Classifications: hormone; androgen/anabolic steroid; Therapeutic: anabolic steroid
Pregnancy Category: X
Controlled Substance: Schedule III
50 mg tablets
Potent steroid with anabolic activity. Mechanism of action in refractory anemias is unclear but may be due to direct stimulation
of bone marrow, protein anabolic activity, or to androgenic stimulation of erythropoiesis.
Stimulates formation of red blood cells in the bone marrow. Stimulates bone growth, aids in bone matrix reconstitution.
Osteoporosis, catabolic conditions.
Prostatic hypertrophy with obstruction; pregnancy (category X); prostatic or male breast cancer; cardiac, renal, hepatic
decompensation; nephrosis; premature infant; use during lactation is not established.
Prepubertal males; geriatric male patients; diabetes mellitus; coronary disease; patient taking ACTH, corticosteroids, anticoagulants.
Route & Dosage
Adult/Child: PO 15 mg/kg/d
- A course of therapy for treatment of osteoporosis is 721 d.
- For treatment of anemias, a minimum trial period of 36 mo is recommended, since response tends to be slow.
- Store at 15°30° C (59°86° F). Protect from heat and light.
Adverse Effects (≥1%)Endocrine:
Androgenic in women: Suppression of ovulation, lactation, or menstruation; hoarseness or deepening of voice
(often irreversible); hirsutism; oily skin; acne;
clitoral enlargement; regression of breasts; male-pattern baldness (in disseminated
breast cancer). Hypoestrogenic effects
in women: Flushing, sweating; vaginitis
with pruritus, drying, bleeding; menstrual irregularities. Men: prepubertal: premature
epiphyseal closure, phallic enlargement, priapism. Postpubertal: testicular atrophy, decreased ejaculatory volume, azoospermia,
oligospermia (after prolonged administration
or excessive dosage), impotence, epididymitis, gynecomastia. CV: Edema,
skin flush. GI: Nausea, vomiting, anorexia, diarrhea
, hepatotoxicity. Urogenital:
Bladder irritability. Metabolic:
May enhance hypoprothrombinemic effects of warfarin. Herbal: Echinacea
may increase risk of hepatotoxicity.
Readily from GI tract. Metabolism:
In liver. Elimination:
In urine. Half-Life:
Assessment & Drug Effects
- Monitor patient with a history of seizures closely because an increase in their frequency may be noted.
- Monitor periodically for edema that may develop with or without CHF.
- Monitor for hypercalcemia (see Appendix F), especially in women with breast cancer.
- Lab tests: Periodic serum calcium; periodic liver function tests are especially important for the older adult patient. Drug
should be stopped with first sign of liver toxicity (jaundice).
Patient & Family Education
- Monitor blood glucose for loss of glycemic control if diabetic.
- Women: Notify physician of signs of virilization.