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Pronunciation:

(oks i METH oh lone)

U.S. Brand Names:

Anadrol®

Generic Available:

Use:

Treatment of anemias caused by deficient red cell production

Restrictions:

C-III

Pregnancy Risk Factor:

Pregnancy Implications:

Oligospermia or amenorrhea may occur resulting in an impairment of fertility.

Lactation:

Excretion in breast milk unknown/not recommended

Contraindications:

Hypersensitivity to oxymetholone or any component of the formulation; breast cancer in men; breast cancer in women with hypercalcemia; prostate cancer; severe liver dysfunction; nephrosis; pregnancy

Warnings/Precautions:

Anabolic steroids may cause peliosis hepatis, liver cell tumors, and blood lipid changes with increased risk of arteriosclerosis; monitor diabetic patients carefully. Use with caution in elderly men; they may be at greater risk for prostate hyperplasia and cancer. Use caution with cardiac, renal, or hepatic disease; may develop edema. In breast cancer, may cause hypercalcemia by stimulating osteolysis. Use caution in children; may accelerate epiphyseal maturation thereby compromising adult height.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Coronary artery disease, peripheral edema

Central nervous system: Excitation, insomnia

Dermatologic: Acne (prepubertal males, women); hirsutism (women), hypercalcemia, hyperchloremia, hyperkalemia, hyperphosphatemia, hyperpigmentation; male-pattern baldness (postpubertal males, women)

Endocrine & metabolic: Amenorrhea, cholesterol increased, clitoromegaly, creatinine phosphokinase increased, glucose tolerance decreased, gynecomastia, HDL-cholesterol decreased, hoarseness (women), hypernatremia, impotence (postpubertal males), LDL-cholesterol decreased, libido increased/decreased, menstrual irregularities, oligospermia, phallic enlargement (prepubertal males), priapism (postpubertal males), testicular atrophy (postpubertal males), testicular dysfunction (postpubertal males); virilism (women, high dose); voice deepening (women)

Gastrointestinal: Diarrhea, nausea, vomiting

Genitourinary: Bladder irritability (postpubertal males), epididymitis (postpubertal males), prostatic hyperplasia (elderly males), seminal volume decreased (postpubertal males)

Hematologic: Iron-deficiency anemia, polycythemia, suppression of clotting factors

Hepatic: Cholestatic hepatitis, hepatic necrosis, hepatocellular carcinoma jaundice, liver cell tumors, peliosis hepatic, transaminases increased

Neuromuscular & skeletal: Premature closure of epiphysis (children)

Overdosage/Toxicology:

Symptoms include confusion and abnormal liver function tests. Treatment is supportive.

Drug Interactions:

Cyclosporine: Androgens may enhance the hepatotoxic effect of cyclosporine.

Warfarin: Androgens may enhance the anticoagulant effect of warfarin.

Stability:

Store at 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

Enhances the production and urinary excretion of erythropoietin in patients with anemias due to bone marrow failure; stimulates erythropoiesis in anemias due to deficient red cell production.

Dosage:

Children and Adults: Erythropoietic effects: Oral: 1-5 mg/kg/day in one daily dose; usual effective dose: 1-2 mg/kg/day; give for a minimum trial of 3-6 months because response may be delayed

Dosing adjustment in hepatic impairment:

Mild to moderate hepatic impairment: Oxymetholone should be used with caution in patients with liver dysfunction because of its hepatotoxic potential

Severe hepatic impairment: Oxymetholone should not be used

Monitoring Parameters:

Liver function, blood sugars, lipid profile, iron studies, hemoglobin/hematocrit, xray of bones every 6 months (prepubertal patients); signs of virilization (females)

Test Interactions:

Decreased thyroxine-binding globulin, T4; increased resin uptake of T3 and T4

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Do not donate blood during or for 1 month following therapy. Take as directed. If you have diabetes, monitor serum glucose closely and notify prescriber of significant changes; medication may increase the effect of insulin and oral hypoglycemic agents. May cause nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); diarrhea (buttermilk, boiled milk, or yogurt may help). Male: acne, swelling of breasts, loss of libido, impotence. Female: virilism, menstrual irregularity (usually reversible). Report changes in menstrual pattern; enlarged or painful breasts; deepening of voice or unusual growth of body hair; fluid retention (eg, swelling of ankles, feet, or hands, respiratory difficulty, or sudden weight gain); bladder irritability; unresolved CNS changes (eg, nervousness, chills, insomnia); change in color of urine or stool; yellowing of eyes or skin; unusual bruising or bleeding; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Do not get pregnant during or for 1 month following therapy. This drug may cause severe fetal defects. Consult prescriber for instruction on appropriate contraceptive measures. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause insomnia

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Tablet: 50 mg

International Brand Names:

Adroyd® (IN); Anapolon® (HK, TR); Androlic® (TH); Roboral® (IL)

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