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Androgel 16.2 mg/g 88 g gel for external use. approx.

APPROVED BY ORDER OF THE CHAIRMAN OF THE PHARMACY COMMITTEE OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINE Androgel® Trade name Androgel® International nonproprietary name Testosterone Dosage form Gel for external use 16.2 mg/g Composition 100 g of gel contain: active substance – testosterone – 1, 62 g excipients: isopropyl myristate, ethanol 96%, carbomer 980, 0.1 M sodium hydroxide solution, purified water. Description Transparent or slightly opalescent colorless gel with the odor of alcohol. Pharmacotherapeutic group Sex hormones and modulators of the reproductive system. Derivatives of 3-oxoandrostene. Testosterone. ATC code G03BA03 Pharmacological properties Pharmacokinetics The degree of testosterone absorption when Androgel 16.2 mg is applied to the skin varies from 1% to 8.5%. After absorption through the skin, testosterone enters the systemic circulation in relatively constant concentrations over a 24-hour cycle. Serum testosterone concentrations increase from the first hour after drug administration, reaching a constant value from the second day of treatment. Daily fluctuations in testosterone concentration have the same amplitude as changes in the level of endogenous testosterone observed in circadian rhythms. Thus, transdermal administration helps avoid the appearance of peaks in testosterone concentrations in the blood that occur after injections. Unlike oral androgens, this method of administration does not cause an increase in the concentration of steroids in the liver above physiological values. The use of Androgel 16.2 mg/g at a dose of 5 g causes an average increase in plasma testosterone levels of approximately 2.3 ng/ml (8.0 nmol/l). After treatment is stopped, testosterone levels begin to decline approximately 2 hours after the last use. Concentrations return to baseline approximately 72-96 hours after the last dose. The main active metabolites of testosterone are dihydrotestosterone and estradiol. Testosterone is mainly excreted in the urine as conjugated metabolites, with a small amount excreted unchanged in the feces. Pharmacodynamics Endogenous androgens, mainly testosterone, secreted by the testes, and their main metabolite, dihydrotestosterone (DHT), are responsible for: - the development of the external and internal genital organs - the preservation of secondary sexual characteristics (body hair growth, libido development). - androgens also affect protein anabolism, the development of skeletal muscle and the distribution of fat in the body, reducing the urinary excretion of nitrogen, sodium, potassium, chloride, phosphorus and water. Testosterone reduces the secretion of gonadotropins by the pituitary gland. The effects of testosterone on certain target organs occur following the peripheral conversion of testosterone to estradiol, which then binds to nuclear estrogen receptors in target organ cells (eg, pituitary gland, adipose tissue, brain, bone, and Leydig cells in the testes). Indications for use: testosterone replacement therapy for male hypogonadism, when testosterone deficiency is confirmed by clinical symptoms and biochemical tests. Directions for use and dosage Adults and older men The recommended dose is 2.5 g, which corresponds to two pumps (or 40.5 mg of testosterone) once a day, at approximately the same time, preferably in the morning. The daily dose is adjusted by the physician depending on the clinical or biological response of the individual patient, but should not exceed 5 g of gel (81 mg of testosterone) per day. Dose adjustment is carried out by successive clicks on the dispenser. The dose is determined based on measuring the level of testosterone in the blood, which should be carried out in the morning before using the drug. A stable concentration of testosterone in plasma is achieved approximately from the 2nd day of treatment with Androgel. Dose adjustments are made based on testosterone levels measured after steady state, the morning before application of the drug. Blood testosterone levels should be assessed periodically. The dosage may be reduced if testosterone levels exceed the required level. If the concentration of testosterone in the blood plasma is low, the dose can be gradually increased, but should not exceed 81 mg of testosterone (four pumps). Treatment should be discontinued if, at a daily dose of 20.25 mg of testosterone (1.25 g of gel or 1 press of the dispenser), the testosterone level in the blood is constantly above the normal range, and also if normal testosterone levels are not achieved at the highest possible level. dose of 81 mg (5 g of gel, or 4 clicks on the dispenser). The gel is applied by the patient to clean, dry, intact skin of the shoulders and upper arms. The gel is applied in a thin layer to the surface of the skin and does not require rubbing. Before getting dressed, let the gel dry for 3-5 minutes. After applying the gel, wash your hands with soap and water. In situations where, after using the drug, contact with the skin of another person is expected, it is necessary to wash the areas where the gel is applied in advance with soap and water. Do not apply the gel to the genital area, since the high content of ethyl alcohol in the drug can cause local irritation. Before receiving the first full dose, the dispenser must be primed. Holding the bottle vertically, slowly and completely press the dispenser 3 times, then remove the gel that comes out of the dispenser. Pumping of the dispenser is required only before first use. After pumping, press the dispenser to ensure that 1.25 g of gel is delivered to the palm; Apply it to the skin of your shoulders and upper arms and get dressed after the gel has dried. Children: Androgel is not used in children and men under 18 years of age; the safety and effectiveness of the drug have not been established. No data available. Side effects The frequency of side effects is determined according to the following criteria: very often (≥ 1/10), often (≥ 1/100 to < 1/10), infrequently (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) Adverse reactions in clinical studies MedRA Organ System Class