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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, buy ultima drostan p 100 mg injectable steroids masteron. 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 category X (see CONTRAINDICATIONS ). 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. 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. 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. There have been no reports of acute overdosage with anabolics. Carcinoma of the prostate or breast in male patients. Carcinoma of the breast in females with hypercalcemia; androgenic anabolic steroids may stimulate osteolyticresorption of bones. 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. Nephrosis or the nephrotic phase of nephritis. Hypersensitivity to the drug.
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