Oxandrin

What is oxandrolone?

Oxandrolone is a man-made steroid, similar to the naturally occurring steroid testosterone. Oxandrolone is an “anabolic” steroid that promotes the growth of muscle tissue.Oxandrolone is used to help you regain weight lost after surgery, severe trauma, or chronic infections. Oxandrolone is also used in people who cannot gain or maintain a healthy weight for unknown medical reasons.

Oxandrolone is also used to decrease muscle loss caused by using steroid medicines, and to reduce bone pain in people with osteoporosis.Oxandrolone may also be used for purposes not listed in this medication guide.

Oxandrin Information

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), or severe trauma (e.g., burns, spinal cord injury).

Oxandrolone is used as an adjunct to conventional therapy for the management of unexplained weight loss.

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.

Osteoporosis

Oxandrolone is labeled for the symptomatic treatment of bone pain accompanying osteoporosis.

Misuse, Abuse, and Dependence

Androgens have been misused and abused by athletes, bodybuilders, weight lifters, and others to enhance athletic performance or physique. Following the review of data from published literature and case reports in October 2016, the FDA concluded that misuse and abuse of androgens are associated with severe adverse cardiovascular, hepatic, endocrine, and mental health effects. (See Misuse, Abuse, and Dependence under Warnings/Precautions: Warnings, in Cautions; see also

Medical and sports experts (e.g., the International Olympic Committee) consider such use to be inappropriate and unacceptable because of known adverse effects and potential long-term sequelae. Such misuse by athletes is contrary to rules and ethical principles of athletic competition.

The manufacturer of oxandrolone states that androgens have not been shown to enhance athletic performance.

Serum testosterone concentrations should be evaluated in patients who may be misusing or abusing androgens (e.g., patients experiencing severe adverse cardiovascular or psychiatric effects); however, serum testosterone concentrations may be below or within the normal range in patients abusing synthetic derivatives of testosterone.

Dosage and Administration

General

The dosage of oxandrolone and the duration of therapy should be carefully individualized according to individual requirements, response, and tolerance. The minimum effective dosage of the drug should be used; oxandrolone is intended for intermittent use.

Administration

Oxandrolone is administered orally 2 to 4 times daily in adults. The drug usually is administered once daily in pediatric patients.

Dosage

Catabolic and Wasting Disorders

Pediatric Patients

Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily for 2-4 weeks. The course of therapy may be repeated intermittently as needed to maintain weight.

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). A more extended period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present.

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.

Adults

Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses for 2-4 weeks. The course of therapy may be repeated intermittently as needed to maintain weight.

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). A more extended period of treatment is necessary to regain lost weight, especially if ongoing catabolic stressors are present. Continuous administration for 3-4 months has been evaluated in patients with HIV-associated wasting syndrome.

Corticosteroid-induced Protein Catabolism

Pediatric Patients

Pediatric patients may receive oxandrolone in a dosage of 0.1 mg/kg or less daily. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Adults

Adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Osteoporosis

Adults

For bone pain accompanying osteoporosis, adults may receive oxandrolone in a dosage of 2.5-20 mg daily in 2-4 divided doses. The manufacturer states that a 2- to 4-week course of therapy usually is adequate to observe a response. The course of therapy may be repeated intermittently as needed.

Special Populations

Geriatric patients may receive oxandrolone in a dosage of 5 mg twice daily for 2-4 weeks. The course of therapy may be repeated intermittently as needed.

Anticoagulants, Oral

May potentiate action of oral anticoagulants and decrease anticoagulant requirements. Increases in plasma concentrations and half-life of warfarin reported; minor bleeding has occurred. 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.

Monitor prothrombin time (PT) or INR when oxandrolone therapy is initiated or discontinued in patients receiving oral anticoagulants and adjust anticoagulant dosage as needed. Initial anticoagulant dosage may be substantially lower in patients receiving oxandrolone. Signs and symptoms of occult bleeding should be monitored.

Antidiabetic Agents, Oral (Sulfonylureas)

Possible inhibition of sulfonylurea metabolism. Use concomitantly with care.

Corticotropin (ACTH) and Corticosteroids

May exacerbate edema. Consider possibility of interaction before use.

Warnings

Hepatic Effects

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.

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. Drug-induced jaundice usually is reversible after discontinuance of drug.

Liver function should be monitored periodically.

Hypercalcemia

Hypercalcemia resulting from osteolysis reported in women with metastatic carcinoma of the breast receiving androgens. Urine and serum calcium concentrations should be monitored frequently during the course of androgen therapy in women with metastatic breast cancer.

If hypercalcemia occurs, discontinue the drug.

Fluid Retention

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.

Misuse, Abuse, and Dependence

Serious adverse effects (e.g., increased aggression, antisocial behavior, manic episode, hostility, depression, changes in libido, increased risk of cardiovascular events, hepatotoxicity, testicular atrophy, sperm abnormalities) 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.

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.

Patients should be informed of the serious adverse effects associated with misuse and abuse of androgens.