Class: Anabolic steroid
- Tablets 50 mg
Suppresses gonadotropic functions of the pituitary and may exert a direct effect upon the testes.
Enhances the production and urinary excretion of erythropoietin in patients with anemias caused by bone marrow failure and stimulates erythropoiesis in anemias caused by deficient RBC production.
Indications and Usage
Treatment of anemias caused by deficient RBC production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis, and the hypoplastic anemias caused by administration of myelotoxic drugs often respond.
Carcinoma of the prostate or the breast in men; carcinoma of the breast in women with hypercalcemia; pregnancy; nephrosis or nephrotic phase of nephritis; hepatic function impairment; hypersensitivity to any component of the product.
Dosage and AdministrationAdults and Children
PO 1 to 5 mg/kg/day.
Store tablets at controlled room temperature (59° to 86°F).
Drug InteractionsAnticoagulants (eg, warfarin)
May increase sensitivity to oral anticoagulants, necessitating a reduction in anticoagulant dosage.Insulin, oral hypoglycemic agents
Dosage of these agents may need adjustment in patients receiving anabolic steroids.
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.
Excitation, increased or decreased libido, insomnia.
Acne (especially in women and prepubertal boys), hirsutism and male-pattern baldness in women, male-pattern baldness in postpubertal males.
Deepening of the voice in women.
Diarrhea, nausea, vomiting.
Gynecomastia, prepubertal phallic enlargement and increased frequency or persistence of erections in men; postpubertal inhibition of testicular function, testicular atrophy, oligospermia, impotence, chronic priapism, epididymitis, bladder irritability, decrease in seminal volume in men, clitoral enlargement and menstrual irregularities in women.
Iron deficiency anemia.
Reversible changes in liver function tests, including bromsulfophthalein retention, increases in serum bilirubin, AST, and alkaline phosphatase.
Increased creatine and creatinine excretion, increased serum creatinine phosphokinase, cholestatic jaundice, hepatocellular neoplasms, peliosis hepatitis.
Decreased glucose tolerance, increased serum levels of LDL, decreased levels of HDL; retention of serum electrolytes (calcium, chloride, phosphate, potassium, sodium).
Premature closure of epiphyses in children, muscle cramps.
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. They 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. Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
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 that iron supplementation likely will be needed and to take iron supplement as prescribed.
- Caution patient that oxymetholone 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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