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Depo-testosterone Generic Name & Formulations
Legal Class
CIII
General Description
Testosterone cypionate 100mg/mL, 200mg/mL; IM inj in cottonseed oil; contains benzyl alcohol.
Pharmacological Class
Androgen.
How Supplied
Vial 100mg/mL (10mL)—1; 200mg/mL (1mL, 10mL)—1
Manufacturer
Depo-testosterone Indications
Indications
Testosterone replacement therapy.
Limitations of Use
Not established in men with age-related hypogonadism.
Depo-testosterone Dosage and Administration
Adult
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. Give by deep IM inj into gluteal muscle once every 2 to 4 weeks. 50–400mg; max 400mg/month.
Children
<12yrs: Not established.
Depo-testosterone Contraindications
Contraindications
Serious cardiac, hepatic, or renal disease. Male breast or prostate cancer. Use in women. Pregnancy (Cat.X).
Depo-testosterone Boxed Warnings
Not Applicable
Depo-testosterone Warnings/Precautions
Warnings/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. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Elderly. Young children. Nursing mothers: not recommended.
Depo-testosterone Pharmacokinetics
See Literature
Depo-testosterone Interactions
Interactions
May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with ACTH, corticosteroids.
Depo-testosterone Adverse Reactions
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.
Depo-testosterone Clinical Trials
See Literature
Depo-testosterone Note
Not Applicable
Depo-testosterone Patient Counseling
See Literature
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