Androgens.

Testosterone

Each capsule contains Testosterone Undecanoate 40.0mg which is equivalent to 25.3mg testosterone.

Oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.

Clinical Indications Testosterone replacement therapy in male hypogonadal disorders, for example: after castration; eunuchoidism; hypopituitarism; endocrine impotence; male climacteric symptoms like decreased libido and decreased mental and physical activity; certain types of infertility due to disorders of spermatogenesis Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.

Dosage

Adults

The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.

Administration

Oral.

To ensure absorption, Restandol Testocaps must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.

Safety and efficacy has not been determined in children.

It should be noted that smaller and less frequent doses may achieve the same response.

Pregnancy

Breast feeding

Known or suspected prostatic or mammary carcinoma;

History of liver tumours

Hypersensitivity to the active substance or to any of the excipients.

Patients, especially the elderly, with the following conditions should be monitored:

Pre-existing cardiac, renal or hepatic disease since oedema with or without congestive heart failure may result from androgen treatment. In addition to discontinuation of the drug, diuretic therapy may be required.

Mammary carcinoma, hypernephroma, bronchial carcinoma, and skeletal metastases, since these conditions may produce hypercalcaemia or hypercalciuria which may in turn be exacerbated by androgen therapy. If hypercalcaemia or hypercalciuria develops treatment should be discontinued.

Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development.

Caution is required when administering with anticoagulants and anti-diabetic agents, since androgens in general can affect glucose tolerance and the action of anticoagulants.

There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnea. Good clinical judgment and caution should be employed in subjects with risk factors such as adiposity or chronic lung diseases.

Androgen therapy should only be used in male hypogonadism in which testosterone levels have been demonstrated to be low.

In treating males, stimulation to the point of increasing nervous, mental and physical activities beyond the patient's cardiovascular capacity should be avoided.

Tumours and other histological abnormalities and disturbances of liver function have been reported in patients subjected to prolonged treatment with some testosterone derivatives. Most of these compounds were 17-alpha alkyl derivatives but a smaller number of cases have occurred with certain 17-beta esters of testosterone. The possibility that such changes result from the use of Restandol Testocaps has not been excluded.

If undesirable effects occur, administration of Restandol Testocaps should be discontinued and/or resumed at a lower dose.

Concurrent administration of liver enzyme inducing drugs such as rifampicin, barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin or primidone may decrease the effect of Restandol Testocaps.

Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic subjects. Patients on insulin or other anti-diabetic medication should be closely monitored, with therapy adjusted as appropriate.

High doses of androgens may enhance the anticoagulant action of coumarine type agents and additional monitoring of INR and adjustment of anticoagulant dose may need to be considered

Restandol Testocaps must be taken with a normal meal to ensure absorption.

If Restandol Testocaps are used in children precocious sexual development and cessation of the bone growth may occur by premature and irreversible epiphyseal closure.

In women, androgens have been described to cause symptoms of virilisation such as hirsutism, acne and voice changes (deepening, hoarsening). The voice changes may be irreversible.

Other adverse drug reactions of testosterone treatments that have been reported are:

Prostatic growth, progression of a sub-clinical prostatic cancer, PSA increased, urinary obstruction, gynaecomastia, pruritis, nausea, cholestatic jaundice, changes in liver function tests, increased or decreased libido, depression, nervousness, mood disturbances, myalgia.

With high doses and prolonged treatment electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), hypertension, oligozospermia, or azospermia, priaprism, changes in lipid metabolism, polycythaemia, oligo- or amenorrhoea.

Organon Laboratories Limited

(POM)

21 May 2009