See Supplemental Patient Information
- Cholestatic hepatitis and jaundice have been reported with 17-alpha-alkylated androgens at a relatively low dose. Drug-induced jaundice is reversible on discontinuation of the drug. Monitor LFTs periodically in view of the risk of hepatotoxicity associated with therapy
- Therapy may cause hypercalcemia by stimulating osteolysis in patients with breast cancer. Discontinue the drug if hypercalcemia occurs
- Concomitant administration of adrenal steroids or ACTH in patients with preexisting cardiac, renal, or hepatic disease may worsen preexisting edema
- Athletic ability has not been enhanced by anabolic steroids
- Closely monitor women for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly) and discontinue therapy at the earliest evidence of mild virilism in order to prevent irreversible changes
- Menstrual irregularities such as amenorrhea may occur with therapy
- Diabetic patients who are on anabolic steroids may need to adjust the dose of insulin or oral hypoglycemic agents
- Therapy may cause suppression of clotting factors II, V, VII and X, and increase the prothrombin time
- During the course of therapy, monitor urine and serum calcium levels frequently in women with disseminated breast carcinoma
- Periodic x-ray examinations of bone age, to determine the rate of bone maturation and effects of therapy on epiphyseal centers, should be done q6 months in prepubertal patients
- Monitor hemoglobin and hematocrit periodically for polycythemia in patients receiving high doses of anabolic steroids
- Geriatric male patients treated with anabolic steroids may be at a higher risk for development of prostatic hypertrophy and prostatic carcinoma
- Co-administration with warfarin may result in significant increases in the INR or prothrombin time; consider reducing warfarin doses in such patients to diminish the risk of serious bleeding
- Iron deficiency anemia may occur in patients receiving anabolics; serum iron and iron binding capacity should be determined periodically
Cautions: Use cautiously in
Supplemental Patient Information
- Advise male patients to promptly report their physicians if they experience too frequent or persistent erections of penis or aggravation of acne during therapy; instruct female patients to report any hoarseness, acne, menstrual changes, or increased hair on the face during therapy
- Instruct patients to seek medical attention if they develop nausea, vomiting, changes in skin color or ankle swelling during therapy
Pregnancy Category:X
Breastfeeding: Safety unknown; because of the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of breastfeeding.
Drug Name: Anadrol-50 50 MG Oral Tablet
Ingredient(s): Oxymetholone
Imprint: 0055;ALAVEN
Color(s): White
Shape: Round
Size (mm): 7.00
Score: 2
Inactive Ingredient(s): lactose / magnesium stearate / povidone / starch
Drug Label Author:
ALAVEN Pharmaceutical
DEA Schedule:
CIII