Testosterone Enantate Ampoules

Each ampoule contains 250mg Testosterone Enantate Ph.Eur in oily solution.

Solution for injection.

Mammary carcinoma in the female.

Androgen deficiency in the male.

Females - mammary carcinoma: 250mg every two weeks by intramuscular injection.

Males - Hypogonadism: To stimulate development of underdeveloped androgen-dependent organs and for initial treatment of deficiency symptoms, 250mg Testosterone Enantate intramuscularly every two to three weeks.

For maintenance treatment: 250mg Testosterone Enantate intramuscularly every three to six weeks, according to individual requirement.

Prostatic carcinoma, mammary carcinoma in males, hypercalcaemia, nephrosis, pregnancy and breast feeding. Previous or existing liver tumours (in advanced mammary carcinoma in the female only) if these are not due to metastases.

Testosterone Enantate should be used with caution in the elderly and in patients with renal, hepatic or cardiac impairment (including ischaemic heart disease), hypertension, epilepsy, migraine, diabetes mellitus or skeletal metastases.

Androgens should not be used for enhancing muscular development in healthy individuals or for increasing physical ability.

High dose or long term administration of testosterone occasionally increases the tendency to water retention and oedema. Caution should therefore be exercised in patients predisposed to oedema.

In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as Testosterone Enantate. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn. Regular examination of the prostate is advisable for men receiving androgen therapy.

If, in individual cases, frequent or persistent erections occur, the dose should be reduced or the treatment discontinued in order to avoid injury to the penis.

In women: If hypercalcaemia develops, therapy must be discontinued.

Phenobarbital increases the break-down of steroid hormones in the liver (possible impairment of efficacy).

The clotting status should be monitored particularly closely when Testosterone Enantate is administered together with coumarin derivatives. The hypoglycaemic effect of antidiabetics may be enhanced, possibly requiring a reduction in dosage of the hypoglycaemic agent.

Contra-indicated in pregnancy.

None known.

Water retention and oedema (associated with high doses or long term administration), severe upper abdominal complaints, liver tumours or enlargement, intra-abdominal haemorrhage, prostate abnormalities, hypercalcaemia and frequent or persistent erections may occur. See section 4.4 Special Warnings and Special Precautions for Use for further information on these undesirable effects.

Women treated with Testosterone Enantate may develop signs of virilization, (e.g. acne, hirsutism, voice changes). Particular care is therefore necessary in women whose occupations involve singing or speaking.

Spermatogenesis is inhibited by long-term and high-dose treatment with Testosterone Enantate.

In rare cases, coughing, dyspnoea and circulatory irregularities may occur during or immediately after the injection. Experience has shown that these reactions can be avoided by injecting very slowly.

Other undesirable effects that have been reported are headache, depression, nausea, cholestatic jaundice, gynaecomastia, polycythaemia, anxiety, asthenia, generalised paraesthesia, increased bone growth, male pattern baldness, precocious sexual development and premature closure in pre-pubertal males.

Acute toxicity data show that Testosterone Enantate can be classified as non-toxic following a single intake. Even in the case of an inadvertent administration of a multiple of the dose required for therapy, no acute toxicity risk is expected.

Testosterone Enantate is an ester of the natural male sex hormone testosterone and exhibits all the pharmacological effects of the natural hormone. It differs in that it has a depot effect, due to the fact that Testosterone Enantate is only slowly degraded to testosterone in the body.

Following intramuscular administration of 200mg of Testosterone Enantate to 6 hypogonadal males:-

• Peak serum testosterone levels of 1233 ± 484 ng/ml were achieved at 24 hours.

• Physiological levels of testosterone (approx. 500 ng/ml) were maintained for 11 days.

Half-life in blood was 2-3 days (healthy male volunteers).

Studies in animals showed that the formulation has minimal potential for causing sensitisation or local irritation following intramuscular injection. Long-term systemic studies showed no evidence of testicular toxicity although a temporary inhibition of spermatogenesis may occur. No fertility studies with Testosterone Enantate have been carried out. Administration of Testosterone Enantate is contraindicated during pregnancy due to the possibility of virilisation of the female foetus. However, investigations into embryotoxic, in particular teratogenic, effects gave no indication that further impairment of organ development may occur.

In vitro investigations of mutagenicity gave negative results.

Benzyl benzoate

Castor oil for injection

None so far known.

5 years.

Protect from light.

Clear glass ampoules of 1 ml in packs of 3.

Not applicable.

Alliance Pharmaceuticals Ltd

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

PL 16853/0116

19 September 1996

10/01/2011

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