Oxandrolone (Oxandrin)
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Oxandrolone (Oxandrin)

Oxandrin®
(oxandrolone) Tablets, USP

DRUG DESCRIPTION

Oxandrin® (oxandrolone) oral tablets contain 2.5 mg or 10 mg of the anabolic steroid oxandrolone.

Oxandrolone is 17β-hydroxy-17α-methyl-2-oxa-5α-androstan-3-one with the following structural formula:

Oxandrin® (oxandrolone) Structural Formula Illustration

Inactive ingredients include cornstarch, lactose, magnesium stearate, and hydroxypropyl methylcellulose.

What are the possible side effects of oxandrolone (Oxandrin)?

In rare cases, serious and even fatal cases of liver problems have developed during treatment with oxandrolone. Contact your doctor immediately if you experience abdominal pain, light colored stools, dark colored urine, unusual fatigue, nausea or vomiting, or yellowing of the skin or eyes. These may be early signs of liver problems.

If you experience any of the following serious side effects, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or...

Read All Potential Side Effects and See Pictures of Oxandrin »

What are the precautions when taking oxandrolone (Oxandrin)?

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,...

Read All Potential Precautions of Oxandrin »

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Oxandrin (oxandrolone) is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis (See DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION

Therapy with anabolic steroids is adjunctive to and not a replacement for conventional therapy. The duration of therapy with Oxandrin (oxandrolone) will depend on the response of the patient and the possible appearance of adverse reactions. Therapy should be intermittent.

Adults: The response of individuals to anabolic steroids varies. The daily adult dosage is 2.5 mg to 20 mg given in 2 to 4 divided doses. The desired response may be achieved with as little as 2.5 mg or as much as 20 mg daily. A course of therapy of 2 to 4 weeks is usually adequate. This may be repeated intermittently as indicated.

Children: For children the total daily dosage of Oxandrin (oxandrolone) is ≤ 0.1 mg per kilogram body weight or ≤ 0.045 mg per pound of body weight. This may be repeated intermittently as indicated.

Geriatric Use: Recommended dose for geriatric patients is 5 mg bid.

HOW SUPPLIED

Oxandrin (oxandrolone) 2.5 mg tablets are oval, white, and scored with BTG on one side and "11" on each side of the scoreline on the other side; bottles of 100 (NDC 54396-111-11).

Oxandrin (oxandrolone) 10 mg tablets are capsule shaped, white, with BTG on one side and "10" on the other side; bottles of 60 (NDC 54396-110-60).

Manufactured for: Savient Pharmaceuticals, Inc. Manufactured by: DSM Pharmaceuticals, Inc. Greenville, NC 27834. Pfizer Co. New York, NY 10017. Address medical inquires to: Savient Pharmaceuticals, Inc. One Tower Center. Fourteenth Floor East Brunswick, NJ 08816. 866-692-6374. Issued January 2006.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.

The following adverse reactions have been associated with use of anabolic steroids:

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy (See WARNINGS). Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)

In males

Prepubertal: Phallic enlargement and increased frequency or persistence of erections.

Postpuberal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, and bladder irritability.

In females

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair:Hirsutism and male pattern baldness in females.

Skin:Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children (See PRECAUTIONS: Pediatric use).

Fluid and electrolytes: Edema, retention of serum electrolytes (sodium chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (See PRECAUTIONS: Laboratory tests), increased creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

Drug Abuse And Dependence

Oxandrolone is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III (non-narcotic).

Read the Oxandrin (oxandrolone) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Anticoagulants

Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain desired prothrombin time. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Warfarin: A multidose study of oxandrolone, given as 5 or 10 mg bid in 15 healthy subjects concurrently treated with warfarin, resulted in a mean increase in S-warfarin half-life from 26 to 48 hours and AUC from 4.55 to 12.08 ng*hr/mL; similar increases in R-warfarin half-life and AUC were also detected. Microscopic hematuria (9/15) and gingival bleeding (1/15) were also observed. A 5.5-fold decrease in the mean warfarin dose from 6.13 mg/day to 1.13 mg/day (approximately 80-85% reduction of warfarin dose), was necessary to maintain a target INR of 1.5. When oxandrolone therapy is initiated in a patient already receiving treatment with warfarin, the INR or prothrombin time (PT) should be monitored closely and the dose of warfarin adjusted as necessary until a stable target INR or PT has been achieved. Furthermore, in patients receiving both drugs, careful monitoring of the INR or PT, and adjustment of the warfarin dosage if indicated are recommended when the oxandrolone dose is changed or discontinued. Patients should be closely monitored for signs and symptoms of occult bleeding.

