Product Overview
Composition
Gel for external use. 1 sachet contains:
Active substance: testosterone 0.050 g;
Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.
Active substance: testosterone 0.050 g;
Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.
pharmachologic effect
Endogenous androgens, mainly testosterone secreted by the testes, and their main metabolite, dihydrotestosterone, are responsible for the development of external and internal genital organs and for the preservation of secondary sexual characteristics (stimulation of hair growth, coarsening of the voice, development of libido); for the overall effect on protein anabolism; for the development of skeletal muscles and the distribution of subcutaneous fat; for the reduction of urinary excretion of nitrogen, sodium, potassium, chlorides, phosphates and water.
Testosterone does not cause the development of testicles: it reduces the pituitary secretion of gonadotropins.
The effects of testosterone on certain target organs appear after peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of target organ cells (such as the pituitary gland, adipose tissue, brain, bones, and Leydig testicular cells).
Indications
Replacement therapy for endogenous testosterone deficiency.
Contraindications
Hypersensitivity to testosterone or to other components of the drug; the presence of breast carcinoma, prostate cancer, or if there is a suspicion of their presence; there is no experience with Androgel in women and children.
With caution:
malignant neoplasms (due to the danger of hypercalcemia and hypercalciuria); severe heart, liver, or renal failure; cardiac ischemia; arterial hypertension; epilepsy; migraine.
With caution:
malignant neoplasms (due to the danger of hypercalcemia and hypercalciuria); severe heart, liver, or renal failure; cardiac ischemia; arterial hypertension; epilepsy; migraine.
Side effects
On the part of the blood and lymphatic system: changes in the results of laboratory tests (polycythemia, changes in lipid levels).
From the genitourinary system: changes in the prostate gland, gynecomastia, mastodynia.
From the nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
From the cardiovascular system: increased blood pressure.
From the gastrointestinal tract: diarrhea.
From the skin and its appendages: alopecia, urticaria.
Common disorders: headache.
The drug contains alcohol, so if it is applied frequently to the skin, irritation and dryness may appear.
From the genitourinary system: changes in the prostate gland, gynecomastia, mastodynia.
From the nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
From the cardiovascular system: increased blood pressure.
From the gastrointestinal tract: diarrhea.
From the skin and its appendages: alopecia, urticaria.
Common disorders: headache.
The drug contains alcohol, so if it is applied frequently to the skin, irritation and dryness may appear.
Interaction
Androgel should be used with caution with oral anticoagulants, since it is possible to enhance the action of oral anticoagulants by modifying the synthesis of hepatic coagulation factor and competitive inhibition of plasma protein binding. It is recommended to control prothrombin time.
Patients receiving oral anticoagulants require frequent monitoring, especially at the beginning and / or end of the course of treatment with androgens.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These medicines should be prescribed together carefully, especially in patients suffering from heart, kidney, or liver diseases.
Effects on laboratory tests: androgens can lower thyroxin-binding globulin levels, leading to a decrease in serum concentrations of T4 and an increase in sensitivity to T3 and T4.
The levels of thyroid free hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.
Patients receiving oral anticoagulants require frequent monitoring, especially at the beginning and / or end of the course of treatment with androgens.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These medicines should be prescribed together carefully, especially in patients suffering from heart, kidney, or liver diseases.
Effects on laboratory tests: androgens can lower thyroxin-binding globulin levels, leading to a decrease in serum concentrations of T4 and an increase in sensitivity to T3 and T4.
The levels of thyroid free hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.
How to take, course of administration and dosage
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once a day at about the same time, preferably in the morning.
An individual daily dose can be adjusted by a doctor depending on the clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. Correction of the dosage regimen should be carried out in steps of 2.5 g of gel per day.
The gel is applied to clean, dry, undamaged skin of the shoulders, shoulders and / or abdomen. After opening the bag, immediately apply all its contents to the skin and distribute it in a thin layer. It is not necessary to rub it into the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap after application.
Do not apply the gel on the genital area, as the high content of ethyl alcohol in the preparation may cause local irritation. A constant concentration of testosterone in plasma is achieved on the second day of treatment with Androgel.
