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Hydromac 500 capsules

Generic Name- Hydroxyurea

Drug class- Antineoplastic agent

Hydroxyurea is an antimetabolite agent, which is used for treatment of resistant leukemia’s and carcinomas of the head and neck. It is also used to increase fetal hemoglobin concentration, thus reducing the necessity for blood transfusions in patients with sickle cell anemia. It acts by inhibiting ribonucleotide diphosphatase reductase and blocking the conversion of ribonucleotides to deoxyribonucleotides, thereby interfering DNA synthesis.

Category

Product Description

Hydromac 500 (Hydroxyurea capsules) is an oral anticancer drug.

Indications and Usage

Hydroxyurea is indicated for treatment of:

  • Resistant chronic myeloid leukemia
  • Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation

Limitations of Use

  • This formulation is not intended for treatment of sickle cell anemia

Dosage and Administration

  • Individualize dose and treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards
  • Reduce dose by 50% in patients with creatinine clearance less than 60 ml/min

Dosage Form and Strength

  • Supplied as capsules for oral use
  • Available in 500mg strength

Clinical Efficacy

    • Effective regimen for treatment of patients with stage II and III head and neck cancer, when used in combination with radiation and 5-fluouracil
    • Increases progression-free survival and local/regional control to expected rates in head and neck cancer patients treated with surgery and radiation
    • Produces a higher response rate and significantly reduces symptoms in patients with recurrent and previous irradiated head and neck cancer
    • Achieves response rate of 92.1%, when used in remission-induction therapy of patients with chronic myelogenous leukemia (CML)

    Adverse Reactions

    • The most common adverse events which may occur are nausea, vomiting, diarrhea, constipation, anorexia, bone marrow suppression (anemia and leucopenia), gastric irritation, and mucositis

    Contraindications

    • It is contraindicated in patients with a previous hypersensitivity to hydroxyurea or any other component of its formulation

Special Precautions

  • Dose adjustments should be considered in cases of hematologic toxicities and myelosuppression
  • Blood counts should be monitored weekly throughout the duration of therapy to evaluate signs and symptoms of infection or bleeding immediately
  • Advise protection from sun exposure as hydroxyurea is a carcinogen and monitor patients for development of secondary malignancies
  • Discontinue treatment with hydroxyurea, if any signs of vasculitic toxicities and secondary malignancies including leukemia and skin cancers appears
  • Avoid use of live vaccine in patients taking hydroxyurea, as it may result in severe infections
  • Pancreatitis, hepatotoxicity, and peripheral neuropathy occurs with concomitant use of hydroxyurea with antiretroviral drugs, so monitor symptoms in HIV patients taking anti-retroviral drugs and discontinue hydroxyurea use
  • Patients who have received previous radiotherapy, should be monitored for the signs of skin erthyema and managed symptomatically
  • Women are advised to use effective contraceptive to avoid pregnancy
  • Do not use hydroxyurea in pregnant and breast feeding mothers, as it can cause harm to fetus
Hydromac 500 capsules - ADMAC Life Science