OMNADREN OIL SOLUTION AMPOULE 250MG 1 ML

PACKAGED 1 ampoule

Indications

In men:

- postcastration syndrome;

- oligospermia;

- eunuchoidism;

- hypopituitarism;

- impotence;

- male menopause;

- androgen deficiency (including with Addison's disease, pituitary anise, adiposogenital syndrome);

- infertility (violation of spermatogenesis).

Among women:

- osteoporosis (against the background of androgen deficiency);

- mammary cancer;

- ovarian cancer;

- dysfunctional uterine bleeding with hyperestrogenism;

- uterine fibroids;

- endometriosis;

- premenstrual tension syndrome;

- conditions associated with menopause (in combination with estrogen);

- for virilization of the external genital organs with various forms of hermaphroditism.

Dosing regimen

The drug is injected deep into the gluteus maximus muscle.

Doses set individually depending on the evidence and the patient's response to treatment.

Usually prescribed in 1 ml 1 time in 28 days.

At primary male hypogonadism Depending on the degree of insufficiency of the gonads (according to clinical evaluation and laboratory results), Omnadren 250 is injected intramuscularly 1 time every 7-14-21 days.

At the beginning of treatment, the drug is administered every 7-14 days, and after reaching a therapeutic effect, 1 time in 21 days.

At male climax omnadren 250 is administered once every 14 days, after the development of the therapeutic effect - 1 time in 21 days.

At male infertility (azoospermia, oligospermia) Omnadren 250 is prescribed in 2 ml 1 time in 14 days.

In the event of a painful erection of the penis, discontinue treatment with the drug.

Women with climacteric syndrome designate 1 ml 1 time every 14-21 days.

At breast and ovarian cancer - 1-2 ml every 7-14 days for a long time.

Adverse Effects

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 bone epiphyses.

From the reproductive system: violation of libido.

Dermatologic: acne, male pattern baldness.

Gastrointestinal: nausea, abnormal liver function, hepatic purpura, tumor liver diseases, cholestatic jaundice, increased activity of hepatic transaminases.

From the blood coagulation system: inhibition of plasma coagulation factors II, V, VII and X, bleeding in patients taking anticoagulant drugs orally, polycythemia.

Nervous system: headaches, fear, paresthesias.

Metabolism: increased cholesterol in the blood plasma.

Local reactions: inflammation and pain at the injection site.

Contraindications

- established or suspected prostate carcinoma;

- gynecomastia;

- hypercalcemia;

- hypercalciuria;

- heart failure;

- renal failure;

- liver failure;

- asthenia;

- use in boys in the prepubertal period;

- use in older men;

- pregnancy;

- breast-feeding;

- Hypersensitivity to the drug.

Pregnanacy and breastfeeding

The drug is contraindicated for use in pregnancy.

If necessary, the use of the drug during lactation breastfeeding should be discontinued.

Application for violations of the liver

The drug is contraindicated in liver failure.

If you develop symptoms of hepatitis, jaundice, or changes in liver function, you should stop Omnadren 250 and determine the etiology of these changes. Liver function should be monitored.

Application for violations of kidney function

The drug is contraindicated in hypercalciuria, renal failure.

Special notes

The drug should not be administered in / in.

Androgen therapy in breast cancer may cause hypercalcemia associated with osteolysis stimulation. This process may increase metastasis to the skeletal system. When treating women with Omnadren 250, the concentration of Calcium in the serum should be monitored.

When prescribing androgenic drugs in high doses, hemoglobin levels and hematocrit should be monitored.

If you develop symptoms of hepatitis, jaundice, or changes in liver function, you should stop Omnadren 250 and determine the etiology of these changes.Liver function should be monitored.

In older men, the risk of developing hypertrophy or prostate cancer increases. Before and after treatment, it is necessary to investigate the state of the prostate gland and monitor the level of PSA.

In patients with diseases of the cardiovascular system, liver or kidney, with the development of peripheral edema, the drug should be canceled.

With caution, prescribe androgen therapy to patients with delayed puberty. In this category of patients, the condition of the skeletal system should be monitored every 6 months.

Using the drug Omnadren 250 as doping can cause serious side effects.

Influence on ability to drive motor transport and control mechanisms

No direct influence of Omnadren 250 on the ability to drive vehicles and work with mechanisms was found. The deterioration of concentration and decrease in the rate of psychomotor reactions is possible with the development of heart failure.

Overdosage

Data overdose of the drug Omnadren 250 not provided.

Drug interactions

Patients receiving anticoagulants inside, with the simultaneous use of Omnadren 250, especially at the beginning and with the abolition of therapy, requires constant monitoring of blood coagulation parameters.

In patients with diabetes, androgenic drugs can reduce blood glucose and insulin requirements.

When using Omnadren 250 with ACTH or GCS increases the risk of peripheral edema, especially in patients with diseases of the liver or cardiovascular system.

Drugs that induce microsomal liver enzymes (including rifampicin, barbiturates, Carbamazepine, salicylates, phenylbutazone, phenytoin, primidone) can reduce the effects of testosterone.

Storage conditions

List B. The drug should be stored in a dark place at a temperature of from 15 ° to 25 ° C.