Rx only life was 10.4 hours. No significant differences SOMETIMES PRESENT WITH MINIMAL In patients with breast cancer, anabolic SAVIENT PHARMACEUTICALS, INC. between younger and elderly volunteers were HEPATIC DYSFUNCTION, BUT AT steroid therapy may cause hypercalcemia by C III found for time to peak, peak plasma OTHER TIMES THEY HAVE BEEN stimulating osteolysis. Oxandrolone therapy concentration or AUC after a single dose of ASSOCIATED WITH LIVER FAILURE. should be discontinued if hypercalcemia Oxandrin®(oxandrolone tablets, USP) Oxandrin. The correlation between plasma level THEY ARE OFTEN NOT RECOGNIZED occurs. DESCRIPTION and therapeutic effect has not been defined. UNTIL LIFE-THREATENING LIVER Oxandrin® oral tablets contain 2.5 mg or 10 mg FAILURE OR INTRA-ABDOMINAL Edema with or without congestive heart of the anabolic steroid oxandrolone. INDICATIONS AND USAGE HEMORRHAGE DEVELOPS. failure may be a serious complication in Oxandrolone is 17β-hydroxy-17α-methyl-2- Oxandrin is indicated as adjunctive therapy to WITHDRAWAL OF DRUG USUALLY patients with pre-existing cardiac, renal, or oxa-5α-androstan-3-one with the following promote weight gain after weight loss following RESULTS IN COMPLETE hepatic disease. Concomitant administration structural formula extensive surgery, chronic infections, or severe DISAPPEARANCE OF LESIONS. of adrenal cortical steroid or ACTH may trauma, and in some patients who without LIVER CELL TUMORS ARE ALSO increase the edema. definite pathophysiologic reasons fail to gain or REPORTED. MOST OFTEN THESE to maintain normal weight, to offset the protein TUMORS ARE BENIGN AND In children, androgen therapy may accelerate catabolism associated with prolonged ANDROGEN-DEPENDENT, BUT FATAL bone maturation without producing administration of corticosteroids, and for the MALIGNANT TUMORS HAVE BEEN compensatory gain in linear growth. This relief of the bone pain frequently accompanying REPORTED. WITHDRAWAL OF DRUG adverse effect results in compromised adult Inactive ingredients include cornstarch, lactose, osteoporosis (See DOSAGE AND OFTEN RESULTS IN REGRESSION OR height. The younger the child, the greater magnesium stearate, and hydroxypropyl ADMINISTRATION). CESSATION OF PROGRESSION OF THE the risk of compromising final mature height. methylcellulose. TUMOR. HOWEVER, HEPATIC The effect on bone maturation should be DRUG ABUSE AND DEPENDENCE TUMORS ASSOCIATED WITH monitored by assessing bone age of the left CLINICAL PHARMACOLOGY Oxandrolone is classified as a controlled ANDROGENS OR ANABOLIC STEROIDS wrist and hand every 6 months (See Anabolic steroids are synthetic derivatives of substance under the Anabolic Steroids Control ARE MUCH MORE VASCULAR THAN PRECAUTIONS: Laboratory Tests). testosterone. Certain clinical effects and adverse Act of 1990 and has been assigned to Schedule OTHER HEPATIC TUMORS AND MAY reactions demonstrate the androgenic properties III (non-narcotic). BE SILENT UNTIL LIFE-THREATENING Geriatric patients treated with androgenic of this class of drugs. Complete dissociation of INTRA-ABDOMINAL HEMORRHAGE anabolic steroids may be at an increased risk anabolic and androgenic effects has not been CONTRAINDICATIONS DEVELOPS. BLOOD LIPID CHANGES for the development of prostatic hypertrophy achieved. The actions of anabolic steroids are 1. Known or suspected carcinoma of the THAT ARE KNOWN TO BE and prostatic carcinoma. therefore similar to those of male sex hormones prostate or the male breast. ASSOCIATED WITH INCREASED RISK with the possibility of causing serious 2. Carcinoma of the breast in females with OF ATHEROSCLEROSIS ARE SEEN IN ANABOLIC STEROIDS HAVE NOT BEEN disturbances of growth and sexual development if hypercalcemia (androgenic anabolic PATIENTS TREATED WITH SHOWN TO ENHANCE ATHLETIC given to young children. Anabolic steroids steroids may stimulate osteolytic bone ANDROGENS OR ANABOLIC ABILITY. suppress the gonadotropic functions of the resorption). STEROIDS. THESE CHANGES INCLUDE pituitary and may exert a direct effect upon the 3. Pregnancy, because of possible DECREASED HIGH-DENSITY PRECAUTIONS testes. masculinization of the fetus. Oxandrin LIPOPROTEINS AND SOMETIMES Concurrent dosing of oxandrolone and has been shown to cause embryotoxicity, INCREASED LOW-DENSITY warfarin may result in unexpectedly large During exogenous administration of anabolic fetotoxicity, infertility, and LIPOPROTEINS. THE CHANGES MAY increases in the INR or prothrombin time androgens, endogenous testosterone release is masculinization of female animal BE VERY MARKED AND COULD HAVE (PT). When oxandrolone is prescribed to inhibited through inhibition of pituitary offspring when given in doses 9 times A SERIOUS IMPACT ON THE RISK OF patients being treated with warfarin, doses luteinizing hormone (LH). At large doses, the human dose. ATHEROSCLEROSIS AND CORONARY of warfarin may need to be decreased spermatogenesis may be suppressed through 4. Nephrosis, the nephrotic phase of ARTERY DISEASE. significantly to maintain the desirable INR feedback inhibition of pituitary follicle- nephritis. level and diminish the risk of potentially stimulating hormone (FSH). 