AndroGel 
(ANDROGEL)

Composition and form of release
Androgel Gel for external use only 1% of transparent or slightly opalescent, colorless, with the smell of alcohol.

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

2.5 g or 5 g sachet, 10 or 30 bags in a package

Pharmacological action

Androgel - androgenic. Endogenous androgens (mainly testosterone) secreted by the testes, and their major metabolite dihydrotestosterone are responsible for the development of external and internal genital organs and secondary sexual characteristics (stimulating hair growth, coarsening of the voice, the development of libido). Have a general effect on protein anabolism, the development of skeletal muscle and distribution of subcutaneous fat, to reduce the excretion of nitrogen, sodium, potassium, chloride, phosphate and water. Testosterone does not cause testicular development: it reduces the secretion of pituitary gonadotropins.

Effects of testosterone on some target organs are shown 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, bone and testicular Leydig cells)

Statement

Substitution treatment for testosterone deficiency.

Contraindications:

Carcinoma of the breast or a suspicion of its presence;

Prostate cancer or suspicion of its presence;

High sensitivity to testosterone or other ingredients.

Experience in applying AndroGel for women and children missing.

Precautions should be prescribed the drug in malignant tumors (because of the risk of hypercalcemia and hypercalciuria) with severe heart, liver or kidney failure, and coronary heart disease, hypertension, epilepsy, migraine.

Application of pregnancy and breastfeeding

Androgel is not applied with women.

In the case of pregnancy, sexual partners of patients need more care to comply with precautionary measures. Pregnant women should avoid any contact with the skin preparation. In case of contact with the drug to the woman as soon as possible wash exposed with soap and water.

Dosing and Administration
The recommended daily dose is 5 g of gel (50 mg testosterone). Androgel applied 1 time per 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 dosage regimen should be conducted in steps of 2.5 g gel / day.

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

Rules of the drug
Androgel applied to clean, dry, intact skin of shoulders, forearms and / or abdomen. Never apply the gel on the genital area, because high content of ethanol in the product may cause local irritation.

After opening the bag must be immediately applied on the skin all of its contents and spread a thin layer. Does not necessarily rub it into the skin. You can allow it to dry for at least 3-5 minutes before dressing. After the application should wash hands with soap and water.

Side effect:
Local reaction: irritation and dryness of the skin at the site of application of the drug, especially when it is often applied.
From the endocrine and reproductive system: changes in the prostate, gynecomastia (mostly in patients receiving treatment for hypogonadism).
CNS and peripheral nervous system: dizziness, headache, amnesia, mood changes, paresthesia, hyperesthesia.
Cardio-vascular system: increased blood pressure.
From the digestive system: diarrhea.
Dermatological reactions: erythema, acne, and in rare cases - alopecia.
Other: changes in laboratory test results (polycythemia, reduction in lipid levels).

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

Cautions

Androgel should be used only for testosterone deficiency, are accompanied by clinical manifestations, as regression of secondary sex characteristics, changes in body composition, fatigue, decreased libido, erectile dysfunction. Before treatment is necessary to exclude other possible causes underlying the above symptoms.

Currently there are no clear rules on the age-dependent values of testosterone. However, one should take into account the fact that physiological levels of serum testosterone levels decline with advancing age.

Due to variability in laboratory values, determining the concentration of testosterone should be in the same laboratory.

Androgel is not used for the treatment of male infertility or erectile dysfunction, the cause of which is not associated with testosterone deficiency.

Prior to the appointment of testosterone, all patients should be screened to exclude the presence of prostate cancer, since androgens may accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia. Should conduct a careful and regular surveillance of the prostate (digital rectal examination, determination of prostate-specific antigen (PSA) in serum) and mammary glands, at least once a year every year, and in elderly patients and patients at risk (with clinical or familial factors) - twice a year.

Terms & Storage
Keep out of reach of children at or above 25 ° C.
Shelf life - 3 years.