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Androgel 16.2 mg/g 88g gel (topical application)




The instruction for medical use of Androgel® medicine the Trade name of Androgel® the International unlicensed name Testosterone Dosage Form Gel for external use of 16.2 mg/g Structure of 100 g of gel is contained: active agent – testosterone – 1.62 g excipients: an isopropyl myristate, ethanol of 96%, carbomer 980, 0.1M sodium solution hydroxide, water purified. The description Transparent or poorly opalescent colourless gel with an alcohol smell. Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Derivative 3 oxoandrostenums. Testosterone. The ATX G03BA03 code varies the Pharmacological Pharmacokinetics Degree properties of absorption of testosterone when drawing Androgel’s of 16.2 mg on skin ranging from 1% up to 8.5%. After dermal absorption testosterone comes to a system blood stream in rather constant concentration during a 24-hour cycle. Concentration of testosterone increase in serum from the first hour after drug use, reaching constant value from the second day of treatment. Daily fluctuations of concentration of testosterone have the same amplitude, as well as the changes of level of endogenous testosterone observed in circadian rhythms. Thus, transdermalny introduction helps to avoid emergence of peaks of concentration of testosterone in blood which arise after injections. Unlike oral androgens, this route of administration does not cause increase in concentration of steroids in a liver above physiological values. Use of drug Androgel 16, 2 mg/g in a dose of 5 g, causes average increase in level of testosterone in plasma approximately on 2.3 ng/ml (8.0 nmol/l). After the treatment termination the level of testosterone begins snizhatsyaprimerno in 2 hours after the last use. Concentration is restored to initial level approximately in 72-96 h after reception of the last dose. The main active metabolites of testosterone are dihydrotestosterone and oestradiol. Testosterone is generally removed with urine in the form of konyyugirovannykhmetabolit, a small amount is removed in not changed view with a stake. A pharmacodynamics the Endogenous androgens, generally testosterone cosecreted by testicles and their main metabolite — dihydrotestosterone (DGT), are responsible: – for development of external and internal genitals – preservation of secondary sexual characteristics (growth of hair on a body, development of a libido). – androgens also influence proteinaceous anabolism, development of skeletal muscles and distribution of fat in an organism, reducing excretion with urine of nitrogen, sodium, potassium, chlorides, phosphorus and water. Testosterone reduces secretion of gonadotrophins a hypophysis. Effects of testosterone on some target organs it is shown after peripheral transformation of testosterone to oestradiol which then contacts nuclear receptors of estrogen in cells of target organs (for example, a hypophysis, fatty tissue, a brain, bones and cells of Leydiga in testicles). Indications – replacement therapy by testosterone at a men’s hypogonadism when the deficiency of testosterone is confirmed with clinical symptoms and biochemical tests. A route of administration and doses Adult and elderly men the Recommended dose – 2.5 g that corresponds to two pressing (or 40.5 mg of testosterone) once a day, approximately at the same time, is preferable in the morning. The daily dose is adjusted by the doctor depending on a clinical or biological response of the specific patient, however should not exceed 5 g of gel (81 mg of testosterone) a day. Correction of a dose is carried out by consecutive pressing the doser. The dose is defined on the basis of measurement of level of testosterone in blood which has to be carried out before drug use in the morning. Steady concentration of testosterone in plasma is reached approximately from the 2nd day of treatment by Androgel. Correction of a dose is made on the basis of the level of testosterone measured after achievement of an equilibrium state, in the morning before putting drug. Testosterone level needs to be estimated at blood periodically. The dosage can be reduced if the level of testosterone exceeds the required level. If concentration of testosterone in blood plasma low, a dose can be gradually increased, but should not exceed 81 mg of testosterone (four pressing the doser). The number of pressing Amount of gel (g) Amount of testosterone applied to skin (mg) 1 1,25 20,25 2 2,5 40,5 3 3,75 60,75 4 5,0 81,0 Treatment has to be stopped if at a daily dose of 20.25 mg of testosterone (1.25 g of gel or 1 pressing the doser) testosterone level constantly is in blood above normal range and also if the normal level of testosterone is not reached at the highest dose of 81 mg (5 g of gel, or the 4th pressing the doser). Gel is applied by the patient to the clean, dry, uninjured skin of shoulders and nadplechiya. Gel is applied with a thin layer on the surface of skin and does not demand