oxandrolone 10 mg tablet

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Medication name

Generic name:
Oxandrolone - oral

Pronunciation
(ox-AN-droe-lone)

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 hormones made by the body.

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to increase height in girls and young women with a certain genetic disorder (Turner's syndrome).

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. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

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 lab tests (such as thyroid function tests), possibly causing false test results. Make sure lab 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 1-800-222-1222. Canada residents can call 1-844-764-7669.

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 .

Important note

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.

Information last revised October 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.