|Manufacturer:||Savient Pharmaceuticals, Inc.|
Oxandrin is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (See DOSAGE AND ADMINISTRATION).
-- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.
Known or suspected carcinoma of the prostate or the male breast.Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).Pregnancy, because of possible masculinization of the fetus.
Oxandrin has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.Nephrosis, the nephrotic phase of nephritis.Hypercalcemia.
-- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)
-- Development of male secondary SEX CHARACTERISTICS in the FEMALE. It is due to the effects of androgenic metabolites of precursors from endogenous or exogenous sources, such as ADRENAL GLANDS or therapeutic drugs.
-- Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
-- Pathological processes of the KIDNEY without inflammatory or neoplastic components. Nephrosis may be a primary disorder or secondary complication of other diseases. It is characterized by the NEPHROTIC SYNDROME indicating the presence of PROTEINURIA and HYPOALBUMINEMIA with accompanying EDEMA.
-- Inflammation of any part of the KIDNEY.
-- Abnormally high level of calcium in the blood.
Cholestatic hepatitis and jaundice may occur with 17-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.
The effect on bone maturation should be monitored by assessing bone age of the left wrist and hand every 6 months (See PRECAUTIONS: Laboratory Tests).Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY.
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