oxandrolone (Rx)

Brand and Other Names:Oxandrin
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule III

  • 2.5mg
  • 10mg

Bone Pain Due to Osteoporosis

2.5-20 mg/day PO divided q6-12hr for 2-4 weeks

May repeat intermittently PRN

Weight Gain

Promote weight gain after weight loss following extensive surgery, chronic infections or severe trauma, or weight loss due to unknown etiology

2.5-20 mg/day divided q6-12hr PO for 2-4 weeks

May repeat intermittently PRN

Offset Protein Catabolism

Due to prolonged admin corticosteroids or associated with catabolic illness (off-label)

2.5-20 mg/day divided q6-12hr PO for 2-4 weeks

HIV-Wasting Syndrome (Orphan)

Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome

Orphan indication sponsor

  • Bio-Technology General Corp; One Tower Center Boulevard, 12 th floor; East Brunswick, NJ 08816

Muscular Dystrophy (Orphan)

Treatment of patients with Duchenne's muscular dystrophy and Becker's muscular dystrophy

Orphan indication sponsor

  • Savient Pharmaceuticals, Inc; One Tower Center Boulevard, 12th floor; East Brunswick, NJ 08816

Dosage Forms & Strengths

tablet: Schedule III

  • 2.5mg
  • 10mg

Bone pain

≤ 0.1 mg/kg/day PO; repeat intermitently as indicated  

Protein Catabolism

≤ 0.1 mg/kg/day PO; repeat intermitently as indicated

Weight Gain

≤ 0.1 mg/kg/day PO; repeat intermitently as indicated

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Interactions

Interaction Checker

and oxandrolone

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (4)

              • cyclosporine

                oxandrolone increases effects of cyclosporine by decreasing metabolism. Avoid or Use Alternate Drug.

              • pexidartinib

                oxandrolone and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.

              • pretomanid

                oxandrolone, pretomanid. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.

              • warfarin

                oxandrolone increases levels of warfarin by decreasing metabolism. Avoid or Use Alternate Drug.

              Monitor Closely (1)

              • carbamazepine

                oxandrolone increases toxicity of carbamazepine by decreasing metabolism. Use Caution/Monitor.

              Minor (38)

              • acarbose

                oxandrolone increases effects of acarbose by pharmacodynamic synergism. Minor/Significance Unknown.

              • androstenedione

                androstenedione increases effects of oxandrolone by pharmacodynamic synergism. Minor/Significance Unknown.

              • budesonide

                oxandrolone, budesonide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • chlorpropamide

                oxandrolone increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • clobetasone

                oxandrolone, clobetasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • cortisone

                oxandrolone, cortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • deflazacort

                oxandrolone, deflazacort. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • dexamethasone

                oxandrolone, dexamethasone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • epoetin alfa

                oxandrolone increases effects of epoetin alfa by pharmacodynamic synergism. Minor/Significance Unknown. Androgens may be used to decrease necessary dose of epoetin alfa.

              • fludrocortisone

                oxandrolone, fludrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • glimepiride

                oxandrolone increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

              • glipizide

                oxandrolone increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

              • glyburide

                oxandrolone increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

              • hydrocortisone

                oxandrolone, hydrocortisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • insulin aspart

                oxandrolone increases effects of insulin aspart by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin detemir

                oxandrolone increases effects of insulin detemir by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glargine

                oxandrolone increases effects of insulin glargine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin glulisine

                oxandrolone increases effects of insulin glulisine by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin lispro

                oxandrolone increases effects of insulin lispro by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin NPH

                oxandrolone increases effects of insulin NPH by pharmacodynamic synergism. Minor/Significance Unknown.

              • insulin regular human

                oxandrolone increases effects of insulin regular human by pharmacodynamic synergism. Minor/Significance Unknown.

              • metformin

                oxandrolone increases effects of metformin by pharmacodynamic synergism. Minor/Significance Unknown.

