Anadrol (Anapolon) Oxymetholone
ANADROL® (oxymetholone) Tablets for oral administration each contain 50 mg of the steroid oxymetholone, a potent anabolic and androgenic drug.
The chemical name for oxymetholone is 17β-hydroxy-2-(hydroxymethylene)-17-methyl-5α-androstan-3-one. The structural formula is:
ANADROL Tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond.
ANADROL Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids.
DOSAGE AND ADMINISTRATION
The recommended daily dose in children and adults is 1-5 mg/kg body weight per day. The usual effective dose is 1-2 mg/kg/day but higher doses may be required, and the dose should be individualized. Response is not often immediate, and a minimum trial of three to six months should be given. Following remission, some patients may be maintained without the drug; others may be maintained on an established lower daily dosage. A continued maintenance dose is usually necessary in patients with congenital aplastic anemia.
ANADROL (oxymetholone) Tablets is supplied in bottles of 100 white scored tablets imprinted with 8633 and UNIMED (NDC 0051-8633-33).
Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP].
Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroidtherapy (see WARNINGS).
Prepubertal: Phallic enlargement and increased frequency of erections.
Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, bladder irritability and decrease in seminal volume.
Clitoral enlargement, menstrual irregularities.
In Both Sexes
Increased or decreased libido.
CNS: Excitation, insomnia.
Leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role, if any, of oxymetholone is unclear because malignant transformation has been seen in patients with blood dyscrasias and leukemia has been reported in patients with aplastic anemia who have not been treated with oxymetholone.
Larynx: Deepening of the voice in women.
Hair: Hirsutism and male-pattern baldness in women, male-pattern of hair loss in postpubertal males.
Skin: Acne (especially in women and prepubertal boys).
Skeletal: Premature closure of epiphyses in children (see PRECAUTIONS, Pediatric Use), muscle cramps.
Body as a Whole: Chills.
Fluid and Electrolytes: Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).
Metabolic/Endocrine: Decreased glucose tolerance (see PRECAUTIONS), increased serum levels of low-density lipoproteins and decreased levels of high-density lipoproteins (see PRECAUTIONS, Laboratory Tests), increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Reversible changes in liver function tests also occur, including increased Bromsulphalein (BSP) retention and increases in serum bilirubin, glutamic-oxaloacetic transaminase (SGOT), and alkaline phosphatase.
Drug Abuse And Dependence
ANADROL Tablets is considered to be a controlled substance and is listed in Schedule III.
Warfarin: Clinically significant pharmacokinetic and pharmacodynamic interactions between anabolic steroids and warfarin have been reported in healthy volunteers. When anabolic steroid therapy is initiated in a patient already receiving treatment with warfarin, the INR (international normalized ratio) or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved. Furthermore, in patients receiving both ANADROL Tablets and warfarin, careful monitoring of the INR or PT and adjustment of the warfarin dosage, if indicated, are recommended when the ANADROL dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.
Anticoagulants: Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.
Drug/Laboratory Test Interferences
Therapy with androgenic anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction. Altered tests usually persist for 2 to 3 weeks after stopping anabolic therapy.
Anabolic steroids may cause an increase in prothrombin time.
Anabolic steroids have been shown to alter fasting blood sugar and glucose tolerance tests.
The following conditions have been reported in patients receiving androgenic anabolic steroids as a general class of drugs:
Peliosis hepatis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times they have been associated with liver failure. They are often not recognized until life-threatening liver failure or intra-abdominalhemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.
Liver cell tumors are also reported. Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of drug often results in regression or cessation of progression of the tumor. 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 that are known to be associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high density lipoprotein and sometimes increased low density lipoprotein. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. Clinical jaundice may be painless, with or without pruritus. It may also be associated with acutehepatic enlargement and right upper-quadrant pain, which has been mistaken for acute (surgical) obstruction of the bile duct. Drug-induced jaundice is usually reversible when the medication is discontinued. Continued therapy has been associated with hepatic coma and death. Because of the hepatoxicity associated with oxymetholone administration, periodic liver function tests are recommended.
In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued.
Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. Concomitant administration with adrenal steroids or ACTH may add to the edema. This is generally controllable with appropriate diuretic and/or digitalis therapy.
Geriatric male patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostate hypertrophy and prostatic carcinoma.
Anabolic steroids have not been shown to enhance athletic ability.