HYDROXYUREA Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
HYDROXYUREA is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Hydroxyurea capsules, USP is indicated for the treatment of: Resistant chronic myeloid leukemia.Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation.
What should I know before taking it?
Hydroxyurea capsules is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.
What important warnings are listed?
Hydroxyurea causes severe myelosuppression. Treatment with hydroxyurea should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia. Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents; use hydroxyurea cautiously in such patients. Evaluate hematologic status prior to and during treatment with hydroxyurea capsules. Provide supportive care and modify dose or discontinue hydroxyurea as needed. Recovery.
How is this medication usually taken?
Hydroxyurea is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. Base all dosage on the patient’s actual or ideal weight, whichever is less. Hydroxyurea is a cytotoxic drug. Follow applicable special handling and disposal procedures [ see References (15) ]. Swallow hydroxyurea capsule whole. Do NOT open, break, or chew capsules because hydroxyurea is a cytotoxic drug. Prophylactic administration of folic acid is recommended [ see Warnings and Precautions (5.8)]. Monitor blood counts at.
What side effects are listed?
• Myelosuppression [see Warnings and Precautions (5.1)] • Hemolytic anemia [see Warnings and Precautions (5.2)] • Malignancies [see Warnings and Precautions (5.3)] • Vasculitic toxicities [see Warnings and Precautions (5.5)] • Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7)] • Radiation recall [see Warnings and Precautions (5.8)] • Macrocytosis [see Warnings and Precautions (5.9)] • Pulmonary Toxicity [see Warnings and Precautions (5.10)] The following adverse reactions have been identified during post-approval use of hydroxyurea capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to.
What interactions are listed?
Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis. Hepatotoxicity Hepatotoxicity and hepatic failure resulting in death have been reported during postmarketing surveillance in patients with HIV.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b42f2b4-3880-e7a9-e063-6294a90a5fd0
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.