              • methylprednisolone

                oxandrolone, methylprednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • miglitol

                oxandrolone increases effects of miglitol by pharmacodynamic synergism. Minor/Significance Unknown.

              • nateglinide

                oxandrolone increases effects of nateglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • pioglitazone

                oxandrolone increases effects of pioglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • prednisolone

                oxandrolone, prednisolone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • prednisone

                oxandrolone, prednisone. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • repaglinide

                oxandrolone increases effects of repaglinide by pharmacodynamic synergism. Minor/Significance Unknown.

              • rosiglitazone

                oxandrolone increases effects of rosiglitazone by pharmacodynamic synergism. Minor/Significance Unknown.

              • saw palmetto

                saw palmetto decreases effects of oxandrolone by pharmacodynamic antagonism. Minor/Significance Unknown.

              • saxagliptin

                oxandrolone increases effects of saxagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • sitagliptin

                oxandrolone increases effects of sitagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

              • tacrolimus

                oxandrolone increases effects of tacrolimus by decreasing metabolism. Minor/Significance Unknown.

              • tolazamide

                oxandrolone increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • tolbutamide

                oxandrolone increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • triamcinolone acetonide injectable suspension

                oxandrolone, triamcinolone acetonide injectable suspension. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May enhance edema formation.

              • vildagliptin

                oxandrolone increases effects of vildagliptin by pharmacodynamic synergism. Minor/Significance Unknown.

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              Adverse Effects

              Frequency Not Defined

              Males

              • Gynecomastia
              • Inhibition of testicular function
              • Impotence
              • Priapism
              • Bladder irritability

              Females

              • Hirsutism
              • Male-pattern baldness
              • Menstrual irregularities
              • Virilism

              Serious

              • Neoplasm of liver, Peliosis hepatis
              • Premature epiphyseal closure, Children

              Edema

              Increased risk of atherosclerosis

              Habituation

              Changes in libido

              Acne

              Retention of electrolytes

              Serum lipid levels

              Cholestatic hepatitis

              Hepatic d/o

              Jaundice

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              Warnings

              Black Box Warnings

              Peliosis Hepatis

              • Peliosis hepatitis has been reported with androgenic anabolic steroid therapy In this condition, the liver & sometimes splenic tissue is replaced with blood-filled cysts
              • These cysts sometimes present with minimal hepatic dysfunction but have been associated with liver failure
              • Often not detected until life-threatening liver failure or intra-abdominal hemorrhage develops
              • Discontinuing an anabolic steroid usually results in complete disappearance of lesions

              Liver Cell Tumors

              • Liver cell tumors have been reported
              • Typically, these tumors are benign & androgen-dependent, but fatal malignant tumors have been reported
              • Discontinuing anabolic steroids often result in regression or arrested progression of tumor
              • Important to recognize that hepatic tumors associated w/ androgens or anabolic steroids are much more vascular than other hepatic tumors & may be silent until life-threatening intra-abdominal hemorrhage develops

              Blood Lipid Changes

              • May cause blood lipid changes associated w/ increased risk of atherosclerosis
              • Lipid changes include decreased HDL & sometimes increased LDL; changes may be very marked & could have serious impact on risk for atherosclerosis & coronary artery disease

              Contraindications

              Known or suspected prostate or breast CA in males

              Females: breast cancer with hypercalcemia

              Pregnancy

              Nephrosis or the nephrotic phase of nephritis

              Hypercalcemia

              Cautions

              Increases risk of peliosis hepatis & liver cell tumors has been reported with anabolic steroids

              Risk of cholestatic hepatitis & jaundice - discontinue if cholestatic hepatitis with jaundice appears or LFTS abnormal

              Risk of hypercalcemia in breast CA patients - discontinue if hypercalcemia occurs

              Increases risk of prostatic hypertrophy & prostate CA in geriatric patients

              Concomitant administration with warfarin may require dose reduction of warfarin

              Risk of growth retardation in children

              Concurrent dosing with warfarin may result in unexpectedly high increases in INR & PT

