Anadrol-50

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

To be sure this medicine is helping your condition, you may need frequent blood tests. You may not notice any change in your symptoms, but your blood work will help your doctor determine how long to treat you with oxymetholone.

Tell your doctor if you have any changes in weight. Oxymetholone doses are based on weight, and any changes may affect the dose.

It may take 3 to 6 months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using oxymetholone.

Oxymetholone is only part of a treatment program that may also include blood transfusions and/or using other medicines. Follow your doctor's instructions very closely.

Once your condition is under control, you may be able to stop taking oxymetholone. Some people must continue taking a small amount of oxymetholone to keep their red blood cells from getting too low. You may need to take oxymetholone for the rest of your life. Follow your doctor's instructions.

Store at room temperature away from moisture, heat, and light.

Do not share this medicine with another person. Keep track of the amount of medicine used from each new bottle. Oxymetholone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy (see WARNINGS).

In Men

Prepubertal: Phallic enlargement and increased frequency of erections.

Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, bladder irritability and decrease in seminal volume.

In Women

Clitoral enlargement, menstrual irregularities.

In Both Sexes

Increased or decreased libido.

CNS: Excitation, insomnia.

Gastrointestinal: Nausea, vomiting, diarrhea.

Hematologic: Bleeding in patients on concomitant anticoagulant therapy, iron-deficiency anemia.

Leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role, if any, of oxymetholone is unclear because malignant transformation has been seen in patients with blood dyscrasias and leukemia has been reported in patients with aplastic anemia who have not been treated with oxymetholone.

Breast: Gynecomastia.

Larynx: Deepening of the voice in women.

Hair: Hirsutism and male-pattern baldness in women, male-pattern of hair loss in postpubertal males.

Skin: Acne (especially in women and prepubertal boys).

Skeletal: Premature closure of epiphyses in children (see PRECAUTIONS, Pediatric Use), muscle cramps.

Body as a Whole: Chills.

Fluid and Electrolytes: Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (see PRECAUTIONS), increased serum levels of low-density lipoproteins and decreased levels of high-density lipoproteins (see PRECAUTIONS, Laboratory Tests), increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Reversible changes in liver function tests also occur, including increased Bromsulphalein (BSP) retention and increases in serum bilirubin, glutamic-oxaloacetic transaminase (SGOT), and alkaline phosphatase.

Drug Abuse And Dependence

ANADROL Tablets is considered to be a controlled substance and is listed in Schedule III.

The following conditions have been reported in patients receiving androgenic anabolic steroids as a general class of drugs:

Peliosis hepatis, a condition in which liver and sometimes splenic tissue is replaced with blood-filled cysts, has been reported in patients receiving androgenic anabolic steroid therapy. These cysts are sometimes present with minimal hepatic dysfunction, but at other times they have been associated with liver failure. They are often not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.

Liver cell tumors are also reported. Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have been reported. Withdrawal of drug often results in regression or cessation of progression of the tumor. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening intra-abdominal hemorrhage develops.

Blood lipid changes that are known to be associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high density lipoprotein and sometimes increased low density lipoprotein. The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.

Cholestatic hepatitis and jaundice occur with 17-alpha-alkylated androgens at relatively low doses. Clinical jaundice may be painless, with or without pruritus. It may also be associated with acute hepatic enlargement and right upper-quadrant pain, which has been mistaken for acute (surgical) obstruction of the bile duct. Drug-induced jaundice is usually reversible when the medication is discontinued. Continued therapy has been associated with hepatic coma and death. Because of the hepatoxicity associated with oxymetholone administration, periodic liver function tests are recommended.

In patients with breast cancer, anabolic steroid therapy may cause hypercalcemia by stimulating osteolysis. In this case, the drug should be discontinued.

Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. Concomitant administration with adrenal steroids or ACTH may add to the edema. This is generally controllable with appropriate diuretic and/or digitalis therapy.

Geriatric male patients treated with androgenic anabolic steroids may be at an increased risk for the development of prostate hypertrophy and prostatic carcinoma.

Anabolic steroids have not been shown to enhance athletic ability.

Pregnancy Category: X

Lactation: Unknown if excreted; not recommended

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Tell all of your health care providers that you take this medicine. 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 Anadrol-50.
• 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 this medicine.
• 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 Anadrol-50 with care. You could have more side effects.
• 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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

You should not use this medication if you are allergic to oxymetholone, or if you have:

• prostate cancer;
• male breast cancer;
• female breast cancer with high levels of calcium in the blood;
• severe liver disease;
• severe kidney disease; or
• if you are pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using oxymetholone, tell your doctor if you have:

• liver disease;
• kidney disease;
• heart disease, congestive heart failure;
• high cholesterol or triglycerides;
• coronary artery disease (atherosclerosis); or
• an enlarged prostate.

FDA pregnancy category X. This medication can cause birth defects. Do not use oxymetholone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

It is not known whether oxymetholone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Children being treated with oxymetholone may need x-ray examinations every 6 months to make sure the medication is not causing harmful effects on bone growth.

Oxymetholone will not enhance athletic performance and should not be used for that purpose or shared with another person.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using oxymetholone.