Monograph Details
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Endocrine System
> Hypogonadism
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DELATESTRYL |
| Manufacturer |
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Indevus Pharmaceuticals, Inc. |
| Legal Classification |
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CIII |
| Pharmacological Class |
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Androgen. |
| Generic Name |
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Testosterone enanthate 200mg/mL; IM inj; in sesame oil; contains chlorobutanol. |
| Indications |
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Testosterone replacement therapy. |
| Children |
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Not recommended. |
| Adults |
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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 |
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Male breast or prostate cancer. Use in women. Pregnancy (Cat.X). |
| Precautions |
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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 |
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May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with ACTH, corticosteroids. |
| Adverse Reactions |
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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 |
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• Related Prescribing Note |
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