rubbing in. Before putting on, let’s gel dry within 3-5 min. After use of gel wash up hands with water and soap. In situations when after use of drug the contact with skin of other person is expected, it is necessary to wash beforehand sites of application of gel with water with soap not to apply gel on area of genitalias as the high content of alcohol in drug can cause local irritation. Before receiving the first full dose, it is necessary to pump over the doser. Holding a bottle vertically, slowly and completely press the doser 3 times then remove the gel which went out of the doser. Pumping of the doser is required only before the first use. After pumping press the doser to provide receipt of 1.25 g of gel on a palm, apply it to skin of shoulders and nadplechiya and put on after gel dries. Children: Androgel do not apply at children and men 18 years are younger, safety and efficiency of drug are not established. Data are absent. Side effects Determination of frequency of by-effects is carried out according to the following criteria: very often (≥ 1/10), it is frequent (≥ from 1/100 to & lt, 1/10), infrequently (≥ from 1/1000 to & lt, 1/100), is rare (≥ 1/10000 to & lt, 1/1000), very seldom (& lt, 1/10000) Side reactions in clinical trials the Class of a system of bodies MedRA Frequency also gt is frequent, 1/100 to & lt, 1/10 is rare 1/1000 to & lt, 1/100 Disturbances of mentality Sharp differences of mood, emotional disorders, anger, aggression, irritability, insomnia, unusual dreams, increase in a libido of Disturbance from vessels Arterial hypertension, inflows, Disturbance phlebitis from digestive tract Diarrhea, an abdominal distension, the Disturbance mouth pain from skin and hypodermic fabrics the Acne, an alopecia, xeroderma, injuries of skin, contact dermatitis, discoloration of hair, rash, hypersensitivity, an itching in the site of application of Disturbance from genitals and a mammary gland the Gynecomastia, nipple pain, pain in testicles, increase in an erection the General disorders and disturbances in the injection site Swelled with formation of yellowish crusts in the site of application Influence on results of the laboratory researches The Raised Specific Antigen of Prostate, Increase in Hematocrit and Hemoglobin Post-marketing Side Reactions Class of a System of Bodies MedRA Adverse reactions of Disturbance from blood and lymphatic system the Polycythemia, anemia of Disturbance of mentality Insomnia, a depression, alarm, aggression of Disturbance from nervous system the Headache, dizziness, Disturbance paresthesias from Vazodilatation’s (inflows) vessels, the Disturbance deep vein thrombosis from respiratory organs the Disturbance Asthma from digestive tract Disturbance Nausea from skin and hypodermic fabrics of Reaction on the site of application, the acne, an alopecia, perspiration, a hypertrichosis, increase in weight of Disturbance from skeletal and muscular and connective tissue Skeletal and muscular pains of Disturbance from kidneys and urinary tract of Difficulty with urination of Disturbance from genitals of a mammary gland the Gynecomastia, testicular disorders, increase in a prostate, an oligospermatism, a benign hyperplasia of a prostate the General disorders and disturbances in the injection site the Asthenia, hypostases, an indisposition Influence on results of the laboratory researches Increase in Level of Prostatspetsifichesky Antigen, a hematocrit and hemoglobin of the Contraindication – cancer of chest gland or suspicion on its existence – a prostate cancer or suspicion on its existence – hypersensitivity – is not applied to testosterone or other components of drug at female persons Medicinal interactions At simultaneous use of Androgel and indirect anticoagulants strengthening of action of the last by modification of synthesis of a hepatic factor of coagulation and competitive inhibition of linking with proteins of plasma is possible. The patients receiving oral anticoagulants against the background of Androgel’s use are recommended to control a prothrombin time, it is especially frequent at the beginning and/or at the end of a course of treatment androgens. Combined use of Androgel with AKTG or corticosteroids can increase risk of appearance of hypostases. It is necessary to show care at combined use of these medicines, especially at patients with diseases of heart, kidneys or a liver. Androgens can reduce levels of tiroksinsvyazyvayushchy globulin, leading to reduction of serumal concentration of T4 and to increase in sensitivity to T3 and T4. Levels of free hormones of a thyroid gland, however, remain invariable, and clinical manifestations of a hypothyroidism at the same time are absent. At reception of androgens, izmeneniyachuvstvitelnost to insulin, tolerance to glucose, the level of glucose, content of sugar and hemoglobin in blood were registered. Sick diabetes the dose decline of antidiabetic drugs can be required. Use of sunblock cream or lotion does not reduce efficiency of