5. Hypercalcemia. Cholestatic hepatitis and jaundice may occur serious bleeding (See PRECAUTIONS: with 17-alpha-alkylated androgens at a Drug Interactions). Anabolic steroids have been reported to increase WARNINGS relatively low dose. If cholestatic hepatitis low-density lipoproteins and decrease high- with jaundice appears or if liver function tests General: density lipoproteins. These levels revert to PELIOSIS HEPATIS, A CONDITION IN become abnormal, oxandrolone should be Women should be observed for signs of normal on discontinuation of treatment. WHICH LIVER AND SOMETIMES discontinued and the etiology should be virilization (deepening of the voice, SPLENIC TISSUE IS REPLACED WITH determined. Drug-induced jaundice is hirsutism, acne, clitoromegaly). In a single dose pharmacokinetic study of BLOOD-FILLED CYSTS, HAS BEEN reversible when the medication is Discontinuation of drug therapy at the time of Oxandrin in elderly subjects, the mean REPORTED IN PATIENTS RECEIVING discontinued. evidence of mild virilism is necessary to elimination half-life was 13.3 hours. In a ANDROGENIC ANABOLIC STEROID prevent irreversible virilization. Some previous single dose pharmacokinetic study in THERAPY. THESE CYSTS ARE virilizing changes in women are irreversible younger volunteers, the mean elimination half- even after prompt discontinuance of therapy serum calcium levels during the course of patient already receiving treatment with the development of prostatic hypertrophy and and are not prevented by concomitant use of therapy. (See WARNINGS). warfarin, the INR or prothrombin time (PT) prostatic carcinoma. estrogens. Menstrual irregularities may also should be monitored closely and the dose of occur. Because of the hepatotoxicity associated with warfarin adjusted as necessary until a stable Pregnancy: Teratogenic effects-Pregnancy the use of 17-alpha-alkylated androgens, liver target INR or PT has been achieved. Category X (See CONTRAINDICATIONS). Anabolic steroids may cause suppression of function tests should be obtained periodically. Furthermore, in patients receiving both drugs, clotting factors II, V, VII, and X, and an careful monitoring of the INR or PT, and Nursing mothers: increase in prothrombin time. Periodic (every 6 months) x-ray examinations of adjustment of the warfarin dosage if indicated It is not known whether anabolic steroids are bone age should be made during treatment of are recommended when the oxandrolone dose is excreted in human milk. Because of the Information for patients: children to determine the rate of bone changed or discontinued. Patients should be potential of serious adverse reactions in nursing The physician should instruct patients to report maturation and the effects of androgen therapy closely monitored for signs and symptoms of infants from oxandrolone, a decision should be immediately any use of warfarin and any on the epiphyseal centers. occult bleeding. made whether to discontinue nursing or to bleeding. discontinue the drug, taking into account the The physician should instruct patients to report Androgenic anabolic steroids have been Oral hypoglycemic agents: importance of the drug to the mother. any of the following side effects of androgens: reported to increase low-density lipoproteins Oxandrolone may inhibit the metabolism of oral Males: Too frequent or persistent erections of and decrease high-density lipoproteins. hypoglycemic agents. Pediatric use: the penis, appearance or aggravation of acne. Therefore, caution is required when Anabolic agents may accelerate epiphyseal Females: Hoarseness, acne, changes in administering these agents to patients with a Adrenal steroids or ACTH: maturation more rapidly than linear growth in menstrual periods, or more facial hair. history of cardiovascular disease or who are at In patients with edema, concomitant children and the effect may continue for 6 All patients: Nausea, vomiting, changes in risk for cardiovascular disease. Serum administration with adrenal cortical steroids or months after the drug has been stopped. skin color, or ankle swelling. determination of lipid levels should be ACTH may increase the edema. Therefore, therapy should be monitored by x- performed periodically and therapy adjusted ray studies at 6-month intervals in order to Geriatric Use: accordingly. avoid the risk of compromising adult height. Oxandrin, at daily doses of 5 mg bid and 10 mg Drug/Laboratory