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Oxymetholone

Pronunciation

(oks i METH oh lone)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Slideshow: Saving Lives: Best To Know Your Breast

Tablet, Oral:

Anadrol-50: 50 mg [scored]

Brand Names: U.S.

  • Anadrol-50

Pharmacologic Category

  • Anabolic Steroid

Pharmacology

Enhances production of erythropoietin in patients with anemias which are due to bone marrow failure; stimulates erythropoiesis in anemias due to deficient red cell production

Use: Labeled Indications

Treatment of anemias caused by deficient red cell production

Contraindications

Hypersensitivity to oxymetholone or any component of the formulation; breast cancer in men; breast cancer in women with hypercalcemia; prostate cancer; severe hepatic dysfunction; nephrosis or nephrotic phase of nephritis; pregnancy or use in women who may become pregnant

Dosage

Note: The National Kidney Foundation does not recommend the use of androgens as an adjuvant to ESA treatment in anemic patients with chronic kidney disease (KDOQI, 2006).

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

Dosage adjustment in renal impairment: No dosage adjustment provided in manufacturer’s labeling. Use with caution due to risk of edema in patients with renal impairment.

Dosage adjustment in hepatic impairment:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment: Use is contraindicated.

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Drug Interactions

Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy

Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy

CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification

Test Interactions

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

Adverse Reactions

Frequency not defined.

Cardiovascular: Coronary artery disease, peripheral edema

Central nervous system: Chills, excitation, insomnia

Dermatologic: Acne, hirsutism (women), hyperpigmentation, male-pattern baldness (postpubertal males, women)

Endocrine & metabolic: Amenorrhea, clitoromegaly, glucose tolerance decreased, gynecomastia, HDL-cholesterol decreased, hypercalcemia, hyperchloremia, hyperkalemia, hypernatremia, hyperphosphatemia, LDL-cholesterol increased, libido increased/decreased, menstrual irregularities, virilism (women)

Gastrointestinal: Diarrhea, nausea, vomiting

Genitourinary: Bladder irritability, epididymitis, impotence, oligospermia, penile enlargement, penile erections increased (prepubertal males), priapism, prostate cancer, prostatic hyperplasia (elderly males), seminal volume decreased, testicular atrophy, testicular dysfunction

Hematologic: Bleeding, INR increased, iron-deficiency anemia, leukemia, prothrombin time increased, clotting factors (II, V, VII, X) suppressed

Hepatic: Alkaline phosphatase increased, bilirubin increased, cholestatic hepatitis, cholestatic jaundice, hepatic failure, hepatic necrosis, hepatocellular carcinoma, liver cell tumors, peliosis hepatis, transaminases increased

Neuromuscular & skeletal: Creatine phosphokinase increased, premature closure of epiphysis (children)

Renal: Creatinine increased

Respiratory: Hoarseness (women)

Miscellaneous: Voice deepening (women)

Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014)

ALERT: U.S. Boxed Warning

Peliosis hepatis:

Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.

Liver cell tumors:

Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.

Blood lipid changes:

Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.

Warnings/Precautions

Concerns related to adverse effects:

• Blood lipid changes: [U.S. Boxed Warning]: Anabolic steroids may cause changes in blood lipids (decreased high density lipoproteins and sometimes increased low density lipoproteins), increasing the risk of arteriosclerosis and coronary artery disease.

• Clotting factor alterations: Anabolic steroids may suppress factors II, V, VII, and X; prothrombin time may be increased.

• Hepatic effects: [U.S. Boxed Warning]: Androgenic anabolic steroid treatment may cause peliosis hepatis, which occurs when splenic or hepatic tissue is replaced by cysts (blood-filled); may only cause minimal hepatic dysfunction although has been associated with hepatic failure. Androgenic liver cell tumors, which may be benign, although malignant tumors have also been reported; generally regress when anabolic steroid treatment is withdrawn. Both conditions (peliosis and tumors) may not be apparent until liver failure or intra-abdominal hemorrhage develops. Androgen use (low doses) has also been associated with cholestatic hepatitis and jaundice; may be associated with hepatomegaly and right upper-quadrant pain; jaundice is typically reversible upon discontinuation (continuing treatment has been associated with coma and death). Monitor liver function periodically.

• Prostate conditions: Androgenic anabolic steroid use may cause prostatic hypertrophy or prostate cancer in elderly men.

Disease-related concerns:

• Breast cancer: May cause hypercalcemia in women with breast cancer by stimulating osteolysis.

• Diabetes: Use with caution in patients with diabetes mellitus; insulin or oral hypoglycemic needs may be altered; monitor carefully.

• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.

Special populations:

• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children; effect may continue for 6 months after treatment discontinuation; in prepubertal children perform radiographic examination of the hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.

• Women: Discontinue with evidence of mild virilization in women.

Other warnings/precautions:

• Appropriate use: Oxymetholone should not replace other anemia treatment supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy, and the appropriate use of corticosteroids.

Monitoring Parameters

Periodic liver function tests, lipid profile, hemoglobin and hematocrit; iron studies; serum glucose (may be decreased by testosterone, monitor patients with diabetes); radiologic examination of bones every 6 months (when using in prepubertal children); monitor urine and serum calcium and signs of virilization in women treated for breast cancer

Pregnancy Risk Factor

X

Pregnancy Considerations

Oligospermia or amenorrhea may occur resulting in an impairment of fertility. Use is contraindicated in women who are or may become pregnant.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, insomnia, or sexual dysfunction. Have patient report immediately to prescriber priapism, acne vulgaris, dyspnea, excessive weight gain, edema of extremities, urinary retention, oliguria, asthenia, ecchymosis, hemorrhaging, considerable anxiety, signs of hepatic impairment, or signs of virilization (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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