Testosterone Undecanoate

Indications

The active substance of this preparation is turned into testosterone by your body. Testosterone is the natural male hormone, necessary for the normal growth, development and function of the male sex organs and for secondary male sex characteristics. Preparations containing Testosterone are usually prescribed to replace the hormone if the body is unable to produce enough on its own. Testosterone are soft oval glossy capsules, transparent, orange-red colour, with an oily fill.

Pharmacology

Testosterone plays a key role in male sexual differentiation and is involved in regulation of hematopoiesis, body composition, and bone metabolism. As a result, testosterone replacement therapy in males with hypogonadism can result in improved sexual function, increased lean body mass, bone density, erythropoiesis, prostate size, and changes in lipid profiles.

Testosterone is produced by Leydig cells and exerts it's effects by binding to androgen receptors throughout the body. Testosterone affects the voice, genitalia, mood, and influences muscle growth and protein expression. Accordingly, males with low levels of testosterone often experience decreased libido, fatigue, mood changes and dysphoria. Exogenous sources of testosterone are designed to mimic the effects of endogenous testosterone.

Dosage

Usually, the dosage is 3-4 capsules daily during the first 2-3 weeks, followed by a gradual decrease to 1-3 capsules daily. You must take Testosterone with a meal. Swallow the capsules whole without chewing, using some water or other fluid. Take half of the daily dose in the morning and the other half in the evening. If the daily dose is an uneven number of capsules, take the larger number in the morning. If you have the impression that the effect of Testosterone is too strong or too weak, inform your doctor immediately.

Administration

If you forget to take Testosterone, do not take a double dose to make up for the forgotten individual dose. When treatment with Testosterone is stopped, complaints as those before treatment may re-occur within a few weeks.

Interaction

Food allows Testosterone Undecanoate to be taken up by your body. Therefore, Testosterone must be taken with a meal. Other medicines may influence the effects of Testosterone or Testosterone may affect other medicines. You must tell your doctor or pharmacist if you are using (or intend to use) rifampicin (an antibiotic) or medicines for epilepsy or sleeplessness.

Contraindications

Do not take Testosterone
  • If you have a tumour of the prostate or the breast.
  • If you are hypersensitive (allergic) to Testosterone Undecanoate or any of the other ingredients of Testosterone.

Side Effects

In general:
  • increased sexual desire
  • fluid retention in the tissues, usually marked by swelling of ankles or feet
In men:
  • prolonged abnormal, painful erection of the penis
  • disturbed formation of sperm
  • decreased amount of sperm with seminal discharge
In elderly men:
  • problems with passing urine
In young boys:
  • early sexual development
  • erections occurring more often than normal
  • enlarged penis
  • disturbed growth
Tell your doctor as soon as possible if any side-effect becomes troublesome or continues.

Precautions & Warnings

Extra supervision by a doctor is necessary in the treatment of young boys, since Testosterone suppletion may cause early sexual development and disturb growth. Extra supervision by a doctor is also necessary in the treatment of elderly men, since male hormones may increase the size of the prostate gland. Medical checks may also be necessary for some other conditions.

Therefore, tell your doctor if you have or have ever had:
  • heart disease
  • kidney disease
  • high blood pressure
  • epilepsy
  • migraine headaches
  • prostatic complaints, such as problems with passing urine.

Overdose Effects

If you have taken several capsules at once, there is no need for great concern. However, you should consult your doctor. The oily substance in the capsule may cause diarrhoea.

Therapeutic Class

Male Sex hormones (Androgens)

Storage Conditions

Keep Testosterone out of reach and sight of children. Store at 8°C-30°C. Store in the original package in order to protect from light. Do not use Testosterone after the expiry date stated on the package, sachet and blister.