Class: Anabolic steroid
- Tablets 2.5 mg
- Tablets 10 mg
Suppresses gonadotropic functions of the pituitary and may exert a direct effect upon the testes.
Indications and Usage
Adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some individuals who, without definite pathophysiologic reasons, fail to gain or maintain healthy weight; to offset protein catabolism associated with prolonged administration of corticosteroids; for relief of bone pain frequently accompanying osteoporosis.
Catabolic illness (eg, alcoholic liver disease, burn injury).
Known or suspected carcinoma of the prostate or the breast in men; carcinoma of the breast in women with hypercalcemia; pregnancy; nephrosis or nephrotic phase of nephritis; hypercalcemia.
Dosage and AdministrationAdults
PO 2.5 to 20 mg/day in 2 to 4 divided doses.Children
PO 0.1 mg/kg (0.45 mg/lb) or less daily, repeated intermittently as indicated.
Store tablets at controlled room temperature (59° to 77°F).
Drug InteractionsAdrenal steroids, adrenocorticotropic hormone (ACTH)
May increase edema in patients with this condition.Anticoagulants (eg, warfarin)
May increase sensitivity to oral anticoagulant, necessitating a reduction in anticoagulant dosage.Oral hypoglycemic agents
May inhibit metabolism of oral hypoglycemic agents, increasing their plasma levels.
Laboratory Test Interactions
May decrease levels of thyroxine-binding globulin, resulting in decreased total T 4 serum levels and increased resin uptake of T 3 and T 4 . In addition, a decrease in protein-bound iodine and radioactive iodine uptake may occur.
Changes in libido; depression; excitation; habituation; insomnia.
Acne (especially in women and prepubertal boys); hirsutism, male pattern baldness in women.
Deepening of the voice in women.
Gynecomastia; prepubertal phallic enlargement and increased frequency or persistence of erections in men; postpubertal inhibition of testicular function, testicular atrophy, and oligospermia in men; impotence, chronic priapism, epididymitis, and bladder irritability in men; clitoral enlargement and menstrual irregularities in women.
Cholestatic jaundice; hepatocellular neoplasm; peliosis hepatitis; reversible changes in liver function tests, including increased bromsulfophthalein retention, elevated AST, ALT, and alkaline phosphatase.
Increased creatinine excretion and serum levels of CPK; masculinization of the fetus; inhibition of gonadotropin secretion.
Decreased glucose tolerance; retention of serum electrolytes, including calcium, chloride, phosphate, potassium, and sodium.
Premature closure of epiphyses in children.
Peliosis hepatitis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. The condition may not be recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Lesions completely resolve upon drug discontinuation. Liver cell tumors, often benign and androgen-dependent but sometimes malignant, have occurred. Drug discontinuation often results in regression or cessation of tumor growth. Hepatic tumors associated with androgens or anabolic steroids may be silent until life-threatening, intra-abdominal hemorrhage develops. Blood lipid changes, including decreased HDL and increased LDL, associated with increased risk of atherosclerosis are seen in some patients treated with androgens and anabolic steroids.
Category X .
Use with caution. Epiphyseal maturation may be accelerated more rapidly than linear growth in children and continue for 6 mo after stopping treatment.
May be at increased risk of developing prostatic hypertrophy and prostatic carcinoma.
Special Risk Patients
Use with caution in patients with cardiac, renal, or hepatic disease.
Athletic performance enhancement
Should not be used for this purpose.
Cholestatic hepatitis and jaundice may occur.
Hypercalcemia caused by stimulation of osteolysis may occur in patients with breast cancer.
May occur in women; observe for signs of voice deepening, hirsutism, acne, clitorimegaly, and menstrual irregularities.
- Advise patient that dose will be adjusted based upon response and tolerance to therapy.
- Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
- Caution patient that oxandrolone has not been shown to be safe or effective for enhancing athletic performance and, because of potential for serious health risks, should not be used for this purpose.
- Instruct diabetic patient to monitor blood glucose more frequently when drug is started or dose is changed and to inform health care provider of significant changes in readings.
- Instruct patient to inform health care provider if any of the following occur: appearance or aggravation of acne; nausea; vomiting; changes in skin color; ankle swelling. Instruct women also to report the following: deepening of voice; enlargement of clitoris; menstrual irregularities; increased facial hair. Instruct men also to report persistent erections.
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