Four Star
Concise Prescribing Info
Testosterone undecanoate
Testosterone replacement in primary & secondary male hypogonadism.
Dosage/Direction for Use
1 vial (corresponding to testosterone undecanoate 1,000 mg) slow IM every 10-14 wk. The 1st inj interval may be reduced to a min of 6 wk.
Hypersensitivity. Androgen-dependent carcinoma of the prostate or of the 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; perform regular exam of the prostate. Regularly monitor testosterone levels; Hb, haematocrit, liver function & blood lipid profile. Reports of venous thromboembolic events, including DVT & pulmonary embolism; benign & malignant liver tumors. Patients w/ thrombophilia; severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease; pre-existing HTN. Can cause accelerated growth & bone maturation & premature epiphyseal closure in childn. Appearance of common acne. Pre-existing sleep apnea may be potentiated. Not for enhancing muscular development or increasing physical ability. Anaphylactic reactions. Concomitant use w/ coumarin-derived anticoagulants. May reversibly reduce spermatogenesis. Childn & adolescent (male) <18 yr. Elderly >65 yr.
Adverse Reactions
Polycythaemia; increased wt; hot flush; acne; increased prostate specific antigen, abnormal prostate exam, benign prostate hyperplasia; inj site pain, discomfort, pruritus, erythema, haematoma, irritation, reaction.
Drug Interactions
Increased clearance of testosterone w/ barbiturates & other enzyme inducers. Increased serum levels of oxyphenbutazone. Increased activity of oral coumarin-based anticoagulants. Enhanced blood sugar reducing effects of insulin.
MIMS Class
Androgens & Related Synthetic Drugs
ATC Classification
G03BA03 - testosterone ; Belongs to the class of 3-oxoandrosten (4) derivative androgens used in androgenic hormone preparations.
Nebido inj 1000 mg/4 mL
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in