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All about: Hydroxyurea

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Generic Name: Hydroxyurea Capsules 200 mg, 300 mg, 400 mg (hye-drox-ee-yoor-EE-a)
Brand Name: Droxia

Hydroxyurea may cause severe, sometimes life-threatening side effects. With long-term use in patients with cell development disorders, secondary leukemias have been reported. It is unknown if this is related to Hydroxyurea or to the patient's underlying cell disorder.


Hydroxyurea is used for:

Reducing the number of painful episodes and blood transfusions needed by adults with sickle cell anemia experiencing recurrent episodes associated with moderate to severe pain. It may also be used for other conditions as determined by your doctor.

Hydroxyurea is an antineoplastic agent. Exactly how it works is unknown, but it is thought to increase the ability of deformed red blood cells to change shape, which may lessen pain associated with sickle cell anemia.

Do NOT use Hydroxyurea if:

  • you are allergic to any ingredient in Hydroxyurea
  • you have severe bone marrow depression, low white blood cell counts, low blood platelet levels, or severe anemia

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hydroxyurea :

Some medical conditions may interact with Hydroxyurea . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breastfeeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have kidney problems

Some MEDICINES MAY INTERACT with Hydroxyurea . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Didanosine because the risk of side effects such as inflammation of the pancreas may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydroxyurea may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydroxyurea :

Use Hydroxyurea as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Hydroxyurea may be taken with or without food.
  • Wash your hands before and after handling Hydroxyurea or the bottle it comes in. Wear gloves while you are handling Hydroxyurea or its bottle. Follow your doctor's instructions for disposing of the gloves after you remove them.
  • Hydroxyurea comes with an additional patient leaflet. Read it carefully and reread it each time you get Hydroxyurea refilled.
  • If you have difficulty swallowing, empty the contents of the capsule into a glass of water and drink immediately. Use care when emptying the capsule into water. Do not allow the powder to come into contact with the skin or mucous membranes and do not inhale the powder when opening the capsules. If the powder is spilled, it should be immediately wiped up with a damp towel and disposed of, as should the empty capsules.
  • Drinking extra fluids while you are taking Hydroxyurea is recommended. Check with your doctor for instructions.
  • Do not use Hydroxyurea if the expiration date has passed. Ask your doctor or pharmacist how to properly dispose of expired medicine.
  • If you miss a dose of Hydroxyurea , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydroxyurea .

Important safety information:

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Hydroxyurea .
  • Hydroxyurea may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Hydroxyurea may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
  • Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Hydroxyurea . Vaccinations may be less effective.
  • LAB TESTS, including complete blood cell and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Hydroxyurea with caution in the ELDERLY because they may be more sensitive to its effects.
  • Hydroxyurea is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Hydroxyurea has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Hydroxyurea during pregnancy. Hydroxyurea is excreted in breast milk. Do not breast-feed while taking Hydroxyurea .

Possible side effects of Hydroxyurea :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drowsiness; hair loss; inflammation of the mouth; loss of appetite; nausea; redness of the face.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood disorders, including low numbers of red or white blood cells; blood in the urine; chills; diarrhea; fever; inflammation of the pancreas; liver toxicity; lower back or abdominal pain; painful urination; persistent cough; secondary leukemia; shortness of breath; skin cancer; skin sore or lesions; sore throat; sores on the mouth or lips; unusual bruising or bleeding; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include dark discoloration of the skin; mouth sores; soreness; swelling of palms and soles of the feet followed by scaling of the skin.

Proper storage of Hydroxyurea :

Store Hydroxyurea at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Hydroxyurea out of the reach of children and away from pets.

General information:

  • If you have any questions about Hydroxyurea , please talk with your doctor, pharmacist, or other health care provider.
  • Hydroxyurea is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Hydroxyurea . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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