Gidroksikarʙamid

When ATH:
L01XX05

Characteristic.

Antimetaʙolit, urea derivative, It refers to the group of hydroxylamines. The white crystalline powder, virtually devoid of taste. Molecular weight 76,05.

Pharmacological action.
Antitumor.

Application.

Chronic myelogenous leukemia, osteomyelofibrosis, erythremia, melanoma, brain tumor, heads (except lip) and neck with the impossibility of radical surgery or radiotherapy; cervical cancer (to enhance the effectiveness of radiation therapy).

Contraindications.

Hypersensitivity, acute renal or hepatic failure, thrombocytopenia (меньше 100·10⁹/l), severe leukopenia (меньше 2,5·10⁹/l), profound anemia, Viral (enable vetryanaya, shingles) and other infections.

Pregnancy and breast-feeding.

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects.

From the nervous system and sensory organs: seldom - a headache, dizziness, fatigue, drowsiness, convulsions, disorientation, hallucinations.

Cardio-vascular system and blood: часто — миелосупрессия (anemia, leukopenia, usually asymptomatic; менее часто — с повышением температуры тела; increased erythrocyte sedimentation rate; seldom-B19.

From the respiratory system: pulmonary edema, pulmonary infiltrates.

From the digestive tract: rarely is the disease, anorexia, dyspepsia, ulceration of the gastrointestinal mucosa, increase in liver enzymes.

With the genitourinary system: interstitial nephritis, uremia, hyperuricemia, painful or difficult urination, Impairment of Fertility (azoospermia, ischomenia).

For the skin: maculo-papular rash, itch, facial flushing, hair loss, sores, dermatomelasma, exacerbation of post-radiation erythema, brittle nails.

Other: fever.

Cooperation.

Against the background of uricosuric agents increase the risk of nephropathy. Preparations, causing blood dyscrasias, enhance leukopenia and / or thrombocytopenia, if these drugs have the same effect, as hydroxyurea, in leukocytes and platelets. Other drugs, causing depression of bone marrow function, or potentiate the effect of radiation therapy and additive depress bone marrow function. With the introduction of live virus vaccines may be increased side effects or decreased antibody production; inactivated vaccines - reduction of production of antiviral antibodies.

Overdose.

Symptoms: at higher doses (higher, than 60 mg / kg / day) may increase adverse effects, incl. with severely impaired bone marrow function.

Treatment: symptomatic, preventive anti-infective therapy, transfusion of blood components by indications.

Dosing and Administration.

Inside, if necessary (the impossibility of swallowing capsules) pour the contents of the capsule into a glass of water and immediately take. Used as monotherapy (паллиативная химиотерапия III–IV линии), or in combination with other cytotoxic drugs or radiotherapy. In monotherapy (incl. with the aim of radiosensitization): 20–30 мг/кг ежедневно в течение 3 Sun, суточная доза — 2000 mg; or 80 mg / kg 1 once every 3 day (6-7 Doses). If the 4 weeks of therapy continues to be observed pronounced disease progression, treatment should be stopped. For radiosensibilization recommended the drug for 7 days before the radiotherapy.

When the efficiency of the treatment is sufficient for an unlimited time. Средняя поддерживающая доза — 500–2000 мг. Anemia does not require interruption of treatment with adequate therapy.

При дерматологических заболеваниях средняя доза — 1–2 г в день, разовая доза — 500 mg every 6 no (pustular psoriasis) or once (ordinary psoriasis) 7-10 days, then break 4 day.

Precautions.

Use of hydroxyurea is conducted under strict medical supervision.

Be wary appoint elderly and children (It requires a reduction in dosage), patients, which were previously radiation or chemotherapy, patients with tumors of the kidney, in renal and liver failure. Before treatment is a deep correction of anemia (transfusion of whole blood preparations). Before and during treatment (at least 1 times a week) requires regular blood tests; при уменьшении числа лейкоцитов ниже 2,5·10⁹/л и тромбоцитов ниже 100·10⁹/l course of treatment is interrupted until a clear trend towards normalization of hematologic parameters. It is also recommended the dynamic control of the levels of uric acid, creatinine, transaminases; при снижении Cl креатинина менее 10 мл/мин дозу уменьшают в 2 times.

Dental procedures should be completed before the start of therapy or deferred until the normalization of the blood picture (may increase the risk of microbial infection, slowing the healing process, krovotochivosty right). During treatment caution when using toothbrushes, threads or toothpicks.

During treatment is not recommended vaccination virus vaccines, Avoid contact with people, received the vaccine against polio, patients with bacterial infections. Use live virus vaccine in patients with leukemia in remission should not be at least 3 months after the last cycle of chemotherapy. Immunization of oral polio vaccine people, It is in close contact with the patient, especially family members, should be postponed.

The appearance of signs of depression of bone marrow function, unusual bleeding or hemorrhage, black tarry stools, blood in the urine or feces or point of red spots on the skin require immediate doctor's advice.

Use caution to avoid accidental cuts with sharp objects (safety razor, scissors), Avoid contact sports or other situations, which are likely to hemorrhage or trauma.

During treatment, it is important enough fluid intake and urine output for subsequent amplification providing uricosuric.

Exercise caution in combination therapy; each product must be taken in due time.

In the absence of the patient's clinical response through 6 weeks of treatment, use of the drug should be discontinued; in the case of the effectiveness of the drug therapy can be continued indefinitely.

In patients who develop as a result of hydroxyurea thrombocytopenia recommended special precautions (limit frequency venipuncture, the rejection of the / m injection, Regular inspection of places on / in the preparations, skin and mucous membranes, refusal of the use of acetylsalicylic acid, etc.).

During treatment is not recommended to drive the vehicle and perform the work, associated with high concentration of attention.

A combination with radiation therapy may lead to increased severity of side effects (bone marrow aplasia, dyspepsia and development of ulcerative lesions GIT).

During treatment is recommended to use contraception.

Cautions.

Patients who develop leukopenia should be carefully monitored for signs of infection, при необходимости — назначать антибиотики. Neutropenic patients with an increase in body temperature of broad-spectrum antibiotics prescribed empirically until the results of bacteriological examinations and related diagnostic tests.

Cooperation