Reduced testosterone levels in women. The drug "Androgel": reviews from men, instructions for use, composition, analogues, side effects

Registration number:

LS-000869-151012

Trade name of the drug:

Androgel ®

International nonproprietary name or generic name:

testosterone

Dosage form:

gel for external use

Compound:

1 g of gel contains:
Active substance:
Testosterone 10 mg
Excipients: isopropyl myristate 5 mg, carbomer 980 9 mg, sodium hydroxide 47.2 mg, ethanol 96% 0.714 g, purified water to 1 g

In 1 package containing 2.5 g of gel:
Active substance:
Testosterone 25 mg
Excipients: isopropyl myristate 12.5 mg, carbomer 980 22.5 mg, sodium hydroxide 118 mg, ethanol 96% 1.785 g, purified water to 2.5 g

In 1 packet containing 5.0 g of gel:
Active substance:
Testosterone 50 mg
Excipients: isopropyl myristate 25 mg, carbomer 980 45 mg, sodium hydroxide 236 mg, ethanol 96% 3.570 g, purified water up to 5 g

In 1 extractable dose vial containing 1.25 g of gel:
Active substance:
Testosterone 12.5 mg
Excipients: isopropyl myristate 6.25 mg, carbomer 980 11.25 mg, sodium hydroxide 59 mg, ethanol 96% 0.892 g, purified water to 1.25 g.

Description

Transparent or slightly opalescent colorless gel with the odor of alcohol.

Pharmacotherapeutic group:

androgen.

ATX: G03BA03

Pharmacological properties

Pharmacodynamics
Endogenous androgens, mainly testosterone, secreted by the testes and their main metabolite dihydrotestosterone are responsible for the development of the external and internal genital organs and for the development and maintenance of secondary sexual characteristics (stimulation of hair growth, deepening of the voice), libido; behind overall impact on protein anabolism; for the development of skeletal muscles and the distribution of subcutaneous fat; for reducing urinary excretion of nitrogen, sodium, potassium, chlorides, phosphates and water. Testosterone does not cause testicular development: it reduces the pituitary secretion of gonadotropins.
The effects of testosterone on certain target organs occur after the peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of cells in target organs (such as the pituitary gland, adipose tissue, brain, bones, etc.).
Pharmacokinetics
The rate of absorption of testosterone through the skin varies from approximately 9% to 14% of the applied dose.
After absorption through the skin, testosterone enters the systemic circulation in relatively constant concentrations over a 24-hour period.
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. Daily fluctuations in testosterone concentrations have the same amplitude as those observed in circadian rhythms changes in endogenous testosterone levels. With the external route of administration of the drug, there are no supraphysiological peaks in the concentration of testosterone in the blood that occur with the injection method of administration.

In contrast to oral androgen therapy, external use of the drug does not cause an increase in steroid concentrations in the liver above physiological norms.
The use of 5 g of Androgel causes an average increase in plasma testosterone concentrations of approximately 2.5 ng/ml (8.7 nmol/l).
After treatment is stopped, testosterone concentrations begin to decrease approximately 24 hours after the last dose. Concentration returns to original level approximately 72 to 96 hours after the last dose.
The main active metabolites of testosterone are dihydrotestosterone and estradiol.
Androgel ® is excreted mainly in urine and feces in the form of conjugated testosterone metabolites.

Indications for use

Replacement therapy for endogenous testosterone deficiency.

Contraindications

Androgens are contraindicated:
- in the presence of carcinoma mammary gland, prostate cancer or if their presence is suspected;
- if you have hypersensitivity to testosterone or other components of the drug.
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; ischemic disease hearts; arterial hypertension; epilepsy; migraine.

Directions for use and doses

The recommended dose is 5 g of gel (i.e. 50 mg of testosterone), applied once a day at approximately the same time, preferably in the morning. The individual daily dose can be adjusted by the doctor depending on the clinical and laboratory parameters of the 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, intact skin of the shoulders, upper arms and/or abdomen.
When using the drug in a vial, to obtain a full first extractable dose, it is necessary to fill the dispenser pump container. To do this, hold the container vertically and slowly and fully press the dispenser pump 5 times. After the first five presses, discard the resulting gel, observing safety precautions.
It is necessary to fill the pump dispenser container only before receiving the first extracted dose. After filling the pump dispenser container, you must press the dispenser pump 1 time to release 1 extractable dose of 1.25 g of gel containing 12.5 mg of testosterone.
To receive the prescribed daily dose, you must complete the required number of presses (see table):

The gel should be removed from the bottle or package directly onto the palm and then applied to the required application areas.
After opening the package, you must immediately apply all its contents to the skin and spread in a thin layer.
It is not necessary to rub Androgel ® into the skin. Allow the gel to dry for about at least, 3-5 minutes before dressing. Wash your hands with soap after application.
Do not apply the gel to the genital area, as the high content ethyl alcohol in the preparation may cause local irritation.
A constant concentration of testosterone in plasma is achieved approximately on the second day of treatment with Androgel ®. To adjust the dose of testosterone, it is necessary to determine the concentration of testosterone in the 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 plasma testosterone levels are elevated. If concentrations are low, the dose can be increased, but not more than 10 g of gel per day.

