Androgel gel 1% 5gr #30

Androgel user manual

You can buy Androgel here

pharmachologic effect

Endogenous androgens (mainly testosterone) secreted by the testes and their main metabolite dihydrotestosterone are responsible for the development of the external and internal genital organs and for the development and maintenance of secondary sexual characteristics (stimulating hair growth, coarsening of the voice), libido. They have a general effect on anabolism of proteins, on the development of skeletal muscles and the distribution of subcutaneous fat, reduce the excretion of urine with 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 appear 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, etc.).

Pharmacokinetics

Suction

The degree of absorption of testosterone through the skin varies from approximately 9% to 14% of the applied dose.

Distribution

After absorption through the skin, testosterone enters the systemic circulation in relatively constant concentrations within 24 hours. The concentration of testosterone in the blood serum increases from the first hour after the use of the drug Androgel, reaching a constant value from the second day of treatment. Daily variations in testosterone concentrations have the same amplitude as changes in the content of endogenous testosterone observed in circadian rhythms.
With the external route of administration of Androgel, there are no supraphysiological peaks of testosterone concentration in the blood, arising from the injection method of use. In contrast to oral therapy with androgens, external use of the drug does not cause an increase in the concentration of steroids in the liver above physiological norms. The use of 5 g of the drug Androgel causes an average increase in the concentration of testosterone in the blood plasma by approximately 2.5 ng / ml (8.7 nmol / l).

Metabolism

The main active metabolites of testosterone are dihydrotestosterone and estradiol.

Removal

After cessation of treatment, testosterone concentration begins to decrease approximately 24 hours after the last application. The concentration returns to the initial level approximately 72-96 hours after the last dose has been applied. Androgel is excreted mainly in the urine and feces in the form of conjugated testosterone metabolites.

Indications

- replacement therapy for endogenous testosterone deficiency.

Contraindications

- breast carcinoma or suspicion of its presence;
- prostate cancer or suspicion of its presence;
- hypersensitivity to testosterone or other components of the drug.
Experience with the use of the drug Androgel in women and children is missing.
Caution should be given to Androgel for malignant tumors (due to the danger of hypercalcemia and hypercalciuria), severe cardiac, hepatic or renal failure, coronary artery disease, hypertension, epilepsy, migraine.

Dosage

The recommended daily dose is 5 g of gel (ie, 50 mg of testosterone). The drug is used 1 time / day at about the same time of day, preferably in the morning. The individual daily dose may be adjusted depending on the clinical and laboratory parameters, but should not exceed 10 g of gel per day. Correction of the dosing regimen should be carried out in steps of 2.5 g of gel / day.
The gel is applied to clean, dry, intact skin of the shoulders, shoulder girdle and / or abdomen.
When using Androgel in a vial, to obtain a complete first extractable dose, it is necessary to fill the capacity of the dosing pump. To do this, hold the container vertically, slowly and fully press the pump-dosing pump 5 times. After the first five clicks, discard the resulting gel, observing the precautions. It is necessary to fill the capacity of the pump-dispenser only before receiving the first recoverable dose. After the procedure of filling the capacity of the dosing pump, it is necessary to press the dosing pump 1 time to release 1 recoverable dose of 1.25 g of gel containing 12.5 mg of testosterone.
The gel should be removed from the bottle or from the bag directly on the palm, and then applied to the necessary places of application. After opening the package, you must immediately apply to the skin all its contents and distribute a thin layer.
It is not necessary to rub the drug Androgel into the skin. Allow the gel to dry for at least 3-5 minutes before dressing. Wash hands with soap after application.
Do not apply the gel on the genital area, because high content of ethyl alcohol in the preparation may cause local irritation.
Constant plasma testosterone concentration is reached around the second day of treatment with Androgel. For dose adjustment of testosterone, it is necessary to determine the concentration of testosterone in serum in the morning, before using Androgel, from the third day after the start of treatment (within one week). The dose can be reduced if the testosterone content in the blood plasma is increased. If the concentrations are low, the dose can be increased, but not more than 10 g of gel / day.

Side effects

The most frequent undesirable effects (about 10%) when applying the recommended dose of 5 g of gel / day were: skin reactions at the site of application, erythema, acne, dry skin.
During the clinical trials of the drug Androgel the following undesirable effects were noted (> 1/100, <1/10):
On the part of the blood and lymphatic system: changes in laboratory test results (polycythemia, changes in lipid levels).
On the part of the urogenital system: changes in the prostate gland, gynecomastia, mastodynia.
From the nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
Since the cardiovascular system: increased blood pressure.
On the part of the digestive system: diarrhea.
From the side of skin and its appendages: alopecia, urticaria.
Common disorders: headache.
The drug contains ethyl alcohol, so when it is often applied to the skin, irritation and dryness may appear.

