Testosterone Mix

Package leaflet (information for patients)

Tradename
Testosterone Mix

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 ingredients: testosterone decanoate 100.0 mg, testosterone phenylpropionate 60.0 mg, testosterone isocapronate 60.0 mg, testosterone propionate 30.0 mg.
Auxiliary components: ethyl oleate.

Pharmacotherapeutic group
Androgen.

Pharmacological properties
Testosterone is the main endogenous hormone indispensable for the normal growth and development of male genital organs and male secondary sex characteristics. Throughout life in adult men, testosterone is indispensable for the functioning of the testes and related structures, as well as for maintaining libido, well-being, erectile potency, and for the function of the prostate and seminal vesicles.
Treatment of hypogonadal men with this drug leads to a clinically significant increase in the concentrations of testosterone, dihydrotestosterone, estradiol and androstenedione in plasma, as well as to a decrease in the level of SHBG (globulin that binds sex hormones); Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are restored to normal. Treatment leads to a reduction in testosterone deficiency symptoms. In addition, bone mineral density and muscle mass increase, and body weight decreases in obese patients. During treatment, sexual functions are normalized, including erectile function and libido. When using the drug, the concentration in the blood serum of HDL (high density lipoprotein), LDL (low density lipoprotein) and triglycerides decreases, the concentration of hemoglobin and hematocrit increases, while there is no clinically significant change in the level of liver enzymes and PSA (prostate specific antigen). The drug can cause an increase in the size of the prostate gland, while functional changes are not observed. In hypogonadal men with diabetes mellitus, androgen administration improves insulin sensitivity and / or decreases plasma glucose concentrations.
In boys with delayed growth and puberty, the use of androgens accelerates growth, stimulates the development of secondary sexual characteristics.
Treatment of transgender women with androgens, like Testosterone Mix, promotes virilization.

Indications for use
In men - substitution therapy for primary and secondary hypogonadism (hypopituitarism, eunuchoidism, post-castration syndrome, oligospermia); male menopause, impotence (impotentia generandi virilis); androgen deficiency (Addison's disease, adiposogenital syndrome, pituitary dwarfism), infertility (some types caused by impaired spermatogenesis).
In women - osteoporosis (against the background of androgen deficiency), breast cancer, ovarian cancer, dysfunctional bleeding with hyperestrogenism, uterine myoma, endometriosis, menopausal disorders (together with estrogens), premenstrual syndrome.
Testosterone Mix is sometimes used for various forms of hermaphroditism when there are indications for virilization of the external genital organs.

Method of administration and dosage
Injected deep into the gluteus muscle.
Doses of the drug are set individually, depending on the indications and the patient's response.
Usually, 1 ml is prescribed once every 4 weeks.
Primary male hypogonadism:
Depending on the degree of insufficiency of the gonads (according to clinical assessment and laboratory results), Testosterone Mix is administered intramuscularly every 7-14-21 days.
Initially, the drug is administered every 7-14 days, and after reaching the therapeutic effect, once every 21 days.
Male menopause:
Testosterone Mix is administered once every 14 days, and after the onset of the therapeutic effect - once every 21 days.
Infertility in men (azospermia, oligospermia):
Testosterone Mix is prescribed 2 ml once every two weeks.
In the event of a painful erection of the penis, treatment with the drug should be discontinued.
Women with climacteric syndrome are prescribed 1 ml 1 time in 2-3 weeks; for breast and ovarian cancer, 1-2 ml after 1-2 weeks, long-term treatment.

Side effects
Endocrine and genitourinary system:
- women: menstrual disorders and amenorrhea, inhibition of gonadotropin secretion, masculinization;
- men: gynecomastia, priapism, oligospermia, impaired spermatogenesis.
Skin - hirsutism, male pattern baldness, acne.
Violations of the water-electrolyte state - retention of sodium, chlorine, water, potassium, calcium and inorganic phosphates.
Digestive system - nausea, cholestatic jaundice, abnormal liver function, "hepatic" purpura or neoplastic neoplasms of the liver.
The blood coagulation system - inhibition of the activity of plasma coagulation factors II, V, VII and X, bleeding in patients taking anticoagulant drugs inside, polycythemia.
Central nervous system - libido disorders, headaches, fear, paresthesia.
Metabolic disorders - increased plasma cholesterol levels.
Boys have premature puberty, premature closure of the epiphyses of the bones.
Others are inflammation and soreness at the injection site.

Contraindication
Individual hypersensitivity to the drug, established or suspected carcinoma of the prostate, gynecomastia, hypercalcemia, hypercalciuria, heart failure, renal or hepatic failure, use in boys in prepubertal period.
In women: pregnancy and lactation.
Do not use in asthenics and elderly men.
Identified or suspected prostate or breast cancer.
Hypersensitivity to any component of the preparation, as well as to products containing soy and groundnuts (peanuts).
Children under 3 years of age (due to the content of benzyl alcohol in the preparation).

Overdose
The acute toxicity of Testosterone Mix when administered intramuscularly is very low. Priapism in men is a symptom of chronic overdose. If priapism develops, treatment with Testosterone Mix should be temporarily discontinued and, after the disappearance of the indicated symptom, resumed at lower doses.

Precautions
Patients receiving Testosterone Mix should be monitored before 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 Mix should be temporarily interrupted and, after the symptoms disappear, 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 Mix, in older patients increases the likelihood of developing prostate hypertrophy or cancer.

Interaction with other medicinal products
In patients taking oral anticoagulants, it is necessary to constantly monitor blood clotting while using androgenic drugs, especially at the beginning of treatment or drug withdrawal.
In diabetic patients, androgenic drugs can reduce glucose levels and insulin requirements.
The use of androgenic drugs with adrenocorticotropic hormone or glucocorticosteroids increases the risk of peripheral edema, especially in people with liver or heart disease.
Sometimes drugs that activate "liver" enzymes - rifampicin, barbiturates, carbamazepine, salicylates. phenylbutazone, phenytoin, primidone can reduce the effect of testosterone.

Special instructions
Carefully:
In prepubertal boys, to avoid premature epiphyseal closure and premature puberty.
Chronic heart failure, renal and / or hepatic failure to avoid the development of edema.
Diabetes.
Hypertrophy of the prostate gland with symptoms of urinary retention.
Sleep apnea, as well as risk factors such as obesity and chronic lung disease.
Childhood.

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.