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Testonon 250 mg/ml Ampoules

Testonon 250 mg/ml Ampoules

Name of The Medicinal Product: Testonon 250 mg/ml solution for injection.

Qualitative and Quantitative Composition:

  • Testosterone propionate BP 30 mg/ml .
  • Testosterone phenylpropionate BP 60 mg/ml.
  • Testosterone isocaproate BP 60 mg/ml.
  • Testosterone decanoate BP 100 mg/ ml.

(eq to a total of 176 mg of testosterone).

Adminstration: Deep intramuscular injection.

Therapeutic Indications

TESTONON AMPOULE
TESTONON AMPOULE

Testosterone replacement therapy in male hypogonadal disorders, for example: After castration, Eunchoidism, Hypopituitarism, Endocrine impotence, Male climacteric symptoms like decreased libido, Certain types of infertility due to disorders of spermatogenesis.

Testosterone therapy may also be indicated for the prevention and treatment of osteoporosis in hypogonadal males.

Testosterone administration may also be used as supportive therapy for female-to-male transsexuals.

Posology and Method of Administration

Dosage: In general, dosage should be adjusted to the individual  response of the patient.

  • Adults: Usually, one injection of 1 ml per three weeks is adequate.
  • Elderly: It should be noted that smaller and less frequest doses may achieve the same response.
  • Children: It should be noted that smaller and less frequent doses may achieve the same response.
  • Female-to-male transsexuals: Different specialist centers have used doses varying from one injection of 1 ml every  two weeks to one injection of 1 ml every four weeks.

Special warnings and precautions for use

warning related to Benzyl Alcohol

  • Testonon ampoule contains benzyl alcohol ,which may be fatal in neonates and infants.
  • DO not administer injections preserved with benzyl alcohol to neonates , premature infants below  13 years, pregnant women or nursing mothers.
  • Benzyl alcohol has been associated with serials alters tweets and death, particularly in pediatric patients(it may cause Gasping syndrome ). Injections preservative free should be used in these populations.
  • This product contains benzyl alcohol which is potentially toxic when administered  locally  to neural tissue.

Precautions

Patients, specially the elderly, with the following conditions should be monitored:

  • Ischemic heart disease, since androgens may produce hypercholesterolecmia.
  • Latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or history of these conditions), since androgens may occasionally induce fluid and sodium retention.
  • Skeletal metastases, since androgens may induce hypercalcaemia or hypercalciuria in these patients.
  • Long term monitoring should include measurement of hemoglobin.
  • The use of steroids may influence the results of certain laboratory tests.
  • Androgens should be used cautiously in prepubertal boys to avoid premature epiphyseal  closure or precocious sexual development.
  • If androgen-associated adverse reactions occur, Testonon 250 treatment should be interrupted and after disappearance of the symptoms, be resumed at a lower dosage.
  • Testonon 250 contains Arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. as there is possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Testonon.

Female-to-male transsexual supportive therapy

Before initiating Testonon for female -to-male transsexuals, specialist assessment should be undertaken, including psychiatric assessment. A complete personal and medical history should he taken, during treatment, periodic checkups are recommended of a frequency  and nature adapted to the individual. the following should he monitored:

  • Signs of osteoporosis.
  • Changes in lipid profile.

cancer related precautions and warning

  • In patients with a personal or family history of breast cancer and with a personal history of endometrial cancer careful monitoring should be undertaken.
  • Subject to specialist advice, hysterectomy and bilateral oophorectomy should be considered after 18-24 months of testosterone treatment to reduce the possible increased risk of endometrial and ovarian cancer.
  • Continued surveillance is required to detect osteoporosis in patients who have adergone oophorectomy as testosterone may not fully reverse the decline in bone density in these patients.
  • Continued surveillance is required to detect endometrial and ovarian cancer in patients on long term  treatment who have not proceeded to hysterectomy and bilateral oophorectomy.

Undesirable effects

The following adverse reactions have been associated with androgens therapy in General:

  • In perpubertal boys: precocious sexual development, an increased frequency of erections,  phallic enlargement and premature epiphyseal closure.
  • Priapism and other signs of excessive sexual stimulation.
  • Water and sodium retention.
  • Oligospermia and a decreased ejaculatory volume.
  • Treatment should be interrupted untill these symptoms have disappeared, after which it should be continued at a lower dosage:
  • Hoarseness of the voice may be the first symptoms of vocal changes which may lead to irreversible lowering of the voice. If signs of virilisation develop, particularly lowering of the voice_ treatment should be discontinued unless the effects are desired treatment outcomes.

the following undesirable effects have also been observed:

  • Acne.
  • Disturbance of liver functions.
  • Polycythemia.
  • Hypertension .
  • Weight gain (in female-to-male transsexuals).

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