Overdose

Cases of overdose with the use of the drug Androgel is not fixed. Only one case of overdose has been described after the injection of testosterone administered. It was a stroke in a patient with a high plasma testosterone concentration of 114 ng / ml (395 nmol / l). However, it is unlikely that similar plasma testosterone concentrations can be achieved when the drug is applied to the skin.

Drug interaction

The drug Androgel should be prescribed with caution with oral anticoagulants, since It is possible to enhance the action of oral anticoagulants by modifying the synthesis of hepatic coagulation factor and competitive inhibition of binding to plasma proteins. It is recommended to control prothrombin time. Patients receiving oral anticoagulants require frequent monitoring, especially at the beginning and / or at the end of the course of treatment with androgens.
Co-administration of testosterone and ACTH or corticosteroids may increase the risk of edema. These drugs should be administered together carefully, especially in patients with heart, kidney, or liver disease.
Effects on laboratory tests: androgens may reduce thyroxin-binding globulin levels, leading to a decrease in serum T4 concentrations and to an increase in sensitivity to T3 and T4. The levels of free thyroid hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.

special instructions for Androgel

The drug 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, impaired carbohydrate and lipid metabolism, obesity, asthenia, impaired sexual function (including decreased libido, erectile dysfunction ), decrease in bone mineral density, mood swings, depression, hot flashes, etc. Before starting treatment, other possible causes underlying the above symptoms should be excluded.
Currently, there are no clear age norms 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 the globulin that binds sex steroids, increases. This, respectively, leads to a decrease in the level of biologically active testosterone.
Due to the variability of laboratory values, the determination of testosterone concentration should be carried out in the same laboratory.
The drug Androgel is not used to treat male infertility or erectile dysfunction, the cause of which is not associated with testosterone deficiency.
Before prescribing testosterone, all patients should be examined to rule out 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 should be carried out at least once a year, and in elderly and risk patients (with clinical or family factors) - 2 times a year.
Testosterone preparations should be used with caution in patients with malignant tumors because of the danger of hypercalcemia (and concomitant hypercalciuria), due to bone metastases. In these patients, it is recommended to control the concentration of calcium in the serum.
In patients with severe cardiac, hepatic, or renal failure, treatment with testosterone drugs may cause complications, characterized by edema with or without congestive heart failure. In this case, treatment should be discontinued immediately. In addition, diuretic therapy may be required.
In patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, periodically it is necessary to check the following laboratory parameters: hemoglobin, hematocrit (to detect polycythemia) and liver function tests and lipid profile.
Data have been published on the increased risk of developing sleep apnea in hypogonadal patients receiving testosterone ester treatment, especially those with risk factors such as obesity and chronic respiratory infections.
In patients with diabetes who receive androgens, when normal plasma testosterone levels are reached, an increase in insulin sensitivity may be observed.
Some clinical symptoms: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure, requiring dose adjustment.
If a patient develops a severe local reaction, treatment should be reviewed and, if necessary, discontinued.
When using the drug Androgel in athletes, it is necessary to take into account the fact that the drug contains testosterone, which can give a positive reaction in anti-doping tests.

Potential Testosterone Transfer

When prescribing the drug Androgel it is necessary to inform the patient about the safety measures.
To guarantee the safety of the partner, the patient must, for example, be advised to have sexual intercourse before using the drug or to observe the interval between the use of the drug Androgel and sexual intercourse. If sexual intercourse takes place in the range of up to 6 hours after applying the drug 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 sexual intercourse.
It is preferable to keep at least 6 hours between applying the gel and taking a bath or shower. However, an accidental shower in the period from 1 to 6 hours after applying the gel does not have a significant impact on the treatment.
Patients are advised to observe the following precautions:
- wash your hands with soap and water after applying the gel;
- close the area of ​​application of the gel with clothes after the gel dries;
- take a shower before contact with a partner.
Persons not using the drug Androgel:
- in case of contact with the area of ​​application of the gel, not previously washed with water, it is necessary to wash as soon as possible with soap and water the skin that could get testosterone;
- It is necessary to inform the doctor about the appearance and development of such signs of hyperandrogenization, such as acne or a change in normal hair growth.
If a woman is pregnant, the patient should be more careful with 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.
Patients using Androgel, when in contact with children, are recommended to wear a T-shirt covering the place of application of the gel in order to avoid the risk of skin contact of children with the drug.
The drug Androgel should not be prescribed to patients who are not able to comply with safety instructions (for example, severe chronic alcoholism, substance abuse, severe mental disorders).

Influence on ability to drive vehicles and mechanisms

Currently, there is no data on the effect of the drug Androgel on the ability to drive a car and control machines and mechanisms.

Pregnancy and lactation

Pregnant women should avoid any contact with the drug due to its possible virilizing 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 childhood

Experience with the use of the drug Androgel in children is missing.

In case of impaired renal function

Precautions should be prescribed the drug for renal failure.

With abnormal liver function

Precautions should be prescribed the drug for liver failure.

Pharmacy sales terms

You don't need a prescription to buy Androgel.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C. Shelf life - 3 years. Do not use after the expiration date.