Side effect

The most common adverse effects (about 10%) when using the recommended dose of 5 g of gel per day were; skin reactions at the site of application, erythema, acne, dry skin.
During clinical trials Androgel the following were noted unwanted effects(>1/100, Blood and lymphatic system: changes in laboratory test results (polycythemia, changes in lipid levels).
From the outside genitourinary system: changes in the prostate gland, gynecomastia, mastodynia.
From the outside nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
From the outside of cardio-vascular system: increased blood pressure.
From the outside gastrointestinal tract: diarrhea.
From the skin and its appendages: alopecia, urticaria.
General disorders: headache.
The product contains alcohol, so if it is frequently applied to the skin, irritation and dryness may occur.

Overdose

There have been no cases of overdose when using Androgel. Only one case of overdose has been described following the use of injected testosterone. This was a stroke in a patient with high concentration plasma testosterone 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.

Use during pregnancy and lactation

Pregnant women should avoid any contact with the drug due to its possible virilizing effect on the fetus. In case of contact with the drug, it is necessary to wash the area of ​​contact with soap as soon as possible.

Interaction with other drugs

Androgel ® should be prescribed with caution with oral anticoagulants, since it is possible to enhance the effect of oral anticoagulants by modifying the synthesis of hepatic coagulation factor and competitive inhibition of binding to plasma proteins. It is recommended to monitor prothrombin time. Patients receiving oral anticoagulants, require frequent monitoring, especially at the beginning and/or end of androgen treatment.
Coadministration of testosterone and ACTH or corticosteroids may increase the risk of edema. These drugs should be used together cautiously, especially in patients with heart, kidney, or liver disease.
Effect on Laboratory Tests: Androgens may decrease thyroxine-binding globulin levels, resulting in decreased serum T4 concentrations and increased sensitivity to T3 and T4. Levels free hormones thyroid gland, however, remain unchanged, and there are no clinical manifestations hypothyroidism.

special instructions

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. Others should be excluded before starting treatment possible reasons underlying the symptoms described above.
Currently there are no clear age standards testosterone values. However, it must be taken into account that physiological levels Serum testosterone begins to decline from the age of 30-40, 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 for treatment 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 hyperplasia prostate gland. Careful and regular monitoring of the condition of the prostate gland should be carried out (finger rectal examination, determination of prostate-specific antigen (PSA) in serum) and mammary glands 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), functional tests liver 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 When 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 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 active substance(testosterone), which can give 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.
It is recommended to comply the following measures precautions:
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 will not be able to comply with safety instructions (for example, 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 control machines and mechanisms.

Release form

Gel for external use 10 mg/g:
2.5 or 5.0 g of gel in single-dose bags made of polyethylene and laminated aluminum foil.
10 or 30 packets along with instructions for use in a cardboard box. 75 g of gel (60 doses of 1.25 g of gel) in a plastic bottle with a pump dispenser equipped with a protective cap.
1 bottle or 2 bottles along with instructions for use in a cardboard box.

Storage conditions

At a temperature not higher than 25° C.
Keep out of the reach of children.

Almost all functions of a man’s body depend on the presence in his organs of a sufficient amount of the male sex hormone androgen. It is synthesized in large quantities in the gonads (testicles), and in smaller quantities in the adrenal cortex. Without testosterone or with its deficiency, secondary sexual characteristics in boys and men develop weakly or are absent altogether. In addition, this hormone affects the condition of the hair, skin, bone tissue, many internal organs. One of systemic diseases caused by a lack of testosterone is called hypogonadism. Its treatment is often protracted, and in some cases men have to take hormones almost their entire lives. The most effective remedy in this case, the drug “Androgel”, reviews and instructions for use of which we will try to describe in detail in this article.

Description of the drug, composition

The drug is available in the form of a viscous gel and is intended for external use. Despite this, it has the property of a systemic effect on the body, so Androgel is dispensed from pharmacies only with a prescription from the attending physician. This is due to the fact that uncontrolled use of testosterone can cause hyperandrogenization, which can manifest itself in the form of acne and atypical body hair growth in terms of intensity and location in both men and women.

