OXANDRO® (Oxandrolone)

PLEASE READ THE PACKAGE INSERT CAREFULLY BEFORE USE.

Keep the package insert for reference. If you have any questions that are not addressed here, please consult your physician. This drug has been individually prescribed by your physician for personal use. Under no circumstances do not administer it to others, even if they appear with the same symptoms, it may harm them. If you notice any of the side effects stated in this package please notify your doctor or pharmacist immediately.

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WHAT IS OXANDROLONE

Oxandrolone is a man-made steroid, similar to the naturally occurring steroid testosterone. Oxandrolone is an “anabolic” steroid that promotes the growth of muscle tissue. Oxandrolone is used to help you regain weight lost after surgery, severe trauma, or chronic infections. Oxandrolone is also used in people who cannot gain or maintain a healthy weight for unknown medical reasons. Oxandrolone is also used to decrease muscle loss caused by using steroid medicines, and to reduce bone pain in people with osteoporosis.

Oxandrolone may also be used for purposes not listed in this medication guide.

IMPORTANT INFORMATION

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 oxandrolone.

HOW TO USE OXANDROLONE

Oxandrolone is usually given for only a few weeks. Follow all directions on your prescription label. Do not take oxandrolone in larger or smaller amounts or for longer than recommended. Oxandrolone will not enhance athletic performance and should not be used for that purpose. Oxandrolone may be habit-forming. Never share oxandrolone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. If a child is taking this medicine, tell your doctor if the child has any changes in weight. Oxandrolone doses are based on weight in children. While using oxandrolone, you will need frequent blood tests. Your kidney function may also need to be checked with urine tests. Oxandrolone can cause bone overgrowth in children, especially young children. Bone development may need to be checked with x-rays every 6 months during treatment. Store at room temperature away from moisture and heat.

OXANDROLONE DOSING INFORMATION

Usual Adult Dose for Weight Loss: 2.5 mg to 20 mg orally in 2 to 4 divided doses. Duration of therapy: 2 to 4 weeks, may be repeated intermittently as indicated.

Usual Geriatric Dose for Weight Loss: 5 mg orally twice a day.

Usual Pediatric Dose for Weight Loss: Less than or equal to 0.1 mg per kg body weight, may be repeated intermittently as indicated.

OXANDROLONE SIDE EFFECTS

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;
• 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 oxandrolone 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)