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

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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

            Androgenic anabolic steroids may stimulate osteolytic bone resorption; contraindicated in carcinoma of the breast in females with hypercalcemia

            Cholestatic hepatitis and jaundice may occur with 17-alpha-alkylated androgens at a relatively low dose; if cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, this drug should be discontinued and the etiology determined; drug-induced jaundice is reversible when medication is discontinued

            In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis; this drug should be discontinued if hypercalcemia occurs

            Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease; concomitant administration of adrenal cortical steroid or ACTH may increase the edema

            In children, androgen therapy may accelerate bone maturation without producing compensatory gain in linear growth; this adverse effect results in compromised adult height; the younger the child, the greater the risk of compromising final mature height

            Effect on bone maturation should be monitored by assessing bone age of left wrist and hand every 6 months

            Geriatric patients treated with androgenic anabolic steroids may be at an increased risk for development of prostatic hypertrophy and prostatic carcinoma

            Concurrent dosing with warfarin may result in unexpectedly large increases in the International Normalized Ratio (INR) or prothrombin time (PT); when prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain desirable INR level and diminish risk of potentially serious bleeding

            Women should be observed for signs of virilization (deepening of voice, hirsutism, acne, clitoromegaly); discontinuation of drug therapy at time of evidence of mild virilism is necessary to prevent irreversible virilization

            Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens; menstrual irregularities may also occur

            Anabolic steroids may cause suppression of clotting factors II, V, VII, and X, and an increase in prothrombin time

            Does not improve athletic performance

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            Pregnancy & Lactation

            Pregnancy

            Shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose; contraindicated in pregnancy

            Lactation

            Not known whether anabolic steroids are excreted in human milk; because of potential of serious adverse reactions in nursing infants from this drug, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            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
            oxandrolone oral
            -
            10 mg tablet
            oxandrolone oral
            -
            2.5 mg tablet
            oxandrolone oral
            -
            10 mg tablet
            Oxandrin oral
            -
            2.5 mg tablet
            Oxandrin 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 stomach/abdominal pain that is sudden or doesn't go away, yellowing eyes/skin, dark urine or unusual tiredness.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 as directed by your doctor, usually 2 to 4 times daily. 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 last or get worse, 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 you have any serious side effects, including: 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 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 get medical help right away, or permanent problems could occur.If you are female, tell your doctor right away if any of these 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 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, get medical help right away 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.Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain mineral imbalance (high calcium blood level), heart disease (such as heart failure, chest pain, heart attack), liver problems, kidney problems, cancer (such as breast cancer, prostate 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.Older adults may be at greater risk for prostate/liver problems and swelling of arms/legs while using this drug.Children may be more sensitive to the side effects of this drug. In children, it may affect bone growth. Monitor your child's height periodically.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 unknown if this drug passes into breast milk. It may affect milk production. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: "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.

            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.Lab and/or medical tests (such as red blood cell counts, liver function, blood cholesterol levels, PSA test) should be done while you are taking this medication. Keep all medical and lab appointments. 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 at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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 .

            Information last revised December 2022. Copyright(c) 2022 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.