drug.Washing off of gel from the surface of skin in 2 hours after drawing has no significant effect on testosterone level in blood. Special instructions Androgel should be applied only in case of the confirmed hypogonadism (hypo – and hyper gonadotropic). Any other reasons which are the cornerstone of emergence of clinical symptoms have to be excluded prior to treatment. Insufficiency of testosterone has to correlate accurately with clinical manifestations, such as underdevelopment or regression of secondary sexual characteristics, change of the structure of a body, asthenia, decrease in a libido, erectile dysfunction, etc. and is confirmed by 2 independent measurements of level of testosterone in plasma. Now there is no consensus of rather accurate age norms of level of testosterone. However, it is necessary to take into account that physiological levels of serumal testosterone decrease at men with age. Owing to variability of laboratory values, definition of concentration of testosterone should be carried out in the same laboratory. Androgel is not shown for treatment of male infertility or erectile dysfunction which cause is not connected with insufficiency of testosterone. Before an initiation of treatment all patients have to undergo careful inspection to exclude presence of a prostate cancer. It is necessary to make careful and regular observation of a condition of a prostate (a manual rectal research, definition of prostatspetsifichesky antigen (DOG) in serum) and chest glands at least 1 time a year at all patients accepting testosterone, and at elderly patients and patients from risk group (with clinical or family factors) – 2 times a year. Androgens can accelerate progressing of a subclinical prostate cancer or benign hyperplasia of a prostate. Androgel it is necessary to apply with care at patients with malignant new growths because of danger of a hypercalcemia (and the accompanying hypercalcuria) owing to metastases in a bone. At these patients it is recommended to control concentration of calcium in serum. Can cause the heavy complications which are characterized by hypostases with stagnant heart failure or without it in the patients having a heavy heart, liver or renal failure, coronary heart disease treatment by testosterone. In this case treatment has to be immediately stopped. Besides, therapy by diuretics can be required. At patients with coronary heart disease Androgel it is necessary to use with care. Testosterone can cause increase in arterial blood pressure therefore Androgel it is necessary to use with care at men with arterial hypertension. Measurement of level of testosterone in blood needs to be taken before an initiation of treatment and through regular periods in the course of treatment. The doctor has to control a drug dose at each specific patient to guarantee that the level of testosterone is supported in limits of normal values. At the patients accepting androgens during the long period besides laboratory measurements of concentration of testosterone, it is periodically necessary to check the following laboratory indicators: hemoglobin, a hematocrit (for identification of a polycythemia) both functional trials of a liver and a lipidic profile. The available data on efficiency and safety of use of Androgel for patients are more senior than 65 years are limited. A consensus of rather accurate age norms of level of testosterone does not exist now. However, it is necessary to take into account that physiological levels of serumal testosterone decrease at men with age. Androgel it is necessary to take with caution at patients with epilepsy and migraine as against the background of treatment by testosterone their state can worsen. In scientific literature there are data on increase in risk of developing an apnoea in a dream for the patients with a hypogonadism receiving treatment by testosterone esters patients with obesity and chronic respiratory diseases are especially subject to risk. At the patients with diabetes receiving androgens at achievement of normal concentration of testosterone in blood plasma the increase in sensitivity to insulin can be observed. Some clinical symptoms: irritability, nervousness, increase in body weight, long or frequent erections can indicate the excessive influence of an androgen demanding dose adjustment. Some clinical symptoms: irritability, nervousness, increase in body weight, long or frequent erections can indicate the excessive influence of an androgen demanding dose adjustment. If on the place of use of drug for the patient the heavy local reaction develops, treatment has to be reconsidered and, in case of need, is stopped. High doses of androgens can cause suppression of a spermatogenesis by means of negative feedback through follicle-stimulating hormone of a hypophysis (FSG) that can potentially lead to adverse influence on sperm parameters, such as quantity of spermatozoa. At the patients with a hypogonadism receiving treatment by androgens the gynecomastia can sometimes