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|Oxymetholone

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Oxymetholone

Pronouncation: (OCK-sih-METH-oh-lone)
Class: Anabolic steroid

Trade Names:
Anadrol-50
- Tablets 50 mg

Mechanism of Action

Pharmacology

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.

Unlabeled Uses

HIV-associated wasting.

Contraindications

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 dysfunction; hypersensitivity to any component of the product.

Dosage and Administration

Adults and Children

PO 1 to 5 mg/kg/day.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F).

Drug Interactions

Anticoagulants (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.

Adverse Reactions

CNS

Excitation, increased or decreased libido, insomnia.

Dermatologic

Acne (especially in women and prepubertal boys), hirsutism and male-pattern baldness in women, male-pattern baldness in postpubertal males.

EENT

Deepening of the voice in women.

GI

Diarrhea, nausea, vomiting.

Genitourinary

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.

Hematologic-Lymphatic

Iron deficiency anemia.

Hepatic

Reversible changes in liver function tests, including bromsulfophthalein retention, increases in serum bilirubin, AST, and alkaline phosphatase.

Lab Tests

Increased creatine and creatinine excretion, increased serum creatinine phosphokinase,; cholestatic jaundice, hepatocellular neoplasms, peliosis hepatitis.

Metabolic-Nutritional

Decreased glucose tolerance, increased serum levels of LDL, decreased levels of HDL; retention of serum electrolytes (calcium, chloride, phosphate, potassium, sodium).

Musculoskeletal

Premature closure of epiphyses in children, muscle cramps.

Miscellaneous

Chills, edema.

Precautions

Warnings

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.

Pregnancy

Category X .

Lactation

Undetermined.

Children

Use with caution. Epiphyseal maturation may be accelerated more rapidly than linear growth in children and continue for 6 mo after stopping treatment.

Elderly

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.

Hepatitis

Cholestatic hepatitis and jaundice may occur.

Hypercalcemia

Hypercalcemia, caused by stimulation of osteolysis, may occur in patients with breast cancer.

Virilization

May occur in women; observe for signs of voice deepening, hirsutism, acne, clitorimegaly, and menstrual irregularities.

Patient Information

Explain name, action, and potential side effects of drug.
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.
Advise women to inform health care provider if pregnant, planning to become pregnant, or breastfeeding.
Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
Remind patient that office visits and laboratory tests will be required to monitor therapy and to keep appointments.

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