Brand Names:

• Anadrol-50
• Oxandrin
• Winstrol

Dosage Forms:

• Tablet

Uses of This Medicine:

This medicine belongs to the group of medicines known as anabolic 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.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

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.

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 any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Bupropion
• Celecoxib
• Dicumarol
• Erdafitinib
• Levoketoconazole
• Methotrexate
• Pexidartinib
• Phenindione
• Phenprocoumon
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of medicines in this class. 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 medicines in this class 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 amount of medicine 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 using the medicine.

• 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.
    • 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.

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.

• 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 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 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 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, take it 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 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—

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

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:

For both females and males

Less common

Yellow eyes or skin

Rare (with long-term use)

Black, tarry, or light-colored stools

dark-colored urine

purple- or red-colored spots on body or inside the mouth or nose

sore throat and/or fever

vomiting of blood

Check with your doctor as soon as possible if any of the following side effects occur:

For both females and males

Less common

Bone pain

nausea or vomiting

sore tongue

swelling of feet or lower legs

unusual bleeding

unusual weight gain

Rare (with long-term use)

Abdominal or stomach pain

feeling of discomfort (continuing

headache (continuing)

hives

loss of appetite (continuing)

unexplained weight loss

unpleasant breath odor (continuing)

Incidence not known

Lack or slowing of normal bone growth

For females only

More common

Acne or oily skin

enlarging clitoris

hoarseness or deepening of voice

irregular menstrual periods

unnatural hair growth

unusual hair loss

Less common

Mental depression

unusual tiredness

For young males (boys) only

More common

Acne

enlarging penis

increased frequency of erections

unnatural hair growth

Less common

Unexplained darkening of skin

For sexually mature males only

More common

Enlargement of breasts or breast soreness

frequent or continuing erections

frequent urge to urinate

For elderly males only

Less common

>Difficult or frequent urination

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For both females and males

Less common

Chills

diarrhea

feeling of abdominal or stomach fullness

muscle cramps

trouble in sleeping

unusual decrease or increase in sexual desire

For males only

More common

Acne

Less common

Decreased sexual ability