Description Oxandrolone Strength: 10 mg Molecular Formula: C19H3003 Molecular Weight: 306.44 g/mol Active Ingredient: Oxandrolone CAS number: 53-39-4 Dosage Form: Tablet Route: Oral Market Status: Prescription Company: Hilma Biocare DESCRIPTION Oxandrolone 10 is a well tolerated 17-alpha alkylated anabolic steroid with very low hepatic toxicity. It promotes anabolism through androgen receptor activity and has a low incidence of adverse reactions. When taken in clinical doses, oxandrolone promotes improvements in strength and moderate increases in muscle mass. Oxandrolone has been demonstrated to enhance body fat reduction significantly in both the abdominal and visceral stores (Int. J. Obesity, 1995; 19: 614-624). Oxandrolone will not aromatize and therefore the anabolic effect of this compound can promote linear growth. Oxandrolone has shown great promise in nerve regeneration, skin healing in burn victims, and increased rate of healing after traumatic events. CLINICAL PHARMACOLOGY Anabolic steroids are synthetic derivatives of testosterone. Certain clinical effects and adverse reactions demonstrate the androgenic properties of these drugs. Complete dissociation of anabolic and androgenic effects has not been achieved. The actions of anabolic steroids are thus similar to those of male sex hormones. Anabolic steroids suppress the gonadotropic functions of the pituitary and may exert a direct effect upon the testes. During exogenous administration of anabolic androgens, endogenous testosterone release is inhibited through inhibition of pituitary luteinizing hormone (LH). At large doses, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH). In single dose pharmacokinetic studies of oxandrolone the mean elimination half-life was 13.3 hours in elderly subjects and 10.4 hours in younger subjects. INDICATION AND USAGE Oxandrolone 10 is indicated as an alternate or adjunctive therapy in patients for the promotion of weight gain following weight loss and/or muscular atrophy associated with extensive surgery, chronic infections, long term hospitalization, or severe trauma. Oxandro 10 is indicated to compensate for protein catabolism consequent to corticosteroid therapy and for the reduction of pain associated with osteoporosis. CONTRAINDICATIONS Patients with diagnosed or suspected carcinoma of the breast, prostate, or testis. Women who are pregnant or may become pregnant because of possible masculinization of the fetus. Patients with nephrosis or the nephrotic phase of nephritis. Patients with hypercalcemia. Patients with pre-existing cardiac, respiratory, renal, and/or hepatic disease or history of epilepsy. PRECAUTIONS Elevated liver enzymes and in extreme cases hepatic liver dysfunction may occur. 17-alpha-alkylated androgens may cause cholestatic hepatitis and jaundice, particularly with larger dosages or prolonged treatment. Liver function should be monitored for changes including serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (AP). Edema may be increased in patients on concurrent adrenal cortical steroid or ACTH therapy. Anabolic steroid hormones may increase low-density lipoproteins (LDL) and decrease high density lipoproteins (HDL).Lipids levels generally return to normal upon discontinuation of treatment. Anabolic steroids may reduce clotting factors II, V, VII, and X, and may increase prothrombin time (PT). Patients should be instructed to report any use of warfarin and any irregular bleeding. Diabetics: androgens may alter the metabolism of oral hypoglycemic agents or may change insulin sensitivity in patients with diabetes mellitus which may require adjustment of dosage of insulin and other hypoglycemic drugs. DRUG INTERACTIONS Oral hypoglycemic agents: may inhibit the metabolism of oral hypoglycemic agents which may require adjustment of dosage. Anticoagulants: Patients on anticoagulants should be carefully monitored during anabolic steroid therapy as anabolic steroids may increase sensitivity to oral anticoagulants. Patients should be monitored regularly during anabolic steroid therapy, particularly during initiation and termination of therapy. ADVERSE REACTIONS Male: Gynecomastia, excessive frequency and duration of penile erections, oligospermia. Skin and Appendages: Hirsutism, pattern baldness and acne, gynecomastia. Fluid/electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. Gastrointestinal: Nausea,c cholestatic jaundice, alterations in liver function tests; rarely, hepatocellular neoplasms, peliosis hepatitis, hepatic adenomas, and cholestatic hepatitis. Hematologic: Suppression of clotting factors II, V, VII, & X; bleeding in patients on anticoagulant therapy. Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. Metabolic: Increased serum creatinine phosphokinase (CPK), reduced glucose tolerance, increased creatinine clearance, and inhibition of gonadotropin secretion. Other: Serum lipid changes, hypercalcaemia, hypertension, oedema, priapism, and potentiation of sleep apnea. DOSAGE AND ADMINISTRATION Adult males: 10 – 30 mg taken orally per day in 2 to 3 divided doses for 6 to 8 weeks under care of a physician. PRESENTATION Oxandrolone 10 mg uncoated tablets: 100 tablets in 1 bottle. STORAGE Store in a cool dry place between 15 – 25°C. Protect from light.