Oral hypoglycemic agents

Oxandrolone may inhibit the metabolism of oral hypoglycemic agents.

Adrenal steroids or ACTH

In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema.

Drug/Laboratory test interactions

Anabolic steroids may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged. In addition, a decrease in PBI and radioactive iodine uptake may occur.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE. THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS.

LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS OR ANABOLIC STEROIDS. THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEINS AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEINS. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.

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, oxandrolone should be discontinued and the etiology should be determined. Drug-induced jaundice is reversible when the medication is discontinued.

In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. Oxandrolone therapy 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. The effect on bone maturation should be monitored by assessing bone age of the left wrist and hand every 6 months (See PRECAUTIONS: Laboratory Tests).

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

ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO ENHANCE ATHLETIC ABILITY.

PRECAUTIONS

Concurrent dosing of oxandrolone with warfarin may result in unexpectedly large increases in the INR or prothrombin time (PT). When oxandrolone is prescribed to patients being treated with warfarin, doses of warfarin may need to be decreased significantly to maintain the desirable INR level and diminish the risk of potentially serious bleeding (See PRECAUTIONS: DRUG INTERACTIONS).

General

Women should be observed for signs of virilization (deepening of the voice, hirsutism, acne, clitoromegaly). Discontinuation of drug therapy at the 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.

Geriatric Use

Oxandrin (oxandrolone) , at daily doses of 5 mg bid, and 10 mg bid, was evaluated in four clinical trials involving a total of 339 patients with different underlying medical conditions. The maximum duration of treatment was 4 months with the average duration of treatment from 68.5 days to 94.7 days across the studies. A total of 172 elderly patients ( ≥ 65 years of age) received Oxandrin (oxandrolone) treatment. Mean weight gain was similar in those ≥ 65 and those < 65 years of age. No significant differences in efficacy were detected between the 5 mg bid and 10 mg bid daily doses. The adverse event profiles were similar between the two age groups although the elderly, particularly in women, had a greater sensitivity to fluid retention and increases in hepatic transaminases. A single dose pharmacokinetic study in elderly volunteers revealed an increased half-life when compared to younger volunteers. (see CLINICAL PHARMACOLOGY) Based on greater sensitivity to drug-induced fluid retention and transaminase elevations, a lower dose is recommended in the elderly (see DOSAGE AND ADMINISTRATION).

Laboratory Tests:

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of therapy. (See WARNINGS).

Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Periodic (every 6 months) x-ray examinations of bone age should be made during treatment of children to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers.

Androgenic anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins. Therefore, caution is required when administering these agents to patients with a history of cardiovascular disease or who are at risk for cardiovascular disease. Serum determination of lipid levels should be performed periodically and therapy adjusted accordingly.

Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids.

Carcinogenesis, mutagenesis, impairment of fertility

Animal data

Oxandrolone has not been tested in laboratory animals for carcinogenic or mutagenic effects. In 2-year chronic oral rat studies, a dose-related reduction of spermatogenesis and decreased organ weights (testes, prostate, seminal vesicles, ovaries, uterus, adrenals, and pituitary) were shown.

Human data

Liver cell tumors have been reported in patients receiving long-term therapy with androgenic anabolic steroids in high doses (See WARNINGS). Withdrawal of the drugs did not lead to regression of the tumors in all cases.

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

Pregnancy

Teratogenic effects-Pregnancy Category X (See CONTRAINDICATIONS).

Nursing mothers

It is not known whether anabolic steroids are excreted in human milk. Because of the potential of serious adverse reactions in nursing infants from oxandrolone, 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.

Pediatric use

Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children and the effect may continue for 6 months after the drug has been stopped. Therefore, therapy should be monitored by x-ray studies at 6-month intervals in order to avoid the risk of compromising adult height. Androgenic anabolic steroid therapy should be used very cautiously in children and only by specialists who are aware of the effects on bone maturation (See WARNINGS).

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No symptoms or signs associated with overdosage have been reported. It is possible that sodium and water retention may occur.

