Product image of Hydroxyurea (Hydroxycarbamide) supplied by GNH India

Hydroxyurea

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hydroxyurea (Hydroxycarbamide)

Hydroxycarbamide, the active ingredient in Hydroxyurea, is an antineoplastic agent presented as an oral dosage form for oral use. It is used to treat certain blood disorders and cancers, including chronic myelogenous leukemia, sickle cell disease, polycythemia vera, and essential thrombocythemia.

GNH India supplies Hydroxyurea as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Hydroxyurea is employed in hematologic malignancies and chronic blood disorders.

  • Chronic myelogenous leukemia: reduces leukemic cell proliferation.
  • Sickle cell disease: decreases frequency of painful vaso‑occlusive crises.
  • Polycythemia vera: lowers elevated red blood cell mass.
  • Essential thrombocythemia: reduces platelet count and thrombotic risk.

How It Works

  • Hydroxyurea inhibits ribonucleotide reductase, the enzyme responsible for converting ribonucleotides to deoxyribonucleotides. This blockade limits DNA synthesis, preferentially affecting rapidly dividing cells such as malignant hematopoietic clones and over‑producing blood cells, thereby exerting its antineoplastic and cytoreductive actions.

Side Effects

Hydroxyurea may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Bone marrow suppression: anemia, leukopenia, thrombocytopenia.
  • Gastrointestinal upset: nausea, vomiting, diarrhea.
  • Skin changes: hyperpigmentation, rash.
  • Alopecia: hair thinning or loss.

Serious or Rare Side Effects

  • Severe cytopenias: life‑threatening neutropenia or aplastic anemia.
  • Acute renal failure.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis.

Precautions & Warnings

Hydroxyurea requires careful monitoring and specific safety measures.

  • Pregnancy: category D; avoid unless benefits outweigh risks.
  • Breastfeeding: not recommended; drug may be excreted in milk.
  • Renal impairment: dose adjustment may be needed; monitor renal function.
  • Hepatic impairment: use with caution; monitor liver enzymes.
  • Myelosuppression monitoring: perform regular complete blood counts.
  • Store at room temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Hydroxyurea can interact with several medicines, altering efficacy or toxicity.

Major Interactions (Avoid)

  • Concurrent myelosuppressive agents: may cause profound bone marrow suppression.
  • Live vaccines: increased risk of infection due to immunosuppression.
  • Protease inhibitor antiretrovirals: may raise hydroxyurea plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Allopurinol: can enhance hematologic toxicity.
  • Phenytoin: may reduce hydroxyurea effectiveness.
  • NSAIDs: may increase risk of renal toxicity.

Frequently Asked Questions

Hydroxyurea is indicated for several hematologic conditions, including chronic myelogenous leukemia, sickle cell disease, polycythemia vera, and essential thrombocythemia. In each case, the drug helps to control abnormal cell proliferation or reduce the frequency of disease‑related complications.

Hydroxycarbamide (hydroxyurea) blocks the enzyme ribonucleotide reductase, which is essential for DNA synthesis. By limiting the supply of deoxyribonucleotides, it slows the growth of rapidly dividing cells such as malignant leukemic cells and over‑producing blood cells, providing therapeutic benefit in the indicated disorders.

The dose of Hydroxyurea is individualized and set by the prescribing healthcare professional based on the specific indication, patient weight, renal and hepatic function, and response to therapy. No standard dose is provided here; patients should follow the prescriber’s instructions.

Hydroxyurea is classified as pregnancy category D, meaning it may cause fetal harm and should be avoided unless the potential benefit justifies the risk. It is also not recommended during breastfeeding because it can be excreted in milk and may affect the infant.

To place an order, submit an enquiry on the Hydroxyurea product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Hydroxyurea is a cytoreductive oral agent, often preferred for its ease of administration compared with injectable therapies such as interferon‑alpha or ruxolitinib. While it effectively reduces cell proliferation, alternative drugs may offer different safety profiles or mechanisms, so the choice depends on disease severity, patient tolerance, and clinician judgment.

Hydroxyurea tablets should be stored at room temperature, below 25 °C, in the original packaging to protect them from moisture and light. Keep the container tightly closed and out of reach of children.

Hydroxyurea is taken orally, usually with a full glass of water. It can be taken with or without food, but patients should follow the prescriber’s guidance on timing and any dietary considerations to ensure consistent absorption.

The most serious adverse events include severe bone‑marrow suppression leading to life‑threatening neutropenia or aplastic anemia, acute renal failure, and pulmonary toxicity such as interstitial pneumonitis. Patients should be monitored regularly for blood counts, kidney function, and respiratory symptoms.

Hydroxyurea is contraindicated in patients with known hypersensitivity to the drug, those with severe pre‑existing bone‑marrow suppression, and pregnant women unless the therapeutic benefit outweighs the risk. Caution is also advised for individuals with significant renal or hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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