To adjust the dose of testosterone, it is necessary to determine the concentration of testosterone in serum in the morning, before using the drug, from the third day after the start of treatment (within one week).
The dosage can be reduced if the testosterone content in the plasma is increased. If the concentration is low, the dose can be increased, but not more than 10 g of gel per day.
An individual daily dose can be adjusted by a doctor depending on the clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. Correction of the dosage regimen should be carried out in steps of 2.5 g of gel per day.
The gel is applied to clean, dry, undamaged skin of the shoulders, shoulders and / or abdomen. After opening the bag, immediately apply all its contents to the skin and distribute it in a thin layer. It is not necessary to rub it into the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap after application.
Do not apply the gel on the genital area, as the high content of ethyl alcohol in the preparation may cause local irritation. A constant concentration of testosterone in plasma is achieved on the second day of treatment with Androgel.
To adjust the dose of testosterone, it is necessary to determine the concentration of testosterone in serum in the morning, before using the drug, from the third day after the start of treatment (within one week).
The dosage can be reduced if the testosterone content in the plasma is increased. If the concentration is low, the dose can be increased, but not more than 10 g of gel per day.
Overdose
There have been no cases of overdose when using Androgel.
Only one case of overdose has been described after injection of testosterone.
It was a stroke in a patient with a high plasma testosterone concentration of 114 ng / ml (395 nmol / L).
However, it is unlikely that similar plasma testosterone concentrations can be achieved when the drug is applied to the skin.
Special instructions
Androgel should be used only for testosterone deficiency, accompanied by such clinical manifestations as: underdevelopment or regression of secondary sexual characteristics, changes in body structure, impaired carbohydrate and lipid metabolism, obesity, asthenia, impaired sexual function (decreased libido, erectile dysfunction, etc.), decreased bone mineral density, mood swings, depression, hot flashes, etc.
Before starting treatment, other possible causes underlying the above symptoms should be ruled out. There are currently no clear age standards for testosterone levels. However, it should be taken into account that physiological levels of serum testosterone begin to decline from 30-40 years, and the level of sex steroid-binding globulin rises. This, accordingly, leads to a decrease in the level of biologically active testosterone.
Due to the variability of laboratory values, the determination of testosterone concentration should be carried out in the same laboratory. Androgel is not used to treat male infertility or erectile dysfunction, the cause of which is not associated with testosterone deficiency. Before prescribing testosterone, all patients should be screened to eliminate the risk of prostate cancer, since androgens can accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia.
Careful and regular monitoring of the state of the prostate gland (digital rectal examination, determination of prostate-specific antigen (PSA) in the serum) 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 because of the danger of hypercalcemia (and concomitant hypercalciuria) due to bone metastases. In these patients, it is recommended that serum calcium concentration be monitored.
In patients suffering from severe heart, liver or kidney failure, treatment with testosterone can 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 concentration, 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 developing sleep apnea in patients with hypogonadism who are being treated with testosterone esters, especially those with risk factors such as obesity and chronic respiratory diseases.
In patients with diabetes mellitus receiving androgens, when a normal concentration of testosterone in the blood plasma is reached, an increase in insulin sensitivity may be observed. Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive exposure to androgen, requiring dosage adjustment.
If the patient develops a severe local reaction, treatment should be reviewed 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 transmission
When prescribing Androgel, it is necessary to inform the patient about safety measures. To guarantee 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 intercourse is carried out in the interval up to 6 hours after applying the Androgel preparation, it is recommended to wear a T-shirt covering the place of application of the gel during the period of contact or take a shower before intercourse.
It is preferable to observe an interval of at least 6 hours between applying the gel and taking a bath or shower. However, accidental showering in the period from 1 to 6 hours after applying the gel does not have a significant effect on treatment.
