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Oxymetholone

    DEA Class; Rx

    Common Brand Names; Anadrol-50

    • Anabolic Steroids

    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

    Indicated for the treatment of anemia caused by deficient red cell production, including aplastic anemia (acquired and congenital), myelofibrosis, and hypoplastic anemia due to myelotoxic drugs.
    For the treatment of AIDS-associated wasting syndrome.

    Males: known or suspected prostate or breast CA

    Females: breast cancer with hypercalcemia; pregnancy

    Nephrosis or nephrotic phase of nephritis

    Hypersensitivity

    Severe hepatic dysfunction

    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

    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 Category: X

    Lactation: Unknown if excreted; not recommended

    Adults

    5 mg/kg/day PO.

    Geriatric

    5 mg/kg/day PO.

    Adolescents

    5 mg/kg/day PO.

    Children

    5 mg/kg/day PO.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Oxymetholone

    tablet: Schedule III

    • 50mg