Classifications: hormone; androgen/anabolic steroid; Therapeutic: anabolic steroid
Pregnancy Category: X
Controlled Substance: Schedule III
2.5 mg tablets
Synthetic steroid with anabolic and androgenic activity.
Androgenic activity: Responsible for the growth spurt of the adolescent and for growth termination by epiphyseal closure. Increases erythropoiesis,
possibly by stimulating production of erythropoietin, and promotes vascularization and darkening of skin. Antagonizes effects
of estrogen excess on female breast and endometrium. Anabolic activity: Increases protein metabolism and decreases its catabolism. Large doses suppress spermatogenesis, thereby causing testicular
atrophy. Controls development and maintenance of secondary sexual characteristics.
Adjunctive therapy to promote weight gain, offset protein catabolism associated with prolonged administration of corticosteroids,
relieve bone pain accompanying osteoporosis.
Hypersensitivity or toxic reactions to androgens; severe cardiac, hepatic, or renal disease; pregnancy (category X), lactation;
possibility of virilization of external genitalia of female fetus; polycythemia; hypercalcemia; known or suspected prostatic
or breast cancer in males; benign prostatic hypertrophy with obstruction; patients easily stimulated sexually; asthenic
males who may react adversely to androgenic overstimulation; conditions aggravated by fluid retention; hypertension.
Cardiac, hepatic, and mild to moderate renal disease, hypercholesterolemia, heart failure, peripheral edema, arteriosclerosis,
coronary artery disease, MI; cholestasis; diabetes mellitus; prostatic hypertrophy; prepubertal males, geriatric patients,
acute intermittent porphyria; older adults.
Route & Dosage
Adult: PO 2.5 mg b.i.d. to q.i.d. (max: 20 mg/d) for 24 wk
Child: PO 0.1 mg/kg/d
- Individualize doses; great variations in response exist.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)CNS:
Habituation, excitation, insomnia
, changes in libido. Urogenital: Males:
Phallic enlargement, increased frequency or persistence of erections, inhibition of testicular function, testicular atrophy,
oligospermia, impotence, chronic priapism, epididymitis, bladder irritability; Females:
Clitoral enlargement, menstrual irregularities. Hepatic:
with or without hepatic necrosis and death, hepatocellular neoplasms, peliosis hepatitis (long-term use). Skin:
Hirsutism and male pattern baldness in females, acne
Gynecomastia, deepening of voice in females, premature closure of epiphyses in children, edema, decreased glucose tolerance.
Diagnostic Test Interference
May decrease levels of thyroxine-binding globulin (decreased total T4 and increased T3 RU and free T4).
May increase INR with warfarin.
May inhibit metabolism
of oral hypoglycemic agents
. Concomitant steroids
may increase edema. Herbal: Echinacea
may increase risk of hepatotoxicity.
1013 h (increased in elderly patients).
Assessment & Drug Effects
- Monitor weight closely throughout therapy.
- Assess for and report development of edema or S&S of jaundice (see Appendix F).
- Lab tests: Monitor periodically liver function, lipid profile, Hct and Hgb, PT and INR, serum electrolytes, and CPK.
- Withhold and notify physician if hypercalcemia develops in breast cancer patient.
- Monitor growth in children closely.
Patient & Family Education
- Women: Report signs of virilization, including acne and changes in menstrual periods.
- Men: Report too frequent or prolonged erections or appearance/worsening of acne.
- Report S&S of jaundice (see Appendix F) or edema.
- Monitor blood glucose for loss of glycemic control if diabetic.