Drug: Anadrol-50

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: Inactive Ingredients:    lactose, magnesium stearate, povidone, starch

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Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy (see WARNINGS). Genitourinary System In Men 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. In Women Clitoral enlargement, menstrual irregularities. In Both Sexes Increased or decreased libido. CNS: Excitation, insomnia. Gastrointestinal: Nausea, vomiting, diarrhea. Hematologic: Bleeding in patients on concomitant anticoagulant therapy, iron-deficiency anemia. 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. Breast: Gynecomastia. 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 Controlled Substance ANADROL Tablets is considered to be a controlled substance and is listed in Schedule III. Read the Anadrol-50 (oxymetholone) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.

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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. Read the Anadrol-50 Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.

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  1. Carcinoma of the prostate or breast in male patients.
  2. Carcinoma of the breast in females with hypercalcemia; androgenic anabolic steroids may stimulate osteolytic resorption of bones.
  3. Oxymetholone can cause fetal harm when administered to pregnant women. It is contraindicated in women who are or may become pregnant. If the patient becomes pregnant while taking the drug, she should be apprised of the potential hazard to the fetus.
  4. Nephrosis or the nephrotic phase of nephritis.
  5. Hypersensitivity to the drug.
  6. Severe hepatic dysfunction.
Last reviewed on RxList: 5/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

There have been no reports of acute overdosage with anabolics.

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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]. Manufactured for : Unimed Pharmaceuticals, Inc. by Solvay Pharmaceuticals, Inc Marietta, GA 30062. Address medical inquiries to: Unimed Pharmaceuticals, Inc. 901 Sawyer Road Marietta, GA 30062. Rev Aug 2004. FDA revision date: 8/25/2004 Last reviewed on RxList: 5/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne and clitoromegaly). To prevent irreversible change, drug therapy must be discontinued when mild virilism is first detected. Such virilization is usual following androgenic anabolic steroid use at high doses. Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens. Menstrual irregularities, including amenorrhea, may also occur. The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids. Anabolic steroids may cause suppression of clotting factors II, V, VII and X, and an increase in prothrombin time. 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-alpha-alkylated 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 high-density 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. Carcinogenesis, Mutagenesis, Impairment of Fertility A two-year carcinogenicity study in rats given oxymetholone orally was conducted under the auspices of the US National Toxicology Program (NTP). A wide spectrum of neoplastic and non-neoplastic effects was observed. In male rats, no effects were classified as neoplastic in response to doses up to 150 mg/kg/day (5 times therapeutic exposures with 5 mg/kg based on body surface area). Female rats given 30 mg/kg/day (1 fold the maximum recommended clinical dose of 5 mg/kg/day based on the body surface area) had increased incidences of lung alveolar/bronchiolar adenoma and adenoma or carcinoma combined. At 100 mg/kg/day (about 3 fold the maximum recommended clinical dose of 5 mg/kg/day based on BSA), female rats had increased incidences of hepatocellular adenoma and adenoma or carcinoma combined; the combined incidence of squamous cell carcinoma and carcinoma of the sweat glands also was increased. Human data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases. Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking. In studies conducted under the auspices of the US National Toxicology Program, no evidence of genotoxicity was found using standard assays for mutagenicity, chromosomal aberrations, or induction of micronuclei in erythrocytes. Impairment of fertility was not tested directly in animal species. However, as noted below under ADVERSE REACTIONS, oligospermia in males and amenorrhea in females are potential adverse effects of treatment with ANADROL Tablets. Therefore, impairment of fertility is a possible outcome of treatment with ANADROL Tablets. Pregnancy Pregnancy category X (see CONTRAINDICATIONS). Nursing Mothers It is not known whether anabolics are excreted in human milk. Because of the potential for serious adverse reactions in nursed infants from anabolics, women who take oxymetholone should not nurse. Pediatric Use Anabolic/androgenic steroids should be used very cautiously in children and only by specialists who are aware of their effects on bone maturation. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for 6 months after the drug has been stopped. Therefore, therapy should be monitored by x-ray studies at 6-month intervals in order to avoid the risk of compromising the adult height. Geriatric Use Clinical studies of ANADROL Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Last reviewed on RxList: 5/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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