Composition, form of production and packaging
Solution for the / m introduction in the form of a transparent, oily liquid of light yellow color.
1 ml
testosterone propionate 30 mg
testosterone phenylpropionate 60 mg
testosterone isocaproton 60 mg
testosterone decanoate 100 mg
Excipients: benzyl alcohol - 50 mg, peanut butter - up to 1 ml.
1 ml - ampoules (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
An androgenic preparation containing a mixture of different testosterone esters. Testosterone is necessary for the formation of testicles, the prostate gland, seminal vesicles, and the development of secondary and tertiary sexual characteristics. Participates in the formation of the constitution of the body and sexual behavior, activates libido and potency, stimulates spermatogenesis, weakens the negative manifestations of men's menopause.
Testosterone is an antagonist of female sex hormones - estrogens. It causes inhibition of the gonadotropic function of the pituitary gland and suppresses the function of mammary glands in women. During the treatment, there may be phenomena of masculinization.
Testosterone has an anabolic effect: it stimulates protein synthesis, increases calcium fixation in bones, increases muscle mass, stimulates the formation of erythropoietin in the kidneys, raises hemoglobin levels in the blood.
In healthy men, the administration of exogenous testosterone inhibits the release of one's own (endogenous) hormone by inhibiting the secretion of LH. In high doses, the drug suppresses spermatogenesis, influencing the reverse inhibition of FSH secretion.
In men with functional pituitary insufficiency, testosterone removes the symptoms of hypogonadism. If impotence is not caused by hypogonadism, then the drug does not work.
Ester testosterone esters have different rates of absorption and elimination, which provides rapid development of the effect and a prolonged effect (up to 4 weeks) after a single injection: testosterone propionate is active during the first 24 hours, the action of testosterone phenylpropionate and isocaproate begins 24 hours after injection and lasts up to 2 weeks. Testosterone capronate begins its action at a time when the effect of testosterone isocapro- nate and phenylpropionate is discontinued.
PHARMACOKINETICS
Distribution
The binding to plasma proteins (with a specific fraction of globulins) is about 98%.
Metabolism and excretion
Metabolised in the liver with the formation of various 17-ketosteroids, which after the connection with glucuronic or sulfuric acid are excreted in the urine.
Derived about 90% of the kidneys in the form of metabolites, 6% - through the intestines in an unrelated form.
T 1/2 testosterone - 10-100 min.
INDICATIONS
In men:
- Postcastration syndrome;
- oligospermia;
eunuchoidism;
hypopituitarism;
- impotence;
- male menopause;
- Androgen deficiency (including Addison's disease, pituitary tuberculosis, adiposogenital syndrome);
infertility (impaired spermatogenesis).
Among women:
- osteoporosis (against the background of androgen deficiency);
- mammary cancer;
ovarian cancer;
- dysfunctional uterine bleeding with hyperestrogenism;
- myoma of the uterus;
- endometriosis;
- Premenstrual tension syndrome;
- states associated with menopause (in combination with estrogen);
- for virilization of the external genital organs with various forms of hermaphroditism.
DOSING MODE
The drug is injected deep into the gluteus muscle.
Doses are set individually, depending on the indications and the patient's response to treatment.
Usually prescribe 1 ml 1 time in 28 days.
In primary male hypogonadism , depending on the degree of insufficiency of the gonads (according to the clinical evaluation and the results of laboratory tests) Omnadren 250 is administered / m 1 time every 7-14-21 days.
At the beginning of treatment, the drug is administered every 7-14 days, and after reaching the therapeutic effect 1 time in 21 days.
In men's climax, Omnadren 250 is administered once every 14 days, after the development of the therapeutic effect - once every 21 days.
Infertility in men (azoospermia, oligospermia) Omnadren 250 is prescribed 2 ml once every 14 days.
In the case of a painful erection of the penis should stop treatment with the drug.
