Testosterone

Testosterone and derivatives have been reported to increase the activity of coumarin derived oral anti-coagulants. Patients receiving oral anti-coagulants require close monitoring, especially at the beginning or end of androgen therapy. Increased monitoring of the prothrombin time, and INR determinations, are recommended.

Caution should be exercised in patients predisposed to oedema, e.g. in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, as treatment with androgens may result in increased retention of sodium and water. In case of severe complications characterized by oedema with or without congestive heart failure treatment must be stopped immediately.

Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation.

Testosterone replacement therapy may reversibly reduce spermatogenesis.

Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients. Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Restandol Testocaps treatment.

Androgens may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.

Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.

Testosterone may cause a rise in blood pressure and should be used with caution in men with hypertension.

Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.

Testosterone should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentrations is recommended in these patients.

Pre-existing sleep apnoea may be potentiated.

Testosterone should be used with caution in patients with epilepsy and migraine, as the conditions may be aggravated.

Testosterone is intended for use by men only.

Testosterone is not indicated for treatment in women and therefore must not be used by pregnant women. If used during pregnancy testosterone poses a risk of virilisation of the fetus. No clinical trials have been conducted with this treatment in women.

Pregnant women must avoid any contact with testosterone gel application sites. This product may have adverse virilizing effects on the fetus. In the event of contact, wash with soap and water as soon as possible.

Testosterone is intended for use by men only.

Testosteroneis not indicated for treatment in women and therefore must not be used by breast-feeding women. No clinical trials have been conducted with this treatment in women.

Fertility

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation.

Testosterone replacement therapy may reversibly reduce spermatogenesis.

Testosterone has no influence on the ability to drive or use machines.

No studies on the effects on the ability to drive and use machines have been performed according to the use of testosterone gel.