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.

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.

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. 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 immediately.

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).

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 a poison control center or emergency room immediately. 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 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.