Classes
DEA Class; Rx
Common Brand Names; Anadrol-50
- Anabolic Steroids
Description
Oral anabolic steroid
Approved for the treatment of anemias caused by deficient red cell production; used off-label for HIV-associated wasting
Black box warning for hyperlipidemia, peliosis hepatis (some cases leading to liver failure), and fatal malignant liver cell tumors
Indications
Contraindications
Males: known or suspected prostate or breast CA
Females: breast cancer with hypercalcemia; pregnancy
Nephrosis or nephrotic phase of nephritis
Hypersensitivity
Severe hepatic dysfunction
Adverse Effects
Males
Pre-pubertal phallic enlargement with increased frequency of erection
Postpubertal inhibition of testicular function with testicular atrophy & azospermia
Impotency
Priapism
Epididymitis
Bladder irritability
Females
Alopecia
Virilism
Menstrual irregularities
Male-like voice
Pediatrics
Premature closure of epiphyses
Depression
Excitation
Habituation
Insomnia
Acne
Gynecomastia
Change in libido
Diarrhea
Nausea
Vomiting
Electrolyte & water retention
Decr glucose tolerance
Incr LDL
Decr HDL
Bleeding in pts on anticoagulant tx
Cholestatic jaundice
Muscle cramps
Incr serum CPK
Incr creatine/creatinine excretion
Possibility of leukemia
Warnings
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 and Lactation
Pregnancy Category: X
Lactation: Unknown if excreted; not recommended
Maximum Dosage
5 mg/kg/day PO.
5 mg/kg/day PO.
5 mg/kg/day PO.
5 mg/kg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Oxymetholone
tablet: Schedule III
- 50mg