What are the guidelines for using Oxandrolone (anabolic steroid) for medical treatment?

Medical Guidelines for Oxandrolone Use

Oxandrolone should only be used for specific FDA-approved medical conditions and under close medical supervision due to its potential side effects and risks. 1, 2

FDA-Approved Indications

• Oxandrolone (Oxandrin) is FDA-approved for:
  • Restitution of weight loss after severe trauma, major surgery or infections 1, 2
  • Treatment of malnutrition due to alcoholic cirrhosis 1, 2
  • Management of Duchenne's or Becker's muscular dystrophy 2

Dosage Guidelines

Adults

• Standard adult dosage: 2.5 mg to 20 mg daily, divided into 2-4 doses 1
• Typical treatment course: 2-4 weeks, which may be repeated intermittently as indicated 1
• Geriatric patients: Lower dose of 5 mg twice daily is recommended due to increased sensitivity to fluid retention and hepatic transaminase elevations 1

Children

• Pediatric dosage: ≤0.1 mg per kilogram body weight daily 1
• For Turner syndrome: 0.03-0.05 mg/kg/day starting from age 8-10 years when used as adjunctive therapy with growth hormone 3
• For Fanconi anemia with bone marrow failure: Low-dose oxandrolone has shown efficacy with limited toxicities 4

Monitoring Requirements

• Liver function tests should be obtained periodically due to potential hepatotoxicity 1
• Regular monitoring of lipid profiles as anabolic steroids can increase LDL and decrease HDL 1
• Hemoglobin and hematocrit should be checked periodically for polycythemia in patients receiving high doses 1
• In children, bone age should be monitored with X-rays every 6 months to assess effects on epiphyseal centers 1
• Women should have frequent determination of urine and serum calcium levels during therapy 1

Contraindications and Precautions

• Pregnancy: Contraindicated (Pregnancy Category X) 1
• Prostate cancer: Contraindicated due to potential stimulation of tumor growth 1
• Breast cancer in males: Contraindicated 1
• Hypercalcemia in women with breast cancer: Contraindicated 1
• Severe hepatic, renal, or cardiac disease: Use with caution 1

Drug Interactions

• Anticoagulants: Oxandrolone significantly increases sensitivity to warfarin, requiring up to 80-85% reduction in warfarin dosage 1
• Oral hypoglycemic agents: May inhibit metabolism of these medications 1
• Adrenal steroids or ACTH: May increase edema when used concomitantly 1

Special Populations

Women

• Female patients should be monitored for virilization effects including:
  • Hoarseness or deepening of voice 1
  • Hirsutism and facial hair growth 1, 5
  • Menstrual irregularities 5
  • Clitoromegaly 5, 3
• Women in reproductive years should use effective contraception during treatment 5

Children

• Should be used very cautiously and only by specialists aware of effects on bone maturation 1
• May accelerate epiphyseal maturation more rapidly than linear growth 1
• Effects may continue for 6 months after discontinuation 1

Specific Clinical Applications

Hereditary Angioedema

• Oxandrolone has been used as long-term prophylaxis for hereditary angioedema at doses of 2.5 mg every 3 days to 20 mg daily 5
• Side effects in women include hyperandrogenemia, virilization, hirsutism, hoarseness, weight gain, menstrual irregularities, and breast hypotrophy 5
• Most adverse effects are dose-related and can be minimized by using the lowest effective dose 5

Cancer-Related Cachexia

• There are insufficient consistent clinical data to recommend androgenic steroids like oxandrolone to increase muscle mass in cancer patients 5
• In non-small cell lung cancer patients, anabolic steroids have shown a trend toward smaller weight loss 5
• Not recommended for treatment of cachexia outside clinical trials due to inconsistent evidence and potential side effects 5

Burns and Trauma

• Oxandrolone (1mg/kg/day) has shown benefits in burn injury by:
  • Improving organ function 6
  • Modulating systemic inflammatory response 6
  • Accelerating wound healing 6
  • Increasing net muscle protein balance 6

Duchenne Muscular Dystrophy

• Not considered necessary or appropriate when used with growth hormone therapy 5

Common Side Effects

• Virilization in females 5, 1
• Transient elevations in liver enzymes 1, 2
• Reductions in HDL cholesterol 1, 2
• Fluid retention 1
• Acne 1
• Altered libido 5

Conclusion

Oxandrolone therapy should be adjunctive to conventional therapy and not a replacement. Treatment should be intermittent with careful monitoring for adverse effects. The benefits of therapy must be weighed against potential risks, particularly in women and children where virilization and effects on growth are concerns.