Male hypogonadism

Active Ingredient: Testosterone

Indication for Testosterone

Population group: men, only adults (18 years old or older)

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

For this indication, competent medicine agencies globally authorize below treatments:

1000 mg once every 10-14 weeks

Route of admnistration

Intramuscular

Defined daily dose

1,000 - 1,000 mg

Dosage regimen

From 1,000 To 1,000 mg once every 70 day(s)

Detailed description

1000 mg testosterone undecanoate is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.

Start of treatment

Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.

Maintenance and individualisation of treatment

The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. 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.

Dosage considerations

The injections must be administered very slowly (over two minutes). Care should be taken to inject testosterone deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection.

40-160 mg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

40 - 160 mg

Dosage regimen

From 20 To 80 mg 2 time(s) per day every day

Loading dose

120 mg

Detailed description

The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.

Dosage considerations

To ensure absorption, testosterone must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.

50-100 mg once daily

Route of admnistration

Cutaneous

Defined daily dose

50 - 100 mg

Dosage regimen

From 50 To 100 mg once every day

Loading dose

50 mg

Detailed description

The recommended dose is 50 mg of testosterone applied once daily at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 100 mg of testosterone per day. The adjustment of posology should be achieved by 25 mg of testosterone gel steps.

Dosage considerations

The application should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms or abdomen.

Active ingredient

Testosterone

Testosterone, secreted by the testes and its major metabolite dihydrotestosterone (DHT), is responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

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