testosterone and derivatives




Concise Prescribing Info
Testosterone undecanoate
Testosterone replacement in primary & secondary male hypogonadism.
Dosage/Direction for Use
1 amp (1,000 mg) slow IM inj every 10-14 wk. Serum testosterone levels should be measured before start of treatment. The 1st inj interval may be reduced to a min of 6 wk. Inj interval should be adjusted depending on testosterone serum levels.
Hypersensitivity. Androgen-dependent carcinoma of the prostate or male mammary gland; hypercalcemia accompanying malignant tumors; past or present liver tumors. Women.
Special Precautions
Increased risk for the development of prostatic hyperplasia in older patients. Exclude carcinoma of prostate before starting therapy w/ testosterone prep. Regular exam of prostate is recommended in men. Periodically check Hb & hematocrit in patients on long-term androgen therapy to detect cases of polycythemia. Risk of bleeding in patients w/ acquired or inherited bleeding disorders. Patients w/ thrombophilia. Consider liver tumor in the differential diagnostic if severe upper abdominal complaints, liver enlargement or signs of intra-abdominal hemorrhage occur in men. Patients predisposed to edema eg, cases of severe cardiac, hepatic or renal insufficiency or ischemic heart disease; men w/ HTN. Can cause accelerated growth & bone maturation & premature epiphyseal closure in childn. Preexisting sleep apnea may be potentiated. Not suitable for enhancing muscular development in healthy individuals or for increasing physical activities. Strictly must be injected IM & very slowly as pulmonary microembolism of oily soln occurs rarely & may lead to cough, dyspnoea, malaise, hyperhydrosis, chest pain, dizziness, paraesthesia, or syncope. Suspected anaphylactic reactions. Childn or adolescent <18 yr.
Adverse Reactions
Polycythaemia; increased wt; hot flush; acne; increased prostate specific antigen, abnormal prostate exam, BPH; various kinds of inj site reactions.
Drug Interactions
Increased clearance w/ barbiturates & other enzyme inducers. Increases oxyphenbutazone serum levels. Increases activity of coumarin derived oral anticoagulants. May enhance blood sugar reducing effects of insulin.
ATC Classification
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Nebido inj 250 mg/mL
4 mL x 1's
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