Generic Medicine Info
Indications and Dosage
Adjunct in weight gain, Bone pain associated with osteoporosis, Offset protein catabolism with prolonged corticosteroid administration
Adult: 2.5-20 mg daily in 2-4 divided doses. Usual course: 2-4 wk, may be repeated intermittently as required.
Child: ≤0.1 mg/kg daily, in 2-4 divided doses. Usual course: 2-4 wk, may be repeated intermittently as required.
Elderly: 5 mg bid for 2-4 wk.
Known or suspected prostate cancer; breast cancer, nephrosis, hypercalcaemia. Pregnancy.
Special Precautions
Patient w/ risk factors or pre-existing CV disease, COPD, DM, oedematous conditions (e.g. migraine, seizure disorder). Renal and hepatic impairment. Elderly, childn. Lactation.
Adverse Reactions
Significant: Blood lipid changes (e.g. decreased HDL, increased LDL), cholestatic hepatitis, jaundice, hypercalcaemia, carbohydrate intolerance; oedema; risk of CV disease; virilisation (e.g. baldness, clitoral enlargement, deepening of voice, hirsutism, menstrual irregularities); polycythaemia, accelerated bone maturation (childn); prostatic hypertrophy and prostate cancer (elderly).
Nervous: Habituation, excitement, insomnia, depression.
Genitourinary: Increased CrCl; erectile dysfunction (e.g. increased or persistent erections), phallic enlargement (prepubertal males); inhibition of testicular function, testicular atrophy, oligospermia, impotence, chronic priapism, epididymitis, irritable bladder (postpubertal males).
Hepatic: Increased ALT, AST.
Endocrine: Changes in libido, gynaecomastia, increased creatinine phosphokinase (CPK).
Haematologic: Prolonged prothrombin time, suppressed clotting factors II, V, VII and X.
Musculoskeletal: Premature closure of epiphyses (childn).
Dermatologic: Acne vulgaris, androgenic alopecia, hirsutism.
Potentially Fatal: Peliosis hepatis, malignant liver cell tumours. Rarely, hepatic necrosis.
Monitoring Parameters
Monitor LFT, lipid profile, Hb, haematocrit; urine and serum Ca levels in women w/ metastatic breast cancer. Assess bone maturation in childn via radiographic examination. Monitor signs of virilisation in women.
Drug Interactions
Increased risk of bleeding w/ oral anticoagulants (e.g. warfarin). May increase the effects of oral hypoglycaemic agents. Increased risk of oedema w/ corticosteroids and ACTH.
Lab Interference
May decrease T4 level, protein-bound iodine, and radioactive iodine uptake.
Description: Oxandrolone is a synthetic testosterone derivative w/ androgenic and anabolic properties which causes increase in lean body mass, body cell mass, muscle strength as well as bone mineral content and density. It also increases protein anabolism and amino acid utilisation and enhances production of erythrocytes. It may also supress spermatogenesis at high doses.
Absorption: Rapidly absorbed from the GI tract. Time to peak plasma concentration: Approx 1 hr.
Distribution: Plasma protein binding: 95%.
Excretion: Mainly via urine (28%, as unchanged drug); faeces (small amount). Elimination half-life: 9-13 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Oxandrolone, CID=5878, https://pubchem.ncbi.nlm.nih.gov/compound/Oxandrolone (accessed on Jan. 22, 2020)

Store between 20-25°C.
MIMS Class
Androgens & Related Synthetic Drugs
ATC Classification
A14AA08 - oxandrolone ; Belongs to the class of androstan derivative anabolic steroids used as systemic anabolic agents.
Anon. Oxandrolone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/08/2017.

Buckingham R (ed). Oxandrolone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/08/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Oxandrolone. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 29/08/2017.

Oxandrolone Tablets, USP (Par Pharmaceutical). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 29/08/2017.

Oxandrolone Tablets, USP CIII (Upsher-Smith Laboratories, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 29/08/2017.

Disclaimer: This information is independently developed by MIMS based on Oxandrolone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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