Oxandrolone (By mouth)

Introduction

Oxandrolone (ox-AN-droe-lone)

Used as part of a program to regain weight lost after surgery, illness, trauma, or as a result of treatment with certain steroids. Also treats bone pain caused by osteoporosis. This medicine is an anabolic steroid.

Brand Name(s)

Oxandrin

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine is not for long-term use.It is most often used for a total of 2 to 4 weeks. Your doctor may then repeat your treatment after a rest period.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using other steroids, blood thinners (warfarin, Coumadin®), or oral diabetes medicine (such as glipizide, glyburide, metformin, Actos®, Avandia®, Glucotrol®, Glucophage®, Glucovance®).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breast feeding, or if you have heart disease, high cholesterol, liver disease, kidney disease, prostate problems, or hemophilia (bleeding disorders). Tell your doctor if you have diabetes or have recently had a heart attack.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.Children using this medicine may need to have their bone growth rate checked with x-rays every few months.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine will not enhance or improve athletic performance or ability.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Dark-colored urine or pale stools.
• In men: Frequent or ongoing erection of your penis, acne.
• In women: Acne, facial or chest hair growth, deeper voice.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Changes in your menstrual periods.
• Changes in hair growth or skin color.
• Breast swelling or tenderness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088