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|Oxandrolone

ANABOLIC STEROIDS (Systemic)

Some commonly used brand names are:

In the U.S.—

• Anadrol-50 ³
• Deca-Durabolin ¹
• Durabolin ¹
• Durabolin-50 ¹
• Hybolin Decanoate ¹
• Hybolin-Improved ¹
• Kabolin ¹
• Oxandrin ²
• Winstrol ⁴

In Canada—

• Anapolon 50 ³
• Deca-Durabolin ¹

Category

• Anabolic steroid—Nandrolone; Oxandrolone; Oxymetholone; Stanozolol
• Antianemic—Nandrolone; Oxymetholone; Stanozolol
• Antiangioedema, hereditary, agent—Oxymetholone; Stanozolol
• Antineoplastic—Nandrolone

Description

This medicine belongs to the group of medicines known as anabolic (an-a-BOL-ik) steroids. They are related to testosterone, a male sex hormone. Anabolic steroids help to rebuild tissues that have become weak because of serious injury or illness. A diet high in proteins and calories is necessary with anabolic steroid treatment.

Anabolic steroids are used for several reasons:

• to help patients gain weight after a severe illness, injury, or continuing infection. They also are used when patients fail to gain or maintain normal weight because of unexplained medical reasons.
• to treat certain types of anemia.
• to treat certain kinds of breast cancer in some women.
• to treat hereditary angioedema, which causes swelling of the face, arms, legs, throat, windpipe, bowels, or sexual organs.

Anabolic steroids may also be used for other conditions as determined by your doctor.

Anabolic steroids are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Oxandrolone
  • Tablets (U.S.)
• Oxymetholone
  • Tablets (U.S. and Canada)
• Stanozolol
  • Tablets (U.S.)

• Parenteral
• Nandrolone
  • Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For anabolic steroids, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to anabolic steroids or androgens (male sex hormones). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Anabolic steroids should not be used during pregnancy. They may cause the development of male features in the female fetus and premature growth and development of male features in the male fetus. Be sure you have discussed this with your doctor.

Breast-feeding—It is not known whether anabolic steroids pass into breast milk.

Children—Anabolic steroids should be used with caution in pediatric patients. This medicine may cause children to stop growing or their bone growth to slow down. In addition, they may make male children develop too fast sexually and may cause male-like changes in female children.

Older adults—When elderly male patients are treated with anabolic steroids, they may have an increased risk of enlarged prostate or cancer of the prostate.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking anabolic steroids, it is especially important that your health care professional know if you are taking any of the following:

• Acetaminophen (e.g., Tylenol) (with long-term, high-dose use) or
• Amiodarone (e.g., Cordarone) or
• Androgens (male hormones) or
• Anti-infectives by mouth or by injection (medicine for infection) or
• Antithyroid agents (medicine for overactive thyroid) or
• Carbamazepine (e.g., Tegretol) or
• Carmustine (e.g., BiCNU) or
• Chloroquine (e.g., Aralen) or
• Dantrolene (e.g., Dantrium) or
• Daunorubicin (e.g., Cerubidine) or
• Disulfiram (e.g., Antabuse) or
• Divalproex (e.g., Depakote) or
• Estrogens (female hormones) or
• Etretinate (e.g., Tegison) or
• Gold salts (medicine for arthritis) or
• Hydroxychloroquine (e.g., Plaquenil) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Methyldopa (e.g., Aldomet) or
• Naltrexone (e.g., Trexan) (with long-term, high-dose use) or
• Oral contraceptives (birth control pills) containing estrogen or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Phenytoin (e.g., Dilantin) or
• Plicamycin (e.g., Mithracin) or
• Valproic acid (e.g., Depakene)—Taking anabolic steroids with any of these medicines may increase the chances of liver damage. Your doctor may want you to have extra blood tests to check for this if you must take both medicines

• Anticoagulants, oral (blood thinners you take by mouth)—Anabolic steroids can increase the effect of these medicines and possibly cause excessive bleeding

