Oxymetholone is a potent 17-alpha alkylated derivative of dihydrotestosterone. This is a potent anabolic and androgenic drug despite being weakly bound to the androgen receptor. Oxymetholone promotes protein anabolism and rapid weight gain but has the potential for substantial adverse reactions. Oxymetholone promotes increased strength, muscle mass, and growth of new red blood cells.
Anabolic steroids are synthetic derivatives of testosterone. Nitrogen balance is improved with anabolic agents but only when there is sufficient intake of calories and protein. Whether this positive nitrogen balance is of primary benefit in the utilization of protein-building dietary substances has not been established. Oxymetholone enhances the production and urinary excretion of erythropoietin in patients with anemias due to bone marrow failure and often stimulates erythropoiesis in anemias due to deficient red cell production.
Certain clinical effects and adverse reactions demonstrate the androgenic properties of this class of drugs. Complete dissociation of anabolic and androgenic effects has not been achieved. The actions of anabolic steroids are therefore similar to those of male sex hormones. They suppress the gonadotropic functions of the pituitary and may exert a direct effect upon the testes.
INDICATION AND USAGE
Anemia: indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia,congenital aplastic anemia, myelofibrosis and hypoplastic anemias often respond.
Muscular Atrophy: indicated as an alternate or adjunctive therapy for weight gain and muscle growth following muscular atrophy associated with extensive surgery, chronic infections, long term hospitalization, severe trauma, osteoporosis, long-term corticosteroid therapy, and wasting syndromes.
Patients with known hypersensitivity to any ingredients in this product.
Patients with known or suspected carcinomas of the breast, testis, or prostate.
Patients with heart disease, liver disease, or kidney disease or with a history of epilepsy.
Products containing androgens should not be used in women as they may cause virilization and fetal harm. Oxymetholone 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. Hepatic dysfunction. Hypertension.
Oxymeth 50 is a strong anabolic agent with potentially serious side effects. Rarely, peliosis hepatitis and liver cell tumors have presented, generally resolving after withdrawal of the medication. Patients should be monitored for signs of hepatoxicity. Use only under the care of a qualified physician.
Oxymetholone is extremely hepatotoxic. Liver function tests should be conducted before and during treatment given the association of 17-alpha-alkylated androgens with hepatotoxicity. 17-alpha-alkylated androgens may cause cholestatic hepatitis and jaundice, particularly with larger dosages or prolonged treatment. Monitor for signs of jaundicing.
Anabolic steroid hormones may increase low-density lipoproteins (LDL) and decrease high density lipoproteins (HDL) increasing the risk of atherosclerosis and heart disease. Lipids levels generally return to normal upon discontinuationof treatment.
Anabolic steroids may reduce clotting factors II, V, VII, and X, and may increase pro-thrombin 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.
Elevated oestrogen levels may occur producing estrogen mediated side-effects such as increased water retention and gynecomastia. Physicians are advised to consider concurrent anti-estrogen therapy.
Edema may be increased in patients on concurrent adrenal cortical steroid or ACTH therapy.
Male: Gynecomastia, excessive frequency and duration of penile erections, oligospermia.
Skin and Appendages: Hirsutism, male pattern baldness and acne, gynecomastia.
Fluid/electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
Gastrointestinal: Nausea, 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 anti-coagulant therapy.
Nervous System: Changes in libido, headache, anxiety, aggression, depression, and generalized paresthesia.
Other: Serum lipid changes, hypercalcaemia, hypertension, oedema, priapism, and potentiation of sleep apnea.
Oral hypoglycemic agents: may inhibit the metabolism of oral hypoglycemic agents which may require adjustment of dosage.
Corticosteroids: may exacerbate edema in patients on concurrent adrenal-cortical steroids or ACTH therapy.
Anticoagulants: Patients on anticoagulants such as warfarin should be carefully monitored during anabolic steroid therapy as anabolic steroids may increase sensitivity to oral anticoagulants which may require a concomitant reduction in anticoagulant dosage to achieve a desirable prothrombin time (PT). Anticoagulant patients should be monitored regularly during anabolic steroid therapy, particularly during initiation and termination of therapy. Warfarin patients should have INR and PT monitored throughout androgen therapy and warfarin dosages titrated to achieve the desired INR and PT. Such patients should be monitored for occult bleeding.
DOSAGE AND ADMINISTRATION
Adult male: 50mg taken orally once per day for a duration of 2 to 4 weeks.
Treatment should be under supervision of a qualified physician with laboratory monitoring.
50mg uncoated tablets: 50 tablets in 5 blisters.
Protect from light. Store at 15-25oC.
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