Androgel - instructions for use, analogs, reviews and release forms (gel or ointment for external use of 25 mg and 50 mg) drugs for replacement therapy of testosterone deficiency in men and testicular hypofunction. Composition

In this article, you can read the instructions for using the drug Androgel. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Androgel in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Androgel in the presence of existing structural analogues. Use of testosterone deficiency in men and testicular hypo function for replacement therapy. Composition of the preparation.

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

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

Composition

Testosterone + excipients.

Pharmacokinetics

The degree of absorption of testosterone through the skin varies between approximately 9% and 14% of the applied dose. After absorption, testosterone enters the systemic circulation at relatively constant concentrations for 24 hours.The concentration of testosterone in the serum increases from the first hour after the application of Androgel, reaching a constant value from the second day of treatment. Daily fluctuations in testosterone concentrations have the same amplitude as the changes in endogenous testosterone content observed in circadian rhythms. With the external route of administration of the preparation, there are no supraphysiological peaks of testosterone concentration in the blood arising from the injection method of administration. In contrast to oral androgen therapy, external use of the drug does not cause an increase in the concentrations of steroids in the liver above physiological norms. The main active metabolites of testosterone are dihydrotestosterone and estradiol. After discontinuation of treatment, testosterone concentration begins to decrease approximately 24 hours after the last application. Concentration returns to the baseline level approximately 72-96 hours after the last dose. The drug is excreted mainly with urine and with feces in the form of conjugated testosterone metabolites.

Indications

• substitution therapy for endogenous testosterone deficiency (with hypopituitarism, testicular hypo function).

Forms of release

Gel for external use 25 mg and 50 mg (sometimes mistakenly called ointment or cream).

Instructions for use and how to use them

The recommended daily dose is 5 g of gel (ie 50 mg of testosterone). The drug is used once a day at about the same time of day, preferably in the morning. The daily dose can be adjusted depending on the clinical and laboratory parameters, but should not exceed 10 g of the gel. Correction of the dosing regimen should be performed in steps of 2.5 g of gel per day.

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

Application rules

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

After opening the sachet, it is necessary to immediately apply all of its contents to the skin and distribute it in a thin layer. Do not necessarily rub it into the skin.You can let it dry for at least 3-5 minutes before dressing. After application, wash hands with soap and water.

Side effect

• skin reactions at the site of application;
• erythema;
• acne (blackheads);
• dry skin;
• changes in the results of laboratory tests (polycythemia, changes in lipid levels);
• changes in the prostate gland;
• gynecomastia;
• mammalgia;
• headache;
• dizziness;
• paresthesia;
• amnesia;
• hyperesthesia;
• mood changes;
• increased blood pressure;
• diarrhea;
• alopecia;
• hives.

The drug contains ethyl alcohol, so when it is often applied to the skin may appear irritation and dryness.

Contraindications

• carcinoma of the breast or suspected of its presence;
• prostate cancer or suspected of having it;
• use in women and children;
• hypersensitivity to testosterone or other components of the drug.

Application in pregnancy and lactation

The drug is not used in women.

In the case of pregnancy of the sexual partner, the patient needs to be more careful about the observance of precautionary measures. Pregnant women should avoid any contact with the drug due to its possiblevirilizing effect on the fetus. In case of contact with the drug, it is necessary, as soon as possible, to wash the place of contact with water and soap.

Use in children

Experience with Androgel in children is absent.

special instructions

Androgel should be used only with testosterone deficiency, accompanied by such clinical manifestations as underdevelopment or regression of secondary sexual characteristics, changes in body structure, violation 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 above symptoms should be excluded.

At present, there are no clear age standards for testosterone values. However, it should be taken into account that the physiological levels of serum testosterone 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, 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 the appointment of testosterone, all patients should undergo a checkup 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 the serum) and breast can be performed at least once a year, 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 metastases in the bone. In these patients, it is recommended that the concentration of calcium in the serum be monitored.

In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment with Androgel can cause complications characterized by edema with congestive heart failure or without it. 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, it is periodically necessary to check the following laboratory parameters: hemoglobin, hematocrit (for detection of polycythaemia) and functional liver samples and lipid profile.

Data have been published on the increased risk of sleep apnea in patients with hypogonadism receiving treatment with esters of testosterone, especially in those who have risk factors such as obesity and chronic respiratory diseases.

In patients with diabetes, receiving androgens, when the normal concentration of testosterone in the blood plasma can be increased sensitivity to insulin.

Some clinical symptoms: irritability, nervousness, weight gain,prolonged or frequent erections may indicate an excessive androgen exposure requiring dose adjustment.

If a patient develops a severe local reaction, treatment should be reviewed and, if necessary, discontinued.

When using Androgel, athletes should take into account the fact that the drug contains testosterone, which can give a positive reaction in the anti-doping tests.

The drug is released by prescription.

Potential transfer of testosterone

When appointing Androgel, it is necessary to inform the patient about safety measures.

To ensure the safety of the partner, the patient needs, for example, to advise to have sexual intercourse before using the drug or to observe the interval between the application of Androgel and sexual intercourse. If the sexual intercourse is performed within the interval of up to 6 hours after applying Androgel, during the period of contact it is recommended to wear a T-shirt covering the place of application of the gel or take a shower before the sexual intercourse.

It is preferable to observe an interval of not less than 6 hours between applying the gel and taking a bath or shower.However, occasional showering from 1 to 6 hours after applying the gel does not have a significant effect on the treatment.

The following precautions are recommended for patients:

• Wash hands with soap after applying the gel;
• close the area of ​​application of the gel with clothing, after the gel has dried;
• Take a shower before contacting a partner.

Persons who do not use Androgel:

• in case of contact with the area of ​​application of the gel, previously not washed with water, it is necessary to wash out as soon as possible with soap and water the area of ​​skin on which testosterone could get;
• it is necessary to inform the doctor about the appearance and development of such signs of hyperandrogenization, as acne (acne) or a change in normal hair growth.

Patients treated with Androgel, in 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).

Impact on the ability to drive vehicles and manage mechanisms

At present, there is no data on the influence of Androgel on the ability to drive a car and the control of machinery and mechanisms.

Drug Interactions

With the simultaneous use of Androgel and indirect anticoagulants, it is possible to enhance the effect of the latter by modifying the synthesis of the hepatic coagulation factor and competitive inhibition of binding to plasma proteins. Patients receiving oral anticoagulants against the background of Androgel, it is recommended to monitor prothrombin time, especially often at the beginning and / or end of the course of treatment with androgens.

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

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

Analogues of the drug Androgel

Structural analogs for the active substance:

• Andriol;
• Andraktim gel;
• Nebido;
• Omnadren 250;
• Sustanon 250;
• Testosterone propionate;
• Test for injection 10%.

Analogues for the pharmacological group (androgens and antiandrogens):

• Avodart;
• Alfinal;
• Anandron;
• Andraktim gel;
• Andriol;
• Androblok;
• Androkur;
• Androkur Depot;
• Balutar;
• Bellune 35;
• Bicalutamide;
• Bicutuler;
• Bicane;
• Bikaprost;
• Bilumide;
• Diane 35;
• Grain;
• Casodex;
• Methyltestosterone;
• Nebido;
• Nemestran;
• Omnadren 250;
• Penester;
• Proviron;
• Proscar;
• Prosteride;
• Sustanon 250;
• Testosterone propionate;
• Test for injection 10%;
• Urofin;
• Finasteride;
• Finast;
• Flutakan;
• Flutamide;
• Flutaplex;
• Chloe;
• Cyproterone;
• Erica 35.

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