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 an antimetabolite (ribonucleotide reductase inhibitor) presented as an oral tablet for oral use. It is employed in the management of sickle cell disease, chronic myelogenous leukemia, polycythemia vera and melanoma. By inhibiting DNA synthesis, it reduces abnormal cell proliferation, improving clinical outcomes in these hematologic and oncologic conditions.

GNH India supplies Hydroxyurea Medac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, providing reliable sourcing, regulatory support and timely delivery across global markets.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Hydroxyurea Medac, an antimetabolite that inhibits ribonucleotide reductase, is used in several hematologic and oncologic conditions.

  • Sickle cell disease: decreases vaso‑occlusive episodes and raises fetal hemoglobin levels, helping to reduce anemia complications.
  • Chronic myelogenous leukemia: slows proliferation of malignant myeloid cells, contributing to disease control.
  • Polycythemia vera: lowers elevated red blood cell mass, helping to manage hematocrit and reduce thrombotic risk.
  • Melanoma: used as part of combination therapy to inhibit tumor cell growth.

How It Works

  • Hydroxyurea (hydroxycarbamide) acts by irreversibly inhibiting the enzyme ribonucleotide reductase, which is essential for conversion of ribonucleotides to deoxyribonucleotides. This blockade reduces the intracellular pool of deoxyribonucleic acid precursors, thereby suppressing DNA synthesis and limiting cell division, particularly in rapidly proliferating hematopoietic and malignant cells. The resulting decrease in DNA replication triggers cell‑cycle arrest in the S phase and can induce fetal hemoglobin production in erythroid precursors, contributing to its therapeutic effects in sickle cell disease.

Side Effects

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

Common Side Effects

  • Bone marrow suppression: anemia, neutropenia, thrombocytopenia, which may cause fatigue, increased infection risk and bleeding tendencies.
  • Gastrointestinal upset: nausea, vomiting, abdominal pain or discomfort, often transient.
  • Skin changes: hyperpigmentation of the skin or mild rash, usually reversible after discontinuation.
  • Elevated liver enzymes: mild increases in transaminases (ALT, AST) without clinical hepatitis.
  • Fatigue: persistent tiredness affecting daily activities.
  • Hair loss: mild alopecia that may be temporary.

Serious or Rare Side Effects

  • Severe myelosuppression: life‑threatening pancytopenia requiring transfusion support.
  • Acute renal failure: sudden loss of kidney function, manifested by elevated creatinine.
  • Severe cutaneous reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis, presenting with extensive skin detachment.
  • Teratogenic effects: potential fetal malformations if exposure occurs during pregnancy.
  • Hypersensitivity reactions: fever, chills, hypotension or anaphylaxis.

Precautions & Warnings

Precautions for Hydroxyurea Medac focus on monitoring blood parameters, organ function and patient counseling.

  • Baseline assessment: obtain complete blood count and renal/hepatic function tests before initiating therapy.
  • Monitoring: perform regular CBC, liver enzymes and kidney function during treatment to detect myelosuppression or toxicity.
  • Infection risk: advise patients to report signs of infection promptly and to avoid exposure to contagious diseases.
  • Pregnancy considerations: avoid use in pregnant women unless benefits outweigh risks; discuss contraception.
  • Drug interactions: review concomitant medications for potential additive myelosuppressive effects.
  • Store at ambient temperature: keep below 25°C in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Hydroxyurea can interact with several medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Concurrent use with other myelosuppressive agents (e.g., cytarabine, azathioprine) may cause profound bone marrow depression.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) can increase hydroxyurea plasma levels, raising toxicity risk.

Moderate Interactions (Monitor Closely)

  • Allopurinol may enhance hydroxyurea toxicity; monitor blood counts.
  • NSAIDs can affect renal function when combined with hydroxyurea; assess renal parameters.
  • Antiretroviral protease inhibitors may alter hydroxyurea metabolism; adjust dosing if needed.
  • Trimethoprim‑sulfamethoxazole may potentiate myelosuppression; regular CBC monitoring is advised.
  • High-dose vitamin C may reduce hydroxyurea efficacy; patients should limit excessive supplementation.

Frequently Asked Questions

Hydroxyurea Medac is indicated for the treatment of several hematologic and oncologic disorders. It is used to reduce vaso‑occlusive crises in sickle cell disease, to control disease progression in chronic myelogenous leukemia, to lower red blood cell mass in polycythemia vera, and as part of combination regimens for certain melanomas.

Hydroxycarbamide, the active ingredient in Hydroxyurea Medac, inhibits ribonucleotide reductase, an enzyme required for DNA synthesis. By depleting deoxyribonucleotide pools, it slows cell division, particularly in rapidly proliferating blood‑forming and malignant cells, and can increase fetal hemoglobin production in sickle cell disease.

The dose of Hydroxyurea Medac is individualized and determined by the prescribing clinician based on the specific indication, patient characteristics, laboratory values and treatment goals. Dosage adjustments are made according to response and tolerability, and patients should follow the exact regimen provided by their healthcare professional.

Safety data for hydroxycarbamide in pregnancy are limited, and the drug may pose risks to the developing fetus. It is generally avoided in pregnant women unless the potential benefit justifies the risk. Breastfeeding mothers should discuss potential exposure with their physician, as the drug can be excreted in milk.

To request Hydroxyurea Medac, visit the product page on gnhindia.com and submit an enquiry with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and assistance with import documentation.

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