Omnadren® 250 (Testosterone blend), 5 x 250 mg/1 ml

Omnadren is an oil-based injectable containing a blend of four different testosterone esters: Testosterone propionate, phenylpropionate, isocaproate and caproate. Being as it is a four-ester testosterone, Omnadren is most commonly compared to sustanon. Omnadren is a four-component testosterone. The four different substances work together in such a timely manner that Omnadren remains in the body for a long time. For this reason many compare Omnadren to Sustanon 250.

Common brand names: Androderm (Testosterone), Delatestryl, Striant, Testo-100, Vogelxo, Axiron, Andronate 100, Andronate 200, Andropatch (GlaxoSmithKline), Andropository 200, Andryl 200, Bio-T-Gel (BioSante Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.), Nebido (Bayer), Sustanon (Organon), Synandrol F, Testamone 100, Testaqua IM, Testoderm, Testoderm TTS, Testogel (Bayer), Testolin, Testopatch (Pierre Fabre), Testopel Pellets, Testrin-P.A, Testro AQ, Virormone (Nordic Pharma)

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Composition

1 ml of solution contains:
active substances: testosterone propionate 30 mg, testosterone phenylpropionate 60 mg, testosterone isocapronate 60 mg, testosterone caprate 100 mg
excipients: benzyl alcohol, peanut oil.

Pharmacological properties

Pharmacokinetics

The mixture of testosterone esters contained in the preparation Omnadren® 250 leads to their different absorption and excretion in time. Tmax of testosterone in plasma occurs within 24-48 hours from the moment of injection of the drug and returns to its original value 21 days after administration of Omnadren® 250.

Testosterone propionate after injection immediately manifests its effect, lasting for 24 hours. Testosterone isocapronate and testosterone phenylpropionate begin to take effect after 24 hours, which lasts approximately 2 weeks. Testosterone caprate begins to act during the period when the action of testosterone isocapronate and testosterone phenylpropionate ceases, and lasts up to 2 weeks.

In the blood, testosterone is approximately 98% bound to a specific fraction of globulins that bind testosterone and estradiol. Testosterone is biotransformed in the liver to derivatives of 17-ketosteroids, which, after binding with glucuronic or sulfuric acid, are excreted in the urine, approximately 90%. At the same time, 6% of the administered dose is excreted in the feces in an unbound form. Pharmacodynamics

Omnadren® 250 is a testosterone ester complex in the form of propionate, phenylpropionate, isocapronate and decanoate.

Testosterone is a naturally occurring androgenic hormone produced in men in the Leydig cells of the testes. Plays a major role in stimulating and maintaining sexual function in men. It causes the growth of the gonads, prostate, seminal vesicles, affects spermatogenesis, initiates the development of secondary sexual characteristics.

Testosterone, both in men and women, has an anabolic effect, leads to an increase in muscle mass, increases bone mineral density, potentiates the formation of erythropoietin in the kidneys, and increases the concentration of hemoglobin.

In men with pituitary insufficiency, testosterone relieves the symptoms of hypogonadism. The drug is ineffective in the treatment of impotence unrelated to hypogonadism.

In women, testosterone is antagonistic to estrogen, inhibits the secretion of gonadotropins from the pituitary gland, and inhibits lactation. May cause androgenization during treatment.

 

Indications for use

The drug is intended for the substitution treatment of men with gonadal insufficiency syndrome.

- hypogonadism (delayed puberty, eunuchoidism, anorchism, Klinefelter syndrome, atrophy of the seminal glands)
- impotence caused by testosterone deficiency
- post-castration syndrome
- infertility due to impaired spermatogenesis (oligospermia, azoospermia)

In exceptional cases, the drug is used in women with diseases associated with hyperestrogenism.

 

Method of administration and dosage

Intramuscularly.

The injections should be injected deep into the gluteus muscle.

Doses are selected individually, depending on the form of the disease and the degree of dysfunction of the gonads according to the clinical assessment and the results of laboratory tests, as well as on the effectiveness of treatment, the tolerability of the drug and the general course of the disease. Usually, 1 ml is prescribed once a week.

Primary male hypogonadism (anorchism, Klinefelter syndrome, castration syndrome, atrophy of the seminal glands)

Depending on the degree of dysfunction of the gonads (according to the clinical assessment and the results of laboratory tests), the drug is administered intramuscularly once, 1 ml every 7th, 14th, 21st day. At the beginning of treatment, the drug is administered every 7 and 14 days, and after reaching the therapeutic effect, once every 21 days.

In some forms of male infertility (azoospermia, oligospermia), Omnadren 250 is prescribed in 2 ml at two-week intervals.

In exceptional cases, Omnadren® 250 is used for gender reassignment for various forms of hermaphroditism.

