TESTOSTERONE ENANTHATE — 250 MG/ML, 10 ML
Testosterone Enanthate 250 is an oil-based sterile solution containing testosterone enanthate, an esterified form of testosterone intended for intramuscular administration. According to the supplied product information, serum testosterone levels increase following intramuscular administration and remain elevated for approximately 7–10 days.
Testosterone is an endogenous androgen involved in the development and maintenance of male reproductive organs and secondary sexual characteristics. It also contributes to physiological processes involving muscle tissue, bone health, erythropoiesis and sexual function. Testosterone replacement therapy may be considered in adult males when clinically established testosterone deficiency or absence of endogenous testosterone production is present.
The supplied information identifies Testosterone Enanthate 250 for replacement therapy in adult males with conditions associated with deficient or absent endogenous testosterone. The stated indications include primary hypogonadism and hypogonadotropic hypogonadism.
Primary hypogonadism is associated with inadequate testicular testosterone production. The supplied information identifies conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome and orchidectomy. Hypogonadotropic hypogonadism is associated with inadequate gonadotropin or luteinising hormone-releasing hormone activity, or injury involving the pituitary-hypothalamic system. The supplied information includes tumours, trauma and radiation as possible causes.
Testosterone enanthate is an ester of testosterone. Esterification increases the lipid solubility of testosterone and prolongs its residence following administration. After intramuscular administration in an oily vehicle, the testosterone ester is absorbed gradually into the circulation and subsequently hydrolysed to testosterone.
Circulating testosterone is primarily transported through the blood bound to sex hormone-binding globulin and albumin. Testosterone can be metabolised through several pathways, with estradiol and dihydrotestosterone identified in the supplied information as major active metabolites. Dihydrotestosterone is produced from testosterone through the action of steroid 5-alpha reductase in tissues including the skin, liver and male urogenital tract.
Administration of exogenous testosterone can influence the body’s natural hormonal feedback mechanisms. Endogenous testosterone production may be inhibited through suppression of pituitary luteinising hormone. At higher exposure levels, suppression of follicle-stimulating hormone may also affect spermatogenesis. These effects are important considerations when testosterone therapy is prescribed and monitored.
The supplied product information lists several possible adverse reactions. These include gynecomastia, prolonged or excessive erections, oligospermia, acne, hirsutism, male-pattern baldness and changes in libido. Fluid and electrolyte retention may also occur. Other reported reactions include nausea, changes in liver function tests, cholestatic jaundice, changes in serum lipids, headache, anxiety, depression, hypertension, oedema and priapism.
Testosterone therapy may also influence cardiovascular, metabolic and haematological parameters. The supplied information highlights potential changes in serum cholesterol and other lipids, as well as suppression of certain clotting factors. Patients receiving oral anticoagulant therapy therefore require appropriate medical monitoring.
Before and during treatment, the supplied information recommends monitoring relevant laboratory and clinical parameters. These include cholesterol, HDL, LDL, triglycerides, haemoglobin, haematocrit, liver function tests, PSA and testosterone levels. Dihydrotestosterone and estradiol may also be assessed. For male patients over 40, prostate assessment and PSA evaluation are specifically identified before androgen therapy, with periodic prostate evaluation thereafter.
Testosterone Enanthate is identified in the supplied information as a prescription product. Its use should therefore be based on an appropriate clinical assessment and professional prescribing. The product information should be followed regarding administration, monitoring, contraindications and precautions. Patients should not alter the prescribed dose, injection frequency or treatment duration without medical direction.
The product is presented as a 250 mg/ml, 10 ml multiple-dose vial. The supplied storage instructions state that Testosterone Enanthate should be stored in a cool, dry place between 15–25°C and protected from light.
3. Product Specifications
| Specification | Details |
|---|---|
| Product Name | Testosterone Enanthate |
| Strength | 250 mg/ml |
| Active Ingredient | Testosterone enanthate |
| Molecular Formula | C28H40O3 |
| Molecular Weight | 400.594 g/mol |
| CAS Number | 315-37-7 |
| Dosage Form | Injectable, oil-based sterile solution |
| Route | Intramuscular injection |
| Market Status | Prescription |
| Company | Hilma Biocare |
| Presentation | 10 ml multiple-dose vial |
4. Indications
The supplied information describes Testosterone Enanthate as replacement therapy for adult males with conditions associated with deficient or absent endogenous testosterone production.
Primary hypogonadism may include:
- Cryptorchidism
- Bilateral torsion
- Orchitis
- Vanishing testis syndrome
- Orchidectomy
Hypogonadotropic hypogonadism may include:
- Gonadotropin deficiency
- LHRH deficiency
- Pituitary-hypothalamic injury associated with tumours, trauma or radiation
5. Adverse Reactions
The supplied information lists possible adverse reactions including:
- Gynecomastia
- Excessive or prolonged erections
- Oligospermia
- Acne
- Hirsutism
- Male-pattern baldness
- Changes in libido
- Fluid and electrolyte retention
- Nausea
- Cholestatic jaundice
- Changes in liver function tests
- Changes in serum lipids
- Headache
- Anxiety and depression
- Hypertension
- Oedema
- Priapism
- Potentiation of sleep apnoea
6. Contraindications
According to the supplied information, Testosterone Enanthate should not be used in patients with known hypersensitivity to the product or its ingredients.
It is also contraindicated in patients with known or suspected carcinoma of the breast, testis or prostate, and in patients with severe heart, liver or kidney disease or a history of epilepsy as specified in the supplied information.
Testosterone-containing products should not be used in women because of the stated risk of virilisation and fetal harm.
7. Precautions
Caution is advised in patients with a history of myocardial infarction or coronary artery disease because androgens may alter serum cholesterol concentrations.
Patients receiving oral anticoagulants require appropriate monitoring when androgen therapy is started or stopped.
In patients with diabetes, testosterone may alter glucose metabolism or insulin sensitivity and may affect the requirements for antidiabetic medicines.
8. Patient Monitoring
The supplied information identifies monitoring of:
- Serum cholesterol
- HDL
- LDL
- Triglycerides
- Haemoglobin and haematocrit
- AST/ALT
- PSA
- Total, free and bioavailable testosterone
- Dihydrotestosterone
- Estradiol
- Prostate health where clinically appropriate
9. Drug Interactions
Potential interactions identified in the supplied information include:
- Oral anticoagulants: closer monitoring may be required.
- Oral hypoglycaemic medicines: testosterone may affect their metabolism.
- Insulin and diabetes treatment: changes in insulin sensitivity may occur.
10. Dosage & Administration
The supplied source identifies Testosterone Enanthate as an intramuscular prescription medicine. Administration and dose selection should be determined by a qualified healthcare professional according to the patient’s clinical circumstances and applicable prescribing information.
Do not change the prescribed dose, frequency or duration of treatment without medical supervision.
11. Presentation
Testosterone Enanthate 250 mg/ml, 10 ml multiple-dose vial.
12. Storage
Store in a cool, dry place between 15–25°C.
Protect from light.