The active substance of the drug is testosterone, or more precisely, its esters. Depending on the volume of one gel packet, the amount of active ingredient in the drug may be as follows:

• one dose containing 2.5 g of the drug contains 25 mg of testosterone;
• one dose containing 50 mg of the drug contains 50 mg of the active substance.

The excipients included in the drug "Androgel" 1% are purified water, sodium hydroxide, isopropyl myristate, carbopol and ethanol. Thanks to this composition, the gel is quickly absorbed and does not leave greasy marks on clothes.

The drug "Androgel" has a weak characteristic odor of alcohol. The medicine looks like a transparent, viscous, colorless or pearlescent substance. The gel is packaged in small sachets of 2.5 or 5 g, the amount of the drug is calculated for one use. The sachets, in turn, are placed in a cardboard package (30 pieces each) along with instructions for using the drug.

Pharmacological properties of the drug

Androgenic hormones, including testosterone, which is part of Androgel, as well as its metabolite dihydrotestosterone, affect following processes in the male body:

• development and maintenance of secondary sexual characteristics;
• development of external and internal genital organs;
• regulation of protein metabolism in the body;
• uniform distribution;
• muscle development;
• regulation of pituitary secretion of gonadotropins;
• regulation of urinary excretion of various compounds.

More to the point in simple language, then all these processes can be characterized as an anabolic effect on the body. It consists in stimulating the formation of protein in the body, as well as in the retention in tissues and organs of substances necessary for the construction of protein cells: sulfur, phosphorus and potassium. Thanks to this, a significant increase in muscle mass is achieved. In addition, the use of Androgel promotes the fixation of calcium in the bones.

As can be seen from the list above, testosterone is very important for the male body. "Androgel" contains therapeutic dose This hormone is intended, first of all, to eliminate its deficiency in the body. It is worth noting that no more than 14% of the applied dose is absorbed through the skin. Within 24 hours, the active substance enters the systemic circulation. Starting from the second day from the beginning hormone therapy with the use of the drug "Androgel", a photo of which you can see below, there is a steady change in blood composition in positive side. At the same time, the concentration of testosterone is not subject to unnatural fluctuations during the day, which in itself can cause a deterioration in the patient’s condition.

Another advantage that the drug “Androgel” has is the absence of changes in the liver, which, when injected or oral administration hormones can be expressed in peak values ​​of testosterone content in organ tissue in different time days. Complete elimination of testosterone metabolites from the body occurs within 3-4 days after discontinuation of the Androgel drug.

Indications for use of the drug "Androgel"

Indications for the use of Androgel as the main therapeutic agent is a decrease in the male body. Signs of such hormonal deficiency may include underdevelopment or regression of secondary sexual characteristics and disruption of certain sexual functions. In addition, testosterone deficiency can be expressed in changes in the body structure of a female type, the presence of excess weight, lipid imbalance and carbohydrate metabolism, as well as frequent depressive states etc.

The instructions for use recommend that the drug “Androgel” be prescribed to patients only after a comprehensive examination to ensure that they do not have other diseases that led to the above changes. It is worth noting that this medicine cannot be prescribed for the treatment of infertility and impotence, which is caused by reasons not related to testosterone levels.

Often the drug "Androgel" (analogs and other dosage forms) is used by athletes trying to regulate the ratio of fat and muscle tissue in favor of the latter. However, this phenomenon cannot be called used for therapeutic purposes. In addition, self-prescription of drugs of this kind can cause irreversible changes in patients, which will subsequently be difficult to eliminate. Therefore, in most countries the only way to get original drug"Androgel" is a prescription from the attending physician. Otherwise, there is no guarantee that a person will not experience a number of adverse reactions from many organs and systems.

Contraindications

The external drug "Androgel", reviews of which are very mixed, has a number of contraindications that should always be taken into account when prescribing it to a patient. The drug should not be used if:

1. The man has diseases such as breast carcinoma or oncological neoplasms in the prostate (confirmed or questionable).
2. There is information about the presence of allergic reactions in men to the components of the drug or directly to testosterone.

• heart diseases, including heart failure and coronary artery disease;
• the presence of malignant neoplasms in any organ, including the skin;
• epilepsy;
• migraine;
• renal and liver failure;
• arterial hypertension;
• respiratory diseases in chronic form.

According to studies, these diseases are most often complicated by taking testosterone, since this hormone can directly affect the circulatory system, as well as a number of other functional areas in the body.

But representatives of the fair half of humanity are not allowed to use the drug “Androgel”. For women, it poses a certain danger, since its use can cause atypical changes in their body in the form of:

• increased growth of body hair according to the male type;
• alopecia;
• acne;
• changes in body type towards the male type.