 

Side effects

- retention of sodium, chlorine, potassium, calcium, inorganic phosphates and water
- nausea, diarrhea, liver dysfunction, increased activity of hepatic transaminases, hepatic purpura or tumor neoplasms of the liver
- inhibition of the activity of plasma coagulation factors II, V, VII and X, bleeding in patients taking anticoagulant drugs by mouth, polycythemia
- depression, emotional disturbances, insomnia, anxiety, aggression, irritability
- bronchitis, sinusitis, cough, shortness of breath, snoring, dysphonia
- alopecia, erythema, rash, including papular, itching, acne, dry skin
- joint pain, limb pain, muscle pain; muscle spasm and cramps, increased serum creatine phosphokinase levels
- violation of urination, disorders in the urinary tract, urinary retention, nocturia, dysuria
- impaired libido (decrease or increase)
- headache, dizziness, fear, paresthesia
- raising the level of cholesterol, triglycerides in the blood
- inflammation and soreness at the injection site
- hypercalcemia
- increased blood pressure
- increased appetite, increased body weight
- an increase in the level of prostate-specific antigen (PSA) in serum
- fatigue, asthenia, hyperhidrosis, including at night
- in women - hirsutism, male pattern baldness, acne, menstrual irregularities, amenorrhea, inhibition of gonadotropin secretion, masculinization
- in men - gynecomastia, oligospermia, impaired spermatogenesis, prostatic intraepithelial neoplasia, prostate diseases, including prostatitis, tension in the prostate gland, pain in the testicles, pain and tension in the mammary glands, increased levels of estradiol in blood serum, increased testosterone levels and free testosterone in serum
- in boys - premature puberty, premature closure of the epiphyses of the bones
Seldom
- therapy of hypogonadism through testosterone replacement in rare cases can cause persistent painful erections (priapism)
Rarely
- cholestatic jaundice
In some cases
- nervousness
- short-term involuntary cessation of breathing during sleep
- increased frequency of erections
- seborrhea

 

Contraindications

- hypersensitivity to testosterone and auxiliary components of the drug
- hypercalcemia and hypercalciuria
- abnormal liver and kidney function
- prepubertal period in boys and older men
- pregnancy and lactation
- chronic heart failure, a history of myocardial infarction
- asthenic physique, common atherosclerosis
- prostatic hypertrophy with symptoms of urinary dysfunction
- prostate cancer (suspected or diagnosed) or breast cancer in men

 

Drug interactions

Omnadren increases the effect of indirect anticoagulants, therefore, in patients receiving treatment with oral anticoagulants while using androgens, especially at the beginning of treatment or after discontinuation of use, careful monitoring of the hemostatic system is necessary.

In patients receiving insulin treatment, androgens can reduce glucose concentration and insulin requirements.

When androgens are used together with adrenocorticotropic hormone or glucocorticosteroids, the risk of peripheral edema increases, especially in people with liver or heart disease.

Androgens increase the concentration of simultaneously used oxyphenbutazone.

Inducers of microsomal liver enzymes (rifampicin, barbiturates, carbamazepine, salicylates, phenytoin, etc.), when administered simultaneously, can reduce the effects of testosterone.

 

Special instructions

The drug is intended exclusively for intramuscular injection

In patients with breast cancer, androgen therapy may cause hypercalcemia due to the stimulation of osteolysis. This can increase bone metastasis. Developing hypercalcemia may necessitate discontinuation of the drug. In women undergoing androgen treatment for breast cancer, urinary and serum calcium levels should be monitored.

In patients receiving high doses of androgens, the concentration of hemoglobin and hematocrit should be monitored.

Active hepatitis is the basis for the abolition of androgens and the establishment of the etiology of hepatitis. Prolonged use of large doses of the drug can lead to tumor lesions of the liver. Elderly patients are at increased risk of hyperplasia or prostate cancer. Before and during treatment, the condition of the prostate gland should be assessed and PSA concentration monitored.

With the development of peripheral edema in patients with diseases of the cardiovascular system, liver or kidneys, the drug should be canceled.

Patients with arterial hypertension, migraine, epilepsy need regular medical supervision during treatment.

If a painful erection appears, the drug must be canceled.

Androgen therapy should be used with extreme caution in patients with delayed puberty. The condition of the skeletal system should be monitored every 6 months. Testosterone doping can cause serious side effects.

Cases of an increase in the risk of developing sleep apnea in patients receiving treatment with testosterone esters have been described, especially in the presence of risk factors (obesity, chronic respiratory diseases).

Due to the variability of laboratory parameters, the determination of testosterone concentration should be carried out in the same laboratory.

Sudden withdrawal of long-acting testosterone preparations is not contraindicated and, in addition to the slow return of symptoms of hypogonadism or ADAM (Androgen Deficiency in Aging Men) or PADAM (Partial Androgen Deficiency Syndrome in Men) or decreased libido in some women, no life-threatening symptoms have been described. The product contains peanut butter. Patients who are allergic to peanuts or soy should not use this product.

Features of the impact on the ability to drive a vehicle and potentially dangerous mechanisms

Does not affect the ability to drive vehicles and service moving machinery.

Deterioration in concentration and a decrease in the speed of psychomotor reactions is possible with the development of heart failure.

 

Overdose

An overdose of the drug is unlikely with the recommended route of administration.

Symptoms (due to the use of too high a dose or the administration of the drug more than once a week):

- prolonged erection
- hoarseness, which can lead to irreversible change in voice (in women).

Treatment: stop using the drug, conduct symptomatic therapy.

 

Storage conditions

Store at a temperature not exceeding 25 ° C in a dark place.
Keep out of the reach of children!

Shelf life - 3 years
Do not use after the expiration date.