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TESTOLAND DEPOT 200mg/2mL

TESTOLAND – DEPOT 200 mg
TESTOSTERONE CYPIONATE
I.V.
ADULT USE

FORMULA

Each ampoule contains:
Testosterone cypionate ………………………………………………………. 200 mg
Excipients…………………………………………………………………….. q.s.

DESCRIPTION

Testosterone, main natural androgen, is responsible for the development and maintenance of male secondary sex characteristis, exerting a significant anabolic action. The latter contributes, especially, to accelerate the growth process at puberty, by stimulation of bone growth and modulation of the welding process of the epiphysis of long bones. Under the form of cypionate it has a long therapeutic action, once it has been hydrolized in vivo to free testosterone, being superior in this regard to propionate. Testosterone cypionate binds strongly to plasma proteins approximately in 99% and 80% to globulin, 19% to albumin, and 1% free). It is biotransformed in the liver and eliminated mainly in the urine. Its half-life as intramuscular cyprionate is approximately 8 days. In soft tissues it is turned into 5-?-dihydrotestosterone, which suppresses by negative feedback GHR, LH and FSH.

In normal individuals testosterone stimulates the production of erythrocytes because it enhances the synthesis of factors that promote erythropoiesis.

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 deficiency of LH-RH (luteinising hormone liberating hormone) or hypothalamic pituitary damage due to surgeries, traumas, tumors or radiation. 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.

Male Menopause: as replacement therapy in impotence or other symptoms associated to this disorder, when the etiology is due to a confirmed androgen deficiency.
Severe malnutrition: aplastic anemia myelofibrosis, myelosclerosis, chronic idiopathic myelofibrosis, hypoplastic anemias caused by malignancies or myelotoxic drugs. Inoperable breast carcinoma: in women with hormone-responsive tumors or women that have demonstrated prior response to hormonal therapy.

ADVERSE REACTIONS

The following reactions require medical supervision:
Virilization and menstrual irregularities in women, irritability of the bladder, gynecomastia. Anaphylaxis, oedema, erythrocytes, gastrointestinal irritation, hypercalcemia and polycythemia, androgenic alopecia, seborrhea and acne in women and men. Carcinoma, prostatic hypertrophy and increased sexual desire can be developed by patients.

Adverse reactions of rare ocurrence during a long term therapy or with high doses are: liver necrosis, leucopenia, liver purpura. Other adverse reactions are: constipation, nausea, diarrhea, infection, redness, pain or discomfort at injection site, libido alterations, stomachache, sleeping disorders, impotence, testicular atrophy, headache, anxiety, depression, generalized paresthesia, sleep apnea, rash.

CONTRAINDICATIONS

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

DOSAGE

Hypogonadism, climaterium or impotence (male replacement therapy) 60 to 400 mg I.M. every 2-4 weeks. Delayed 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 I.M. every 2 to 4 weeks.

PRECAUTIONS AND WARNINGS

In palliative treatment of breast cancer do not continue therapy if after three months of treatment ailment continues to develop or hypocalcemia has been observed at any phase of treatment. Androgen therapy in women, even for a short term, can cause virilization, especially of vocal cords and body hair.

Androgen therapy is not recommended to enhance athletic performance. In children, this drug must be used carefully due to adverse effects on bone growth that can be accelerated without producing a compensatory gain in lineal growth.

When male subjects over 50 are treated with androgens, there is a bigger risk of prostate enlargement or development of prostate cancer. For this reason, prostate examinations and blood counts must be indicated before prescribing androgens to males within this age range.

During long-term treatment oligospermia, azoospermia or reduced sperm function can occur, resulting in possible infertility, with spontaneuos remission after withdrawal of treatment. Patients with acute prostatic hypertrophy can develop acute urethral obstruction. In this case drugs should be immediately withdrawn.

Calcium leves in serum and urine should be frequently measured in women with metastatic breast carcinoma under testosterone treatment.

During treatment of prepubertal subjects bone x-rays should be performed every six months.

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

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

DRUG INTERACTIONS

Testoland-depot can interact with the following drugs:
- Adeno-, glyco- or mineralcorticosteroids: corticotrophin, food or drugs that contain sodium (may increase risk of oedema and predispose to acne).
- Oral antidiabetic agents or insulin (because there might be a decrease of glucose serum leves).
- Somatropin
- Hepatotoxic drugs (increase of hepatotoxicity).

OVERDOSE

Frequent doses can trigger symptoms of slow remission, because it is a long-acting medication. Immediate discontinuation of the medication is recommended. Go to Emergency Medical Center (Avda. Gral. Santos and Teodoro S. Mongelós),
Phone: 220 418.

FINDINGS

Use of wet needle or syringe can cause claudiness of solution that does not affect the effectiveness of the drug. If crystalls are formed in vials, gentle heating by friction between the hands or shaking can dissolve crystals. Intramuscular injection is to be administered deep into the muscle, gluteus or deltoid muscle. Do not administer intravenously.

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

PACKAGING

Oily solution for injection: each box contains 3 ampoules of 2 ml

Keep at a temperature below 25º C in a dry place.
Keep out of reach of children.

Sale only with Prescription.
Made in Paraguay