Very often this drug is used by athletes involved in strength sports. It is worth noting that testosterone, which is the main active substance drugs, detected during doping tests. That is why it is often not used to treat professional athletes.

How and where to apply Androgel

The individual therapeutic dose of the drug “Androgel” is determined by the attending physician according to the results of the patient’s examination. The most commonly recommended application is 5 g of gel per day, maximum dose usually does not exceed 10 g of the drug per day. If the patient develops symptoms during treatment that indicate the need to reduce or increase the initially established dosage, the adjustment must be made stepwise: increasing or decreasing the amount of gel by 2.5 g per day.

The instructions for use of the drug "Androgel" recommend applying it at the same time (preferably in the morning) to previously cleansed and dry skin. It is preferable to spread the gel on the area of ​​the forearms, shoulders and abdomen. The presence of medicine in the area of ​​application is unacceptable various kinds injuries (scratches, abrasions, diaper rash, etc.). There is no need to rub the medicine in; just spread it evenly over the surface of the body and let it dry for at least 3 minutes. Application of the drug to the genitals and genital area is not allowed.

After the patient has applied Androgel gel to the body, he should wash his hands thoroughly warm water with soap. This is important to do to prevent the drug from getting on the surface of the body of people in contact with it.

Side effects and overdose

Among the side and undesirable effects caused by the use of the drug Androgel, the instructions for use include skin reactions in the form of rash, redness, dryness and acne-type rashes. All these symptoms appear, as a rule, as a result of exposure of the skin to the alcohol contained in the drug. In addition, while using the drug, patients may experience the following symptoms:

• headache and dizziness;
• paresthesia, hyperesthesia, memory impairment (including amnesia);
• polycythemia and decreased lipid levels in laboratory tests;
• gynecomastia and mastodynia;
• mood swings, depression, nervousness;
• promotion blood pressure;
• weight gain;
• frequent and prolonged erections;
• diarrhea;
• alopecia.

Regarding the use of the drug "Androgel", reviews from experts contain information about the absence of recorded facts of overdose, since the amount of testosterone that is absorbed by the body through the skin does not exceed 14%, as we mentioned earlier. When the dosage is reduced or the drug is discontinued, the body functions that were impaired are gradually restored.

Interaction of the drug "Androgel" with other drugs

Hormonal drugs (and Androgel in particular) require caution when used in conjunction with other drugs. Thus, the prescription of anticoagulants together with testosterone requires constant monitoring, especially at the beginning and at the end of the course of hormonal therapy. Particular caution should be taken when prescribing the combined use of Androgel with, since their interaction often increases the risk of developing severe swelling, including internal ones.

Otherwise, the use of gel with drugs does not pose a serious danger to the patient’s body. However, it is recommended to always inform your doctor about the medications you are taking. This will help you calculate everything possible risks and choose the least safe combination medicines.

Is Androgel safe for women? Precautionary measures

Testosterone is an androgen, that is, a hormone responsible for the proper functioning of the male body. Of course, it is also present in the body of women, but in very small quantities. This is why women do not require additional doses of this organic compound, administered topically, injected or orally. Experts say that excess testosterone in a woman’s body can lead to irreversible consequences, especially if this happened during the formation of the main body systems or during pregnancy.

When prescribing the drug "Androgel", which is dispensed from pharmacies only by prescription, it is important to inform patients about precautionary measures, the observance of which must be precise and strict. Firstly, the rules for the use of this medicine require compliance with certain time intervals between applying the product to the skin and the patient’s contact with other people, including during sexual intercourse. This period of time must be at least six hours.

If a patient using the Androgel drug is forced to contact other people after a shorter period of time, it is recommended to take a shower or cover the area on which the gel was applied with clothing made of natural material (cotton, linen, etc.). In short, it is necessary to completely eliminate the risk of the product getting into pure form or from the patient's skin to the body surface healthy person, especially women and children.

1. Wash your hands every time after applying the gel to your skin.
2. After the product has dried, cover the application area with clothing.
3. Shower before direct contact with people for whom testosterone treatment is not indicated.

Women whose partners are undergoing testosterone therapy should also take precautions: after contact with the partner’s skin, it is important to short time Wash with soap those areas of the body that Androgel could get on. If a rash resembling acne appears on the skin, changes in the growth and location of body hair, which may indicate the onset of hyperandrogenization, a woman should consult a doctor.

Does Androgel gel have any analogues?

