Testosterone Enanthate Ampoules (Cambridge Laboratories)

1. Name Of The Medicinal Product

Testosterone Enanthate Ampoules

2. Qualitative And Quantitative Composition

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

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Mammary carcinoma in the female.

Androgen deficiency in the male.

4.2 Posology And Method Of Administration

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 Enanthate intramuscularly every two to three weeks.

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

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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 Enanthate. 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occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

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

The clotting status should be monitored particularly closely when Testosterone Enanthate is administered together with coumarin derivatives.

4.6 Pregnancy And Lactation

Contra-indicated in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Women treated with Testosterone Enanthate 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 Enanthate.

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.

4.9 Overdose

Acute toxicity data show that Testosterone Enanthate 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Testosterone Enanthate 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 Enanthate is only slowly degraded to testosterone in the body.

5.2 Pharmacokinetic Properties

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

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

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

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

5.3 Preclinical Safety Data

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 Enanthate have been carried out. Administration of Testosterone Enanthate 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.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzyl benzoate

Castor oil for injection

6.2 Incompatibilities

None so far known.

6.3 Shelf Life

5 years.

6.4 Special Precautions For Storage

Protect from light.

6.5 Nature And Contents Of Container

Clear glass ampoules of 1 ml in packs of 3.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cambridge Laboratories Limited

Deltic House

Kingfisher Way

Silverlink Business Park

Wallsend

Tyne & Wear

NE28 9NX

8. Marketing Authorisation Number(S)

PL 12070/0015

9. Date Of First Authorisation/Renewal Of The Authorisation

19 September 1996

10. Date Of Revision Of The Text

September 2003