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Testosterone Enantate Ampoules

Last Updated on eMC 02-Dec-2016 View changes  | Alliance Pharmaceuticals Contact details

1. Name of the medicinal product

Testosterone Enantate 250 mg/ ml Solution for Injection.

2. Qualitative and quantitative composition

Each 1ml ampoule contains 250mg Testosterone Enantate (the equivalent of about 180 mg testosterone) in oily solution.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for injection.

Clear, yellowish oily solution.

4. Clinical particulars
4.1 Therapeutic indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

4.2 Posology and method of administration

Method of Administration

Solution for intramuscular injection.

The injection must be administered extremely slowly (see 4.4 Special warnings and precautions for use and 4.8 Undesirable effects). The oily solution is injected immediately after its drawing up into the syringe.

Posology

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.

Serum testosterone levels should be measured before start of treatment and occasionally during the treatment at the end of an injection interval. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.

Special populations

Paediatric population

Testosterone Enantate is not indicated for use in children and adolescents (see 4.4 Special warnings and precautions for use).

Safety and efficacy have not been adequately determined in children and adolescents.

Elderly patients

Limited data do not suggest the need for a dosage adjustment in elderly patients (see 4.4 Special warnings and precautions for use).

Patients with hepatic impairment

No formal studies have been performed in patients with hepatic impairment. The use of Testosterone Enantate is contraindicated in men with past or present liver tumours (see 4.3 Contraindications).

Patients with renal impairment

No formal studies have been performed in patients with renal impairment.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Androgen-dependent carcinoma of the prostate or of the male mammary gland

• Hypercalcaemia

• Past or present liver tumours

• Nephrosis

4.4 Special warnings and precautions for use

Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia. Although there are no clear indications that androgens actually generate prostatic carcinoma, these can enhance the growth of any existing prostatic carcinoma. Therefore carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.

There is limited experience on the safety and efficacy of the use of Testosterone Enantate in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.

As a precaution, regular examinations of the prostate are recommended in men.

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit (to detect cases of polycythaemia), liver function tests and lipid profile.

In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.

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

Testosterone Enantate should be used with caution in patients with epilepsy, migraine, diabetes mellitus or skeletal metastases.

Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.

Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of 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.

Caution should be exercised in patients predisposed to oedema, as treatment with androgens may result in increased sodium retention (see 4.8 Undesirable effects).

Clotting disorders

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.

In children testosterone, besides masculinisation, can cause accelerated growth and bone maturation and premature epiphyseal closure, thereby reducing final height.

Testosterone Enantate should not be used in women since, depending on the individual sensitivity to androgenic impulses, women may develop signs of virilisation, e.g. acne, hirsutism, voice changes.

Pre-existing sleep apnoea may be potentiated.

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

As with all oily solutions, Testosterone Enantate must be injected strictly intramuscularly and very slowly. Pulmonary microembolism of oily solutions can lead to signs and symptoms such as cough, dyspnoea and chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Treatment is usually supportive, e.g. by administration of oxygen.

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.

4.5 Interaction with other medicinal products and other forms of interaction

Barbiturates and other enzyme inducers

Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of testosterone

Oxyphenbutazone

Increased oxyphenbutazone serum levels have been reported.

Oral anticoagulants

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

Hypoglycaemics

The hypoglycaemic effect of antidiabetics may be enhanced, possibly requiring a reduction in dosage of the hypoglycaemic agent.

4.6 Fertility, pregnancy and lactation

Pregnancy

Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in pregnant women (see 5.3 Preclinical safety data).

Lactation

Testosterone Enantate is intended for use by men only. Testosterone Enantate is not indicated in breast feeding women (see 5.3 Preclinical safety data).

Fertility

Testosterone Enantate replacement therapy may reversibly reduce spermatogenesis (see 4.8 Undesirable effects and 5.3 Preclinical safety data).

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Undesirable effects are listed by MedDRA System Organ Classes.Assessment of undesirable effects is based on the following frequency groupings:

Very common: ≥1/10

Common: ≥1/100 to <1/10

Uncommon: ≥1/1,000 to <1/100

Rare: ≥1/10,000 to <1/1,000

Very rare: <1/10,000

Not known: cannot be estimated from the available data

System Organ Class

Undesirable effect

Frequency

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Benign tumour of liver

Malignant liver tumour

Not known

Blood and lymphatic system disorders

Polycythaemia

Not known

Haematocrit increased

Red blood cell count increased

Haemoglobin increased

Common

Immune system disorders

Hypersensitivity

Not known

Metabolism and nutrition disorders

Hypercalcaemia

Water retention

Not known

Psychiatric disorders

Depression

Anxiety

Not known

Nervous system disorders

Headache

Paraesthesia

Not known

Cardiac disorders

Disorder circulatory system

Not known

Gastrointestinal disorders

Abdominal disorder

Intra-abdominal haemorrhage

Nausea

Not known

Hepatobiliary disorders

Liver function test abnormal

Jaundice

Liver enlargement

Not known

Skin and subcutaneous tissue disorders

Acne

Alopecia

Rash

Urticaria

Pruritus

Male pattern baldness

Not known

Musculoskeletal and connective tissue disorders

Premature epiphyseal closure*

Bone formation increased

Not known

General disorders and administration site conditions

Injection site reaction**

Asthenia

Oedema

Not known

Investigations

Prostatic specific antigen increased

Not known

Reproductive system and breast disorders

Libido increased

Libido decreased

Gynaecomastia

Prostatic disorder

Erection increased

Spermatogenesis abnormal

Precocious puberty*

Not known

*In pre-pubertal males

**Injection site pain, Injection site erythema, Injection site induration, Injection site swelling, Injection site inflammation

Description of selected adverse reactions

Injections of oily solutions such as Testosterone Enantate have been associated with systemic reactions: cough, dyspnoea, chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope.

High-dosed or long-term administration of testosterone increases the tendency to water retention and oedema.

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

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

No special therapeutic measure apart from termination of therapy with the drug or dose reduction is necessary after overdosage.

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.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group:

Androgens, 3-oxoandrosten (4) derivatives

ATC Code: G03BA03

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.

5.2 Pharmacokinetic properties

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).

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 Enantate have been carried out. Testosterone Enantate should not be administered 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

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

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

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

UK

8. Marketing authorisation number(s)

PL 16853/0116

9. Date of first authorisation/renewal of the authorisation

19 September 1996

10. Date of revision of the text

21st October 2016

Company contact details

Alliance Pharmaceuticals

Company image
Address

Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Fax

+44 (0)1249 466 977

Telephone

+44 (0)1249 466 966

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Active ingredients

testosterone enantate

Legal categories

POM - Prescription Only Medicine

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