Instruction for Androgel
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Androgel is an androgenic drug for external use.
Release form and composition
Androgel is produced in the form of a colorless transparent gel in disposable sachets of 25 and 50 mg (in a cardboard box of 10 or 30 sachets with the drug).
The active substance is the hormone testosterone, which is responsible for the development of the external and internal genital organs and secondary sexual characteristics in men. 1 g of the product contains 10 mg of testosterone.
Excipients: isopropyl myristate, sodium hydroxide, ethanol 96%, purified water, carbomer.
Endogenous androgens secreted by the testes (mainly testosterone) and dihydrotestosterone (the main metabolite) are responsible for the development of internal and external genital organs, as well as the development / preservation of secondary sexual characteristics (coarsening of the voice, stimulation of hair growth) and libido.
Androgel has a general effect on protein anabolism, the distribution of subcutaneous fat and the development of skeletal muscles, reduces urinary excretion of water, potassium, sodium, nitrogen, chlorides and phosphates. Testosterone does not stimulate the development of testicles, but decreases the pituitary secretion of gonadotropins.
On some target organs (adipose tissue, pituitary gland, bones, brain, etc.), the effects of the drug appear after the peripheral conversion of testosterone to estradiol, which subsequently binds to estrogen receptors in the nuclei of target organ cells.
The degree of absorption of testosterone when applied externally is in the range of 9-14% of the applied dose.
After absorption through the skin, the substance enters the systemic circulation and is in relatively constant concentrations for 24 hours. Serum testosterone concentration increases from the first hour after Androgel application and reaches a constant value from the second day of therapy. The diurnal fluctuations in the concentration of testosterone have the same amplitude as in the changes in the content of endogenous testosterone observed in circadian rhythms.
When applied externally, there are no supraphysiological peaks in the concentration of testosterone in the blood that occur with the injection route of administration. In contrast to oral administration of androgens, external therapy does not lead to an increase in the level of steroids in the liver above physiological norms. The use of 5 g of Androgel causes an average increase in plasma testosterone concentration in the blood by about 2.5 ng / ml (8.7 nmol / L).
The main active metabolites of testosterone are estradiol and dihydrotestosterone.
After the end of therapy, the testosterone content begins to decrease approximately 24 hours after the last application. The concentration returns to baseline approximately 72–96 hours after the last dose.
Excretion is carried out mainly in the form of conjugated testosterone metabolites with feces and urine.
Indications for use
According to the instructions, the gel is used for replacement therapy for endogenous testosterone deficiency.
Androgel is contraindicated in case of hypersensitivity, prostate cancer, breast carcinoma, as well as if the presence of these diseases is suspected.
Instructions for the use: method and dosage
Therapeutic daily dosage of Androgel gel is 5 g, or 50 mg in terms of testosterone.
Apply the gel once a day, preferably at the same time.
During therapy, depending on laboratory parameters, the dosage of Androgel is increased, the correction is carried out gradually, 2.5 g of gel per day. The dosage regimen is changed on the third day of therapy after determining the morning testosterone level. The maximum allowable dose is 10 g.
The gel is applied to dry and clean, without damage, skin of the abdomen, forearms, shoulders. The drug should not be applied to the genital area, because the alcohol contained in the preparation may cause irritation. The contents of the bag are applied to the skin immediately after opening and spread in a thin layer. It is not necessary to rub the product into the skin, it should be applied 5 minutes before dressing so that the gel has time to dry.
After treating the skin with the drug, you must wash your hands and observe precautions: be sure to wear clothes to cover the treated areas and prevent possible contact with strangers, especially children. Before intercourse, it is recommended to take a shower and rinse off the drug.
The use of Androgel can cause the following side effects:
Dryness and irritation of the skin;
Changes in the prostate gland;
When using the drug in high doses, nervousness, weight gain, frequent and prolonged erections can be observed. In this case, the dosage must be adjusted or the drug withdrawn.
There is no information on cases of Androgel overdose.
There is a description of only one case of overdose after injection of testosterone. It manifested itself as a stroke in a patient with a high plasma testosterone concentration of 114 ng / ml (395 nmol / L). However, it is unlikely that such plasma testosterone concentrations in the blood can be achieved when it is applied to the skin.
The use of Androgel is allowed only with testosterone deficiency, which is accompanied by a change in body structure, regression of secondary sexual characteristics, asthenia, deterioration of libido, erectile dysfunction. Before starting therapy, other causes that could cause similar symptoms are necessarily excluded.
The drug is prescribed with caution in the presence of malignant tumors, with severe renal and hepatic insufficiency, with ischemia, hypertension, migraine and epilepsy.
Application during pregnancy and lactation
Due to the possible virilizing effect on the fetus, pregnant women should avoid any contact with the gel. In case of accidental contact, the place of contact should be washed as quickly as possible with soap and water.
There is no experience of using Androgel in pediatrics.
With impaired renal function
In patients with renal insufficiency, Androgel is used under medical supervision.
For violations of liver function
In patients with hepatic impairment, Androgel is used under medical supervision.
anticoagulants for oral administration: it is possible to increase their effect on the body; combination therapy should be carried out with caution, frequent monitoring of prothrombin time is recommended, especially at the beginning / end of the course of Androgel use;
adrenocorticotropic hormone, corticosteroids: the likelihood of edema increases; combination therapy should be carried out with caution, especially against the background of heart, liver or kidney disease;
Thyroxine-binding globulin: Androgel can decrease its level, which leads to a decrease in serum T4 concentrations and an increase in sensitivity to T3 and T4. At the same time, there is no change in the level of free thyroid hormones, and clinical manifestations of hypothyroidism are not observed.
Terms and conditions of storage
Store at temperatures up to 25 ° C out of the reach of children.
Shelf life is 3 years.
According to a few reviews, Androgel is an effective drug. They also note its good tolerance and convenient method of application. The cost is assessed as high, however, patients indicate that it corresponds to the quality of the gel and the therapeutic effect.
Terms of sell
You don't need a prescription to buy Androgel.