Nebido

Nebido

testosterone

Manufacturer:

Bayer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Testosterone undecanoate
Indications/Uses
Testosterone replacement in primary & secondary male hypogonadism.
Dosage/Direction for Use
1 vial (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.
Contraindications
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. Concomitant use w/ coumarin derived oral anticoagulants. 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. Discontinue treatment immediately in case of severe complications characterized by edema w/ or w/o CHF. Can cause accelerated growth, bone maturation & premature epiphyseal closure in childn. Appearance of common acne. Preexisting sleep apnea may be potentiated. May subject to abuse at higher doses & in combination w/ other anabolic androgenic steroids resulting to dependence & w/drawal symptoms upon significant dose reduction or abrupt discontinuation. 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. May reversibly reduce spermatogenesis. Childn & adolescent <18 yr.
Adverse Reactions
Polycythemia; 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 w/ barbiturates & other enzyme inducers. Increased oxyphenbutazone serum levels. Increases activity of coumarin derived oral anticoagulants. May enhance 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.
Presentation/Packing
Form
Nebido soln for inj 250 mg/mL
Packing/Price
4 mL x 1's
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