The oral LD50 of oxandrolone in mice and dogs is greater than 5,000 mg/kg. No specific antidote is known, but gastric lavage may be used.

CONTRAINDICATIONS

  1. Known or suspected carcinoma of the prostate or the male breast.
  2. Carcinoma of the breast in females with hypercalcemia (androgenic anabolic steroids may stimulate osteolytic bone resorption).
  3. Pregnancy, because of possible masculinization of the fetus. Oxandrin (oxandrolone) has been shown to cause embryotoxicity, fetotoxicity, infertility, and masculinization of female animal offspring when given in doses 9 times the human dose.
  4. Nephrosis, the nephrotic phase of nephritis.
  5. Hypercalcemia.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Anabolic steroids are synthetic derivatives of testosterone. Certain clinical effects and adverse reactions demonstrate the androgenic properties of this class of drugs. Complete dissociation of anabolic and androgenic effects has not been achieved. The actions of anabolic steroids are therefore similar to those of male sex hormones with the possibility of causing serious disturbances of growth and sexual development if given to young children. Anabolic steroids suppress the gonadotropic functions of the pituitary and may exert a direct effect upon the testes.

During exogenous administration of anabolic androgens, endogenous testosterone release is inhibited through inhibition of pituitary luteinizing hormone (LH). At large doses, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH).

Anabolic steroids have been reported to increase low-density lipoproteins and decrease high-density lipoproteins. These levels revert to normal on discontinuation of treatment.

In a single dose pharmacokinetic study of Oxandrin (oxandrolone) in elderly subjects, the mean elimination half-life was 13.3 hours. In a previous single dose pharmacokinetic study in younger volunteers, the mean elimination half-life was 10.4 hours. No significant differences between younger and elderly volunteers were found for time to peak, peak plasma concentration or AUC after a single dose of Oxandrin (oxandrolone) . The correlation between plasma level and therapeutic effect has not been defined.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

The physician should instruct patients to report immediately any use of warfarin and any bleeding.

The physician should instruct patients to report any of the following side effects of androgens:

Males: Too frequent or persistent erections of the penis, appearance or aggravation of acne.

Females: Hoarseness, acne, changes in menstrual periods, or more facial hair.

All patients: Nausea, vomiting, changes in skin color, or ankle swelling.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

The physician should instruct patients to report immediately any use of warfarin and any bleeding.

The physician should instruct patients to report any of the following side effects of androgens:

Males: Too frequent or persistent erections of the penis, appearance or aggravation of acne.

Females: Hoarseness, acne, changes in menstrual periods, or more facial hair.

All patients: Nausea, vomiting, changes in skin color, or ankle swelling.

Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Oxandrin Consumer

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.

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.

Abuse of this medication (such as to improve athletic performance or physical appearance) is very dangerous and may cause serious, sometimes fatal problems.

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.

Abnormal drug-seeking behavior is possible with this medication, and it is frequently misused for its muscle-enhancing effects. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Doing so may increase serious side effects (such as increased risk for heart disease, stroke, liver disease, ruptured tendons/ligaments, improper bone development in adolescents). Properly stop the medication when so directed.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Oxandrin Consumer (continued)

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 your doctor has prescribed this medication because he or she 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 immediately 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 immediately 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.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

If you are female, tell your doctor immediately 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 immediately if any of these unlikely but serious signs of water retention or heart failure occur: decreased exercise ability, hands/ankles/feet swelling, unusual tiredness, shortness of breath while lying down.

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Oxandrin (oxandrolone) Side Effects Center for a complete guide to possible side effects »

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 decrease your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of low blood sugar, such as increased hunger, dizziness, or unusual sweating. Your anti-diabetic medication or diet may need to be adjusted.

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 must not be used during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that women using this medication use 2 effective forms of birth control (such as condoms and birth control pills) while taking this medication. Consult your doctor.

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.

Disclaimer

Oxandrin Consumer (continued)

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).

Corticosteroids (such as hydrocortisone, prednisone) may increase the risk of edema and heart failure.

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. Therefore, 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 overdose is suspected, contact your poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share or sell this medication to others. 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 and resume your usual dosing schedule. 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 May 2010. Copyright(c) 2010 First Databank, Inc.