Experts consider all medicines containing esters to be analogues of the drug Androgel. natural testosterone. Unlike that dosage form, which is discussed in the article, they must be taken orally or by injection. For example, the medicine “Andriol” in tablet form containing a therapeutic dose of testosterone undecanoate. This compound has the property of soluble in fats, in particular, which is also included in each tablet. The main feature of this Androgel analogue is the absorption scheme: hormones enter the systemic bloodstream through lymphatic system small intestine, bypassing the liver. Thus, the hormone is more completely absorbed and its normal concentrations in the blood are quickly achieved.

Another analogue of the drug “Androgel” is “Testosterone propionate”, which also contains active testosterone esters. This drug is introduced into the patient's body intramuscularly by injection and, unlike other drugs, ensures normal testosterone levels in the blood for four weeks after one injection. The only disadvantage of this dosage form is the high risk of testosterone overdose.

Impaired testosterone production in men is serious problem, requiring integrated approach in treatment. This leads to a number of problems with men's health such as decreased potency, deterioration of erection, deterioration physical indicators. For treatment, replacement therapy with testosterone-containing drugs, such as Androgel, is practiced.

Androgel is available in gel form, as is clear from the name of the drug. It contains 1% testosterone. Release forms:

• foil bags 2.5 g;
• foil package 5 g;
• plastic bottle 75 g with a dispenser (rare).

A 5 g sachet contains 50 mg of testosterone. This amount of the drug is designed for one use. The gel itself is transparent, soft in consistency and has a specific alcoholic odor. Additional components in the composition of the drug: ethanol, water, sodium hydroxide, isopropyl myristate.

Androgel is prescription drug, for the purchase of which you must present a prescription with the signature of the attending physician and a wet stamp medical institution, in which testosterone gel was prescribed.

The disadvantages of Androgel are high price and necessity long-term use. The product sachets are packaged in carton boxes, 30 pieces in one package.

Androgel is packaged in single dose sachets

Properties of the drug

Androgel is a gel that exhibits androgenic effects because it contains testosterone. It is applied to the skin and penetrates the blood through the epidermis. When used externally, the drug is highly bioavailable and rapidly absorbed into the general bloodstream. Properties of testosterone Androgel:

• normalizes libido;
• takes part in protein anabolism;
• normalizes the distribution of subcutaneous fat tissue;
• takes part in metabolism;
• improves the excretion of salts by the kidneys.

The drug normalizes the functioning of the male genitourinary and endocrine system, however, has a number of contraindications and side effects. Compared to testosterone tablets, Androgel has less effect on the liver, making it the drug of choice for hormonal therapy if there is a risk of dysfunction of this organ.

The drug is absorbed transdermally. Achieving equilibrium levels of the hormone in the body is achieved 2-3 days after the start replacement therapy. In this case, the gel penetrates into the general bloodstream throughout the day, which reduces the risk of testosterone fluctuations in the blood, ensuring smooth but uniform regulation of hormonal levels.

The gel is intended for the treatment of androgen deficiency, but not as a prophylactic agent. For athletes looking to quickly gain muscle mass, the gel will not work.

The limitation is due to the fact that it is very difficult to achieve high concentrations of Androgel in blood plasma. For the same reason, an overdose of this drug is unlikely.

Indications for use

Testosterone in male body produced by the testicles. The use of Androgel is indicated for testicular dysfunction, resulting in the development of endogenous testosterone deficiency. Signs of androgen deficiency in men:

• weakening libido;
• weak erection;
• vegetative-vascular disorders;
• tides;
• decrease in muscle mass;
• gynecomastia;
• underdevelopment of the genital organs;
• abdominal obesity;
• disturbances in the functioning of the cardiovascular system.

Impaired testosterone production in boys leads to problems during puberty. This may be manifested by impaired development of the genital organs and changes in the type of facial and body hair.

Androgel for men is prescribed only if testosterone deficiency is confirmed during laboratory tests, and androgen deficiency is manifested by specific clinical symptoms.

The gel is used only for laboratory-confirmed testosterone deficiency

Androgel cannot be purchased without a prescription. It is important to understand that this drug is not intended to improve potency or increase tolerance to physical activity, and is prescribed only as replacement therapy for androgen deficiency.

Contraindications

Precautions and contraindications are the same for all testosterone drugs. It is prohibited to use the drug in gel form if you have the following diseases or if you suspect their development:

• malignant neoplasms in the prostate;
• malignant neoplasms of the mammary glands (carcinoma);
• intolerance to testosterone drugs.

If a man has previously taken hormone replacement therapy, but experienced severe side effects, Androgel should not be used. You should also exclude the possibility of developing allergic reaction on the components of the gel before starting therapy.

Androgel should not be used by men with normal level testosterone. Intervention in hormonal background in this case, it is fraught with the development of a number of problems. Using Androgel healthy men can lead to breast enlargement (gynecomastia), acne, and the development of arterial hypertension.

