Monograph Details

Endocrine System > Hypogonadism
DELATESTRYL
Manufacturer
Indevus Pharmaceuticals, Inc.
Legal Classification
CIII
Pharmacological Class
Androgen.
Generic Name
Testosterone enanthate 200mg/mL; IM inj; in sesame oil; contains chlorobutanol.
Indications
Testosterone replacement therapy.
Children
Not recommended.
Adults
Give by deep IM inj into gluteal muscle once every 2 to 4 weeks. Male hypogonadism: 50–400mg. Delayed puberty: 50–200mg. Max 400mg/month.
Contraindications
Male breast or prostate cancer. Use in women. Pregnancy (Cat.X).
Precautions
Discontinue if jaundice, abnormal liver function, hypercalcemia, or edema occurs. Monitor liver function, hemoglobin, hematocrit, prostate specific antigen (PSA), cholesterol, bone age. Cardiac, hepatic, or renal dysfunction. May increase risk of prostatic hyperplasia in elderly. May increase growth of subclinical prostatic carcinoma. Elderly. Young children. Nursing mothers: not recommended.
Interactions
May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with ACTH, corticosteroids.
Adverse Reactions
Inj site reactions, peliosis hepatis, premature epiphyseal closure in adolescents, edema, hepatic carcinoma, prostatic hypertrophy or carcinoma, gynecomastia, priapism, oligospermia, nausea, jaundice, hirsutism, virilization, male pattern baldness, acne, polycythemia, headache, anxiety, depression, paresthesias, altered libido, fluid and electrolyte disturbances, suppression of clotting factors, increased serum cholesterol.
How Supplied
Single-dose syringe—1
Multidose vial (5mL)—1
Additional Resources
Related Prescribing Note