Omnadren® 250 (Omnadren® 250)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTestosterone (a mixture of esters)Testosterone (a mixture of esters)
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  • Omnadren® 250
    solution for injections 
    VALEANT, LLC     Russia
  • Sustanon-250
    solution w / m 
    Aspen Pharma Trading Limited    
    • Dosage form: & nbspinjection solution [oil]
    Composition:

    1 ml contains:

    Active substances: testosterone propionate 30 mg, testosterone phenylpropionate 60 mg, testosterone isocaproate 60 mg, testosterone decanoate 100 mg

    Excipients: petrol alcohol 50 mg, peanut butter - up to 1 ml.

    Description:Transparent oily liquid of light yellow color.
    Pharmacotherapeutic group:Androgen
    ATX: & nbsp

    G.03.B.A   Derivatives of 3-oxoandrostene

    G.03.B.A.03   Testosterone

    Pharmacodynamics:

    Omnadren® 250 is a mixture of natural testosterone hormone esters in oily solution. Testosterone, is produced in the male sex glands, in Leydig cells and is the main endogenous hormone necessary for normal growth and development of male genital organs and the development of secondary and tertiary sexual characteristics in men.

    Have adult men testosterone is necessary for the functioning of the testicles and epididymis, the prostate gland and seminal vesicles, as well as for maintaining libido, well-being, erectile function.

    Treatment of men with hypogonadism with Omnadren® 250 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 concentration of SHBG (sex hormone binding globulin); concentrations of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are restored to normal values.

    Treatment with the drug-Omnadren® 250 leads to a reduction in symptoms of testosterone deficiency. In addition, the mineral density of bones and muscle weight, in obese patients, weight loss occurs. During the treatment, sexual functions are normalized, including erectile function and libido. When the drug is used, the concentration in the serum of HDL cholesterol (lipoproteins, high density) decreases, the concentration of hemoglobin and hematocrit increase, but there is no clinically significant change, the activity of "hepatic" enzymes and PSA (prostate specific agent). The drug can cause an increase in the size of the prostate gland, with no functional changes noted. In men with hypogonadism and concomitant diabetes, the use of androgen improves insulin sensitivity and / or reduces the concentration of glucose in the blood plasma.

    In boys with delayed growth and puberty, the use of androgens, accelerates growth, stimulates the development of secondary sexual characteristics.

    Treatment of transsexual women with androgens promotes masculinization.

    Pharmacokinetics:

    Selection of testosterone esters is dictated by different rates of their absorption and elimination; providing a continuous, uniform androgenic effect of testosterone for 4 weeks after a single dose. Testosterone propionate has a rapid effect immediately after administration and up to 24 hours. Testosterone isocaproate and testosterone phenylpropionate, practically have a similar in duration action, which begins in 24 hours and lasts up to 2 weeks. Testosterone decanoate begins its action at a time when the effect of testosterone isocaproate and phenylpropionate is discontinued.

    A single dose of the drug leads to an increase in total testosterone in the plasma, the maximum concentration reaches about 70 nmol / l (Cmax) and is observed after about 24-48 hours (tmax) after administration.

    In blood testosterone binds (about 98%) to a specific fraction of globulins, - binding testosterone and estradiol.

    Metabolized in the liver to various 17-ketosteroids, which after conjugation with glucuronic or sulfuric acid are excreted by the kidneys in an amount of about 90%.

    With feces, 6% of the dose taken is taken out unbound.

    Half-life (T1/2) of testosterone is 10-100 minutes.

    Indications:

    In men - substitution therapy for primary and secondary hypogonadism (hypopituitarism, eunuchoidism, post-stroke syndrome, oligospermia); infertility (some species caused by a violation of spermatogenesis).

    Have women - climacteric syndrome, breast cancer, ovarian cancer.

    Contraindications:

    Increased individual sensitivity to the drug, established or suspected prostate cancer, gynecomastia, hypercalcemia, hypercalciuria, heart failure, renal or hepatic insufficiency, use in boys in the prepubertal period.

    In women (in addition): pregnancy and the period of breastfeeding.

    Carefully:Asthenics and men over the age of 75 years.
    Dosing and Administration:

    Intramuscularly, inject deeply into the gluteal muscle.

    Doses of the drug are set individually, depending on the indications and reactions of the patient.