Other medical problems—The presence of other medical problems may affect the use of anabolic steroids. Make sure you tell your doctor if you have any other medical problems, especially:

• Breast cancer (in males and some females)

• Diabetes mellitus (sugar diabetes)—Anabolic steroids can decrease blood sugar levels

• Enlarged prostate or
• Prostate cancer—Anabolic steroids may make these conditions worse by causing more enlargement of the prostate or more growth of a tumor

• Heart or blood vessel disease—Anabolic steroids can worsen these conditions by increasing blood cholesterol levels

• Kidney disease

• Liver disease

• Too much calcium in the blood (or history of) (in females)—Anabolic steroids may worsen this condition by raising the amount of calcium in the blood even more

Proper Use of This Medicine

Take this medicine only as directed . Do not take more of it and do not take it more often than your doctor ordered. To do so may increase the chance of side effects.

In order for this medicine to work properly, it is important that you follow a diet high in proteins and calories . If you have any questions about this, check with your health care professional.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking the anabolic steroid .

• For nandrolone decanoate
• For injection dosage form:
  • For treatment of certain types of anemia:
    • Women and girls 14 years of age and older—50 to 100 milligrams (mg) injected into a muscle every one to four weeks.
    • Men and boys 14 years of age and older—50 to 200 mg injected into a muscle every one to four weeks.
      Your doctor may want to continue treatment for up to twelve weeks. After a four-week rest period without receiving this medicine, your doctor may want you to repeat the cycle.
    • Children up to 2 years of age—Dose must be determined by your doctor.
    • Children 2 to 13 years of age—25 to 50 mg injected into a muscle every three to four weeks.

• For nandrolone phenpropionate
• For injection dosage form:
  • For treatment of certain breast cancers in women:
    • Adults—25 to 100 milligrams (mg) injected into a muscle once a week for up to twelve weeks. After a four-week rest period without receiving this medicine, your doctor may want you to repeat the cycle.
    • Children—Dose must be determined by your doctor.

• For oxandrolone
• For oral dosage form (tablets):
  • For treatment in rebuilding tissue after a serious illness or injury:
    • Adults and teenagers—2.5 milligrams (mg) two to four times a day for up to four weeks. Your doctor may increase your dose up to 20 mg a day.
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.25 mg per kilogram (kg) (0.11 mg per pound) of body weight a day.

• For oxymetholone
• For oral dosage form (tablets):
  • For treatment of certain types of anemia:
    • Adults, teenagers, children, and older infants—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 5 milligrams (mg) per kilogram (kg) (0.45 to 2.3 mg per pound) of body weight a day.
    • Premature and newborn infants—Dose is based on body weight or size and must be determined by your doctor. The usual dose is 0.175 mg per kg (0.08 mg per pound) of body weight once a day.

• For stanozolol
• For oral dosage form (tablets):
  • To prevent hereditary angioedema, which causes swelling of the face, arms, legs, throat, windpipe, bowels, or sexual organs:
    • Adults and teenagers—At first, 2 milligrams (mg) three times a day to 4 mg four times a day for five days. Then, your doctor may slowly lower the dose to 2 mg once a day or once every other day.

Missed dose—If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Take the missed dose as soon as possible. However, if you do not remember it until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• More than one dose a day—Take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you have any questions about this, check with your doctor.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.

If your child or teenager is taking this medicine, it is important that the doctor take x-rays every 6 months to check your child for bone growth and height. Anabolic steroids may interfere with normal bone growth.

For diabetic patients:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Side Effects of This Medicine

Tumors of the liver, liver cancer, or peliosis hepatis, a form of liver disease, have occurred during long-term, high-dose therapy with anabolic steroids. Although these effects are rare, they can be very serious and may cause death. Discuss these possible effects with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur :

Also, check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, anabolic steroids may be used in certain patients with the following medical conditions:

• Certain blood clotting diseases
• Growth failure
• Turner"s syndrome

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 10/28/2004

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