Clinical and pharmacological group: & nbsp

Antineoplastic agents

Antimetabolites

Included in the formulation
  • Hydrea®
    capsules inwards 
  • Hydroxycarbamide medec
    capsules inwards 
    medac GmbH     Germany
  • Hydroxycarbamide-LENS
    capsules inwards 
    VEROPHARM SA     Russia
  • Hydroxycarbamide-native
    capsules inwards 
    NATIVA, LLC     Russia
  • Hydroxyurea
    capsules inwards 
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    L.01.X.X.05   Hydroxycarbamide

    Pharmacodynamics:

    Urea derivative, S-phase-specific agent. Selectively inhibits ribonucleotide reductase, which leads to a disruption of DNA repair. Does not affect the synthesis of ribonucleic acids and proteins. Reduces the content of triphosphates in tumor cells, delays their growth in the state of interphase.

    Pharmacokinetics:

    After oral administration, an empty stomach is absorbed up to 80% in the gastrointestinal tract. The maximum concentration in the blood plasma is reached after 2 hours.

    Therapeutic effect develops 6 weeks after the beginning of the admission. Penetrates through the blood-brain and placental barrier, is found in breast milk. Partially exposed to metabolism in the liver and kidneys.

    The elimination half-life is 3-4 hours. Elimination mainly by the kidneys and in a small amount by light in the form of carbon dioxide.

    Indications:

    It is used for the treatment of osteomyelophybrosis, chronic myelogenous leukemia, erythremia, melanoma, essential thrombocytopenia. Used in cases of impossibility of radical treatment for malignant tumors of the head and neck. It is used in combination with radiotherapy for the treatment of cervical cancer.

    II.C43-C44.C43.9   Malignant melanoma of skin, unspecified

    II.C51-C58.C53   Malignant neoplasm of cervix

    II.C51-C58.C58   Malignant neoplasm of placenta

    II.C69-C72.C71   Malignant neoplasm of brain

    II.C69-C72.C72   Malignant neoplasm of the spinal cord, cranial nerves and other parts of the central nervous system

    II.C81-C96.C92.1   Chronic myeloid leukemia

    II.C81-C96.C94.0   Acute erythremia and erythroleukemia

    II.C76-C80.C76.0   Malignant neoplasm of head, face, neck

    II.D37-D48.D47.3   Essential (hemorrhagic) thrombocythemia

    II.C81-C96.C94.1   Chronic erythremia

    II.D37-D48.D45   Polycythemia true

    Contraindications:

    Hypoplastic anemia, individual intolerance, children under 18 years.

    Carefully:

    Viral, bacterial and fungal infections, renal and hepatic insufficiency, hypersensitivity.

    Pregnancy and lactation:

    Recommendations for FDA - category D. Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Inside, 20-30 mg / kg daily within 3 weeks. The treatment regimen is determined individually, depending on the pathology and tolerability of the drug.

    The highest daily dose: 2 g.

    The highest single dose: 30 mg / kg.

    Side effects:

    Central and peripheral nervous system: headache, dizziness, drowsiness; rarely - disorientation, convulsions, hallucinations.

    Hemopoietic system: thrombocytopenia, leukopenia, anemia.

    Respiratory system: pulmonary edema, pulmonary infiltrates.

    Digestive system: anorexia, nausea, vomiting, constipation, stomatitis, bleeding gums.

    Dermatological reactions: alopecia, itching, trophic ulcers, brittle nails.

    Urinary system: interstitial nephritis, hyperuricemia, dysuria.

    Reproductive system: violation of the menstrual cycle, azoospermia.

    Allergic reactions.

    Overdose:

    Increased side effects.

    Treatment is symptomatic. Effective hemodialysis.

    Interaction:

    Enhances the effects of other alkylating drugs and antimetabolites of pyrimidine and purine structures.

    Special instructions:

    Monitoring the composition of peripheral blood. With the development of thrombocytopenia (less than 100 · 109 / l) or severe leukopenia (less than 2.5 · 109 / L), the drug is canceled.

    Vaccination of patients and members of their families is contraindicated.

    In the treatment it is not recommended to drive vehicles and work with moving mechanisms.

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