develop. Androgel it is not necessary to apply at women because of a possible masculinization. Athletes have to be informed that as active agent drug contains testosterone which can yield positive take at doping control. The risk of accidental transfer of testosterone in the absence of precautionary measures, testosterone transfer to other person after use of drug can happen at the time of close contact of skin to the field of putting gel that leads to increase in level of testosterone, and, in case of repeated contact (accidental androgenization), to possible emergence of side effects (to increase in growth of hair in the face and/or a body, deepening of timbre of a voice, disturbance of a menstrual cycle at women, to premature puberty and development of genitalias in children). At virilescence emergence the treatment by testosterone has to be immediately stopped until the reason is not established. The doctor needs to inform the patient on risk of a peredachitestosteron and on precautionary measures (see below). ANDROGEL gel patients should not appoint 16.2 mg/g with risk of non-compliance with safety rules (for example, in cases of heavy alcoholism, drug addiction, heavy mental disorders). The possible risk of transfer considerably decreases (but is not eliminated) by wearing clothes (for example, shirts with a long sleeve), an okhva
yvayushchy the field of putting gel. The majority of residual testosterone is removed from the surface of skin by washing by water with soap just before contact. It is recommended to observe the following precautionary measures: For the patient: – to wash hands with soap after putting gel, – to cover the field of drawing with clothes (for example, a shirt with sleeves) after gel dries, – to take a shower and to carefully wash sites of application of gel with water with soap before any contact with risk of transfer of testosterone. To the persons which are not applying Androgel 16.2 mg/g: in case of contact with the patient’s skin in the field of putting gel as soon as possible to wash up the surface of skin on which there could be a transfer, water to soap, – to report about emergence and development of signs of an androgenization, such as acne or change of usual growth of hair. By results of the research on studying absorption of testosterone conducted by in Vivo with Androgel gel use preferably that patients took a bath or a shower not less, than in 2 hours after putting gel. Nevertheless, the bathtub or a shower accepted accidentally in an interval of 2 – 6 hours after putting gel have no significant effect on efficiency of treatment. To guarantee safety of the partner, the patient needs to be informed on need to wash the field of putting gel with water with soap before sexual intercourse or if it is impossible, to put on the clothes covering the site of application of drug. To the patients accepting Androgel at contact with children recommend to wear the t-shirt covering the site of application of gel to avoid risk of contact of skin of children with drug. Pregnancy and the period of a lactation eremenny women have to avoid contact with sites of use of Androgel. If the partner is pregnant, the patient has to be especially vigilant concerning the precautionary measures described above as this drug can have the undesirable virilizing action on a fruit. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Research on studying influence of Androgel on ability to drive the car and the equipment were not carried out. Androgel has no or has insignificant impact on ability to run vehicles and mechanisms. Overdose of Cases of overdose at Androgel’s use it is noted. Only one case of overdose after use of testosterone entered injektsionno is described: a stroke at the patient with high concentration of testosterone in plasma – 114 ng/ml (395th nmol/l). However it is improbable that similar concentration of testosterone in plasma can be reached when putting drug on skin. Treatment in case of overdose to be carried out by drug withdrawal in combination with the corresponding maintenance therapy. The form of release and packing On 88 g of drug in a bottle from polypropylene with a pomp doser and a polypropylene cover On 1 bottle together with the instruction for medical use in the state and Russian languages place in a cardboard pack Storage conditions At a temperature not over 25 to °SHranit out of children’s reach! 3 years not to apply a period of storage after an expiration date! Prescription status According to the prescription of Producer / Upakovshchik Bezen Manyufekchuring Beldzhium SA, Belgium Groot, Biygaardenstraat of 128, 1620 Drogenbos, Belgium the Name and the country of the holder of the registration certificate of Bezen Helscare SA, Belgium 287 Avenue Louise, 1050 Brussels, Belgium the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: Representative office ‘Bezen Helscare the Czech Republic of SRO’ in Kazakhstan, Almaty, Samal-2, 77 And
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