The correlation between plasma level and therapeutic effect has not been defined. Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of and has been assigned to Schedule III non-narcotic. Cholestatic hepatitis and jaundice may occur with alpha-alkylated androgens at a relatively low dose. If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, oxandrolone should be discontinued and the etiology should be determined.
Drug-induced jaundice is reversible when the medication is discontinued. In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. Oxandrolone therapy should be discontinued if hypercalcemia occurs. Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.
Concomitant administration of adrenal cortical steroid or ACTH may increase the edema. In children, androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect results in compromised adult height.
The younger the child, the greater the risk of compromising final mature height. Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma. Concurrent dosing of oxandrolone with warfarin may result in unexpectedly large increases in the INR or prothrombin time PT.
Women should be observed for signs of virilization deepening of the voice, hirsutism, acne, clitoromegaly. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens.
Menstrual irregularities may also occur. The physician should instruct patients to report immediately any use of warfarin and any bleeding. Males: Too frequent or persistent erections of the penis, appearance or aggravation of acne. Females: Hoarseness, acne, changes in menstrual periods, or more facial hair. All patients: Nausea, vomiting, changes in skin color, or ankle swelling. Oxandrin, at daily doses of 5 mg bid, and 10 mg bid, was evaluated in four clinical trials involving a total of patients with different underlying medical conditions.
The maximum duration of treatment was 4 months with the average duration of treatment from No significant differences in efficacy were detected between the 5 mg bid and 10 mg bid daily doses. The adverse event profiles were similar between the two age groups although the elderly, particularly in women, had a greater sensitivity to fluid retention and increases in hepatic transaminases. A single dose pharmacokinetic study in elderly volunteers revealed an increased half-life when compared to younger volunteers.
Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of therapy. Because of the hepatotoxicity associated with the use of 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 children to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers. Androgenic anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins. Therefore, caution is required when administering these agents to patients with a history of cardiovascular disease or who are at risk for cardiovascular disease.
Serum determination of lipid levels should be performed periodically and therapy adjusted accordingly. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids. Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.
A multidose study of oxandrolone, given as 5 or 10 mg bid in 15 healthy subjects concurrently treated with warfarin, resulted in a mean increase in S-warfarin half-life from 26 to 48 hours and AUC from 4. When oxandrolone therapy is initiated in a patient already receiving treatment with warfarin, the INR 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 drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated are recommended when the oxandrolone dose is changed or discontinued.
Patients should be closely monitored for signs and symptoms of occult bleeding. In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema. Anabolic steroids 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.
Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur. Oxandrolone has not been tested in laboratory animals for carcinogenic or mutagenic effects. In 2-year chronic oral rat studies, a dose-related reduction of spermatogenesis and decreased organ weights testes, prostate, seminal vesicles, ovaries, uterus, adrenals, and pituitary were shown.
Withdrawal of the drugs did not lead to regression of the tumors in all cases. It is not known whether anabolic steroids are excreted in human milk. Because of the potential of serious adverse reactions in nursing infants from oxandrolone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 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 adult height. The following adverse reactions have been associated with use of anabolic steroids: Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Prepubertal: Phallic enlargement and increased frequency or persistence of erections. Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.
CNS: Habituation, excitation, insomnia, depression, and changes in libido. Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy. Human growth hormone is also controversial because of side effects and questions about whether it can increase strength. Companies like GTx and Ligand Pharmaceuticals are trying to develop drugs that possess the muscle-building ability of testosterone without its side effects, like the development of facial hair and other masculine features in women.
These drugs are called selective androgen receptor modulators, or Sarms. Pfizer, Amgen and Acceleron Pharma are separately pursuing drugs that block myostatin, a protein made by the body that acts as a brake on muscle formation. Belgian Blue cattle, which do not make myostatin, have huge, rippling muscles and yet are otherwise apparently healthy.
Several years ago, scientists reported that a German boy who lacked myostatin because of genetic mutations had abnormal strength and muscle mass. Most of the drugs have been tested in only early-stage clinical trials so far, and there have been many setbacks.
Belgian Blue cattle, which do not make myostatin, have huge, rippling muscles and yet are otherwise apparently healthy. Several years ago, scientists reported that a German boy who lacked myostatin because of genetic mutations had abnormal strength and muscle mass.
Most of the drugs have been tested in only early-stage clinical trials so far, and there have been many setbacks. Wyeth, now part of Pfizer, dropped a myostatin inhibitor that did not work well in a muscular dystrophy clinical trial. Amgen last month called off a trial to test its myostatin blocker for age-related muscle decline. But those companies all say they are not giving up on the quest.
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