(oks AN droe lone)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Oxandrin: 2.5 mg [scored]
Oxandrin: 10 mg
Generic: 2.5 mg, 10 mg
Brand Names: U.S.
Synthetic testosterone derivative with similar androgenic and anabolic actions
Oral: Well absorbed (Orr 2004)
Urine (28% as unchanged drug) (Orr 2004)
Time to Peak
Concentration: ~1 hour (Orr 2004)
10 to 13 hours
95% (Orr 2004)
Use: Labeled Indications
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 protein catabolism with prolonged corticosteroid administration; relief of bone pain associated with osteoporosis
Nephrosis; carcinoma of breast (women with hypercalcemia or men) or prostate; hypercalcemia; pregnancy
Weight gain (adjunct): Oral: 2.5-20 mg in divided doses 2-4 times daily based on individual response; a course of therapy of 2-4 weeks is usually adequate. This may be repeated intermittently as needed.
Weight gain (adjunct): Oral: 5 mg twice daily
Weight gain (adjunct): Oral: Children: Total daily dose: ≤0.1 mg/kg; may be repeated intermittently as needed
Dosing: Renal Impairment
No dosage adjustment provided in manufacturer’s labeling; use with caution due to propensity to cause edema.
Dosing: Hepatic Impairment
No dosage adjustment provided in manufacturer’s labeling; use with caution.
A 1 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of Ora-Sweet® and Ora-Plus®, or a 1:1 mixture of Ora-Sweet® SF and Ora-Plus®. Crush twenty-four 2.5 mg tablets in a mortar to a fine powder. Add small portions of chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 60 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 60 mL. Thoroughly mix the suspension by shaking. Label “shake well” and “protect from light”. Stable for 90 days at room temperature (Johnson, 2011).Johnson CE, Cober MP, Hawkins KA, et al, “Stability of Extemporaneously Prepared Oxandrolone Oral Suspensions,” Am J Health-Syst Pharm, 2011, 68(6):519-21.21378300
Store at 20°C to 25°C (68°F to 77°F).
Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Monitor therapy
Blood Glucose Lowering Agents: Androgens may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification
May suppress factors II, V, VII, and X; may increase PT; may decrease thyroxine-binding globulin and radioactive iodine uptake
Frequency not defined.
Central nervous system: Deepening of the voice (females), depression, excitement, habituation, insomnia
Dermatologic: Acne vulgaris (females and prepubertal males), androgenetic alopecia (females)
Endocrine & metabolic: Changes in libido, decreased glucose tolerance, decreased HDL cholesterol, electrolyte disturbance, gynecomastia, hirsutism (females), increased LDL cholesterol, inhibition of gonadotropin secretion, menstrual disease (females)
Genitourinary: Clitoromegaly (females), epididymitis (postpubertal males), erectile dysfunction (prepubertal males; increased or persistent erections), impotence (postpubertal males), inhibition of testicular function (postpubertal males), irritable bladder (postpubertal males), oligospermia (postpubertal males), phallic enlargement (prepubertal males), priapism (chronic; postpubertal males), testicular atrophy (postpubertal males)
Hematologic & oncologic: Clotting factors suppression, prolonged prothrombin time
Hepatic: Cholestatic jaundice, hepatocellular neoplasm, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, peliosis hepatitis (long-term therapy)
Neuromuscular & skeletal: Increased creatine phosphokinase, premature epiphyseal closure (children)
Renal: Increased creatinine clearance
<1% (Limited to important or life-threatening): Hepatic necrosis, hepatotoxicity (idiosyncratic; Chalasani 2014)
Concerns related to adverse effects:
• Blood lipid changes: [U.S. Boxed Warning]: May cause blood lipid changes with increased risk of arteriosclerosis.
• Hepatic effects: [U.S. Boxed Warning]: Anabolic steroids may cause peliosis hepatis or liver cell tumors which may not be apparent until liver failure or intra-abdominal hemorrhage develops. Discontinue in case of cholestatic hepatitis with jaundice or abnormal liver function tests. Use with caution in patients with hepatic impairment.
• Breast cancer: Use with caution in patients with breast cancer; may cause hypercalcemia by stimulating osteolysis. Discontinue use if hypercalcemia occurs.
• Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in patients with diabetes.
• COPD: Use with caution in patients with COPD.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
Concurrent drug therapy issues:
• Warfarin: Use caution with concomitant warfarin therapy; warfarin dose may need to be significantly decreased.
• Elderly: Use with caution in elderly patients, they may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and transaminase elevations.
• Pediatric: May accelerate bone maturation without producing compensatory gain in linear growth in children; effect may continue for 6 months after the drug is stopped; in prepubertal children perform radiographic examination of the left hand and wrist every 6 months to determine the rate of bone maturation and to assess the effect of treatment on the epiphyseal centers.
• Females: May cause mild virilization in females; monitor for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinue with evidence of mild virilization in female patients; early discontinuation may prevent irreversible virilization.
• Appropriate use: Anabolic steroids have not been shown to improve athletic ability.
Liver function tests, cholesterol profile, hemoglobin/hematocrit; INR/PT in patients on anticoagulant therapy
Children: Radiographs of left wrist and hand every 6 months (to assess bone maturation)
Adult females: Signs of virilization (deepening voice, hirsutism, acne, clitoromegaly); urine and serum calcium in women with breast cancer
Pregnancy Risk Factor
Use is contraindicated in women who are or may become pregnant; masculinization of the fetus has been reported.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience insomnia or sexual dysfunction. Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), priapism, acne, urinary retention, change in amount of urine passed, muscle weakness, severe anxiety, bruising, bleeding, signs of virilization (in females a deep voice, facial hair, pimples, or period changes), shortness of breath, excessive weight gain, or swelling of arms or legs (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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Other brands: Oxandrin