Oxymetholone Dosage
Applies to the following strengths: 50 mg
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Anemia
Individualize therapy:
1 to 5 mg/kg orally per day
- Usual effective dose: 1 to 2 mg/kg/day; however, higher doses may be required
Comments:
- Response is not immediate and a minimum trial of three to six months should be given.
- Following remission, some patients may be maintained without the drug while others may need a maintenance dose; a continued maintenance dose is generally necessary in patients with congenital aplastic anemia.
- Treatment with this drug should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B or pyridoxine deficiency, antibacterial therapy, and the appropriate use of corticosteroids.
Use: Treatment of anemias caused by deficient red cell production.
Usual Pediatric Dose for Anemia
Individualize therapy:
Children: 1 to 5 mg/kg orally per day
- Usual effective dose: 1 to 2 mg/kg/day; however, higher doses may be required
Comments:
- Response is not immediate and a minimum trial of three to six months should be given.
- Following remission, some patients may be maintained without the drug while others may need a maintenance dose; a continued maintenance dose is generally necessary in patients with congenital aplastic anemia.
- Treatment with this drug should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B or pyridoxine deficiency, antibacterial therapy, and the appropriate use of corticosteroids.
Use: Treatment of anemias caused by deficient red cell production.
Renal Dose Adjustments
Use with caution
Liver Dose Adjustments
Severe hepatic dysfunction: Contraindicated
Dose Adjustments
Elderly: Dose selection should be cautious, generally starting at the low end of the dosing range.
Precautions
US BOXED WARNING: PELIOSIS HEPATITIS/LIVER CELL TUMORS/BLOOD LIPID CHANGES
- Peliosis hepatitis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times they have been associated with liver failure; they are often not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops; drug withdrawal usually results in complete disappearance of lesions.
- Liver cell tumors have also been reported, most often they are benign and androgen-dependent, but fatal malignant tumors have been reported; drug withdrawal often results in regression or cessation of progression of the tumor. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening intraabdominal hemorrhage develops.
- Blood lipid changes that are known to be associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids; these changes include decreased high density lipoprotein and sometimes increased low density lipoprotein. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
CONTRAINDICATIONS:
- Men with carcinomas of the breast or with known or suspected carcinomas of the prostate
- Women who are or may become pregnant
- Breast Cancer in females with hypercalcemia
- Nephrosis or the nephrotic phase of nephritis
- Hypersensitivity to the drug
- Severe hepatic dysfunction
Consult WARNINGS section for additional precautions.
US Controlled Substance: Schedule III
Dialysis
Data not available
Other Comments
Administration advice:
- Administer orally
Storage requirements:
- Protect from light and moisture
General:
- Patients with acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond to treatment with this drug.
- Use with caution in children; use should be by specialists who are aware of their effects on bone maturation.
Monitoring:
- Periodic liver function tests should be performed
- Prepubertal males should have X-ray examinations of bone age every 6 months
- Periodic evaluation of hemoglobin and hematocrit checking for polycythemia should be performed, especially with high doses
- Periodic evaluation of serum iron and iron binding capacity
- Periodic evaluation of serum lipids
- Women should have frequent determinations of urine and serum calcium levels
Patient advice:
- Female patients should be instructed to report signs of virilization such as deepening voice, hirsutism, acne, clitoromegaly, and/or menstrual irregularities.
- Male patients should be instructed to report too frequent or persistent penile erections or aggravation of acne.
- All patients should be instructed to report signs and symptoms of jaundice or edema, or bleeding, especially if concomitantly using warfarin.
- Patients should understand that this drug has been subject to abuse; steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.
- Female patients who are or who are planning to become pregnant should talk with their healthcare provider.
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