Description
Oxymetholone
Strength: 50 mg
Molecular Formula: C21H3203
Molecular Weight: 332.48 g/mol
Active Ingrediet: Oxymetholone
CAS number: 434-07-1
Dosage Form: Tablet
Route: Oral
Market Status: Prescription
Company: Hilma Biocare
DESCRIPTION
Oxymetholone 50 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 50 promotes protein anabolism and rapid weight gain but has the potential for
substantial adverse reactions. Oxymetholone 50 promotes increased strength, muscle mass,
and growth of new red blood cells.
CLINICAL PHARMACOLOGY
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.
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.
CONTRAINDICATIONS
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.
WARNINGS
Oxymetholone 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 hepatotoxicity. Use only under the
care of a qualified physician.
PRECAUTIONS
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 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. 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.
ADVERSE REACTIONS
Male: Gynecomastia, excessive frequency and duration of penile erections, oligospermia.
Skin and Appendages: Hirsutism, male pattern baldness and acne, gynecomastia.
Fluid/electrolyte 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. Disturbances: 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.
DRUG INTERACTIONS
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 adrenocortical 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 eM monitored throughout androgen therapy and warfarin doses 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.
PRESENTATION
Oxymetholone 50 mg uncoated tablets: 100 tablets in 1 bottle.
STORAGE
Store in a cool dry place erw between 15 – 25°C. Protect from light.
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