Each ampoule of 1 ml solution contains: Testosterone enanthate 250 mg
TESTOSTERON DEPOT is an ester of testosterone and enanthic acid. In the body, testosterone enanthate is hydrolysed to yield testosterone, resulting in no difference in action of esters and hormones. Testosterone main activity is: LH secretion regulation, spermatogenesis, male phenotype formation in the process of sexual differentiation and sexual maturity at puberty period in males. Testosterone enanthate in oily solution is a depo preparation of slow absorption, resulting in prolonged hormone activity. Drug is primarily metabolized in the liver, same as natural hormone, without provoking liver damage. About 90% of administered drug is excreted in the urine (as testosterone and its metabolites conjugates). Only 6% is excreted in feces, mainly in non-conjugated form.
Male hypogonadal disorders of various etiology (primary hypogonadism, hypogonadothropic hypogonadism, including micropenis in early childhood and delayed puberty). - estrogen- dependant breast carcinoma in female pre-menopause and post-menopause (1-5 years after menopause), - refractory anemias of various etiology, - osteoporosis in androgen deficiency individuals
Male hypogonadism Primary and hypogonadothropic hypogonadism: 50-400 mg every 2-4 weeks, or 250 mg every 2-3 weeks initially, and maintenance dosage of 250 mg every 3-6 weeks, by slow intramuscular injection is recommended. Micropenis: 20-50 mg every 3 weeks by slow intramuscular injection, in a short period of early childhood. Delayed puberty: 50-200 mg every 2-4 weeks by slow intramuscular injection. In general, dosage and time intervals should be individualized, depending on testosterone plasma levels and/or clinical response of the patient. In case of male child delayed puberty the skeleton maturity should be controlled every 6 months. Refractory anemias of various origin: 200-400mg, every 2-4 weeks, by slow intramuscular injection is recommended. Therapy should be discontinued after 3 months and restarted only in case haematocrit reaches the level before treatment, but after therapy discontinuation. Osteoporosis in male androgen deficiency: 250 mg 2-3 weeks at therapy start, to be followed by maintenance dose of 250 mg every 3-6 weeks, by slow intramuscular injection.
Following adverse reactions have been reported to occur as result of TESTOSTERON DEPOT treatment : 1.virilization in women: acne, facial hair growth and voice coarseness, menstrual flow disturbances. In prolonged treatment of breast carcinoma: male-pattern baldness, heavy body hairiness, increased muscle mass, clitoris hypertrophy, virilization in children: growth delay, virilization in men: constant erections at initiation of the therapy (provoked by long-term therapy or dosage decrease), azoospermia; 2.feminization in men and children: gynaecomastia; 3.toxicity: oedema (specially in high dosage therapy).
is contraindicated in: - male breast carcinoma, prostatic carcinoma , - hypercalcaemia , pregnancy, lactation, nephrosis, severe cardiac insufficiency and hypersensitivity to the drug.
TESTOSTERON DEPOT should be administered with caution in patients with: bone metastasis and immobilization, due to hypercalcaemia risk; impaired cardiac, renal or hepatic function, due to edema risk (followed or not by congestive cardiac insuficiency as complication); in elderly patients, due to hypertrophy risk and/or prostatic carcinoma; epilepsy and migraine; in boys in delayed puberty, due to inadequate skeleton growth risk. This drug has not been reported to have toxic effect. More excessive adverse reactions may be expected in case of overdosage, while symptomatic treatment and testosterone enanthate therapy discontinuation should be exercised.
In rare cases, TESTOSTERON DEPOT may cause insulin-related dosage changes in diabetic patients, and concurrent administration with spirinolactone reduces TESTOSTERON DEPOT activity. Concomitant use with corticosteroids, ACTH and oxyphenbutazone should be avoided.
On physician's prescription only.
See the package. Keep out of reach of children.