Oxandrolone has been discontinued in the US. Because this drug is no longer available in the US market, the material in this monograph is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information. |
Oxandrolone is a synthetic androgenic anabolic steroid hormone.1, 4
Catabolic and Wasting Disorders
Oxandrolone is used as an adjunct to conventional therapy to promote weight gain in individuals who experience weight loss following extensive surgery, chronic infections (e.g., HIV-associated wasting syndrome; designated an orphan drug by the US Food and Drug Administration [FDA] for this use),3 or severe trauma (e.g., burns, spinal cord injury).1, 5, 17, 19, 22, 32
Oxandrolone is used as an adjunct to conventional therapy for management of unexplained weight loss.1
Corticosteroid-induced Protein Catabolism
Oxandrolone is used as an adjunct to conventional therapy to offset protein catabolism (e.g., muscle wasting, muscle pain or weakness, delayed wound healing, atrophy of protein matrix of bone) associated with long-term corticosteroid therapy.1, 4, 20, 21, 33
Oxandrolone is labeled for the symptomatic treatment of bone pain accompanying osteoporosis.1, 4, 23
Androgens have been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique†.6, 7, 8, 9, 10, 32, 193, 194 Following review of data from published literature and case reports in October 2016, the FDA concluded that misuse and abuse of androgens are associated with serious adverse cardiovascular, hepatic, endocrine, and mental health effects.193, 194
Medical and sports experts (e.g., International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae.9 Such misuse by athletes is contrary to rules and ethical principles of athletic competition.7, 8, 9, 10
The manufacturer of oxandrolone states that androgens have not been shown to enhance athletic performance.1
Serum testosterone concentrations should be evaluated in patients who may be misusing or abusing androgens (e.g., patients experiencing serious adverse cardiovascular or psychiatric effects); however, serum testosterone concentrations may be below or within the normal range in patients abusing synthetic derivatives of testosterone.135, 194
The dosage of oxandrolone and the duration of therapy should be carefully individualized according to individual requirements, response, and tolerance.1, 4 The minimum effective dosage of the drug should be used; oxandrolone is intended for intermittent use.1, 4, 22
Oxandrolone is administered orally 2 to 4 times daily in adults.1, 4 The drug usually is administered once daily in pediatric patients.1
Catabolic and Wasting Disorders
Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily for 2-4 weeks.1, 4 The course of therapy may be repeated intermittently as needed to maintain weight.1, 4, 32
The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response (i.e., slowing or cessation of weight loss).1, 4, 32 A longer period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present.32
A higher than recommended oxandrolone dosage of 0.1 mg/kg twice daily for 5 days to 12 months† has been evaluated in pediatric patients with burns.1, 4, 5, 16, 17, 18, 32
Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses for 2-4 weeks.1, 4 The course of therapy may be repeated intermittently as needed to maintain weight.1, 4, 32
The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response (i.e., slowing or cessation of weight loss).1, 4, 32 A longer period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present.32 Continuous administration for 3-4 months has been evaluated in patients with HIV-associated wasting syndrome.5, 19
Corticosteroid-induced Protein Catabolism
Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily.1, 4 The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response.1, 4, 32 The course of therapy may be repeated intermittently as needed.1, 4, 32
Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses.1, 4 The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response.1, 4, 32 The course of therapy may be repeated intermittently as needed.1, 4, 32
For bone pain accompanying osteoporosis, adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses.1, 4 The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response.1, 4 The course of therapy may be repeated intermittently as needed.1, 4
Geriatric patients may receive oxandrolone in a dosage of 5 mg twice daily for 2-4 weeks.1 The course of therapy may be repeated intermittently as needed.1