              Risk of edema with or without CHF in patients with preexisting cardiac, renal or liver disease

              Does not improve athletic performance

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              Pregnancy & Lactation

              Pregnancy Category: X

              Lactation: Discontinue drug if choosing to breastfeed or do not nurse

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Anabolic steroid; promotes body tissue building, increases production of erythropoietin, increases Hgb & RBC volume

              Pharamacokinetics

              Half-life: 10-13 hr

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Oxandrin oral
              -
              10 mg tablet
              Oxandrin oral
              -
              2.5 mg tablet
              oxandrolone oral
              -
              10 mg tablet
              oxandrolone oral
              -
              2.5 mg tablet
              oxandrolone oral
              -
              10 mg tablet

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              oxandrolone oral

              OXANDROLONE - ORAL

              (ox-AN-droe-lone)

              COMMON BRAND NAME(S): Oxandrin

              WARNING: Rarely, this drug has caused serious, sometimes fatal liver problems including liver failure, liver cysts, and liver tumors. Tell your doctor promptly if you have any signs of liver problems such as yellowing eyes/skin, dark urine, unusual tiredness, or sudden/persistent stomach/abdominal pain.This drug may also affect your cholesterol and may increase your risk of heart or blood vessel problems (coronary artery disease). Your doctor will monitor your cholesterol level closely.

              USES: This medication is used to help people regain weight they have lost due to certain medical conditions (such as surgery, chronic infection, trauma, long term use of corticosteroid medication such as hydrocortisone/prednisone). It is also used to relieve bone pain due to bone loss (osteoporosis). Oxandrolone belongs to a class of drugs known as anabolic steroids. These drugs are similar to male hormones made by the body.

              HOW TO USE: Take this medication by mouth usually 2 to 4 times daily or as directed by your doctor. It may be taken with food or milk if stomach upset occurs.Dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. This medication is usually used for short-term treatment only.Misuse or abuse of an anabolic steroid can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When an anabolic steroid is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, headache, skin color changes, increased/decreased sexual interest, oily skin, hair loss, and acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as anxiety, depression, increased anger), trouble sleeping/snoring.If you are male, tell your doctor right away if any of these unlikely but serious side effects occur: trouble urinating, breast swelling/tenderness, too frequent/prolonged erections.Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and seek immediate medical attention, or permanent problems could occur.If you are female, tell your doctor right away if any of these unlikely but serious side effects occur: deepening of the voice, hoarseness, unusual facial/body hair growth, enlarged clitoris, irregular menstrual periods.This medication can cause your body to hold on to extra body water (edema). This can increase your risk of heart failure. Tell your doctor right away if any of these unlikely but serious signs of water retention or heart failure occur: shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using oxandrolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer in men, prostate cancer, certain mineral imbalance (high calcium blood level).Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack), liver problems, kidney problems, other types of cancer, high cholesterol, high blood pressure, enlarged prostate, breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD), diabetes.If you have diabetes, this product may lower your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of low blood sugar, such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor if you become bed-ridden (unable to walk) for a prolonged time while using this medication. Your doctor may monitor your blood calcium level to prevent problems.Caution is advised when using this drug in older adults because they may be at greater risk for prostate/liver problems and swelling of arms/legs.Caution is advised when using this drug in children because bone growth may be affected, causing shorter adult height. Your child's doctor will monitor growth and bone development during treatment.This medication can affect fertility in males. Ask your doctor for more details.This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.It is not known whether this drug passes into breast milk. It may affect milk production and it may harm a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (such as warfarin).This medication may interfere with certain laboratory tests (including thyroid function tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Do not share this medication with others. Sharing it is against the law.Laboratory and/or medical tests (such as red blood cell counts, liver function tests, blood cholesterol levels, PSA test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

              STORAGE: Store between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.