Women with menopausal syndrome appoint 1 ml 1 time every 14-21 days.
In breast and ovarian cancers - 1-2 ml each 7-14 days for a long time.
SIDE EFFECT
On the part of the endocrine system: in women - dysmenorrhea, inhibition of gonadotropin secretion, masculinization, hirsutism; in men - gynecomastia, priapism, oligospermia, impaired spermatogenesis; in boys - premature puberty, premature closure of the epiphyses of bones.
On the part of the reproductive system: a violation of libido.
Dermatological reactions: acne, male pattern baldness.
On the part of the digestive system: nausea, impaired liver function, hepatic purpura, tumor liver disease, cholestatic jaundice, increased activity of hepatic transaminases.
From the coagulation system: inhibition of plasma clotting factors II, V, VII and X, bleeding in patients taking anticoagulant drugs inside, polycythemia.
From the central nervous system and peripheral nervous system: headaches, fear, paresthesia.
From the side of metabolism: increase in the level of cholesterol in the blood plasma.
Local reactions: inflammation and pain at the injection site.
CONTRAINDICATIONS
- established or suspected carcinoma of the prostate;
- gynecomastia;
- hypercalcemia;
- hypercalciuria;
- heart failure;
- kidney failure;
- liver failure;
- asthenia;
- use in boys in the prepubertal period;
- use in men of advanced age;
- Pregnancy;
- breast-feeding;
- Hypersensitivity to the drug.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy.
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in hypercalciuria, renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in case of liver failure.
If there are symptoms of hepatitis, jaundice, or changes in liver function indicators, Omnadren 250 should be revoked and the etiology of these changes should be determined. It is necessary to monitor the state of liver function.
SPECIAL INSTRUCTIONS
The drug can not be administered iv.
Androgen therapy in breast cancer may be the cause of hypercalcemia associated with the stimulation of osteolysis. This process can increase metastasis in the bone system. When treating women Omnadren 250 should monitor the concentration of calcium in the blood serum.
When assigning androgenic drugs in high doses, it is necessary to monitor the level of hemoglobin and hematocrit.
If there are symptoms of hepatitis, jaundice, or changes in liver function indicators, Omnadren 250 should be revoked and the etiology of these changes should be determined. It is necessary to monitor the state of liver function.
In elderly men, the risk of developing hypertrophy or prostate cancer increases. Before and after treatment, it is necessary to examine the condition of the prostate and monitor the level of PSA.
In patients with diseases of the cardiovascular system, liver or kidney in the development of peripheral edema, the drug should be discarded.
With care, prescribe androgen therapy to patients with delayed puberty. In this category of patients should monitor the condition of the osseous system every 6 months.
The use of Omnadren 250 as a dope can cause serious side effects.
Impact on the ability to drive vehicles and manage mechanisms
There was no direct influence of Omnadren 250 on the ability to drive vehicles and work with mechanisms. Deterioration of concentration and decrease in the speed of psychomotor reactions is possible with the development of heart failure.
OVERDOSE
Data on an overdose of Omnadren 250 is not available.
DRUG INTERACTION
In patients receiving anticoagulants inside, with the simultaneous use of Omnadren 250, especially at the beginning and with the withdrawal of therapy, constant monitoring of blood coagulation is required.
In patients with diabetes, androgenic drugs can reduce blood glucose levels and the need for insulin.
When Omnadren 250 is used with ACTH or GCS, the risk of peripheral edema is increased, especially in patients with liver or cardiovascular disease.
Drugs that cause the induction of microsomal liver enzymes (including rifampicin, barbiturates, carbamazepine, salicylates, phenylbutazone, phenytoin, primidone), can reduce the effects of testosterone.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored in a dark place at a temperature of 15 В° to 25 В° C. Shelf life - 3 years.
In case of appearance in the oily solution of a precipitate in the form of flakes, you should place the ampoule for several minutes in warm water (37 В° C).
