Oxandrolone

What it is and how it works

Oxandrolone is an orally active 17-alpha-alkylated androgen with high anabolic and relatively low androgenic activity; it promotes protein synthesis, nitrogen retention and lean body mass.

Indications

Adjunctive therapy to promote weight gain after extensive surgery, chronic infection, severe trauma or burns; offsetting protein catabolism with prolonged corticosteroids; relief of bone pain in osteoporosis; short stature in Turner syndrome (specialist use). Availability has declined; the US product was withdrawn in 2023.

Dosage and administration (summary)

Oral: adults usually 2.5–20 mg daily in 2–4 divided doses, generally for courses of 2–4 weeks, repeated intermittently as indicated.

Contraindications

Known or suspected carcinoma of the prostate or male breast, carcinoma of the breast with hypercalcaemia in women, nephrosis, hypercalcaemia and pregnancy.

Warnings and precautions

Peliosis hepatis, liver tumours and cholestatic hepatitis can occur with 17-alpha-alkylated androgens; monitor liver function. It adversely affects serum lipids (lowers HDL) and may cause fluid retention and virilisation in women. Potentiates warfarin; INR should be monitored and anticoagulant doses reduced.

Pregnancy

Contraindicated because of the risk of virilisation of the female fetus.

Storage and supply

Store below 25 °C.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.