Pronunciation: hye DROX ee yoo REE a

Brand: Droxia, Hydrea

Droxia 200 mg

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capsule, turquoise, imprinted with DROXIA 6335

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Droxia 300 mg

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capsule, purple, imprinted with DROXIA 6336

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Droxia 400 mg

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capsule, orange, imprinted with DROXIA 6337

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Hydrea 500 mg

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capsule, pink/turquoise, imprinted with HYDREA 830

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Hydroxyurea 500 mg-BAR

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capsule, pink/purple, imprinted with barr, 882

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Hydroxyurea 500 mg-ROX

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green/peach, imprinted with 54 072

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What is the most important information I should know about hydroxyurea?

Hydroxyurea can cause severe or life-threatening side effects, and may increase your risk of developing other types of cancer or leukemia. Talk with your doctor about your specific risk.

You should not use hydroxyurea if you have severe bone marrow suppression, severe anemia, or low levels of platelets in your blood.

Hydroxyurea can harm an unborn baby, and may affect your ability to have children, whether you are a man or a woman.

What is hydroxyurea?

Hydroxyurea affects certain cells in the body, such as cancer cells or sickled red blood cells.

Hydroxyurea is used to treat chronic myelocytic leukemia, ovarian cancer, and certain types of skin cancer (melanoma and primary squamous cell cancer of the head and neck).

Hydroxyurea is also used to reduce pain episodes and the need for blood transfusions in people with sickle cell anemia. Hydroxyurea will not cure sickle cell anemia.

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

What should I discuss with my healthcare provider before taking hydroxyurea?

You should not use hydroxyurea if you are allergic to it, or if you have:

  • severe bone marrow suppression;
  • severe anemia; or
  • low levels of platelets in your blood.

To make sure hydroxyurea is safe for you, tell your doctor if you have:

  • bone marrow suppression;
  • HIV or AIDS;
  • liver disease;
  • kidney disease; or
  • if you are receiving chemotherapy or radiation.

Using hydroxyurea may increase your risk of developing other types cancer or leukemia. Talk with your doctor about your specific risk.

Do not use hydroxyurea if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

Hydroxyurea can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking hydroxyurea.

Older adults may be more likely to have side effects from this medicine.

How should I take hydroxyurea?

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.

Drink 8 to 10 glasses of liquid per day while you are taking hydroxyurea. You may take the medicine with or without food.

Hydroxyurea is either taken once per day or once every third day, depending on the condition being treated. On each of your dosing days, take the medicine at the same time of day. Your doctor may also want you to take a folic acid supplement. Follow your doctor's instructions very carefully.

Wash your hands before and after you handle a hydroxyurea capsule or the bottle that contains the pills. For best protection, wear disposable gloves when handling the pills.

Do not open the hydroxyurea capsule. Do not use a pill that has been accidentally opened or broken. The medicine from an open capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

If any powder from an open capsule is spilled, wipe it up at once with a damp paper towel and throw the towel away in a sealed plastic bag where children and pets cannot get to it.

You may need frequent medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.

Use hydroxyurea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

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.

What happens if I overdose?

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

Overdose symptoms may include drowsiness, mouth sores, and swelling with pain and purple discoloration in your hands and feet.

What should I avoid while taking hydroxyurea?

Do not handle hydroxyurea pills or the medicine bottle without skin protection (disposable gloves).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

This medicine can pass into body fluids (including urine, feces, vomit). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of hydroxyurea?

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

Call your doctor at once if you have:

  • painful or difficult urination;
  • skin numbness or purple discoloration, skin ulcers or open sores;
  • confusion, hallucinations, seizure;
  • signs of a weak immune system --fever, chills, body aches, flu symptoms, sores in your mouth and throat, pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • pancreas problems --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • hair loss;
  • skin peeling or itching, mild rash;
  • upset stomach, constipation, diarrhea, vomiting;
  • headache, dizziness; or
  • swelling in your hands or feet.

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.

What other drugs will affect hydroxyurea?

Some medicines can increase your risk of certain side effects while taking hydroxyurea. Tell your doctor if you are also using didanosine, stavudine, or an interferon (such as Actimmune, Alferon, Avonex, Betaseron, Extavia, Infergen, Intron, Rebetron, Rebif, or Roferon).

Other drugs may interact with hydroxyurea, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about hydroxyurea.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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