Androgel gel for external use 1% pack 5g №30

Dosage form

Gel for external use

Composition

1 g of gel contains 10 mg of testosterone,
Excipients: isopropyl myristate, ethanol 96%, carbopol 980, sodium hydroxide, purified water.

Packaging

30 sachets of 5 g.

Mechanism of action

Androgel is an androgenic drug. 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 secondary sexual characteristics (stimulating hair growth, coarsening of the voice, development of libido). They have a general effect on protein anabolism, on the development of skeletal muscles and the distribution of subcutaneous fat, on the reduction of urinary excretion of nitrogen, sodium, potassium, chlorides, phosphates and water. Testosterone does not cause the development of the testicles: it reduces the pituitary secretion of gonadotropins. The effects of testosterone on certain target organs manifest themselves after peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of target organs (such as the pituitary, adipose tissue, brain, bones and testicular Leydig cells)

Indications and usage

Replacement therapy for testosterone deficiency.

Contraindications

Breast carcinoma or suspicion of its presence;
Cancer of the prostate gland or suspicion of its presence;
Increased sensitivity to testosterone or other components of the drug. Experience with Androgel in women and children is missing.

Carefully the drug should be prescribed for malignant tumors (due to the danger of hypercalcemia and hypercalciuria), with severe cardiac, hepatic or renal failure, with IHD, hypertension, epilepsy, migraine.

Androgel does not apply to women.
In the case of pregnancy, the sexual partner, the patient must be more careful in the observance of precautionary measures. Pregnant women should avoid any skin contact with the drug. In case of contact with the drug, the woman should wash the contacted place as soon as possible with soap and water.

Dosage and administration

The recommended daily dose is 5 g of gel (ie, 50 mg of testosterone). Androgel used 1 time / day at about the same time of day, preferably in the morning. The daily dose may be adjusted depending on the clinical and laboratory parameters, but should not exceed 10 g of gel. Correction of the dosing 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 content of testosterone in plasma is increased or vice versa increased, if the concentration of testosterone is low.

Rules of use of the drug
Androgel is applied to clean, dry, intact skin of the shoulders, forearms and / or abdomen. You can not apply the gel on the genital area, because high content of ethyl alcohol in the preparation may cause local irritation.

After opening the bag, you must immediately apply to the skin all its contents and distribute a thin layer. It is not necessary to rub it into the skin. You can let it dry for at least 3-5 minutes before dressing. Wash hands with soap and water after application.

Adverse reactions

Local reactions: irritation and dryness of the skin at the site of application of the drug, especially with its frequent application.
From the endocrine and reproductive system: changes in the prostate, gynecomastia (mainly in patients receiving treatment for hypogonadism), mastodynia.
CNS and peripheral nervous system: dizziness, headache, amnesia, changes in mood, paresthesia, hyperesthesia.
Cardiovascular: increase in blood pressure.
Gastrointestinal: diarrhea.
Dermatologic: erythema, acne; in rare cases - alopecia.
Other: changes in laboratory test results (polycythemia, lipid reduction).

In the appointment of the drug in high doses may develop the following clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections. These conditions require dose adjustment.

Special notes

Androgel should be used only with testosterone deficiency, accompanied by such clinical manifestations as regression of secondary sexual characteristics, changes in the structure of the body, asthenia, decreased libido, erectile dysfunction. Before starting treatment, it is necessary to exclude other possible causes underlying the above symptoms.
Currently, there are no clear norms on age-dependent testosterone values. However, it should be taken into account that the physiological levels of serum testosterone decrease with increasing age.
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.
Prior to testosterone administration, all patients should be screened to exclude the presence of prostate cancer, because androgens may 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 serum prostate-specific antigen (PSA)) and mammary glands at least once a year annually and in elderly and at-risk patients (with clinical or family factors) - twice a year.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25 ° C.