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Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.
The following adverse reactions have been associated with use of anabolic steroids:
Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy (See WARNINGS). Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)
Prepubertal: Phallic enlargement and increased frequency or persistence of erections.
Clitoral enlargement, menstrual irregularities.
Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.
Larynx: Deepening of the voice in females.
Hair:Hirsutism and male pattern baldness in females.
Skin:Acne (especially in females and prepubertal males).
Skeletal: Premature closure of epiphyses in children (See PRECAUTIONS: Pediatric use).
Metabolic/Endocrine: Decreased glucose tolerance (See PRECAUTIONS: Laboratory tests), increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.
Drug Abuse And Dependence
Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).
Read the Oxandrin (oxandrolone) Side Effects Center for a complete guide to possible side effects
Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.
Warfarin: A multidose study of oxandrolone, given as 5 or 10 mg bid in 15 healthy subjects concurrently treated with warfarin, resulted in a mean increase in S-warfarin half-life from 26 to 48 hours and AUC from 4.55 to 12.08 ng*hr/mL; similar increases in R-warfarin half-life and AUC were also detected. Microscopic hematuria (9/15) and gingival bleeding (1/15) were also observed. A 5.5-fold decrease in the mean warfarin dose from 6.13 mg/day to 1.13 mg/day (approximately 80-85% reduction of warfarin dose), was necessary to maintain a target INR of 1.5. When oxandrolone therapy is initiated in a patient already receiving treatment with warfarin, the INR or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved. Furthermore, in patients receiving both drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated are recommended when the oxandrolone dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.
Oral hypoglycemic agents
Oxandrolone may inhibit the metabolism of oral hypoglycemic agents.
Adrenal steroids or ACTH
In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema.
Drug/Laboratory test interactions
Anabolic steroids may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur.
Read the Oxandrin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Oxandrin Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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