Dosing & Uses
Dosage Forms & Strengths
tablet: Schedule III
Dosage Forms & Strengths
tablet: Schedule III
Anemia Due to Deficient Red Cell Production
1-5 mg/kg PO qDay for 3-6 months
1-2 mg/kg PO qDay usually effective
Includes acquired aplastic anemia, congenital anemia, myelofibrosis, & hypoplastic anemia due to admin of myelotoxic drugs
Off-label: HIV-associated wasting
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
- Pre-pubertal phallic enlargement with increased frequency of erection
- Postpubertal inhibition of testicular function with testicular atrophy & azospermia
- Bladder irritability
- Menstrual irregularities
- Male-like voice
- Premature closure of epiphyses
Change in libido
Electrolyte & water retention
Decr glucose tolerance
Bleeding in pts on anticoagulant tx
Incr serum CPK
Incr creatine/creatinine excretion
Possibility of leukemia
Black Box Warnings
- Peliosis hepatitis has been reported w/ androgenic anabolic steroid therapy In this condition, the liver & sometimes splenic tissue is replaced w/ blood-filled cysts
- These cysts sometimes present with minimal hepatic dysfunction but have been associated with liver failure
- Often not detected until life-threatening liver failure or intra-abdominal hemorrhage develops
- Discontinuing an anabolic steroid usually results in complete disappearance of lesions
Liver Cell Tumors
- Liver cell tumors have been reported
- Typically, these tumors are benign & androgen-dependent, but fatal malignant tumors have been reported
- Discontinuing anabolic steroids often result in regression or arrested progression of tumor Important to recognize that hepatic tumors associated w/ androgens or anabolic steroids are much more vascular than other hepatic tumors & may be silent until life-threatening intra-abdominal hemorrhage develops
Blood Lipid Changes
- May cause blood lipid changes associated w/ increased risk of atherosclerosis
- Lipid changes include decreased HDL & sometimes increased LDL; changes may be very marked & could have serious impact on risk for atherosclerosis & coronary artery disease
Males: known or suspected prostate or breast CA
Females: breast cancer with hypercalcemia; pregnancy
Nephrosis or nephrotic phase of nephritis
Severe hepatic dysfunction
Peliosis hepatitis has been reported in pts receiving androgenic anabolic steroid therapy; may be associated with life-threatening liver failure or intra-abdominal hemorrhage; condition usually resolves completely with drug D/C
Liver cell tumors have been reported- most often benign and androgen-dependent but fatal malignant tumors have been reported
Cholestatic hepatitis & jaundice may occur at low doses
Caution in cardiac disease, DM, hepatic disease, renal, elderly, pediatric patients, women, edematour conditions
Concomitant administration of adrenal corticoid steroid or ACTH, oral anticoagulants
Hypercalcemia may occur in breast CA patients
Decr. total T4 serum levels, incr. T3/T4 resin uptake, unchanged free thyroid hormone levels, & no clinical evidence for thyroid dysfunction
May accelerate bone maturation in children
Increases Prothrombin time; suppresses clotting factors V, VII, and X
May increases LDL & decreases HDL
Pregnancy & Lactation
Pregnancy Category: X
Lactation: Unknown if excreted; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Anabolic steroid; promotes body tissue building, increases production of erythropoietin in patients with anemia resulting from bone marrow failure or from deficient red cell production
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