Males with breast cancer or known or suspected prostate cancer.1, 4
Women with hypercalcemia associated with metastatic breast cancer.1, 4 Women with known or suspected pregnancy.1, 4
Patients with nephrosis or hypercalcemia.1, 4
Potentially serious and/or life-threatening adverse hepatic effects (e.g., peliosis hepatis, hepatic adenomas, hepatocellular carcinoma) have been reported in patients receiving long-term therapy with high dosages of androgens.1, 4, 5, 6, 7, 9, 10, 22
If cholestatic hepatitis with jaundice occurs, or if liver function test results become abnormal during therapy, oxandrolone should be discontinued and the etiology of these disorders should be investigated.1, 4 Drug-induced jaundice usually is reversible after discontinuance of drug.1, 4
Liver function should be monitored periodically.1, 4, 17, 22
Hypercalcemia resulting from osteolysis reported in women with metastatic carcinoma of the breast receiving androgens.1, 4 Urine and serum calcium concentrations should be monitored frequently during the course of androgen therapy in women with metastatic breast cancer.1, 4, 30
If hypercalcemia occurs, discontinue the drug.1, 4
Edema, with or without congestive heart failure, may occur as a result of sodium and water retention; this may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.1, 4, 30
Serious adverse effects (e.g., increased aggression,6, 7, 8, 10, 13, 22 antisocial behavior,6, 7 manic episode,6, 22 hostility,194 depression,9 changes in libido,6, 7, 8, 9, 10, 22 increased risk of cardiovascular events,6, 7, 8, 9 hepatotoxicity,6, 7, 8, 9, 10 testicular atrophy, sperm abnormalities135, 193, 194 ) are associated with misuse and abuse of androgens; oxandrolone preparations currently are subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as schedule III (C-III) drugs.11, 32
Manifestations of withdrawal (e.g., depressed mood, major depression, fatigue, cravings, restlessness, irritability, anorexia, insomnia, decreased libido, hypogonadotropic hypogonadism) may occur if androgens are discontinued abruptly or the dosage is substantially reduced in physically dependent patients or in those taking supratherapeutic dosages of the drug; withdrawal symptoms may persist for weeks or months.135
Patients should be informed of the serious adverse effects associated with misuse and abuse of androgens.135
Virilization, including baldness, clitoral enlargement, deepening of voice, hirsutism, and menstrual irregularities, may occur in females.1, 4, 5, 6, 9, 13
Monitor women receiving oxandrolone therapy for signs of virilization.1, 4 If virilization occurs, promptly discontinue therapy.1, 4 Some changes may not be reversible (e.g., clitoral enlargement, voice changes) after discontinuance of the drug; concomitant use of estrogen with androgens does not prevent these effects.1, 4, 6, 7, 32
Possible polycythemia, especially in patients receiving high dosages of androgens.1, 4, 30 Perform periodic hemoglobin and hematocrit determinations in patients receiving high dosages of androgens.1, 4, 30
Anabolic steroids may suppress clotting factors II, V, VII, and X and prolong prothrombin time.1, 4
Androgens may increase LDL-cholesterol and decrease HDL-cholesterol concentrations; the increased risk for cardiovascular disease should be considered.1, 4, 5, 6, 7, 10, 12, 13, 19, 22, 32 Lipid concentrations return to baseline values approximately 1 month after discontinuance of androgen therapy.22
Use with caution in patients with cardiovascular disease or risk factors for cardiovascular disease.1, 4 Determine serum lipid concentrations periodically; adjust therapy accordingly.1, 4
Androgens may decrease thyroxine-binding globulin concentrations, resulting in decreased total serum thyroxine (T4) concentrations and increased resin uptake of triiodothyronine (T3) and T4.1, 4, 16
Free thyroid hormone concentrations remain unchanged.1, 4
Protein-bound iodine (PBI) concentrations and radioactive iodine uptake may be decreased.1, 4
Category X.1
May cause fetal harm; potential for virilization of fetus.1, 4
Fetotoxicity, embryotoxicity, infertility, and virilization of female offspring demonstrated in animals.1, 4
Not known whether oxandrolone is distributed into milk.1, 4 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1, 4
May accelerate bone maturation without producing compensatory gain in linear growth, possibly resulting in compromised adult stature.1, 4, 10 The younger the child, the greater the risk of the drug compromising final mature stature.1, 4
