Testosterone enantate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of testosterone enantate.
Drugs List
Therapeutic Indications
Uses
Androgen deficiency
Unlicensed Uses
Carcinoma of breast
Sexual maturation in males: induction and maintenance of
Dosage
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.
Adults
Androgen deficiency
Initial treatment of deficiency symptoms: 250mg every two to three weeks.
Maintenance treatment: 250mg every three to six weeks, according to individual requirement.
Carcinoma of breast (unlicensed)
250mg every two to three weeks.
Children
Induction and maintenance of sexual maturation in males (unlicensed)
To be given under specialist supervision.
Children aged 12 to 18 years: 25 to 50mg/metre squared every month. Increase dose every six to twelve months, titrated to response.
Administration
Administer by slow intramuscular injection only.
Contraindications
Children under 12 years
Androgen-dependent neoplasm
Breast cancer in males
Breastfeeding
Hepatic neoplasm
History of hepatic neoplasm
Hypercalcaemia
Nephrotic syndrome
Pregnancy
Precautions and Warnings
Children aged 12 to 18 years
Females
Predisposition to fluid retention
Predisposition to hypercalcaemia
Prepubertal males
Cardiac impairment
Diabetes mellitus
Epileptic disorder
Hepatic impairment
Hypertension
Ischaemic heart disease
Migraine
Renal impairment
Skeletal metastasis
Sleep apnoea
Thrombophilia
Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Monitor testosterone levels at baseline and periodically during treatment
If upper abdominal complaints/liver enlargement consider liver tumour
Monitor hepatic function, haematocrit and haemoglobin in long term therapy
Monitor serum lipids
Potential for drug abuse
Regular examination of prostate advised to exclude prostatic cancer
If frequent/persistent erections occur reduce dose/discontinue
Increased risk of premature sexual development+epiphyseal closure in boys
Discontinue if oedema progresses or signs of cardiac failure occur
Not licensed for all indications in all age groups
May affect spermatogenesis
Measure serum testosterone levels before the start of treatment and at various points during treatment once an injection interval has finished. Serum levels below the normal range would require shorter injection intervals whereas high serum levels may require an extension of injection intervals.
Pregnancy and Lactation
Pregnancy
Testosterone enantate is contraindicated during pregnancy.
The manufacturer does not recommend using testosterone enantate during pregnancy.
Lactation
Testosterone enantate is contraindicated during breastfeeding.
The manufacturer does not recommend using testosterone enantate during breastfeeding.
Side Effects
Abdominal disorders
Abnormal liver function tests
Acne
Alopecia
Anxiety
Asthenia
Changes in libido
Cholestatic jaundice
Circulatory disturbances
Depression
Fluid retention
Gastrointestinal bleeding
Gynaecomastia
Headache
Hepatic tumours
Hepatomegaly
Hirsutism
Hypercalcaemia
Hypersensitivity reactions
Increase in haematocrit
Increase in haemoglobin
Increase in prostate specific antigen (PSA)
Increased bone growth
Injection site reactions
Interference with spermatogenesis
Intra-abdominal haemorrhage
Male pattern baldness
Nausea
Oedema
Paraesthesia
Polycythaemia
Precocious sexual development (pre-pubertal males)
Premature closure of epiphyses (in pre-pubertal males)
Priapism
Prostate abnormalities
Prostate cancer
Pruritus
Rarely coughing, dyspnoea and circulatory disorders
Rash
Seborrhoea
Urticaria
Virilism in females
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Testosterone Enantate Ampoules. Alliance Pharmaceuticals. Revised October 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 August 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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