It is indicated for testosterone replacement therapy; in hypogonadal disorders as: eunuchoidism, hypopituitarism, endocrine impotence, male menopause symptoms such as decreased libido and decay of mental and physical activity, certain types of infertility caused by disturbances of spermatogenesis.
A testosterone therapy might be indicated in cases of osteoporosis caused by androgen deficiency.
Delayed Puberty: in cases of history of delayed puberty, not secondary to a pathological disorder, in patients who did not respond to psychological support therapy.
Congenital or acquired primary hypogonadism: in cases of testicular failure due to cryptorchidism, bilateral torsion, testicular absence syndrome or orchydoctomy.
Breast carcinoma: as secondary palliative treatment of metastatic breast cancer in women with hormone-responsive tumors or women that have demonstrated prior response to hormonal therapy.
Microphallus Treatment: also called micropenis, a disease in which the child is born with abnormally small penis.
MECHANISM OF ACTION
In many sites of action testosterone is not the active form of the hormone, it is converted by means of steroid 5-reductase in dihydrotestosterone which is more active.
Dihydrotestosterone binds to an intracelular receptor protein and this complex is fixed in the core, to specific hormoneregulatory elements on chromosomes and acts to increase RNA synthesis and specific proteins.
Androgens are responsible for the stimulation of spermatogenesis, the development of sexual characteristics, and maturity of sexual stimulation at puberty.
DOSAGE AND USE
An injection of 1 ml every three weeks is recommended, but it is preferable that the physician establishes the dose according to individual patient response
CONTRAINDICATIONS AND RESTRICTIONS
In case of having any of the following diseases: breast tumors in men, prostate tumors, high blood calcium levels, severe liver or kidney failure. This drug must not be used during pregnancy since it has been demonstrated that it produces a high percentage of fetal harm.
ADVERSE REACTIONS AND SIDE EFFECTS
In prepubertal children: precocious sexual development, increased frequency of erection, increase or welding failure of the epiphysis of the bone, excessive development of mammary glands and delayed growth.
Oligosperm or decreased ejaculatory volume.
Salt and water retention.
Priapism or excessive sexual stimulation signals.
When used in high doses in women, testosterone can cause masculinization with signs such as hair growth and hoarse voice that usually disappear when treatment is withdrawn.
PRECAUTIONS AND WARNINGS
Patients with latent or overt cardiac failure, kidney failure, hypertension, epilepsy should be monitored because androgens may induce water and salt retention.
This drug should not be administered to children as it can cause a delay in growth and appearance of signs of early puberty.
Administration of this drug to elderly patients can increase the size of prostate.
In case of administration to women with breast tumors, treatment should be discontinued if there is a significant increase of blood calcium levels.
It should be administered with caution in case of having any of the following diseases: diabetes, swelling of face, hands or feet, moderate liver failure, enlarged prostate.
It is important to inform the physician of all medications the patient is consuming because of possible drug interactions. Some of them are:
Anticoagulants: anticoagulant effect may be increased because of decreased procoagulant factor, caused by its decreased synthesis.
Antidiabetic agents (insulin): androgens may decrease blood glucose concentration.
There is drug interaction with: amiodarone, antibiotics, female hormones, oral contraceptives, phenytoin or valproic acid.
In case of adverse effects withdraw use of the drug and immediately call your doctor or pharmacist.
Intramuscular injection is to be administered deep into the muscle, due to its oily vehicle. Do not administer intravenously. Keep at 15-30º C. Do not freeze. Shake well before use. Any adverse effect after the use of this product please report in writing to the National Health Surveillance DINAVISA (Brasil 783 and Fulgencio R. Moreno).
Box with 1 ml ampoule.
Keep at a temperature below 25º C in a dry place.
Keep out of reach of children.
Sale only with Prescription.
Made in Paraguay