For malignant neoplasms in the reproductive system, the use of the gel is prohibited

Directions for use and dosage

A detailed description of the use of Androgel is given in the instructions for use. The medication is prescribed by a doctor. On the recommendation of a specialist, dosages can be changed, but you cannot adjust the treatment regimen yourself. If the doctor does not give precise explanations, the gel should be used exactly according to the instructions.

The drug should be used once a day. It is important to apply the gel at the same time every day - this will ensure a uniform flow of testosterone into the blood throughout 24 hours and prevent hormonal fluctuations.

Areas for applying gel:

• abdominal area;
• forearms;
• shoulders.

It is strictly forbidden to apply the medicine to sensitive areas of the body, chest and the genital area. Please note that the medicine contains ethanol, which can irritate the skin. In this regard, the drug should be applied exclusively to clean and dry areas of the epidermis, without wounds, cracks or rashes.

Places of application of Androgel

Initial daily dosage– this is 5 g of product. Apply it better in the morning. The gel must be spread evenly over the skin immediately after opening the package. Unused gel cannot be stored. The drug does not need to be rubbed in, it should be absorbed on its own. This takes about five minutes. After the gel has completely dried, you can get dressed.

If necessary, the dosage can be increased, but should not exceed 10 g of gel (two sachets) per day. Increasing the amount of the drug used should be gradual and carried out by adding 2.5 g of the drug per week.

Important! After applying the medicine, you should wash your hands thoroughly with soap and water, otherwise, when in contact with other people, gel residues may get on their skin, which is unsafe for healthy people.

Side effects

Most common adverse reactions at the beginning of therapy, this is irritation of the epidermis at the site of application of the drug. This is due, first of all, to the high concentration of alcohol in the gel. This is manifested by itching, peeling, rash, and acne.

Frequent side effects encountered by every tenth patient undergoing Androgel replacement therapy:

• migraine;
• hypertension;
• diarrhea;
• hives;
• mood swings (increasing aggression).

In approximately one case out of a hundred, more severe disorders were diagnosed - changes in the functioning of the prostate gland, gynecomastia, androgenetic alopecia. Due to the effects of testosterone on the cardiovascular system, there is a risk of increased blood pressure and hot flashes. Such side effects require attention. In some cases, abuse of the gel can cause the development of secondary arterial hypertension.

Gynecomastia is a fairly common side effect in patients undergoing hormone replacement therapy for hypogonadism.

Side effects detected in rare cases:

• obesity;
• muscle cramps;
• depression;
• frequent erections;
• decrease in testicular size;
• obstruction of the urinary tract;
• swelling.

The occurrence of side effects requires attention. If the body’s negative reactions to the use of the drug are pronounced and do not go away during the first week of treatment, it is recommended to consult a doctor about adjusting the dosage of the drug.

If side effects continue to bother you a week after starting therapy, you should tell your doctor

Androgel during pregnancy

The use of Androgel for women is contraindicated. The instructions for use of the drug Androgel warn: women should avoid skin contact with this drug in every possible way. The drug is especially dangerous for pregnant women, as it quickly penetrates into the general bloodstream through the skin and can cause fetal development abnormalities.

If skin contact with the gel does occur, you should immediately rinse the epidermis big amount water and soap.

Use for liver and kidney dysfunction

Androgel can be used for minor disorders of the liver and kidneys, but only after comprehensive examination body and consultation with a specialist. The use of the drug for severe disorders of the liver can provoke the development of neoplasms in the organ, jaundice, portal hypertension. Therapy should be stopped immediately if organ function deteriorates.

For severe renal failure taking the drug is contraindicated. The drug can cause edema and the development of heart failure due to inhibition of kidney function. The development of any negative reactions from the urinary system is an indication for immediate cessation of therapy.

Transferring testosterone to a partner

Androgel is applied to open areas bodies, upon contact with which another person can get small dose testosterone. This is dangerous for a healthy person, so it is important to avoid contact with the skin in the first 6 hours after applying the gel.

You should be especially careful during sexual intercourse. Contact of the drug on a woman's skin can lead to an increase in testosterone levels. This is fraught hormonal imbalance, disturbances in the functioning of the cardiovascular system, excessive hair growth. At least 6 hours should pass between application of the product and sexual intercourse. In this case, the man is recommended to additionally wear a T-shirt to reduce the risk of contact of his partner with the areas where the gel is applied.

If the gel gets on the skin of a woman or other healthy person, you should immediately wash the epidermis with plenty of soap and water.

Married men should also be careful when interacting with children. Contact of even a small amount of gel on a child's skin can be dangerous to the baby's health.

