Active ingredient: Oxandrolone - Basic Profile / Key Facts

Basic Profile / Key Facts

Drug Category

• Anabolic Agents
• Androgens

Dosage Forms

• Not Available

Indications

Use to promote weight gain after weight loss following extensive surgery.

Pharmacology

Oxandrolone is an anabolic steroids indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis. Anabolic steroids are synthetic derivatives of testosterone.

Mechanism of Action

Oxandrolones interact with androgen receptors in target tissues.

Absorption

Not Available

Toxicity

Not Available

Biotrnasformation / Drug Metabolism

Renal

Contraindications

1. Known or suspected carcinoma of the prostate or the male breast.

2. Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).

3. Pregnancy, because of possible masculinization of the fetus. Oxandrin has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.

4. Nephrosis, the nephrotic phase of nephritis.

5. Hypercalcemia.

Drug Interactions

Anticoagulants

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.