Oxandrolone

(ox an' droe lone)

Brand Name(s): Oxandrin^®; also available generically

IMPORTANT WARNING:

Oxandrolone and similar medications may cause damage to the liver or spleen (a small organ just below the ribs) and tumors in the liver. If you experience any of the following symptoms, call your doctor immediately: upset stomach; extreme tiredness; unusual bruising or bleeding; lack of energy; loss of appetite; pain in the upper right part of the stomach; yellowing of the skin or eyes; flu-like symptoms; pale, cool, or clammy skin; nausea or vomiting.

Oxandrolone may increase the amount of low density lipoprotein (LDL; 'bad cholesterol') and decrease the amount of high density lipoprotein (HDL; 'good cholesterol') in your blood. This may increase your risk of developing heart disease or cause an accumulation of cholesterol and fats along the walls of your arteries (atherosclerosis). Tell your doctor if you or anyone in your family has or has ever had high cholesterol, heart disease, a heart attack, chest pain, or a stroke.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to oxandrolone.

Talk to your doctor about the risks of taking oxandrolone.

WHY is this medicine prescribed?

Oxandrolone is used with a diet program to cause weight gain in people who have lost too much weight due to surgery, injury, chronic (long-lasting) infections, trauma, or who are underweight for unknown reasons. Oxandrolone is also used to treat bone pain in people with osteoporosis (a condition in which the bones become thin and weak and break easily) and to prevent certain side effects in people who take corticosteroids (a group of medications used to treat many conditions that involve inflammation or swelling of part of the body) for a long time. Oxandrolone is in a class of medications called androgenic hormones. It works by increasing the amount of protein made by the body. This protein is used to build more muscle and increase body weight.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Oxandrolone comes as a tablet to take by mouth. It is usually taken two to four times a day. To help you remember to take oxandrolone, take it around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxandrolone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably tell you to take oxandrolone for 2 to 4 weeks. You may need to take oxandrolone for additional time period depending on your condition.

What SPECIAL PRECAUTIONS should I follow?

Before taking oxandrolone,

• tell your doctor and pharmacist if you are allergic to oxandrolone, any other medications, or any of the ingredients in oxandrolone tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); corticotrophin (ACTH, Acthar); oral medications for diabetes; or oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had high levels of calcium in your blood, breast cancer, prostate (a male reproductive organ) cancer, or kidney disease. Your doctor will probably tell you not to take oxandrolone.

• tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant during your treatment with oxandrolone. If you become pregnant while taking oxandrolone, call your doctor immediately. Oxandrolone may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Oxandrolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• difficulty falling asleep or staying asleep
• enlargement of the breasts
• changes in sex drive or ability

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately. Some of these side effects may never go away if they are not treated immediately:

• swelling of the arms, hands, feet, ankles, or lower legs
• new or worsening acne (especially in women and prepubertal men)
• enlargement of the clitoris, deepening of voice, increase in facial hair, and baldness(in women)
• abnormal or absent menstrual periods
• erections of the penis that happen too often or do not go away
• enlarged penis
• pain, swelling, or decreased size of testes
• frequent, difficult, or painful urination
• inability to control urination

Oxandrolone may prevent normal growth in children. Children who take oxandrolone may be shorter as adults then they would have been if they had not taken the medication. Oxandrolone is more likely to interfere with the growth of younger children than older children. Your child's doctor will take x-rays regularly to be sure your child is growing normally. Talk to your child's doctor about the risks of giving this medication to your child.

Oxandrolone may decrease fertility in men. Talk to your doctor if your partner plans to become pregnant while you are taking oxandrolone.

Oxandrolone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• swelling of the arms, hands, feet, ankles, or lower legs

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking oxandrolone. Oxandrolone may affect the results of certain laboratory tests.

Do not let anyone else take your medication. Oxandrolone has not been shown to improve athletic ability. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: June 15, 2017.