Oxandrin Patient Information Including Side Effects

Brand Names: Oxandrin

Generic Name: oxandrolone (Pronunciation: ox AN droe lone)

What is oxandrolone (Oxandrin)?

Oxandrolone is a man-made steroid, similar to the a naturally occuring steroid testosterone.

Oxandrolone is used to promote weight gain following extensive surgery, chronic infection, or severe trauma, and in other cases that result in inadequate weight gain or maintenance. Oxandrolone is also used to decrease muscle loss caused by treatment with corticosteroids and to reduce bone pain associated with osteoporosis.

Oxandrolone may also be used for purposes other than those listed here.

Oxandrin 10 mg

oblong, white, imprinted with BTG, 10

Oxandrin 2.5 mg

oval, white, imprinted with BTG, 11 11

What are the possible side effects of oxandrolone (Oxandrin)?

In rare cases, serious and even fatal cases of liver problems have developed during treatment with oxandrolone. Contact your doctor immediately if you experience abdominal pain, light colored stools, dark colored urine, unusual fatigue, nausea or vomiting, or yellowing of the skin or eyes. These may be early signs of liver problems.

If you experience any of the following serious side effects, contact your doctor immediately or seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • swelling of the arms or legs (especially ankles);
  • frequent or persistent erections, or breast tenderness or enlargement (male patients); or
  • voice changes (hoarseness, deepening), hair loss, facial hair growth, clitoral enlargement, or menstrual irregularities (female patients).

Other less serious side effects may also occur. Talk to your doctor if you experience

  • new or worsening acne;
  • difficulty sleeping;
  • headache; or
  • changes in sexual desire.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Oxandrin (oxandrolone) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about oxandrolone (Oxandrin)?

In rare cases, serious and even fatal cases of liver problems have developed during treatment with oxandrolone. Contact your doctor immediately if you experience abdominal pain, light colored stools, dark colored urine, unusual fatigue, nausea or vomiting, or yellowing of the skin or eyes. These may be early signs of liver problems.

Side Effects Centers

Oxandrin Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking oxandrolone (Oxandrin)?

Do not take oxandrolone without first talking to your doctor if you have

  • prostate cancer;
  • breast cancer; or
  • a high level of calcium in the blood (hypercalcemia).

Before taking oxandrolone, talk to your doctor if you

  • have heart or blood vessel disease;
  • have had a heart attack;
  • have a high level of cholesterol in the blood;
  • have bleeding or blood clotting problems;
  • have diabetes;
  • take an oral anticoagulant (blood thinner);
  • have liver problems; or
  • have kidney problems.

You may not be able to take oxandrolone, or you may require a dosage adjustment or special monitoring during treatment.

Oxandrolone is in the FDA pregnancy category X. This means that oxandrolone is known to cause birth defects in an unborn baby. Do not take this medication if you are pregnant or could become pregnant during treatment.

It is not known whether oxandrolone passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take oxandrolone (Oxandrin)?

Take oxandrolone exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.

Take oxandrolone with a full glass of water.

Oxandrolone can be taken with or without food.

It is important to take oxandrolone regularly to get the most benefit.

Your doctor may want you to have blood tests or other medical evaluations during treatment with oxandrolone to monitor progress and side effects.

Store oxandrolone at room temperature away from moisture, heat, and direct light.

Side Effects Centers

Oxandrin Patient Information including If I Miss a Dose

What happens if I miss a dose (Oxandrin)?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the dose you missed, and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose (Oxandrin)?

An overdose of this medication is unlikely to threaten life. Contact an emergency room or poison control center for advice if an overdose is suspected.

Symptoms of an oxandrolone overdose are not known.

What should I avoid while taking oxandrolone (Oxandrin)?

There are no restrictions on food, beverages, or activities while you are taking oxandrolone unless otherwise directed by your doctor.

What other drugs will affect oxandrolone (Oxandrin)?

Before taking oxandrolone, talk to your doctor if you are taking any of the following medicines:

  • an anticoagulant (blood thinner) such as warfarin (Coumadin); or
  • insulin or an oral diabetes medicine such as glipizide (Glucotrol), glyburide (DiaBeta, Glynase, Micronase), glimipiride (Amaryl), chlorpropamide (Diabinese), acetohexamide (Dymelor), tolbutamide (Orinase), tolazamide (Tolinase), and others.

You may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with oxandrolone. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about oxandrolone written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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