Testosterone replacement therapy in patients with male hypogonadism, after confirming the testosterone deficiency based on clinical features and biochemical tests.
Composition:
1 sachet (5 g) contains 50 mg of testosterone.
Action:
Testosterone gel for percutaneous administration. Testosterone is an endogenous androgen responsible for the development of external and internal sexual organs and for the preservation of secondary sexual characteristics. Increases protein anabolism and skeletal muscle development, affects the distribution of fat in the body, reduces the excretion of nitrogen, sodium, potassium, chloride, phosphate in the urine, reduces the secretion of gonadotropins by the pituitary gland. The skin absorbs from 9 to 14% of the administered dose. By diffusion, testosterone penetrates into the systemic circulation, where it maintains its relatively constant concentration within 24 h of the cycle (diurnal changes in concentration have an amplitude similar to changes in the circadian rhythm of endogenous testosterone secretion). Administration of the product at a dose of 5 g results in an increase of testosterone concentration in the plasma by approximately 2.5 ng / ml (8.7 nmol / l). At the end of treatment, testosterone levels begin to decrease after 24 h, to normal return after 72-96 h after the last dose. The most important active metabolites are dihydrotestosterone and estradiol. Testosterone is excreted primarily in the urine and faeces in the form of conjugated metabolites.
Contraindications:
Hypersensitivity to the components of the preparation. Diagnosis or suspected prostate cancer or breast cancer. Children and youth under 18 years.
Precautions:
Before starting treatment, prostate cancer should be excluded. During the treatment, it is necessary to regularly monitor the condition of the prostate gland and breasts (at least once a year, and in the elderly and at the risk group - twice a year). The preparation should be used with caution in patients with cancer who are at increased risk of hypercalcemia. In patients with severe heart, hepatic or renal failure, the preparation may cause edema with or without congestive heart failure. The preparation should be used with caution in patients with ischemic heart disease, hypertension, epilepsy and migraine. The preparation should not be used by women due to possible virilising effects. There are reports of an increased risk of sleep apnea in people treated with testosterone esters (especially in people with chronic respiratory and obese diseases). Special care should be taken that the preparation is not passed on to other people during direct skin contact.
Pregnancy and lactation:
The preparation is intended only for men. Pregnant women must avoid contact with application sites.
Side effects:
Very common: skin reactions (erythema, acne, dry skin, reaction at the site of application); common: prostate disorder, gynecomastia, mastodynia, headache and dizziness, paresthesia, amnesia, hyperaesthesia, mood disorders, hypertension, diarrhea, alopecia, urticaria, polycythemia, changes in blood lipids. Other side effects observed during treatment with testosterone-containing preparations (whether orally or injections): libido changes, increased erection frequency, disturbances or decreased spermatogenesis resulting in testicular reduction (high doses), priapism, prostate disorders, prostate cancer (data inconclusive ), impaired urination, weight gain, changes in electrolyte concentration - sodium, chlorine, potassium, Calcium, inorganic phosphate and water retention, edema (high doses and / or long-term treatment), muscle spasms, nervousness, depression, hostility, apnea nocturnal, jaundice and abnormal liver function tests (very rarely), seborrhea acne, alopecia, hypersensitivity reactions.
Dosage:
Outwardly. Adult men: the recommended dose is 5 g of gel once a day, every day at the same time (preferably in the morning). The daily dose should be adjusted depending on the clinical response or the results of laboratory tests.Serum testosterone determinations for dose adjustment should be made no earlier than the 3rd day of therapy, preferably after a week. The dose is adjusted gradually by 2.5 g of the gel once. Do not exceed the dose of 10 g of gel a day. The gel should be smeared with a thin layer on clean, dry, healthy skin on both shoulders or abdomen. The gel does not have to be rubbed into the skin. Allow to dry for 3-5 minutes before wearing. After applying the product, wash your hands with soap and water. It is recommended to keep a gap of 6 hours between the application and the bath. Do not use on the genital area.
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