Droxia (Hydroxyurea Capsules) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Droxia

Sickle Cell Disease (Sickle Cell Anemia) »

What is sickle cell anemia?

Sickle cell anemia (sickle cell disease) is a disorder of the blood caused by an inherited abnormal hemoglobin (an oxygen-carrying protein within the red blood cells). The abnormal hemoglobin causes distorted (sickled) red blood cells. The sickled red blood cells are fragile and prone to rupture. When the number of red blood cells decreases from rupture (hemolysis), anemia is the result. This condition is referred to as sickle cell anemia. The irregular sickled cells can also block blood vessels causing tissue and organ damage and pain.

Sickle cell anemia is one of the most common inherited blood anemias. The disease primarily affects Africans and African Americans. It is estimated that in the United States, some 50,000 African Americans are afflicted with the most severe form of sickle cell anemia. Overall, current estimates are that one in 1,875 U.S. African American is affected with sickle cell anemia./...

Read the Sickle Cell Disease (Sickle Cell Anemia) article »

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Droxia

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DROXIA®
(hydroxyurea) Capsules, USP

WARNING

Treatment of patients with DROXIA may be complicated by severe, sometimes lifethreatening, adverse effects. DROXIA should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of DROXIA relative to the undefined risk of developing secondary malignancies.

DRUG DESCRIPTION

DROXIA® (hydroxyurea capsules, USP) is available for oral use as capsules providing 200 mg, 300 mg, and 400 mg hydroxyurea. Inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants; FD&C Blue No. 1 and FD&C Green No. 3 (200 mg capsules); D&C Red No. 28, D&C Red No. 33, and FD&C Blue No. 1 (300 mg capsules); D&C Red No. 28, D&C Red No. 33, and D&C Yellow No. 10 (400 mg capsules).

Hydroxyurea is an essentially tasteless, white crystalline powder. Its structural formula is:

DROXIA® (hydroxyurea) Structural Formula Illustration

What are the possible side effects of hydroxyurea (Droxia, Hydrea)?

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

Call your doctor at once if you have any of these serious side effects:

pinpoint red spots on your skin;
red patches, skin ulcers, or darkened skin (especially on your legs or feet);
fever, chills, body aches, flu symptoms;
nausea or vomiting;
loss of appetite;
diarrhea;
white patches or...

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What are the precautions when taking hydroxyurea capsules (Droxia)?

Before taking hydroxyurea, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), HIV infection, high uric acid level in the blood.

Hydroxyurea can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such...

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Last reviewed on RxList: 2/16/2012
This monograph has been modified to include the generic and brand name in many instances.