When contacting areas of the body where the gel was applied, another person also receives a dose of testosterone

special instructions

Before starting drug therapy, a man must undergo a series of examinations. Among them:

• TRUS of the prostate;
• PSA analysis;
• liver tests;
• testosterone concentration analysis;
• Ultrasound of the mammary glands.

The listed examinations are necessary to exclude possible contraindications, such as malignant neoplasms in the prostate and mammary glands in men. The use of drugs with testosterone for prostate cancer can lead to rapid progression of cancer.

Athletes should take into account that the drug gives a positive reaction when passing doping tests.

The drug is prescribed with caution in the following cases:

• cardiac ischemia;
• heart failure;
• arterial hypertension;
• renal failure;
• epilepsy.

Androgel is intended only for the treatment of androgen deficiency. This drug cannot be used independently in the treatment of infertility, with decreased sperm motility or with erectile dysfunction. The gel does not enlarge the penis and does not prolong sexual intercourse; moreover, it is prohibited to apply it to the genital area due to the presence of alcohol in the composition.

Drug interactions

1. As the body gets used to the action of the drug, in patients with diabetes mellitus, the effectiveness of insulin may increase, which increases the risk of developing hypoglycemia. This feature requires adjustment of the dose of administered insulin.
2. The drug enhances the effect of oral anticoagulants, and therefore you should consult your doctor about changing your regimen for taking these medications.
3. Simultaneous use with corticosteroids is dangerous for the development of edema.
4. The drug contains alcohol in high concentration. For people undergoing Teturam therapy, Androgel may be contraindicated. Also, the gel should not be used by patients who have completed a course drug treatment alcoholism special drugs, against the background of which alcohol intolerance develops.
5. Long-term therapy with the drug may lead to changes in laboratory blood parameters and the concentration of thyroid hormones, which must be taken into account during routine examination.

Cost of the drug and analogues

Androgel is an effective, but quite expensive and rare drug

Androgel, the price of which is about 2,500 rubles per package, can be purchased only with a prescription from your doctor. The drug is quite rare in pharmacies, so purchasing it may be difficult.

If it is necessary to replace the drug Androgel, analogues should be selected by a doctor. List of possible substitutes:

• Testenate (solution for injection);
• Methyltestosterone (tablets);
• Sustanon (mixture of esters for intramuscular injections);
• Testosterone propionate (solution for injection).

In terms of the number of side effects, Androgel is best choice for hormonal therapy. The tablets negatively affect liver function, and intramuscular injection testosterone often provokes the development of acne, gynecomastia and other side effects.

Androgenic drug. Endogenous androgens (mainly testosterone), secreted by the testes, and their main metabolite dihydrotestosterone are responsible for the development of the external and internal genital organs and for the development and maintenance of secondary sexual characteristics (stimulation of hair growth, deepening of the voice), libido. They have a general effect on protein anabolism, on the development of skeletal muscles and the distribution of subcutaneous fat, and reduce the urinary excretion of nitrogen, sodium, potassium, chlorides, phosphates and water. Testosterone does not cause testicular development: it reduces the pituitary secretion of gonadotropins.

The effects of testosterone on certain target organs occur after the peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of cells in target organs (such as the pituitary gland, adipose tissue, brain, bones, etc.).

Pharmacokinetics

Suction

The rate of absorption of testosterone through the skin varies from approximately 9% to 14% of the applied dose.

Distribution

After absorption, testosterone enters the systemic circulation in relatively constant concentrations for 24 hours. 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. Daily fluctuations in testosterone concentrations have the same amplitude as changes in endogenous testosterone levels observed in circadian rhythms.

With the external route of administration of the drug, there are no supraphysiological peaks in the concentration of testosterone in the blood that occur with the injection method of administration. In contrast to oral androgen therapy, external use of the drug does not cause an increase in steroid concentrations in the liver above physiological norms. The use of 5 g of Androgel causes an average increase in plasma testosterone concentrations of approximately 2.5 ng/ml (8.7 nmol/l).

Metabolism

The main active metabolites of testosterone are dihydrotestosterone and estradiol.

Removal

After treatment is stopped, testosterone concentrations begin to decrease approximately 24 hours after the last application. Concentrations return to baseline approximately 72-96 hours after the last dose. The drug is excreted mainly in urine and feces in the form of conjugated testosterone metabolites.

Release form

Gel for external use is transparent or slightly opalescent, colorless, with the smell of alcohol.

	1 g	1 pack
testosterone	10 mg	50 mg

Excipients: isopropyl myristate - 25 mg, ethanol (96%) - 3.57 g, carbomer 980 - 45 mg, sodium hydroxide - 236 mg, purified water - up to 5 g.