    In men:

    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 intramuscularly every 7-14-21 day.

    Initially, the drug is administered every 7-14 days, and after achieving therapeutic effect 1 time in 21 days.

    Infertility

    Omnadren® 250 is prescribed 2 ml once every two weeks.

    In the case of a painful erection of the penis should stop treatment with the drug.

    In women:

    With menopausal syndrome prescribe 1 ml 1 time every 2-3 weeks;

    In breast and ovarian cancers 1-2 ml after 1-2 weeks, treatment is long.

    Side effects:

    Endocrine and genitourinary system

    women: violation of menstruation and amenorrhea, inhibition of gonadotropin secretion, masculinization. With prolonged use: atrophy of the mammary glands, virile syndrome (coarsening of the voice, excessive growth of hair on the face and body);

    men: gynecomastia, priapism, oligospermia, impaired spermatogenesis.

    Leather: Hirsutism, male pattern baldness, acne.

    Violations of the water-electrolyte state: the retention of sodium, chlorine, water, potassium, calcium and inorganic phosphates.

    Digestive system: nausea, cholestatic jaundice, impaired liver function, "hepatic" purpura, or tumor neoplasms of the liver.

    Blood coagulation system: inhibition of plasma clotting factors II, V, VII and X, bleeding in patients taking anticoagulant drugs inside.

    central nervous system: violations of libido, headaches, fear, paresthesia.

    Metabolic disorders: increasing the concentration of cholesterol in the blood plasma.

    Boys: premature puberty, premature closure of the epiphyses of bones.

    Others: polycythemia, inflammation and tenderness at the injection site.

    Overdose:

    Symptoms: priapism.

    Treatment: cessation of therapy until the disappearance of symptoms, followed by the appointment of smaller doses.
    Interaction:
    Patients who take anticoagulants inward need to maintain constant monitoring of blood coagulability with the simultaneous use of androgenic drugs, especially at the beginning of treatment or withdrawal of drugs.

    In patients with diabetes, androgenic drugs can reduce glucose and the need for insulin.

    The use of androgenic drugs with adrenocorticotropic hormone or glucocorticosteroids increases the risk of peripheral edema, especially in people with liver or heart disease.

    Inductors of microsomal liver enzymes - rifampicin, barbiturates, carbamazepine, salicylates, phenylbutazone, phenytoin, primidon can reduce the effect of testosterone.

    Special instructions:

    The drug can not be administered intravenously.

    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. With increasing hypercalcemia, the drug should be discontinued. In women, in the treatment of androgenic drugs should carefully monitor the concentration of calcium in urine and blood serum.

    When treating high doses of androgenic drugs, it is necessary to monitor the hemoglobin level in the blood and the hematocrit.

    Emerging symptoms of hepatitis: jaundice or a change in liver function is an excuse for reversing androgenic drugs andclarifying the etiology of these changes. It is necessary to monitor the functional state of the liver.

    In men of advanced age, the risk of developing hypertrophy or prostate cancer increases. Before and after treatment, it is necessary to examine the prostate gland and monitor the concentration PSA.

    The emergence of peripheral edema in individuals with diseases of the cardiovascular system, liver or kidney may be the reason for the withdrawal of the drug.

    Androgen therapy for patients with delayed puberty should be administered with caution. It is necessary to monitor the condition of the bone system every 6 months.

    The use of Omnadren® 250 as a dope may cause serious side effects.

    In the case of the precipitation of flakes in the oil solution, the ampoule should be placed for several minutes in warm water (temperature 37 ° C).

    Effect on the ability to drive transp. cf. and fur:

    There was no direct influence of Omnadren® 250 on the ability to drive vehicles and service potentially dangerous mechanisms. Possible violation of the above functions may occur in connection with the occurrence of heart failure.

    Form release / dosage:

    Solution for intramuscular administration [oily].

    Packaging:

    1 ml per ampoule of colorless glass. On the ampoule is a brown strip and the designation of the place of dissection is a white dot and a colorless notch.

    On the ampoule stick a label of self-adhesive paper.

    5 ampoules together with instructions for use are placed in a cardboard box.
    Storage conditions:

    Store in a dark place at a temperature of 15 ° to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N014397 / 01-2002
    Date of registration:03.10.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp07.06.2017
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