The following precautions are recommended: for the patient: wash hands with soap and water after applying the gel; to cover the area of ​​application of the gel with clothing after the gel has dried; take a shower before contacting a partner. for people who are not taking Androgel: in case of contact with the area of ​​application of the gel, not previously washed with water, it is necessary to wash as soon as possible with soap and water the skin area on which testosterone could get; you must inform your doctor about the appearance and development of signs of hyperandrogenization, such as acne or a change in normal hair growth.
In the case of pregnancy of the partner, the patient must be more attentive to the observance of precautionary measures. Pregnant women should avoid any contact with the skin. In case of contact with the drug, a woman needs to wash the contacted place with soap and water as soon as possible.
When in contact with children, it is recommended to wear a T-shirt covering the place of application of the gel in order to avoid the risk of children's skin contact with the drug.
Androgel should not be prescribed to patients who cannot comply with safety instructions (for example, severe chronic alcoholism, substance abuse, severe mental disorders).
Influence on the ability to drive vehicles and other mechanisms requiring increased concentration of attention
Currently, there is no data on the influence of Androgel on the ability to drive a car and control cars and mechanisms.
Before starting treatment, other possible causes underlying the above symptoms should be ruled out. There are currently no clear age standards for testosterone levels. However, it should be taken into account that physiological levels of serum testosterone begin to decline from 30-40 years, and the level of sex steroid-binding globulin rises. This, accordingly, leads to a decrease in the level of biologically active testosterone.
Due to the variability of laboratory values, the determination of testosterone concentration should be carried out in the same laboratory. Androgel is not used to treat male infertility or erectile dysfunction, the cause of which is not associated with testosterone deficiency. Before prescribing testosterone, all patients should be screened to eliminate the risk of prostate cancer, since androgens can accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia.
Careful and regular monitoring of the state of the prostate gland (digital rectal examination, determination of prostate-specific antigen (PSA) in the serum) 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 because of the danger of hypercalcemia (and concomitant hypercalciuria) due to bone metastases. In these patients, it is recommended that serum calcium concentration be monitored.
In patients suffering from severe heart, liver or kidney failure, treatment with testosterone can 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 concentration, 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 developing sleep apnea in patients with hypogonadism who are being treated with testosterone esters, especially those with risk factors such as obesity and chronic respiratory diseases.
In patients with diabetes mellitus receiving androgens, when a normal concentration of testosterone in the blood plasma is reached, an increase in insulin sensitivity may be observed. Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive exposure to androgen, requiring dosage adjustment.
If the patient develops a severe local reaction, treatment should be reviewed 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 transmission
When prescribing Androgel, it is necessary to inform the patient about safety measures. To guarantee 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 intercourse is carried out in the interval up to 6 hours after applying the Androgel preparation, it is recommended to wear a T-shirt covering the place of application of the gel during the period of contact or take a shower before intercourse.
It is preferable to observe an interval of at least 6 hours between applying the gel and taking a bath or shower. However, accidental showering in the period from 1 to 6 hours after applying the gel does not have a significant effect on treatment.
The following precautions are recommended: for the patient: wash hands with soap and water after applying the gel; to cover the area of ​​application of the gel with clothing after the gel has dried; take a shower before contacting a partner. for people who are not taking Androgel: in case of contact with the area of ​​application of the gel, not previously washed with water, it is necessary to wash as soon as possible with soap and water the skin area on which testosterone could get; you must inform your doctor about the appearance and development of signs of hyperandrogenization, such as acne or a change in normal hair growth.
In the case of pregnancy of the partner, the patient must be more attentive to the observance of precautionary measures. Pregnant women should avoid any contact with the skin. In case of contact with the drug, a woman needs to wash the contacted place with soap and water as soon as possible.
When in contact with children, it is recommended to wear a T-shirt covering the place of application of the gel in order to avoid the risk of children's skin contact with the drug.
Androgel should not be prescribed to patients who cannot comply with safety instructions (for example, severe chronic alcoholism, substance abuse, severe mental disorders).
Influence on the ability to drive vehicles and other mechanisms requiring increased concentration of attention
Currently, there is no data on the influence of Androgel on the ability to drive a car and control cars and mechanisms.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life
3 years
