Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.
Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.
Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.
Burn management, severe; to increase lean muscle mass and promote wound healing: Limited data available: Children and Adolescents: Oral: 0.1 mg/kg/dose twice daily for up to 12 months has been shown to increase lean body mass, bone mineral density, and muscle strength; shortened length of ICU stay and improved donor site wound healing were also observed (Hart 2001; Jeschke 2007; Murphy 2004; Porro 2012; Przkora 2005). Benefits have been shown to persist for up to 5 years post burn (Porro 2012; Przkora 2005).
Constitutional delay of growth and puberty (CDGP) (males): Limited data available: Children and Adolescents 9 to 16 years: Oral: 1.25 to 2.5 mg once daily in the evening; usual duration: 3 to 12 months although longer (~5 years) has been reported (Albanese 1994; Buyukgebiz 1990; Papadimitriou 1991; Schroor 1995; Stanhope 1985; Stanhope 1988; Tse 1990)
Turner Syndrome (females): Limited data available: Children and Adolescents ≥8 years: Oral: Reported range: 0.03 to 0.06 mg/kg/day at bedtime in combination with growth hormone and/or estrogen; maximum single dose: 2.5 mg/dose; due to risks of dose-related virilization, doses ≥0.05 mg/kg/day should generally be avoided. Typically, therapy initiated at 8 to 9 years of age and continued until goal height attained or further growth is unlikely (eg, bone age ≥14 years and growth velocity <2 cm/year) (Bareille 1997; NIH [Bondy 2007]; Freriks 2012; Gault 2011; Haeusler 1995; Menke 2010; Nilsson 1996).
Weight gain, adjunct: Children and Adolescents: Oral: Total daily dose: ≤0.1 mg/kg; may be repeated intermittently as needed; in adult patients, the daily dose is divided 2 to 4 times daily; typical duration of therapy: 2 to 4 weeks
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
All patients: There are no dosage adjustments provided in the manufacturer's labeling. Caution is recommended because of the propensity of oxandrolone to cause edema and water retention.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Oxandrolone: Drug information")
Burns, severe (off-label): Oral, Enteral feeding tube: 10 mg every 12 hours beginning ~5 days after injury (Li 2016; Wolf 2006)
Weight gain (adjunctive therapy ): Oral: 2.5 to 20 mg in divided doses 2 to 4 times daily based on individual response; a course of therapy of 2 to 4 weeks is usually adequate. May repeat intermittently as needed.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution due to propensity to cause edema.
Preexisting impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
Hepatotoxicity during therapy: Discontinue use if abnormal liver function tests or cholestatic hepatitis with jaundice occurs.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Oxandrin: 2.5 mg [DSC], 10 mg [DSC]
Generic: 2.5 mg, 10 mg
Yes
C-III
Oral: For patients unable to swallow tablets, an oral suspension may be extemporaneously prepared (see Extemporaneous Preparations for additional information). In adults (severe burn), oxandrolone tablets were dissolved in ethanol and administered through enteral feeding tube (Wolf 2006); pediatric experience has not been reported.
Enteral feeding tube (off-label): In severe burn patients unable to tolerate oral administration, may dissolve oxandrolone tablets in ethanol and administer through enteral feeding tube (Wolf 2006).
Store at 20°C to 25°C (68°F to 77°F).
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 and for the relief of bone pain associated with osteoporosis (All indications: FDA approved in children and adults); has also been used in the management of Turner syndrome in girls, constitutional delay of growth and puberty (CDGP), and for postoperative burn management to increase lean muscle mass and promote wound healing.
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Edema
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%, postmarketing, and/or case reports: Hepatic necrosis, hepatotoxicity (idiosyncratic; Chalasani 2014)
Nephrosis; breast cancer in females with hypercalcemia; known or suspected prostate or breast cancer in males; hypercalcemia; pregnancy
Concerns related to adverse effects:
• Blood lipid changes: [US Boxed Warning]: May cause blood lipid changes with increased risk of arteriosclerosis. Use caution in patients at risk for, or with a history of cardiovascular disease; monitor lipid profile and adjust therapy as indicated. Lipid changes are usually reversible upon discontinuation of therapy.
• Gynecomastia: May cause gynecomastia.
• Hepatic effects: [US 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; drug-induced jaundice is reversible upon discontinuation. Use with caution in patients with hepatic impairment.
• Oligospermia: May suppress spermatogenesis; oligospermia may occur.
• Polycythemia: Increased hemoglobin and hematocrit may occur with high doses of anabolic steroids; monitor.
• Priapism: Priapism or excessive sexual stimulation may occur.
Disease-related concerns:
• Breast cancer: Use with caution in females with breast cancer; may cause hypercalcemia by stimulating osteolysis; use is contraindicated in females with breast cancer and hypercalcemia. Discontinue use if hypercalcemia occurs. Use is contraindicated in males with known or suspected breast cancer.
• 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, hepatic impairment, renal impairment); may cause fluid retention.
Special populations:
• Elderly: Use with caution in elderly patients, elderly males may be at greater risk for prostatic hyperplasia and prostate cancer.
• 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.
None known.
Agents with Blood Glucose Lowering Effects: Androgens may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ajmaline: Androgens may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Risk C: Monitor therapy
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Risk C: Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider avoiding concomitant use of androgens and cyclosporine. If concomitant use is unavoidable, monitor serum cyclosporine concentrations and for signs and symptoms of hepatotoxicity. Cyclosporine dose reductions may be required. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Monitor for increased effects of vitamin K antagonists if an androgen is initiated/dose increased, or decreased effects if androgen is discontinued/dose decreased. Significant reductions in vitamin K antagonist dose are likely required. Risk D: Consider therapy modification
Use is contraindicated in pregnant women; masculinization of the fetus has been reported.
Liver function tests, lipid profile, hemoglobin/hematocrit; INR/PT in patients on anticoagulant therapy
Children: Radiographs of left wrist every 6 months to assess bone maturation
Females: Signs of virilization (deepening voice, hirsutism, acne, clitoromegaly); urine and serum calcium in women with breast cancer
Synthetic testosterone derivative with similar androgenic and anabolic actions
Absorption: Oral: Well absorbed (Orr 2004)
Protein binding: 95% (Orr 2004)
Half-life elimination: 10 to 13 hours
Time to peak serum concentration: ~1 hour (Orr 2004)
Excretion: Urine (28% as unchanged drug) (Orr 2004)
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).
Tablets (Oxandrolone Oral)
2.5 mg (per each): $5.53 - $6.69
10 mg (per each): $18.75 - $23.81
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