no clear age standards for testosterone levels have been established. However, it must be taken into account that physiological levels of serum testosterone begin to decline from the age of 30-40 years, and the level of sex steroid binding globulin increases. This, accordingly, leads to a decrease in the level of biologically active testosterone. Due to the variability of laboratory values, testosterone concentrations should be determined in the same laboratory. Androgel® is not used to treat male infertility or erectile dysfunction, the cause of which is not related to testosterone deficiency. Before testosterone is prescribed, all patients should be screened to rule out the possibility of prostate cancer, as androgens may accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia. Careful and regular monitoring of the prostate gland (digital rectal examination, determination of prostate-specific antigen (PSA) in serum) and breast glands should be carried out at least once a year annually, and in elderly patients and patients at risk (with clinical or family factors) – twice a year. The drug should be used with caution in patients with malignant neoplasms due to the risk of hypercalcemia (and concomitant hypercalciuria) due to bone metastases. In such patients, it is recommended to monitor serum calcium concentrations. In patients suffering from severe heart, liver or kidney failure, treatment with testosterone preparations may cause complications characterized by edema with or without congestive heart failure. In this case, treatment should be stopped immediately. In addition, diuretic therapy may be required. In patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, the following laboratory parameters should be periodically checked: hemoglobin, hematocrit (to detect polycythemia), liver function tests, and lipid profile. Evidence has been published of an increased risk of sleep apnea in hypogonadal patients treated with testosterone esters, especially those with risk factors such as obesity and chronic respiratory disease. In patients with diabetes mellitus receiving androgens, when normal plasma testosterone concentrations are achieved, an increase in insulin sensitivity may be observed. Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure, requiring dosage adjustment. If the patient develops a severe local reaction, treatment should be reconsidered and, if necessary, discontinued. When using Androgel in athletes, it is necessary to take into account the fact that this drug contains an active substance (testosterone), which can give a positive reaction in anti-doping tests. Potential transfer of testosterone When prescribing Androgel, it is necessary to inform the patient about safety precautions. To ensure the safety of the partner, the patient should, for example, be advised to have sexual intercourse before using the drug or to observe the interval between the use of Androgel and sexual intercourse. If sexual intercourse is carried out within 6 hours after applying Androgel®, during the period of contact it is recommended to wear a T-shirt covering the area where the gel was applied or take a shower before sexual intercourse. It is preferable to maintain an interval of at least 6 hours between applying the gel and taking a bath or shower. However, occasional showering within 1 to 6 hours of applying the gel does not have a significant effect on treatment. It is recommended to observe the following precautions: • for the patient: - wash your hands with soap after applying the gel; - cover the area where the gel is applied with clothing after it has dried; - take a shower before contacting your partner. • for persons not taking Androgel®: - in case of contact with the area of application of the gel that has not been previously washed with water, wash the area of skin where testosterone may have come into contact with soap and water as soon as possible; - You must inform your doctor about the appearance and development of signs of hyperandrogenization such as acne or changes in normal hair growth. If the partner is pregnant, the patient needs to be more careful about taking precautions. Pregnant women should avoid any contact of the drug with the skin. In case of contact with the drug, a woman should wash the contacted area with soap and water as quickly as possible. When in contact with children, it is recommended to wear a T-shirt covering the area where the gel is applied to avoid the risk of children's skin coming into contact with the drug. Androgel® should not be prescribed to patients who cannot comply with safety instructions (for example, those suffering from severe chronic alcoholism, substance abuse, severe mental disorders). Effect on the ability to drive a car and other mechanisms. Currently, there is no data on the effect of Androgel on the ability to drive a car and operate machines and mechanisms.