5 g - single-dose packages (30) - cardboard packs.

Dosage

The recommended daily dose is 5 g of gel (i.e. 50 mg of testosterone). The drug is used 1 time/day at approximately the same time of day, preferably in the morning. Daily dose can be adjusted depending on clinical and laboratory parameters, but should not exceed 10 g of gel. Correction of the dosage regimen should be carried out in steps of 2.5 g of gel/day.

To adjust the dose of the drug, it is necessary to determine the concentration of testosterone in the serum in the morning, before using the drug, from the third day after the start of treatment (within one week). The dose can be reduced if the plasma testosterone level is elevated or, conversely, increased if the testosterone concentration is low.

Rules for using the drug

The gel is applied to clean, dry, intact skin of the shoulders, forearms and/or abdomen. Do not apply the gel to the genital area, because the high content of ethyl alcohol in the preparation may cause local irritation.

After opening the sachet, you must immediately apply all its contents to the skin and spread in a thin layer. You don't have to rub it into your skin. You can let it dry for at least 3-5 minutes before putting it on. After application, wash your hands with soap.

Overdose

There have been no cases of overdose when using Androgel. Only one case of overdose has been described following the use of injected testosterone. This 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.

Interaction

With the simultaneous use of Androgel and indirect anticoagulants it is possible to enhance the effect the latter through modification of the synthesis of hepatic coagulation factor and competitive inhibition of binding to plasma proteins. For patients receiving oral anticoagulants while using Androgel, it is recommended to monitor prothrombin time, especially often at the beginning and/or end of the course of androgen treatment.

Concomitant use of Androgel with ACTH or corticosteroids may increase the risk of edema. Caution should be exercised when joint use these drugs, especially in patients with heart, kidney, or liver disease.

Androgens can decrease thyroxine-binding globulin levels, resulting in decreased serum T4 concentrations and increased sensitivity to T3 and T4. Levels of free thyroid hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.

Side effects

The most common undesirable effects (about 10%) when using the recommended dose of 5 g of gel/day were: skin reactions at the application site, erythema, acne, dry skin.

During clinical trials of Androgel, the following undesirable effects were noted (> 1/100,<1/10):

From the blood and lymphatic system: changes in laboratory test results (polycythemia, changes in lipid levels).

From the genitourinary system: changes in the prostate gland, gynecomastia, mastodynia.

From the nervous system: headache, dizziness, paresthesia, amnesia, hyperesthesia, mood changes.

From the cardiovascular system: increased blood pressure.

From the digestive system: diarrhea.

Dermatological reactions: alopecia, urticaria.

The drug contains ethyl alcohol, so if it is frequently applied to the skin, irritation and dryness may occur.

Indications

Replacement therapy for endogenous testosterone deficiency.

Contraindications

• breast carcinoma or suspicion of its presence;
• prostate cancer or suspicion of its presence;
• hypersensitivity to testosterone or other components of the drug.

There is no experience with the use of Androgel in women and children.

The drug should be prescribed with caution for malignant neoplasms (due to the risk of hypercalcemia and hypercalciuria), for severe cardiac, hepatic or renal failure, for ischemic heart disease, arterial hypertension, epilepsy, migraine.

Features of application

Use during pregnancy and breastfeeding

The drug is not used in women.

If a sexual partner is pregnant, the patient needs to be more careful about taking precautions. Pregnant women should avoid any contact with the drug due to its possible virilizing effect on the fetus. In case of contact with the drug, wash the area of ​​contact with soap and water as soon as possible.

Use for liver dysfunction

In patients suffering from severe liver failure, treatment with Androgel may cause complications characterized by edema with or without congestive heart failure. In this case, treatment should be stopped immediately.

Use for renal impairment

In patients suffering from severe renal failure, treatment with Androgel may cause complications characterized by edema with or without congestive heart failure. In this case, treatment should be stopped immediately.

Use in children

There is no experience with the use of Androgel in children.

special instructions

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 (including decreased libido, erectile dysfunction ), 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 exclude the presence of prostate cancer, since androgens can 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) - 2 times a year.

Androgel ® 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 cardiac, hepatic or renal failure, treatment with Androgel 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), and 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 dose 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 the drug contains 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, accidental showering within 1 to 6 hours after applying the gel does not have a significant effect on treatment.

• 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 using 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 should inform your doctor about the appearance and development of signs of hyperandrogenization, such as acne or changes in normal hair growth.

Patients using Androgel ® are advised to wear a T-shirt covering the area where the gel is applied when in contact with children 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).

Impact on the ability to drive vehicles and operate machinery

Currently, there is no data on the effect of Androgel on the ability to drive a car and control machines and mechanisms.