Frequency Common > 1/100 to <1/10 Rare 1/1000 to <1/100 Mental disorders Sudden mood swings, emotional disorders, anger, aggression, irritability, insomnia, unusual dreams, increased libido Vascular disorders Arterial hypertension, hot flashes, phlebitis Gastrointestinal disorders Diarrhea, bloating, pain in the mouth Physical disorders skin and subcutaneous tissues Acne, alopecia, dry skin, skin lesions, contact dermatitis, hair color change, rash, hypersensitivity, itching at the application site Genital and breast disorders Gynecomastia, nipple pain, testicular pain, increased erection General disorders and disorders at the injection site Swelling with the formation of yellowish crusts at the application site Effect on laboratory results Elevated prostate specific antigen, increased hematocrit and hemoglobin Post-marketing adverse reactions MedRA organ system class Adverse reactions Blood and lymphatic system disorders Polycythemia, anemia Psychiatric disorders Insomnia , depression, anxiety, aggression Nervous system disorders Headache, dizziness, paresthesia Vascular disorders Vasodilation (hot flashes), deep vein thrombosis Respiratory disorders Dyspnea Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Application site reactions, acne, alopecia, sweating, hypertrichosis, weight gain Musculoskeletal and connective tissue disorders Musculoskeletal pain Renal and urinary tract disorders Difficulty urinating Genital breast disorders Gynecomastia, testicular disorders, prostate enlargement, oligospermia, benign prostatic hyperplasia General disorders and disorders at the injection site Asthenia, edema, malaise Impact on laboratory test results Increased levels of prostate-specific antigen, hematocrit and hemoglobin Contraindications - breast cancer or suspicion of its presence - prostate cancer or suspicion for its presence - hypersensitivity to testosterone or other components of the drug - not used in females Drug interactions With the simultaneous use of Androgel and indirect anticoagulants, it is possible to enhance the effect of the latter by modifying the synthesis of the hepatic coagulation factor and competitive inhibition of binding to plasma proteins. For patients receiving oral anticoagulants while using Androgel, it is recommended to monitor prothrombin time, especially often at the beginning and/or end of the course of androgen treatment. Concomitant use of Androgel with ACTH or corticosteroids may increase the risk of edema. Caution is advised when using these drugs together, especially in patients with heart, kidney, or liver disease. Androgens can decrease thyroxine-binding globulin levels, resulting in decreased serum T4 concentrations and increased sensitivity to T3 and T4. Levels of free thyroid hormones, however, remain unchanged, and there are no clinical manifestations of hypothyroidism. Changes in insulin sensitivity, glucose tolerance, blood glucose, blood sugar, and hemoglobin have been reported with androgens. Patients with diabetes may need to reduce the dose of antidiabetic drugs. The use of sunscreen or lotion does not reduce the effectiveness of the drug. Washing off the gel from the surface of the skin 2 hours after application does not have a significant effect on the level of testosterone in the blood. Special instructions Androgel should be used only in cases of confirmed hypogonadism (hypo- and hypergonadotropic). Any other causes underlying the occurrence of clinical symptoms must be excluded before starting treatment. Testosterone deficiency must clearly correlate with clinical manifestations, such as underdevelopment or regression of secondary sexual characteristics, changes in body structure, asthenia, decreased libido, erectile dysfunction, etc. and is confirmed by 2 independent measurements of plasma testosterone levels. Currently, there is no consensus regarding clear age norms for testosterone levels. However, it should be taken into account that physiological levels of serum testosterone decrease in men with age. Due to the variability of laboratory values, testosterone concentrations should be determined in the same laboratory. Androgel is not indicated for the treatment of male infertility or erectile dysfunction, the cause of which is not related to testosterone deficiency. Before starting treatment, all patients should undergo a thorough examination to exclude the presence of prostate cancer. Careful and regular monitoring of the condition of the prostate gland (digital rectal examination, determination of prostate-specific antigen (PSA) in serum) and mammary glands should be carried out at least once a year in all patients taking testosterone, and in elderly patients and patients at risk ( with clinical or family factors) - 2 times a year. Androgens may accelerate the progression of subclinical prostate cancer or benign prostatic hyperplasia. Androgel should be used with caution in patients with malignant neoplasms due to the risk of hypercalcemia (and concomitant hypercalciuria) due to bone metastases. It is recommended to monitor serum calcium concentrations in these patients. In patients suffering from severe cardiac, hepatic or renal failure, or coronary artery disease, treatment with testosterone can cause severe complications characterized by edema with or without congestive heart failure. In this case, treatment should be stopped immediately. In addition, diuretic therapy may be required. In patients with coronary heart disease, Androgel should be used with caution. Testosterone can cause an increase in blood pressure, so Androgel should be used with caution in men with arterial hypertension. Testosterone levels in the blood should be measured before starting treatment and at regular intervals during treatment. The doctor should monitor the dose of the drug in each individual patient to ensure that testosterone levels are maintained within normal limits. In patients taking androgens for a long period, in addition to laboratory measurements of testosterone concentrations, the following laboratory parameters should be periodically checked: hemoglobin, hematocrit (to detect polycythemia), and liver function tests and lipid profile. Available data on the effectiveness and safety of Androgel in patients over 65 years of age are limited. There is currently no consensus regarding clear age norms for testosterone levels. However, it should be taken into account that physiological levels of serum testosterone decrease in men with age. Androgel should be taken with caution in patients with epilepsy and migraine, as their condition may worsen during testosterone treatment. There is evidence in the scientific literature of an increased risk of developing sleep apnea in patients with hypogonadism treated with testosterone esters; Patients with obesity and chronic respiratory diseases are especially at risk. In patients with diabetes mellitus receiving androgens, when normal plasma testosterone concentrations are achieved, 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. 