Androgel, gel 10 mg/g 30 pcs

Endogenous androgens, mainly testosterone secreted by the testicles, and their main metabolite dihydrotestosterone are responsible for the development of external and internal genitalia and for the maintenance 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 distribution of subcutaneous fat; for reduction of urinary excretion of nitrogen, sodium, potassium, chloride, phosphate and water.

Testosterone does not cause testicular development: it reduces pituitary gonadotropin secretion.

Indications

Replacement therapy for endogenous testosterone deficiency.

Active ingredient

Testosterone

Composition

Gel for external use. 1 sachet contains:

Active ingredient: testosterone 0.050 g;

Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.

How to take, the dosage

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 may be adjusted by the physician depending on clinical and laboratory parameters in patients, but should not exceed 10 g of gel per day. The dosage regimen should be corrected in steps – 2.5 g of gel per day.

The gel is applied to the clean, dry and undamaged skin of the shoulders, upper arms and/or abdomen. After opening the sachet you should immediately apply all of its contents to the skin and spread 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 putting it on. Wash your hands with soap and water after application.

Do not apply gel to the genital area, as the high ethanol content of the product may cause local irritation. The constant plasma concentration of testosterone is reached approximately on the second day of treatment with Androgel.

To adjust the testosterone dose, the testosterone concentration in the serum should be determined in the morning, before using the drug, from the third day after the start of treatment (for one week).

The dosage can be reduced if plasma testosterone concentrations are elevated. If concentrations are low, the dose can be increased, but not to more than 10 g of gel per day.

Interaction

Androgel should be used with caution with oral anticoagulants because the effect of oral anticoagulants may be enhanced 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.

Co-prescribing testosterone and ACTH or corticosteroids may increase the risk of edema. These medications should be prescribed together with caution, especially in patients with heart, kidney, or liver disease.

Effects on laboratory tests: androgens may decrease thyroxine-binding globulin levels, leading to decreased serum T4 concentrations and increased sensitivity to T3 and T4.

Free thyroid hormone levels, however, remain unchanged and there are no clinical manifestations of hypothyroidism.

Special Instructions

AndroGel should be used only in cases 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 function disorders (decreased libido, erectile dysfunction, etc.), reduced bone mineral density, mood swings, depression, hot flashes, etc.

Other possible causes underlying the symptoms described above must be ruled out before starting treatment. There are currently no clear age norms for testosterone values. However, it should be taken into consideration that physiological levels of serum testosterone begin to decrease from the age of 30-40 years, while the level of globulin, which binds sex steroids, increases. This consequently leads to lower levels of biologically active testosterone.

Due to the variability of laboratory values, determination of testosterone concentration should be performed in the same laboratory. Androgel is not used to treat male infertility or erectile dysfunction whose cause is not related to testosterone insufficiency. Prior to prescribing testosterone, all patients should be screened to rule out the risk of prostate cancer, as androgens can accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia.

Careful and regular monitoring of the prostate (finger rectal examination, serum prostate-specific antigen (PSA) determination) and the breasts must be carried out at least once a year, and twice a year in elderly patients and patients at risk (with clinical or familial factors).

Testosterone preparations should be used with caution in patients with malignancies because of the risk of hypercalcemia (and associated hypercalciuria), due to bone metastases. In these patients it is recommended to monitor the serum calcium concentration.

In patients with severe cardiac, hepatic, or renal insufficiency, 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, therapy with diuretics 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), functional liver tests and lipid profile.

Data have been published about an increased risk of sleep apnea in hypogonadism patients treated with testosterone esters, especially those who had risk factors such as obesity and chronic respiratory disease.

In patients with diabetes mellitus receiving androgens, increased insulin sensitivity may be observed when normal plasma testosterone concentrations are reached. Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.

If a 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 the active substance (testosterone), which may produce a positive reaction in anti-doping tests.

Potential testosterone transmission

The patient should be informed of safety precautions when prescribing AndroGel. To ensure the safety of the partner, the patient should, for example, be advised to have intercourse before using the drug or to observe the interval between the use of Androgel and sexual intercourse.

If intercourse takes place up to 6 hours after application of Androgel, during the period of contact it is recommended to wear a T-shirt covering the gel application site or take a shower before intercourse.

It is preferable to keep 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 gel application has no significant effect on the treatment.

The following precautions are recommended: for the patient: wash hands with soap and water after applying the gel; cover the gel application area with clothing after the gel has dried; take a shower before having contact with a partner. for persons not taking Androgel: in case of contact with the gel application area not previously washed with water, it is necessary to wash with soap and water as soon as possible the area of skin where testosterone could get; it is necessary to inform the doctor about the appearance and development of such signs of hyperandrogenism as acne or changes in the usual hair growth.

If the partner is pregnant, the patient should be more careful to take precautions. Pregnant women should avoid all contact of the drug with the skin. In case of contact with the drug the woman should wash the contacted area with soap and water as soon as possible.

In case of contact with children it is recommended to wear a T-shirt covering the place of gel application in order to avoid the risk of skin contact of children with the drug.

Androgel should not be prescribed to patients who will not be able to comply with safety instructions (e.g., severe chronic alcoholism, substance abuse, severe mental disorders).

Influence on the ability to drive vehicles and other mechanisms requiring increased attention

There are currently no data on the effect of Androgel on the ability to drive and operate machines and mechanisms.

Contraindications

Hypersensitivity to testosterone or other drug components; presence of carcinoma of the breast, prostate cancer or suspicion of their presence; no experience in the use of Androgel in women and children.

With caution:

malignant neoplasms (because of the risk of hypercalcemia and hypercalciuria); severe cardiac, hepatic or renal failure; coronary heart disease; arterial hypertension; epilepsy; migraine.

Side effects

Blood and lymphatic system disorders: changes in the results of laboratory tests (polycythemia, changes in lipid levels).

And the urinary system: changes in the prostate, gynecomastia, mastodynia.

Nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.

Cardiovascular system: BP increase.

Gastrointestinal tract: diarrhea.

Sides of the skin and its appendages: alopecia, urticaria.

General disorders:headache.

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

Overdose

There have been no recorded cases of overdose during the use of Androgel.