Androgel gel for external use 5 g 30 pcs
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Active ingredients
Testosterone
Release form
Gel
Composition
1 package: Active substances: testosterone - 50 mg. Adjuvants: isopropyl myristate - 25 mg, ethanol (96%) - 3.57 g, carbomer 980 - 45 mg, sodium hydroxide - 236 mg, purified water - up to 5 g.
Pharmacological effect
Androgenic drug. 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), and 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 some target organs appear after peripheral conversion of testosterone to estradiol, which then binds to estrogen receptors in the nuclei of target cells (such as pituitary, fattening tissue, brain, bones etc.).
Pharmacokinetics
Absorption The amount of testosterone absorption through the skin varies from about 9% to 14% of the applied dose. Distribution After absorption, testosterone enters the systemic circulation in relatively constant concentrations for 24 hours. Serum testosterone concentration increases from the first hour after using Androgel; reaching constant values from the second day of treatment. Daily fluctuations in testosterone concentrations have the same amplitude as changes in endogenous testosterone levels observed in circadian rhythms. In the external route of administration of the drug, there are no supraphysiological peaks in testosterone concentrations in the blood that occur during the injection method of administration. 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). Metabolism The main active metabolites of testosterone are dihydrotestosterone and estradiol. Exposure After stopping 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. The drug is excreted mainly in the urine and feces in the form of conjugated testosterone metabolites.
Indications
- replacement therapy for endogenous testosterone deficiency.
Contraindications
- carcinoma of the mammary gland or suspicion of its presence; - prostate cancer or suspicion of its presence; - hypersensitivity to testosterone or other components of the drug. The experience with Androgel in women and children is absent. You should prescribe the drug for malignant tumors ( for the danger of hypercalcemia and hypercalciuria), with severe heart, liver or kidney failure, with coronary artery disease, arterial hypertension, epilepsy, migraine.
Use during pregnancy and lactation
The drug is not used in women. In the case of pregnancy, the sexual partner, the patient should be more careful about the precautions. 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.
Dosage and administration
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 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 plasma content of testosterone is increased or vice versa increased if the concentration of testosterone is low. The rules for using the drug are 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, it is necessary to immediately apply all its contents to the skin and distribute it in 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. After application, wash hands with soap and water.
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 clinical trials of Androgel, the following undesirable effects (> 1/100, <1 / 10): From the side of blood and lymphatic system: changes in the results of laboratory tests (polycythemia, changes in lipid levels). From the urogenital system: changes in the prostate gland, gynecomastia, mastodynia. From the nervous system: headache, dizziness, paresis Zia, amnesia, hyperesthesia, mood changes. From the cardiovascular system: increase in blood pressure. From the digestive system: diarrhea. Dermatological reactions: alopecia, urticaria. The preparation contains ethyl alcohol, so if it is frequently applied to the skin, irritation and dryness may occur. .
Overdose
Cases of overdose in the application of 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.
Interaction with other drugs
With the simultaneous use of Androgel and indirect anticoagulants, it is possible to enhance the action of the latter by modifying the synthesis of hepatic coagulation factor and competitive inhibition of binding to plasma proteins. Patients receiving oral anticoagulants while using Androgel are recommended to control prothrombin time, especially often at the beginning and / or at the end of the course of treatment with androgens. Combined use of Androgel with ACTH or corticosteroids may increase the risk of edema. Care should be taken when using these drugs together, especially in patients with heart, kidney, or liver disease. Androgens can 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
Androgel; should be used only with testosterone deficiency, accompanied by such clinical manifestations as underdevelopment or regression of secondary sexual characteristics, changes in the structure of the body, carbohydrate and lipid metabolism, obesity, asthenia, sexual dysfunction (including decreased libido, erectile dysfunction), decreased bone mineral density, mood swings, depression, hot flashes, etc. Before starting treatment, other possible causes underlying the above symptoms should be excluded. At present, 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, accordingly, 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; Do not use for the treatment of male infertility or erectile dysfunction, the cause of which is not related to testosterone deficiency. Before prescribing testosterone, all patients should be examined to exclude the presence of prostate cancer, because androgens may accelerate the progression of subclinical prostate cancer and benign prostatic hyperplasia glands. 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 at-risk patients (with clinical or family factors) - 2 times a year. Androgel; should be used with caution in patients with malignant neoplasms due to the danger of hypercalcemia (and concomitant hypercalciuria), due to bone metastases. In these patients, it is recommended to control serum calcium concentration. In patients suffering from severe cardiac, hepatic or renal failure, treatment with Androgel 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. Patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, periodically need to check the following laboratory indicators: hemoglobin, hematocrit (to detect polycythemia) and functional liver tests and lipid profile. Data were published about the increased risk of sleep apnea in hypogonadal patients receiving testosterone ester treatment, especially those with risk factors a, such as obesity and chronic respiratory diseases. Patients with diabetes who receive androgens, when normal plasma testosterone levels are achieved, may experience an increase in insulin sensitivity. 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 response, treatment should be reviewed and, in the case of neo obstruction. When using 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 transfer of testosterone. When administering Androgel, it is necessary to inform the patient about safety measures. for example, to advise 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 application of the drug Androgel ;, it is recommended to wear a T-shirt covering the place of application of the gel or take a shower before sexual intercourse during the contact period. However, accidental showering between 1 and 6 hours after applying the gel does not have a significant effect 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 clothing,after the gel dries; - take a shower before contact with a partner. Persons who do not use Androgel;: - in case of contact with the area of application of the gel, not previously washed with water, wash the skin with soap and water 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. Patients using Androgel; avoid the risk of skin contact of children with the drug. Androgel; should not be prescribed to patients who will not be able to comply with safety instructions (for example, severe chronic alcoholism, substance abuse, severe mental disorders). Effect on ability to drive vehicles and control machinery and mechanisms.