SUSTALAB

Testosterone salts 250 mg

Injectable solution - USE FOR ADULTS

Deep IM

FORMULA

Testosterone salts 250 mg

Injectable solution - USE FOR ADULTS

Deep IM

INDICATIONS

It is indicated for testosterone replacement therapy; in hypogonadal disorders such as: eunucoidism, hypopituitarism, endocrine impotence, the symptoms of male menopause such as decreased libido and decline in mental and physical activity, certain types of infertility caused by alterations in spermatogenesis.

Testosterone therapy may be indicated in cases of osteoporosis caused by androgen deficiency.

Delayed puberty: in cases of a history of delayed puberty, not secondary to a pathological disorder, in patients who do 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 a secondary palliative treatment of metastatic breast cancer in women with tumors or women who respond to hormones that have shown prior response to hormone therapy.

Microphallus treatment: Also called micropenis, a disease in which the child is born with a very small penis.

MECHANISM OF ACTION

At many sites of action, testosterone is not the active form of the hormone, it is converted by steroid 5-reductase into dihydrotestosterone, which is more active.

Dihydrotestosterone binds to an intracellular receptor protein and this complex binds in the nucleus, to specific hormoneregulatory elements on the chromosomes and acts to increase the synthesis of RNA and specific proteins.

Androgens are responsible for the stimulation of spermatogenesis, the development of sexual characteristics, and the maturity of sexual stimulation at puberty.

DOSE AND USE

An injection of 1 ml every three weeks is recommended, but it is preferable that the doctor sets the dose according to the individual response of the patient

CONTRAINDICATIONS AND RESTRICTIONS

In case they have any of the following diseases: breast tumors in men, prostate tumors, calcium levels in the blood, liver or kidney failure. This medicine should not be used during pregnancy as it has been shown to cause a high percentage of fetal harm.

Adverse reactions and side effects

In prepubertal children: early sexual development, increased frequency of erection, increased or failed welding of the epiphysis of the bone, excessive development of the mammary glands and growth retardation.

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 a hoarse voice that often disappear when treatment is stopped.

PRECAUTIONS AND WARNINGS

Patients with latent or manifest heart failure, kidney failure, hypertension, epilepsy should be monitored because androgens can induce water and salt retention.

This medicine should not be given to children as it may cause growth retardation and the appearance of signs of precocious puberty.

The administration of this drug to elderly patients can increase the size of the prostate.

In case of administration to women with breast tumors, treatment should be stopped if there is a significant increase in calcium levels in the blood.

It should be administered with caution in case they have any of the following diseases: diabetes, swelling of the face, hands or feet, moderate liver failure, an enlarged prostate.

Interactions with other medications

It is important to inform the physician of all medications the patient is taking due to possible drug interactions. Some of them are:

Anticoagulants: anticoagulant effect may be increased due to the decrease in the procoagulant factor, caused by the decrease in its synthesis.

antidiabetic agents (insulin): androgens can lower the level of glucose in the blood.

There is a drug interaction with: amiodarone, antibiotics, female hormones, oral contraceptives, phenytoin or valproic acid.

OVERDOSE OVERDOSE

In case of adverse effects, withdraw the use of the medicine and immediately call your doctor or pharmacist.

RECOMMENDATIONS

The intramuscular injection is to be administered deep into the muscle, due to its oily vehicle. Do not administer intravenously. Store at 15-30º C. Do not freeze. Shake well before use. Any adverse effect after the use of this product, report in writing to the National Health Surveillance Dinavisa (Brasil 783 and Fulgencio R. Moreno).

PACKAGING

oily solution for injection 10 ML VIAL

Store at a temperature below 25 ° C in a dry place.

Keep out of the reach of children.

The sale only with the prescription.