TESTOLAB

Testosterone Enanthate 250mg / ml

IV

USE FOR ADULTS

FORMULA

Testosterone Enanthate 250mg / ml

IV

USE FOR ADULTS

DESCRIPTION

Testosterone, the main natural androgen, is responsible for the development and maintenance of male secondary sexual properties, exerting a significant anabolic action.

The latter contributes, especially, to accelerate the growth process at puberty, by stimulating bone growth and modulating the welding process of the epiphysis of long bones. In normal subjects it promotes enzyme RNA polymerase activity and specific RNA synthesis, resulting in increased protein production.

Testosterone stimulates erythrocite production by promoting the synthesis of erythropoiesis-stimulating factors.

INDICATIONS

Congenital or acquired primary hypogonadism: in cases of testicular failure due to cryptorchidism, bilateral torsion, testicular absence syndrome or orchydoctomy.

Hypogonadotrophic hypogonadism: in cases of congenital or acquired LH-RH (luteinizing hormone releasing hormone) deficiency or pituitary hypothalamic damage due to surgery, trauma, tumors, or radiation.

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.

Male menopause: as replacement therapy in impotence or other symptoms associated with this disorder, when the etiology is due to a confirmed androgen deficiency.

Severe malnutrition.

Specific anemia: myelofibrosis aplastic anemia, myelosclerosis, chronic idiopathic myelofibrosis, anemias caused by hypoplasia malignant tumors or myelotoxic drugs.

Inoperable breast carcinoma: as a secondary palliative - tertiary treatment of metastatic breast cancer in women with tumors or women who respond to hormones that have shown prior response to hormone therapy.

ADVERSE REACTIONS

The following reactions require medical supervision:

Virilization and menstrual irregularities in women, bladder irritability, gynecomastia. Anaphylaxis, edema, erythrocytes, gastrointestinal irritation, hypercalcemia and polycythemia, androgenic alopecia, seborrhea, and acne in women and men. Carcinoma, prostatic hypertrophy and increased sexual desire.

Rare adverse reactions during long-term or high-dose therapy are: liver necrosis, leukopenia, liver purpura.

Other adverse reactions are: constipation, nausea, diarrhea, infection, redness, pain or discomfort at the injection site, changes in libido, stomach pain, sleep disorders, impotence, testicular atrophy, headache, anxiety, depression, generalized paraesthesia, sleep apnea, skin rash.

CONTRAINDICATIONS

This drug is contraindicated in male patients with breast cancer, diagnosed or suspected prostate cancer or adenoma, severe cardiac, liver or kidney failure, in prepubertal patients or in aggressive state, during pregnancy, hypercalcemia.

DOSAGE

Hypogonadism, climacteric or impotence (male replacement therapy) 50 to 400 mg intramuscularly every 2-4 weeks.

delay of male puberty (replacement therapy) 25 to 200 mg every 2-4 weeks, for a limited period of 6 months.

Antineoplastic, in inoperable breast cancer (women) 200 to 400 mg intramuscularly every 2 to 4 weeks.

PRECAUTIONS AND WARNINGS

In the palliative treatment of breast cancer do not continue therapy if after three months of treatment ailment continues to develop or hypocalcaemia has been reported in any phase of treatment.

Androgen therapy in women, even for a short term, can cause virilization, especially of the vocal cords and body hair.

Androgen therapy is not recommended to improve athletic performance. In children, this medicine should be used with caution due to adverse effects on bone growth that can be accelerated without producing a compensatory increase in linear growth.

When male subjects older than 50 are treated with androgens, there is an increased risk of an enlarged prostate or the development of prostate cancer. For this reason, prostate examinations and blood counts should be indicated before prescribing androgens in men within this age range.

During long-term treatment oligospermia, azoospermia or reduced sperm function may occur, resulting in possible infertility, with spontaneous remission after withdrawal of treatment.

Patients with benign prostatic hypertrophy can develop acute urethral obstruction. In this case, the drugs must be withdrawn immediately.

Mild serum and urine calcium should frequently be measured in women with metastatic breast carcinoma on testosterone treatment.

During the treatment of subjects prepubertal bone radiographs should be performed every six months.

In patients with acute intermittent porphyria, androgens can precipitate attacks of this condition.

It is generally recommended to start with full doses and titrate according to individual needs.

Interactions with other medications

Testosterone can interact with the following medications:

- Adrenocorticosteroids, glycocorticosteroids or mineralocorticoids: corticotropin, foods or medicines containing sodium (may increase the risk of edema and predispose to acne).

- Oral antidiabetic agents or insulin (because there may be a slight decrease in serum glucose).

- Somatropin

- Hepatotoxic drugs (increased hepatotoxicity).

OVERDOSE

Frequent doses can trigger slow remission symptoms, because it is a long-acting drug. Immediate discontinuation of medication is recommended.

RECOMMENDATIONS

The use of a wet needle or syringe can cause solution claudiness that does not affect the effectiveness of the drug. If it crystallizes in the vial, slight friction heating between the hands or shaking can dissolve the crystals.

The intramuscular injection is to be administered deep into the muscle, gluteal or deltoid muscle. Do not administer intravenously.

Store at 15-30º C. Do not freeze. Shake well before use.

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.