Hydrea 500 Mg (Hydroxyurea) Capsule

Introduction

Hydrea 500 mg, containing the active compound Hydroxyurea, is an oral antineoplastic agent widely used in the treatment of various hematologic and solid malignancies. Manufactured by Everest Pharmaceuticals Ltd and globally distributed by Orio Pharma, Hydrea is a reliable and cost-effective solution in cancer therapy, particularly for patients with chronic myeloid leukemia (CML), sickle cell anemia, and head and neck cancers. With a strong global supply footprint, Orio Pharma ensures consistent quality and availability for oncology centers, hospitals, and pharmacies worldwide.

Key Indications

Hydrea (Hydroxyurea) 500 mg is indicated in the following conditions:

1. Chronic Myeloid Leukemia (CML)

Hydroxyurea is widely used in the management of chronic phase CML. It reduces elevated white blood cell counts, thereby controlling disease progression and alleviating symptoms such as splenomegaly and bone pain.

2. Head and Neck Cancer

Used as a radiosensitizer, Hydrea is often prescribed in combination with radiation therapy in locally advanced squamous cell carcinomas of the head and neck, particularly for palliative management.

3. Sickle Cell Anemia

Hydrea increases fetal hemoglobin (HbF) levels, which decreases the frequency of painful crises and reduces the need for blood transfusions in patients with sickle cell disease.

4. Refractory Ovarian Cancer

Hydroxyurea may be used as a palliative treatment option for advanced or relapsed ovarian cancer that is unresponsive to standard platinum-based therapy.

5. Essential Thrombocythemia & Polycythemia Vera

As a cytoreductive agent, Hydroxyurea is effective in reducing elevated platelet or red blood cell counts in myeloproliferative disorders, lowering the risk of thrombosis.

Mechanism of Action

Hydroxyurea works by inhibiting the enzyme ribonucleotide reductase, which is essential for DNA synthesis. By interfering with DNA replication, Hydroxyurea prevents the proliferation of malignant cells. In sickle cell anemia, it induces the production of fetal hemoglobin, which reduces sickling and improves red blood cell flexibility, leading to fewer vaso-occlusive events.

Dosage and Administration

Hydrea 500 mg capsules should be administered under the supervision of a qualified oncologist or hematologist. Dosage must be tailored to the individual patient based on disease type, severity, body weight, renal function, and hematologic parameters.

Typical Adult Dosage Regimens:

CML: Initial dose of 20-30 mg/kg orally once daily; maintenance dose adjusted based on WBC counts.
Head and Neck Cancer (with radiation): 80 mg/kg orally every third day or as per radiation protocol.
Sickle Cell Disease: 15 mg/kg once daily; titrated every 8 weeks up to 35 mg/kg/day based on clinical response and hematologic parameters.
Polycythemia Vera / Essential Thrombocythemia: 15-20 mg/kg/day, adjusted to maintain target blood counts.

Capsules should be swallowed whole with water and may be taken with or without food.

Contraindications

Hydrea is contraindicated in:

Hypersensitivity to Hydroxyurea or any capsule component
Severe bone marrow suppression (neutrophils < 2500/mm³ or platelets < 100,000/mm³)
Pregnancy and breastfeeding due to teratogenic risk

Side Effects

Common Adverse Effects:

Bone marrow suppression (anemia, leukopenia, thrombocytopenia)
Gastrointestinal disturbances (nausea, vomiting, diarrhea, mucositis)
Skin changes (hyperpigmentation, nail changes, rash)
Fever, fatigue, and headache

Rare but Serious Effects:

Secondary leukemia
Pulmonary fibrosis
Hepatotoxicity
Leg ulcers (long-term use)

Frequent monitoring of complete blood counts (CBC), liver function, and renal parameters is recommended.

Drug Interactions

Antiretrovirals: Increased risk of bone marrow suppression when co-administered with nucleoside reverse transcriptase inhibitors (NRTIs).
Other cytotoxic agents or radiation therapy: Increased toxicity risk.
Live vaccines: Should be avoided during treatment due to immunosuppression.

Precautions and Warnings

Myelosuppression: Close monitoring is essential; dose adjustments or interruptions may be necessary.
Carcinogenic potential: Long-term use is associated with secondary malignancies.
Renal or Hepatic Impairment: Dose adjustment may be required; monitor organ function regularly.
Fertility: Hydroxyurea may impair male and female fertility.

Use in Special Populations

Pregnancy: Category D – known teratogen. Contraindicated unless benefits outweigh risks.
Lactation: Contraindicated due to risk to the infant.
Pediatric Use: Safety and efficacy established in sickle cell disease; dosing must be carefully adjusted.
Geriatric Use: No specific age-related differences observed; caution required due to increased susceptibility to side effects.

Storage Instructions

Store below 30°C in a dry place, protected from light and moisture.
Keep out of reach of children.
Do not use after the expiry date printed on the package.

Packaging Information

Hydrea 500 mg is supplied in high-quality, tamper-proof blister packs or HDPE containers to maintain product integrity during transportation and storage. Packaging complies with international regulatory standards and is suitable for global markets.

Availability and Global Distribution

Orio Pharma ensures seamless and timely distribution of Hydrea 500 mg across multiple continents, including Asia, Africa, Europe, and the Middle East. Backed by Everest Pharmaceuticals Ltd’s robust manufacturing capabilities, Hydrea is delivered with assured compliance, quality control, and regulatory documentation support.

Conclusion

Hydrea 500 mg (Hydroxyurea) Capsule remains an essential component in the treatment landscape for multiple hematologic and solid tumors. Its versatile therapeutic role—from managing chronic myeloid leukemia to improving life quality in sickle cell patients—makes it a cornerstone in oncologic and hematologic care. Supplied by Orio Pharma, a trusted global oncology medicine supplier, and manufactured by Everest Pharmaceuticals Ltd, Hydrea combines proven efficacy with worldwide accessibility. For institutions seeking reliable oncology medications backed by stringent quality assurance and international compliance, Hydrea is an ideal choice.