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Androgel is androgenic.
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; for the overall effect on protein anabolism; for the development of skeletal muscles and the distribution of subcutaneous fat; for a decrease in 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 cells (such as the pituitary, adipose tissue, brain, bone, etc.).
The degree of absorption of testosterone through the skin varies from approximately 9% to 14% of the applied dose.
After absorption through the skin, testosterone enters the systemic circulation in relatively constant concentrations within 24 hours.
The concentration of testosterone in 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 the drug, 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 Androgel causes an average increase in plasma testosterone concentration by approximately 2.5 ng / ml (8.7 nmol / l).
After stopping treatment, the testosterone concentration begins to decline approximately 24 hours after the last dose. Concentration returns to baseline approximately 72-96 hours after the last dose.
The main active metabolites of testosterone are dihydrotestosterone and estradiol.
Androgel is excreted mainly in the urine and feces in the form of conjugated testosterone metabolites.
Replacement therapy for endogenous testosterone deficiency.
1 bag contains:
Active substance: testosterone 0.050 g;
Excipients: isopropyl myristate, ethanol (96%), carbomer, sodium hydroxide, purified water.
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Dosage and Administration
The recommended dose is 5 g of gel (ie, 50 mg of testosterone), used once a day at about the same time, preferably in the morning. The individual daily dose can be adjusted by the doctor depending on the clinical and laboratory parameters in patients, 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 per day.
The gel is applied to clean, dry, intact skin of the shoulders, shoulder girdle and / or abdomen. 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. 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, since high content of ethanol in the preparation can cause local irritation.
Constant plasma testosterone concentration is reached around the second day of treatment with Androgel. To adjust the dose of testosterone, 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). Dosage can be reduced if plasma testosterone levels are elevated. If the concentrations are low, the dose can be increased, but not more than 10 g of gel per day.
From the side of blood and lymphatic system: changes in laboratory test results (polycythemia, lipid level changes).
From the genitourinary system: changes in the prostate gland, gynecomastia, mastodynia.
From the nervous system: dizziness, paresthesia, amnesia, hyperesthesia, mood changes.
Since the cardiovascular system: increase in blood pressure.
From the gastrointestinal tract: diarrhea.
From the skin and its appendages: alopecia, urticaria.
Common disorders: headache.
The drug contains alcohol, so when it is often applied to the skin, irritation and dryness may appear.
Carefully: malignant neoplasms (due to the danger of hypercalcemia and hypercalciuria); severe heart, liver or kidney failure; coronary heart disease; arterial hypertension; epilepsy; migraine.
Androgel should be carefully prescribed 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 end of the course of treatment with androgens.
The joint appointment 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 T concentrations.4 and to increase sensitivity to T3 and t4. The levels of free thyroid hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism.
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 preparation, it is necessary to wash the place of contact with soap and water as soon as possible.
Androgel should be used only for testosterone deficiency, accompanied by such clinical manifestations as: underdevelopment or regression of secondary sexual characteristics, changes in body structure, carbohydrate and lipid metabolism disorders, obesity, asthenia, sexual dysfunction (decreased libido, erectile dysfunction, etc.), decreased 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 to 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.
Androgel is not used to treat male infertility or erectile dysfunction, the cause of which is not related to testosterone deficiency.
Prior to testosterone administration, all patients should be screened to eliminate the risk of having prostate cancer, since 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, and in elderly or at-risk patients (with clinical or family factors) - twice a year.
Testosterone preparations should be used with caution in patients with malignant neoplasms because of the danger of hypercalcemia (and concomitant hypercalciuria), due to bone metastases. In these patients, it is recommended to control the serum calcium concentration.
In patients with severe heart, liver or kidney failure, treatment with testosterone drugs can 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.
Patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, periodically need to check the following laboratory parameters: hemoglobin, hematocrit (to detect polycythemia), 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 are receiving 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 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 an active substance (testosterone), which can give a positive reaction in anti-doping tests.
Potential Testosterone Transfer
When prescribing Androgel, it is necessary to inform the patient about the safety measures.
To ensure the safety of the partner, the patient should, for example, be advised to have sexual intercourse before using the drug or to observe the interval between the use of 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 observe the interval of 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.
It is recommended to observe the following precautions:
for the patient:
- wash hands with soap after applying the gel;
- close the area of application of the gel with clothes after the gel has dried;
- take a shower before contacting a partner.
for persons not taking 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 area of 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 the 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.
When in contact with children, it is recommended to wear a T-shirt covering the place of application of the gel, in order to avoid the risk of contact of the skin of children with 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).
Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention
Currently, there is no data on the effect of Androgel on the ability to drive a car and control machines and mechanisms.
Cases of overdose in the application of Androgel is not fixed. Only one case of overdose is 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.
- Brand name: Androgel
- Active ingredient: Testosterone
- Dosage form: Gel
- Manufacturer: Besins
- Country of Origin: Belgium
Studies and clinical trials of Androgel (Click to expand)
- Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim™, compared to AndroGel®
- Efficacy of clomid, arimidex, and androgel in normalizing testosterone in young hypogonadal men presenting with infertility and sexual dysfunction
- Adjunctive use of AndroGel (testosterone gel) with sildenafil to treat erectile dysfunction in men with acquired androgen deficiency syndrome after failure using sildenafil alone
- MP-11.09: Application of Androgel During Androgen Deficiency in Aging Male
- Androxal™ (oral enclomiphene citrate) raises free and total serum testosterone in hypogonadal men: Comparison with Androgel 1%®
- Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men
- Rationale, design and methods of the ESPRIT study: Energy, Sexual desire and body PropoRtions wIth AndroGel®, Testosterone 1% gel therapy, in hypogonadal men
- Reply to ‘Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men’
- Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men
- Response to: Efficacy of changing testosterone gel preparations (Androgel or Testim) among suboptimally responsive hypogonadal men
- Prospective Study of Topical Testosterone Gel (AndroGel) Versus Intramuscular Testosterone in Testosterone-Deficient HIV-Infected Men
- PII-LBA7 IN TWO PHASE III STUDIES, ENDROXAL™ (ENCLOMIPHENE CITRATE) SIGNIFICANTLY IMPROVES TOTAL TESTOSTERONE LEVELS COMPARED TO ANDROGEL 1.62%, WITHOUT SUPPRESSION OF SPERMATOGENESIS AND TESTICULAR FUNCTION IN OVERWEIGHT MALES WITH SECONDARY HYPOGONADISM.
- PD07-08 CHANGES IN TESTICULAR VOLUME AND FUNCTION AFTER TESTOSTERONE REPLACEMENT VS. RESTORATION: ANALYSIS OF A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED TRIAL OF ENCLOMIPHENE CITRATE VS. ANDROGEL™ 1.62% IN MEN WITH SECONDARY HYPOGONADISM