Testosterone Undecanoate Capsules

Testosterone is an important endogenous hormone essential for the growth and development of male sex organs and secondary sexual characteristics (stimulating hair growth, voice change and sexual desire). Oral administration of this product to hypogonadal men can achieve physiological testosterone levels in the blood circulation. In addition, it can also cause clinically significant increases in the plasma concentrations of dihydrotestosterone and estradiol, and decreases in the plasma levels of SHBG (sex hormone binding globulin). Treatment of men with primary hypogonadism (excessive secretion of gonadotropins) with this product can restore gonadotropin levels to normal. Hypogonadism in men is manifested by low serum testosterone concentrations. Symptoms of hypogonadism in men include: impotence, decreased sexual drive, fatigue, lack of energy, depression, and decreased secondary sexual characteristics. Androgens have a general effect on protein anabolism, skeletal muscle development and the distribution of fat in the body. In addition, it can also cause fluid and salt retention. Androgens also play a role in the rapid growth of puberty and the end of linear growth. Androgens can increase the production of erythropoietin, thereby stimulating the production of red blood cells. In addition, testosterone is converted into estradiol in the periphery and binds to the estradiol receptors in the target cell nuclei in certain target organs, thereby enhancing its effect in this target organ. This process can occur in the pituitary gland, adipose tissue, brain, bone and testicular interstitial cells. The inhibitory effect of exogenous androgens on the release of endogenous testosterone is dose-dependent. High doses of exogenous androgens can inhibit sperm production. Data from preclinical studies, including safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity studies and reproductive toxicity studies, did not indicate that this product is harmful to humans.

The main ingredient of this product is testosterone undecanoate, and its chemical name is: 17β-hydroxyandrost-4-ene-3-one undecanoate. Its structural formula is: Molecular formula: C30H48O3 Molecular weight: 456

This product is an oval, smooth, transparent orange capsule containing a yellow oily liquid.

Male: Testosterone replacement therapy for primary or secondary hypogonadism, such as: · after orchiectomy; · agenesis; · hypopituitarism; · endocrine impotence; · infertility caused by spermatogenesis disorders; · male menopausal symptoms, such as loss of libido, decreased mental and physical strength, etc. Female: Male gender reassignment: · masculinize females.

In general, the dosage should be adjusted appropriately according to each patient's response to drug treatment or follow the doctor's advice. Usually the starting dose is 120-160 mg per day (calculated as testosterone undecanoate, i.e. 3-4 pills) for 2-3 weeks, and then a maintenance dose of 40-120 mg per day (calculated as testosterone undecanoate, i.e. 1-3 pills). This product should be taken with meals, and can be swallowed with a small amount of water if necessary. The whole capsule must be swallowed without chewing. The daily dose can be divided into two equal parts, one in the morning and one in the evening. If the number of capsules cannot be divided into two equal parts, take the larger portion in the morning.

The adverse reactions that may be caused by androgen therapy are as follows: If the above adverse reactions occur, treatment should be stopped until the symptoms disappear and then resumed from a low dose.

1. Men diagnosed or suspected of prostate cancer or breast cancer 2. Pregnancy 3. Breastfeeding 4. People who are allergic to any ingredient in this product.

Precautions for children: There is a lack of safety research data on the use of this product in children. Precautions for pregnancy and lactation: This product is contraindicated for pregnant women. There have been reports of pregnant women taking testosterone, and the results showed that testosterone was harmful to the fetus (genital abnormalities, pseudohermaphroditism). Animal studies have shown reproductive toxicity. It is not clear to what extent testosterone is excreted through breast milk. In view of the lack of data, this product should not be used by lactating women. Precautions for the elderly: There is a lack of safety research data on the use of this product in elderly patients.

1. Must be taken with meals to produce appropriate plasma testosterone levels. 2. Protein-bound iodine (PBI) may decrease, but this phenomenon has no clinical relevance. 3. Androgens will enhance the anticoagulant effect of coumarin preparations. Therefore, it is recommended to monitor prothrombin time and INR frequently. 4. Androgen treatment of diabetic patients may lead to increased insulin sensitivity. 5. The use of this product may affect the results of certain laboratory tests.

Store below 30℃, no need to refrigerate. Store in aluminum foil packaging away from light.

40mg

36 months.