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 at the site of administration of the drug, treatment should be reconsidered and, if necessary, discontinued. High doses of androgens may cause suppression of spermatogenesis through negative feedback via pituitary follicle-stimulating hormone (FSH), potentially leading to adverse effects on sperm parameters such as sperm count. Patients with hypogonadism treated with androgens may sometimes develop gynecomastia. Androgel should not be used in women due to possible masculinization. Athletes should be informed that the drug contains testosterone as an active substance, which can give a positive result during doping control. Risk of accidental transfer of testosterone In the absence of precautions, transfer of testosterone to another person after use of the drug can occur at the moment of close skin contact with the area of application of the gel, which leads to an increase in testosterone levels, and, in case of repeated contact (accidental androgenization), to the possible occurrence of side effects effects (increased hair growth on the face and/or body, deepening of the voice, menstrual irregularities in women, premature puberty and development of the genitals in children). If virilization occurs, testosterone treatment should be discontinued immediately until the cause is identified. The physician should inform the patient of the risk of testosterone transmission and precautions (see below). ANDROGEL 16.2 mg/g gel should not be prescribed to patients at risk of non-compliance with safety instructions (for example, in cases of severe alcoholism, drug addiction, severe mental disorders). The possible risk of transmission is greatly reduced (but not eliminated) by wearing clothing (such as a long sleeve shirt) that covers the area where the gel is applied. Most residual testosterone is removed from the surface of the skin by washing with soap and water immediately before contact. It is recommended to observe the following precautions: For the patient: - wash hands with soap after applying the gel; - cover the application area with clothing (for example, a shirt with sleeves) after the gel has dried; - take a shower and thoroughly wash the areas where the gel is applied with soap and water before any contact with the risk of testosterone transfer. For persons not using Androgel 16.2 mg/g: in case of contact with the patient’s skin in the area where the gel is applied, wash the surface of the skin to which transfer may have occurred as soon as possible with soap and water; - report the appearance and development of signs of androgenization, such as acne or changes in normal hair growth. Based on the results of an in vivo testosterone absorption study using Androgel gel, it is preferable that patients take a bath or shower at least 2 hours after applying the gel. However, a bath or shower taken accidentally between 2 and 6 hours after applying the gel does not have a significant effect on the effectiveness of the treatment. To ensure the safety of the partner, the patient should be informed to wash the area where the gel is applied with soap and water before sexual intercourse or, if this is not possible, to wear clothing that covers the application site. In contact with children, patients taking androgel are recommended to wear a t -shirt covering the place of gel application in order to avoid the risk of contacting the skin of children with the drug. Pregnancy and lactation period Eradeen women should avoid contact with androgel use areas. If the partner is pregnant, the patient should be especially vigilant in relation to the precautions described above, since this drug may have an undesirable virilizing effect on the fetus. Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms of research on the study of the influence of androgel on the ability to drive a car and equipment were not carried out. Androgel does not have or has a slight effect on the ability to drive vehicles and mechanisms. An overdose of cases of an overdose when using androgel was not noted. Only one case of an overdose after the use of testosterone introduced injected: a stroke in a patient with a high concentration of testosterone in plasma is 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. Treatment in case of an overdose is carried out by canceling the drug in combination with appropriate maintenance therapy. The form of release and packaging of 88 g of the drug in a polypropylene bottle with a pump-dosper and a polypropylene cover 1 bottle along with the instructions for medical use in the state and Russian languages are placed in a cardboard pack of storage conditions at a temperature of not higher than 25 ° C. children place! The shelf life of 3 years is not used after expiration of the shelf life! Conditions of vacation from pharmacies according to the recipe manufacturer/ Packer Bezen Magnujoring Beldzhium SA, Belgium Grot, Bihagahardenstate 128, 1620 Droogenbos, Belgium name and country of the holder of the registration certificate Helskaa Sa, Belgium 287 Avenue Luiza, 1050 Brussels, Belgium Name, Address and Contact data Organizations On the territory of the Republic of Kazakhstan, which accepts claims (proposals) on the quality of medicines from consumers and responsible for post-passing monitoring of the safety of the drug: representative office in Kazakhstan, Almaty, Samal-2, 77 A, office 3/2