Use with extreme caution in children and only under the supervision of a specialist who is aware of the adverse effects of oxandrolone on bone maturation.1, 4 Perform radiographic examination of the left hand and wrist every 6 months to determine rate of bone maturation and to assess the effect of treatment on epiphyseal centers.1, 4
Possible increased risk of developing prostatic hypertrophy and prostate cancer during androgen therapy.1, 4, 30
Response in patients 65 years of age or older does not appear to differ from that in younger adults.1 Increased sensitivity to fluid retention and increases in hepatic transaminase values reported, particularly in geriatric women.1 Use lower dosage to minimize adverse effects.1
Elevated aminotransferases (ALT, AST),1, 4, 5, 13, 17, 19 lipid abnormalities (e.g., decreased HDL cholesterol concentrations).1, 4, 5, 13, 19
May potentiate action of oral anticoagulants and decrease anticoagulant requirements.1, 4, 22, 24, 26, 32 Increases in plasma concentrations and half-life of warfarin reported; minor bleeding has occurred.1, 4 In one study, a substantial decrease (i.e., 80-85%) in warfarin dosage (from a mean dosage of 6.13 mg daily to a mean of 1.13 mg daily) was needed to maintain target international normalized ratio (INR) of 1.5.1, 4, 32
Monitor prothrombin time (PT) or INR when oxandrolone therapy is initiated or discontinued in patients receiving oral anticoagulants and adjust anticoagulant dosage as needed.1, 4, 32 Initial anticoagulant dosage may be substantially lower in patients receiving oxandrolone.32 Signs and symptoms of occult bleeding should be monitored.1, 4
Antidiabetic Agents, Oral (Sulfonylureas)
Possible inhibition of sulfonylurea metabolism.1, 4, 32 Use concomitantly with care.6
Corticotropin (ACTH) and Corticosteroids
May exacerbate edema.1, 4 Consider possibility of interaction before use.13
Oxandrolone produces marked anabolic activity and relatively few androgenic effects.5, 6, 7, 13, 14, 22 The drug causes increases in lean body mass, body cell mass, and muscle strength,7, 9, 16, 17, 18, 19, 20, 22 as well as increases in bone mineral density and content.5, 13, 16, 22
Oxandrolone produces retention of nitrogen,5, 7, 13, 17, 22 increases protein anabolism and amino acid utilization, and decreases urinary calcium concentrations.2, 5, 13, 16, 18, 23
Oxandrolone inhibits protein catabolism induced by corticosteroids.5, 6, 8, 17, 22
Androgens stimulate production of erythrocytes, apparently by enhancing production of erythropoietin.22
Oxandrolone inhibits release of endogenous testosterone via feedback inhibition of pituitary luteinizing hormone (LH).1, 4, 7, 8, 10, 19, 22, 32 Large doses of androgens may suppress spermatogenesis.1, 4, 6, 7, 8, 9, 22
Importance of advising patients of the potential for serious adverse effects associated with misuse and abuse of androgens.135
Risk of virilization in females.1, 2, 4, 6 Advise female patients to contact their clinician if they notice hoarseness, acne, menstrual changes, baldness, genital changes, or growth of facial hair.1, 2, 4
Risk of priapism; importance of males informing clinicians if too frequent or persistent penile erections occur.1, 4
Advise male patients to contact their clinician if they notice new or worsening acne.1, 4
Importance of periodic assessments to determine rate of bone maturation in pediatric patients.1, 4
Importance of informing clinician if nausea, vomiting, changes in skin color, or ankle swelling occurs.1, 4
Risk of potential liver toxicity and/or lipid abnormalities (e.g., increased LDL-cholesterol concentrations and decreased HDL-cholesterol concentrations).1, 4 Importance of regular laboratory monitoring of liver function and cholesterol concentrations.1, 4
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1, 4
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription (e.g., warfarin, antidiabetic medications) and OTC drugs and herbal supplements, as well as any concomitant illnesses.1, 4
Importance of informing patients of other important precautionary information.1, 4
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Oxandrolone is subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as a schedule III (C-III) drug.11
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 2.5 mg | Oxandrolone Tablets (C-III; scored) | |
10 mg | Oxandrolone Tablets (C-III) |
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