Product image of Hydroxyurea Medac (Hydroxycarbamide) supplied by GNH India

Hydroxyurea Medac

Active Ingredient:
Hydroxycarbamide
Origin:
EU

Hydroxyurea Medac (Hydroxycarbamide)

Hydroxycarbamide, the active ingredient in Hydroxyurea Medac, is a ribonucleotide reductase inhibitor presented as an oral formulation for oral use. It is employed to manage sickle cell disease, chronic myelogenous leukemia, polycythemia vera and essential thrombocythemia in adult patients.

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

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Hydroxyurea is used in hematologic disorders that involve abnormal cell proliferation or sickling of red blood cells.

  • Sickle cell disease: reduces frequency of painful crises and improves hemoglobin levels.
  • Chronic myelogenous leukemia: slows disease progression by inhibiting leukemic cell growth.
  • Polycythemia vera: decreases red blood cell mass and helps control hematocrit.
  • Essential thrombocythemia: lowers platelet counts and reduces thrombotic risk.

How It Works

  • Hydroxyurea inhibits ribonucleotide reductase, the key enzyme that converts ribonucleotides to deoxyribonucleotides. This blockade lowers intracellular deoxyribonucleotide pools, impeding DNA synthesis and cell division, particularly in rapidly proliferating hematopoietic cells, thereby exerting its antineoplastic and disease‑modifying effects.

Side Effects

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

Common Side Effects

  • Myelosuppression: anemia, neutropenia, thrombocytopenia.
  • Gastrointestinal upset: nausea, vomiting, diarrhea.
  • Skin changes: hyperpigmentation, rash.
  • Alopecia: hair thinning or loss.
  • Mild fever or malaise.

Serious or Rare Side Effects

  • Severe bone‑marrow suppression leading to infection or bleeding.
  • Renal impairment or acute kidney injury.
  • Hepatotoxicity with elevated liver enzymes.
  • Life‑threatening cutaneous reactions (e.g., Stevens‑Johnson syndrome).
  • Teratogenic effects causing fetal harm.
  • Rare pulmonary toxicity.

Precautions & Warnings

Hydroxyurea requires careful monitoring and patient education before and during therapy.

  • Blood count monitoring: perform complete blood counts regularly to detect cytopenias.
  • Renal/hepatic function: adjust dose in patients with impaired kidney or liver function.
  • Pregnancy risk: avoid use in pregnancy unless benefits outweigh risks; ensure effective contraception.
  • Breastfeeding: contraindicated as drug is excreted in milk.
  • Pre‑existing bone‑marrow disorders: use with caution and close hematologic surveillance.
  • Store at room temperature: keep in original container, protect from moisture and direct sunlight.

Avoid Interactions

Hydroxyurea can interact with other medicines, altering its safety or effectiveness.

Major Interactions (Avoid)

  • Concurrent myelosuppressive chemotherapy: may cause profound cytopenias.
  • Live vaccines: increased risk of infection due to immunosuppression.
  • Zidovudine or other antiretrovirals: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • NSAIDs: may increase risk of renal toxicity.
  • Phenytoin: may reduce hydroxyurea plasma levels, decreasing efficacy.
  • High‑dose vitamin C: can increase hydroxyurea absorption and toxicity.
  • Allopurinol: may enhance hematologic toxicity.
  • Sulfonamides: potential for increased myelosuppression.

Frequently Asked Questions

Hydroxyurea Medac is prescribed for several hematologic disorders, including sickle cell disease, chronic myelogenous leukemia, polycythemia vera, and essential thrombocythemia. In each case, the drug helps control abnormal blood cell production or reduces sickling of red cells, improving clinical outcomes.

Hydroxycarbamide (hydroxyurea) works by inhibiting the enzyme ribonucleotide reductase, which is essential for making deoxyribonucleotides—the building blocks of DNA. This inhibition lowers DNA synthesis, slowing the proliferation of rapidly dividing cells such as malignant leukocytes or abnormal red blood cells.

The dosage of Hydroxyurea Medac is individualized by the prescribing clinician based on the specific indication, patient weight, renal and hepatic function, and blood‑count response. Patients should follow the dose and schedule provided by their healthcare professional.

Hydroxyurea is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should be avoided during pregnancy unless no safer alternative exists and the benefits outweigh the risks. The drug is also excreted in breast milk, so breastfeeding is not recommended while taking Hydroxyurea.

To order Hydroxyurea Medac, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The sales team will then respond with pricing, availability, shipping details and any required import documentation.

Hydroxyurea is the only disease‑modifying oral therapy approved for sickle cell disease, whereas alternatives such as blood transfusions or newer gene‑editing approaches are more invasive or still investigational. Hydroxyurea reduces painful crises and transfusion needs, offering a convenient oral option with a well‑characterized safety profile.

Hydroxyurea Medac should be stored at room temperature, below 25 °C, in its original packaging to protect it from moisture and light. Do not store in a bathroom or near a heat source, and keep the container tightly closed when not in use.

Hydroxyurea Medac is taken orally, usually with a glass of water. The tablet should be swallowed whole and not crushed or chewed unless the prescriber advises otherwise. Dosing times are typically consistent each day to maintain stable drug levels.

The most serious risks include severe bone‑marrow suppression leading to infections or bleeding, renal or hepatic toxicity, and teratogenic effects that can harm a developing fetus. Patients should be monitored regularly for blood‑count changes and organ function, and pregnancy must be avoided.

Hydroxyurea Medac is contraindicated in patients with known hypersensitivity to hydroxyurea, those who are pregnant without a compelling indication, and individuals with severe bone‑marrow failure not related to the target disease. Caution is also advised for patients with significant renal or hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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