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Oxandrolone

    DEA Class; Rx

    Common Brand Names; Oxandrin

    • Androgens

    Oral synthetic anabolic steroid with anabolic potency 3 to 13 times that of testosterone
    Indicated as adjunctive therapy to offset the protein catabolism associated with prolonged corticosteroid use, and for the relief of the bone pain due to osteoporosis
    Abuse for androgenic actions can lead to serious side effects

    Indicated as adjunctive therapy to offset the protein catabolism (cachexia) associated with prolonged administration of corticosteroids and for the relief of the bone pain frequently associated with osteoporosis.

    Promote weight gain after weight loss following extensive surgery, chronic infections or severe trauma, or weight loss due to unknown etiology

    For the treatment of AIDS-associated wasting syndrome and associated muscle weakness.
    To improve muscle strength in the management of Duchenne muscular dystrophy.
    For the treatment of growth failure.

    Known or suspected prostate or breast CA in males

    Females: breast cancer with hypercalcemia

    Pregnancy

    Nephrosis or the nephrotic phase of nephritis

    Hypercalcemia

    Males

    • Gynecomastia

    • Inhibition of testicular function

    • Impotence

    • Priapism

    • Bladder irritability

    Females

    • Hirsutism

    • Male-pattern baldness

    • Menstrual irregularities

    • Virilism

    Serious

    • Neoplasm of liver, Peliosis hepatis

    • Premature epiphyseal closure, Children

    Edema

    Increased risk of atherosclerosis

    Habituation

    Changes in libido

    Acne

    Retention of electrolytes

    Serum lipid levels

    Cholestatic hepatitis

    Hepatic d/o

    Jaundice

    Androgenic anabolic steroids may stimulate osteolytic bone resorption; contraindicated in carcinoma of the breast in females with hypercalcemia

    Cholestatic hepatitis and jaundice may occur with 17-alpha-alkylated androgens at a relatively low dose; if cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, this drug should be discontinued and the etiology determined; drug-induced jaundice is reversible when medication is discontinued

    In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis; this drug should be discontinued if hypercalcemia occurs

    Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease; concomitant administration of adrenal cortical steroid or ACTH may increase the edema

    In children, androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth; this adverse effect results in compromised adult height; the younger the child, the greater the risk of compromising final mature height

    Effect on bone maturation should be monitored by assessing bone age of left wrist and hand every 6 months

    Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for development of prostatic hypertrophy and prostatic carcinoma

    Concurrent dosing with warfarin may result in unexpectedly large increases in the International Normalized Ratio (INR) or prothrombin time (PT); when prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain desirable INR level and diminish risk of potentially serious bleeding

    Women should be observed for signs of virilization (deepening of voice, hirsutism, acne, clitoromegaly); discontinuation of drug therapy at time of evidence of mild virilism is necessary to prevent irreversible virilization

    Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens; menstrual irregularities may also occur

    Anabolic steroids may cause suppression of clotting factors II, V, VII, and X, and an increase in prothrombin time

    Does not improve athletic performance

    Shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose; contraindicated in pregnancy

    Not known whether anabolic steroids are excreted in human milk; because of potential of serious adverse reactions in nursing infants from this drug, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

    Adults

    Maximum dosage information is not available.

    Elderly

    Maximum dosage information is not available.

    Adolescents

    Maximum dosage information is not available.

    Children

    Maximum dosage information is not available.

    Oxandrolone

    tablet: Schedule III

    • 2.5mg
    • 10mg