Oxandrolone

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.

Frequency Not Defined

Males

• Gynecomastia
• Inhibition of testicular function
• Impotence
• Priapism
• Bladder irritability

Females

• Hirsutism
• Male-pattern baldness
• Menstrual irregularities
• Virilism

Serious

• Neoplasm of liver, Peliosis hepatis
• Premature epiphyseal closure, Children

Edema

Increased risk of atherosclerosis

Habituation

Changes in libido

Acne

Retention of electrolytes

Serum lipid levels

Cholestatic hepatitis

Hepatic d/o

Jaundice

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.

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 entire FDA prescribing information for Oxandrin (Oxandrolone)

Take oxandrolone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Oxandrolone dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oxandrolone is available in the following doses:

• Oxandrolone 10 Mg Oral Tablet
• Oxandrolone 2.5 Mg Oral Tablet

You should not use oxandrolone if you have prostate cancer, advanced kidney disease, high levels of calcium in your blood, breast cancer, or if you are pregnant.

Some people using anabolic steroid medicine have developed life-threatening side effects on the liver, spleen, and blood vessels. These conditions can occur without warning or symptoms and can lead to liver failure, internal bleeding, cancer, stroke, heart attack, or death. Talk with your doctor about the risks and benefits of using this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• new or worsening acne;

• shortness of breath (even with mild exertion), swelling in your ankles or feet, rapid weight gain;

• increased or ongoing erection of the penis;

• unusual penis growth before puberty;

• impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;

• painful or difficult urination;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• high levels of calcium in your blood--vomiting, stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

Women receiving oxandrolone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medicine and call your doctor at once if you notice any of these signs of excess testosterone:

• acne;

• changes in menstrual periods;

• male-pattern hair growth (such as on the chin or chest);

• hoarse or deepened voice; or

• enlarged clitoris.

Common side effects (in men or women) may include:

• breast swelling;

• feeling excited;

• sleep problems (insomnia); or

• increased or decreased interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Synthetic androgenic anabolic steroid hormone.1 4

Storage

Oral

20–25°C.4

• If you have an allergy to oxandrolone or any other part of oxandrolone.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Breast cancer, high calcium levels, kidney disease, or prostate cancer.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with oxandrolone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take oxandrolone. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with the doctor.
• This medicine does not help you to be better at sports.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with oxandrolone.
• Use with care in children. Talk with the doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use birth control that you can trust to prevent pregnancy while taking oxandrolone.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

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. 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.

• Oxandrin

No dosage adjustment provided in manufacturer’s labeling; use with caution.

Data not available