Sustamed
Producer: SC Balkan Pharmaceuticals SRL (Balkans Pharmasyyutikals) Republic of Moldova
Code of automatic telephone exchange: G03BA03
Release form: Liquid dosage forms. Solutio oleosa for injections.
General characteristics. Structure:
Active ingredients of a dosage of 125 mg/ml: 15 mg of Testosteroni propionas, 30 mg of testosterone of a fenilpropionat, 30 mg of testosterone of an izokapronat, 50 mg of testosterone of a dekanoat.
Active ingredients of a dosage of 250 mg/ml: 30 mg of Testosteroni propionas, 60 mg of testosterone of a fenilpropionat, 60 mg of testosterone of an izokapronat, 100 mg of testosterone of a dekanoat.
Excipients: benzyl alcohol, benzyl benzoate, oil peanut or peach.
Oil mix of androgenic hormones.
Pharmacological properties:
Pharmacodynamics. Sustamed consists of four esters of testosterone (propionate, a fenilpropionat, an izokapronat and a dekanoat).
Testosterone is primary male sex hormone synthesized and emitted by testicles. It stimulates growth and development of men's generative organs and secondary sexual characteristics (maturing of a prostate, seed bubbles, a penis and a scrotum), distribution of hair on men's type on a face, a pubis, a breast), development of a throat, muscles of a body and fat distribution. Nitrogen, sodium, potassium and phosphorus detains, strengthens anabolism and reduces a catabolism of proteins. Premature increase in concentration of testosterone in a blood plasma during the period before puberty causes closing of an epiphysis and suspension of growth. Stimulates products of erythropoetin and erythrocytes. On a negative feedback mechanism (feedback) oppresses secretion of luteinizing and follicle-stimulating hormones of a hypophysis and the spermatogenesis oppresses. At men with primary hyper gonadotropic hypogonadism normalization of level of gonadotrophins is noted.
At women oppresses gonadotropic function of a hypophysis, function of ovaries, mammary glands, causes an endometria atrophy. Antagonistic action in relation to estrogen is applied at treatment of myomas, endometriosis, breast cancer. Shows beneficial effect at complaints of a climacteric.
Pharmacokinetics. The ethers of testosterone which are a part of drug have various speed of absorption and removal that provides bystry and long (to 4 weeks) effect after a single injection: Testosteroni propionas works within the first days, effect of testosterone of a fenilpropionat and izokapronat begins in 24 h after an injection and continues to 2 weeks. Testosterone деканоат begins the effect later, but works is longer. In blood of nearly 98% of testosterone contacts the specific fraction of globulins connecting testosterone and oestradiol. Biotransformation occurs in a liver to various 17 ketosteroids which after conjugation with glucuronic or sulphuric acid are allocated with urine (about 90%). About 6% of the absorbed drug are removed with a stake in an untied look.
Indications to use:
Men have an androgenic insufficiency after castration, an eunuchoidism, a hypopituitarism, impotence of a hormonal origin, symptoms of a men's climax (decrease in a libido, intellectual and physical activity), some forms of infertility with disturbance of a spermatogenesis, the osteoporosis caused by androgenic insufficiency; women have a hyperestrogenism; hysteromyoma; endometriosis; breast cancer; osteoporosis.
Route of administration and doses:
Intramusculary, it is deep in a gluteus. The dose is established individually depending on indications and reaction of the patient.
As a rule, the adult in oil enter 1 ml of solution in 14 days; at achievement of therapeutic effect – 1 ml in oil in 28 days. Duration of treatment is established individually.
At infertility at men (an azospermiya, an oligospermatism): on 2 ml of 1 times each 2 weeks (at emergence of a painful erection of a penis treatment is stopped).
At a breast cancer at women: on 1–2 ml each 1–2 weeks, prolonged treatment.
The drug cannot be administered intravenously!
Features of use:
In case of androgenzavisimy side reactions treatment by testosterone should be stopped. After disappearance of side effects to resume treatment in lower doses.
Patients with the latent or expressed heart failure, a renal failure, hypertensia, epilepsy or migraine (or existence of these states in the anamnesis) are subject to constant observation as androgens can cause a delay of sodium and water in some cases. At long reception to check functions of a liver. At patients with cancer of a mammary gland, a hypernephroma, lung cancer with metastasises in bones to check calcium level in blood and urine.
At boys in the prepubertatny period androgens have to be applied with care in order to avoid premature closing of an epiphysis and the accelerated sexual development.
Side effects:
Pain, itch and hyperemia in the place of an injection are possible.
Interaction with other medicines:
Increases efficiency of anticoagulants and hypoglycemic means (it is necessary to change doses), inhibits cyclosporine removal. Inductors of liver enzymes (barbiturates, rifampicin, carbamazepine, phenylbutazone, Phenytoinum) reduce effect of testosterone.
Contraindications:
The increased individual sensitivity to drug components, a carcinoma of a prostate or mammary gland; a prostatauxe with symptoms of disturbance of an urination; nephrosis or nephrotic phase of nephrite, hypostases; hypercalcemia; abnormal liver function; diabetes mellitus; heart and coronary failure, a myocardial infarction in the anamnesis, atherosclerosis at elderly men; pregnancy, feeding by a breast.
Overdose:
At acute overdose toxicity of testosterone extremely low. At chronic overdose development of a priapism is possible. In this case treatment should be stopped, and after disappearance of symptoms - to begin in smaller doses.
Storage conditions:
To store at a temperature of 15-25 °C, in dry, protected from light and the place, unavailable to children. Period of validity of 5 years. Not to use after the expiry date specified on packaging.
Issue conditions:
According to the recipe
Packaging:
Solution for injections of oil 125 mg/ml and 250 mg/ml on 1 ml or 2 ml in ampoules and on 2 ml or 5 ml in bottles.