Testosterone Enanthate

Package leaflet (information for patients)

Tradename
Testosterone enanthate

Dosage form
Solution for injection 250 mg/ml.

Description
Transparent liquid of light yellow color with a weak odor.

Composition
1 ml of solution contains:
Active ingredient: Testosterone Enanthate 250mg.
Auxiliary components: ethyl oleate.

Pharmacotherapeutic group
Androgen.

Pharmacological properties
Testosterone Enanthate is a testosterone ester.
Testosterone is the primary male sex hormone synthesized and secreted by the testicles. It stimulates the growth and development of male genital organs and secondary sexual characteristics (maturation of the prostate, seminal vesicles, penis and scrotum), male-pattern hair distribution on the face, pubis, chest), the development of the larynx, body muscles and fat distribution. Retains nitrogen, sodium, potassium and phosphorus, enhances anabolism and reduces protein catabolism. A premature increase in the concentration of testosterone in the blood plasma in the period before puberty causes the closure of the pineal glands and the suspension of growth. Stimulates the production of erythropoietin and erythrocytes. By the mechanism of negative feedback inhibits the secretion of luteinizingand follicle-stimulating hormones of the pituitary gland and inhibits spermatogenesis. In men with primary hypergonadotropic hypogonadism, the level of gonadotropins is normalized.
In women, it inhibits the gonadotropic function of the pituitary gland, the function of the ovaries, mammary glands, and causes endometrial atrophy. Antagonistic action in relation to estrogen is used in the treatment of fibroids, endometriosis, breast cancer. Shows a beneficial effect on complaints of the climacteric period.

Indications for use
In men, Testosterone enanthate is used in hormone replacement therapy for disorders associated with testosterone deficiency:
- delayed puberty;
- eunuchoidism, underdevelopment of the genitals;
- endocrine impotence;
- hypopituitarism ;
- symptoms of male menopause (decreased libido, mental and physical activity);
- post - castration syndrome (androgen deficiency after castration);
- osteoporosis due to androgen deficiency.
In women, indications for use are:
- hyperestrogenism, functional bleeding; uterine fibroids; endometriosis ; menopause (in combination with estrogen); mammary cancer;
- osteoporosis.

Method of administration and dosage
Testosterone enanthate is injected intramuscularly, deep into the gluteus muscle. The dosage regimen is selected individually, depending on the disease, gender, age, clinical effect.
As a rule, adults are injected intramuscularly with 50-200 mg every 2-4 weeks.
It is not recommended to exceed the dose of 400 mg per month. The duration of treatment is set individually.
For hypogonadism in men such as eunuchoidism, the recommended dose is 50-400 mg every 2-4 weeks.
With a delay in puberty, 50-200 mg is used every 2-4 weeks for 4-6 months.
For breast cancer in women: 200-400 mg every 2-4 weeks.
The drug should not be administered intravenously!

Side effects
Priapism and other signs of excessive sexual stimulation (frequent erections); in boys in the prepubertal period - accelerated sexual development, increased frequency of erections, enlarged penis and premature closure of the epiphyses; damage to spermatogenesis and impaired sperm maturation, oligospermia and a decrease in ejaculate volume ; anomalies of the prostate gland.
in women - bleeding from the birth canal, increased libido; with prolonged use of the drug, symptoms of virilization are possible; hirsutism, gynecomastia; seborrhea, acne, oily skin, accelerated hair loss; sodium and water retention, edema; symptoms of hypercalcemia ; thrombophlebitis; nausea, cholestatic jaundice, increased levels of liver aminotransferases (as the intake is discontinued, they normalize); headache, depression, aggressiveness, anxiety, sleep disturbance, paresthesia.
Pain, itching and redness at the injection site are possible.
In acute overdose, testosterone toxicity is extremely low.
With chronic overdose, priapism may develop. In this case, treatment should be discontinued, and after the disappearance of symptoms, start in lower doses.

Contraindication
Hypersensitivity to the components of the drug, prostate or breast carcinoma; hypertrophy of the prostate gland with symptoms of urinary disorders; nephrosis or nephrotic phase of nephritis, edema; hypercalcemia ; impaired liver function; diabetes; heart and coronary insufficiency, a history of myocardial infarction, atherosclerosis in older men; pregnancy, breastfeeding.

Overdose
When using the drug in high doses for a long time, the side effects and symptoms described above associated with androgen dependence occur. Treatment in this case should be suspended until stabilization of the condition, after which Testosterone propionate should be prescribed in lower doses.
In women, overdose may cause cessation of menstruation.

Precautions
Patients receiving Testosterone Enanthate should be monitored by a physician before starting treatment and quarterly for 12 months and thereafter once a year. The following studies should be carried out:
Digital rectal examination (DRE) to exclude benign prostatic hyperplasia (see the same sentence) and determination of prostate specific antigen (PSA) to exclude subclinical forms of prostate cancer;
Measurement of hematocrit and hemoglobin to exclude polycythemia.
In patients with preexisting heart, kidney, or liver disease, androgen treatment can cause complications characterized by edema with or without acute heart failure.
In case of adverse reactions associated with the use of androgens, treatment with Testosterone Enanthate should be temporarily interrupted and, after the disappearance of symptoms, resumed at a lower dose.
The use of androgens off-label, but to enhance endurance in athletes, poses serious health risks. The use of androgens, including Testosterone Enanthate, in older patients increases the likelihood of developing prostate hypertrophy or cancer.

Interaction with other medicinal products
Increases the effectiveness of anticoagulants and hypoglycemic agents (it is necessary to change the dose), inhibits the excretion of cyclosporine. Liver enzyme inducers (barbiturates, rifampicin, carbamazepine, phenylbutazone, phenytoin ) reduce the effect of testosterone.

Special instructions
In the event of androgen - dependent adverse reactions, testosterone treatment should be discontinued. After the side effects disappear, resume treatment at lower doses.
Patients with latent or severe heart failure, impaired renal function, hypertension, epilepsy, or migraine (or a history of these conditions) should be monitored continuously, since androgens can in some cases cause sodium and water retention. With prolonged use, check liver function. In patients with breast cancer, hypernephroma, lung cancer with bone metastases, check the level of calcium in the blood and urine.
In prepubertal boys, androgens should be used with caution to avoid premature epiphyseal closure and accelerated sexual development.

Pregnancy and elbowing
Pregnant and breastfeeding women are prohibited from taking the drug, since it has a teratogenic effect.

Influence on the ability to drive vehicles and work with mechanisms
Does not affect

Storage conditions
Store away from sunlight, out of reach of children at a temperature of 5–25 ° С., out of the reach of children.

Shelf life
5 years. Do not use after the expiration date printed on the package.

Vacation conditions
On prescription.

Packaging
The solution is in 1 ml glass ampoules. Each ampoule is fixed in a plastic clip for 5 ampoules. 5 ampoules are packed in a cardboard box in a fixer together with an enclosed leaflet.