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 presented as an oral tablet for oral use. It is employed to modify disease processes in several hematologic disorders and certain solid tumors.

GNH India supplies Hydroxyurea Medac as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support import and distribution across EU and other markets, and ensures timely delivery to meet clinical demand.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Hydroxyurea Medac is used in hematologic disease pathways and certain malignancies to reduce abnormal cell proliferation.

  • Sickle cell disease: increases fetal hemoglobin levels, reducing vaso‑occlusive crises.
  • Chronic myelogenous leukemia: inhibits leukemic cell proliferation.
  • Polycythemia vera: lowers red blood cell mass and hematocrit.
  • Essential thrombocythemia: reduces platelet counts and thrombotic risk.
  • Melanoma: used as part of combination regimens to limit tumor growth.

How It Works

  • Hydroxycarbamide inhibits ribonucleotide reductase, the enzyme responsible for converting ribonucleotides to deoxyribonucleotides. This blockade decreases the intracellular pool of deoxyribonucleotides, impairing DNA synthesis and repair, which leads to reduced proliferation of rapidly dividing cells, particularly malignant and abnormal hematopoietic cells.

Side Effects

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

Common Side Effects

  • Myelosuppression (anemia, neutropenia, thrombocytopenia)
  • Gastrointestinal upset (nausea, vomiting, abdominal pain)
  • Skin changes (hyperpigmentation, rash)
  • Alopecia (hair loss)
  • Elevated liver enzymes
  • Fever or flu‑like symptoms

Serious or Rare Side Effects

  • Severe bone marrow failure
  • Acute renal insufficiency
  • Pulmonary toxicity (interstitial pneumonitis)
  • Leg ulcers or severe skin ulceration
  • Teratogenic effects (birth defects)
  • Secondary malignancies (e.g., leukemia).

Precautions & Warnings

Hydroxyurea requires careful monitoring and patient counseling due to its potent pharmacologic activity.

  • Baseline and periodic blood counts: monitor for myelosuppression.
  • Liver and renal function tests: assess organ tolerance before and during therapy.
  • Pregnancy risk: contraindicated in pregnancy; discuss contraception.
  • Breastfeeding: avoid use while nursing.
  • Drug interactions: review concomitant medications that affect bone marrow.
  • Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Hydroxyurea may interact with other agents, altering efficacy or toxicity.

Major Interactions (Avoid)

  • Concurrent use with other myelosuppressive drugs (e.g., chemotherapy, azathioprine) may exacerbate bone marrow suppression.
  • Live vaccines: increased risk of infection; avoid during treatment.

Moderate Interactions (Monitor Closely)

  • Antiretrovirals (e.g., zidovudine): may enhance hematologic toxicity.
  • NSAIDs: can increase risk of gastrointestinal irritation.
  • Allopurinol: may affect renal clearance of hydroxyurea.
  • Phenytoin: may reduce hydroxyurea plasma levels.
  • Vitamin C supplements: may increase hydroxyurea absorption and toxicity.

Frequently Asked Questions

Hydroxyurea Medac is indicated for sickle cell disease, chronic myelogenous leukemia, polycythemia vera, essential thrombocythemia and certain melanoma treatment protocols. It works by reducing abnormal cell proliferation in these hematologic and oncologic disorders.

Hydroxycarbamide inhibits the enzyme ribonucleotide reductase, which is essential for producing deoxyribonucleotides. By limiting the supply of DNA building blocks, it slows DNA synthesis and cell division, particularly affecting rapidly dividing malignant or abnormal blood cells.

The dose of Hydroxyurea Medac is individualized by the prescribing clinician based on the specific indication, patient weight, laboratory parameters and treatment response. Dosage adjustments are made during therapy to balance efficacy and safety.

Hydroxyurea Medac is classified as Pregnancy Category D, indicating evidence of fetal risk. It should not be used during pregnancy, and breastfeeding is contraindicated because the drug can be excreted in milk and may harm the infant.

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, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and necessary import documentation.

Hydroxyurea Medac is the most widely used disease‑modifying therapy for sickle cell disease, primarily because it increases fetal hemoglobin and reduces pain crises. Alternative options include newer agents such as voxelotor or crizanlizumab, which target hemoglobin oxygen affinity or adhesion pathways, respectively, but hydroxyurea remains the first‑line oral therapy.

Hydroxyurea Medac tablets should be stored at ambient temperature, below 25 °C, in the original container to protect from moisture and light. Do not refrigerate or freeze the product.

Hydroxyurea Medac is taken orally, usually with a full glass of water. The tablet should be swallowed whole and not crushed or chewed, unless the prescriber provides specific instructions for a different administration method.

The most serious risks include severe bone‑marrow suppression leading to anemia, neutropenia or thrombocytopenia, potential renal or hepatic toxicity, and rare but serious complications such as pulmonary fibrosis, leg ulcers and secondary malignancies. Regular monitoring helps detect these issues early.

Hydroxyurea Medac is contraindicated in pregnant women, nursing mothers, patients with severe bone‑marrow failure, active uncontrolled infections, or those with known hypersensitivity to hydroxycarbamide. It should also be avoided in individuals with significant renal or hepatic impairment unless closely supervised.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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