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CLINICAL STUDIES
Pavlatos AM, Review of Oxymetholone: A 17 (ALPHA SYMBOL) – Alkylated Anabolic-Androgenic Steroid. Clinical Therapeutics/Vol. 23 No. 6. 2001; 789-801
Hengge UR, Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting. AIDS. 2003; 17:699-710
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Molinari PF, Neri LL. Effect of a single oral dose of oxymetholone on the metabolism of human erythrocytes. Exp Hematol. 1978;6:648-654
Gaughan WJ, Liss KA, Dunn SR, et al. A 6-month study of low-dose recombinant human erythropoietin alone and in combination with androgens for the treatment of anemia in chronic hemodialysis patients. Am J Kidney Dis. 1997;30:495-500.
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.
PRECAUTIONS/LAB TESTS
The PRECAUTIONS for usage of Anadrol®-50 include, concurrent dosing of an anabolic steroid and warfarin may result in unexpectedly large increases in the INR or prothrombin time (PT). When an anabolic steroid is prescribed to a patient being treated with warfarin, doses ofwarfarin may need to be decreased significantly to maintain the desirable INR level and diminish the risk of potentially serious bleeding.
LABORATORY TESTS:
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of androgenic anabolic steroid therapy (see WARNINGS). Because of the hepatoxicity associated with the use of 17-alphaalkylated androgens, liver function tests should be obtained periodically. Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of prepubertal patients to determine the rate of bone maturation and the effects of androgenic anabolic steroid therapy on the epiphyseal centers. Anabolic steroids have been reported to lower the level of highdensity lipoproteins and raise the level of low-density lipoproteins. These changes usually revert to normal on discontinuation of treatment. Increased low-density lipoproteins and decreased high-density lipoproteins are considered cardiovascular risk factors. Serum lipids and high-density lipoprotein cholesterol should be determined periodically.
Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolics. Because iron deficiency anemia has been observed in some patients treated with oxymetholone, periodic determination of the serum iron and iron binding capacity is recommended. If iron deficiency is detected, it should be appropriately treated with supplementary iron. Oxymetholone has been shown to decrease 17-ketosteroid excretion.
CONTRAINDICATIONS
Anadrol-50 is contraindicated in: male patients with carcinoma of the prostate or breast; females with hypercalcemia with carcinoma of the breast; women who are or may become pregnant; patients with nephrosis or the nephrotic phase of nephritis; patients with hypersensitivity to the drug or with severe hepatic dysfunction.
DRUG INTERACTIONS
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-50 Tablets and warfarin, careful monitoring of the INR or PT and adjustment of the warfarin dosage, if indicated, are recommended when the ANADROL-50
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.
WARNINGS
WARNINGS for Anadrol-50 in the following conditions include reports 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. Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. 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.
SEE FULL BOXED WARNING FOR MORE INFORMATION ON THESE CONDITIONS IN THE FULL PRESCRIBING INFORMATION.
Please See Full Prescribing Information pdf
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