• Code CAS
Most popular brand: Hydrea
Active ingredient: Hydroxyurea
Available dosage forms: 500 mg
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Hydroxyurea general information
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Permanent liver damage may happen. It is rather painful and can lead to damage to this tissue causing impotence. In some instances, the final stage can result in respiratory failure because of excessive scarring and maybe even lung cancer. There are only two forms of polycythemia vera that could affect a patient.
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Hydroxycarbamide (Hydroxycarbamide): instruction, and the use of a formula
The nosological classification (ICD – 10)
Feature substance Hydroxycarbamide
antimetabolite, a urea derivative, refers to the hydroxylamine group. The white crystalline powder, practically devoid of taste. The molecular weight of 76,05.
Mode of action – antitumor.
Is the S – fazospetsifichnym means inhibits ribonucleotide reductase, quickly disrupting DNA synthesis. without affecting the synthesis of RNA and protein, leading to the cytotoxic effect. It inhibits the activity of polymerases, resulting in impaired DNA repair process after a potentially lethal damage by radiation or chemical agents. This mechanism of action of hydroxycarbamide can use it as a radiosensitizer.
An adequate period for evaluating the anti-tumor effectiveness of hydroxyurea is considered to be 6 weeks of therapy. The presence of the effect suggests a reduction in tumor size or cessation of tumor growth.
significantly increases the effectiveness of radiation therapy in brain tumors, cervical cancer.
Can be used in the treatment of psoriasis (primarily pustular form) disease Sneddon ; Wilkinson, gangrenous pyoderma, erythrodermic psoriasis, sickle – cell anemia.
In the various test – systems identified genetic toxicity of hydroxyurea. The incidence of secondary leukemia were observed in patients receiving the drug for a long time in the treatment of myeloproliferative disorders (polycythemia vera, thrombocythemia).
In animal studies revealed teratogenic and carcinogenic effects; effect on fertility; shown that hydroxyurea passes through the placenta and has embryotoxic action. However, adequate and well-controlled studies in pregnant women have been conducted. In the experiments, in vitro hydroxycarbamide mutagenic effect on bacterial cells, fungi, protozoa and mammals; clastogenicity hydroxycarbamide confirmed in experiments in vitro (on the cells of hamsters and lymphoblasts person) and in vivo (exchange test of sister chromatids in rodent micronucleus test in mice).
Once inside well absorbed from the gastrointestinal tract and immediately penetrates the tissues, not accumulates in the body. The cerebrospinal fluid is 10 – 20%, ascites ; 15 – 50% of plasma concentrations. Bioavailability averages (108 & plusmn; 36)%. It passes through the BBB. C max is achieved in 2 hours after administration and is an average of 22,9 – 65,6 mg / l. After 24 hours the plasma levels close to zero. T 1/2 ; 3 –. 4 h partly metabolized in the liver and kidneys. Distinguished mainly by the kidneys (with oral or on / in a 7 to 30 mg / kg 80% of the dose excreted in the urine within 12 hours), 50% unchanged and in small amounts in the form of urea. Displays also the airways in the form of carbon dioxide.
Treated elimination during dialysis.
Application of the substance Hydroxycarbamide
Chronic myelogenous leukemia, osteomyelofibrosis, erythremia, essential thrombocythemia, melanoma; malignant tumors of the head and neck (excluding lip cancer) it is impossible radical surgery or radiation therapy; cervical cancer (in combination with radiation therapy).
Hypersensitivity, thrombocytopenia (less than 100 · 10 9 / L), severe leukopenia (less than 2,5 · 10 9 / L), pregnancy, breastfeeding.
Restrictions on the use
The renal and / or hepatic impairment; anemia (must be removed before starting the treatment); viral (including chicken pox, herpes zoster), fungal and bacterial infections.
Application of pregnancy and breastfeeding
Category effects on the fetus by FDA ; D.
is contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Side effects of substance Hydroxycarbamide
From the nervous system and sensory organs: headache, dizziness, fatigue, drowsiness, convulsions, disorientation; rare ; seizures, hallucinations.
From the cardio – vascular system and blood: leukopenia, anemia, thrombocytopenia.
From the respiratory system: pulmonary edema, pulmonary infiltrates.
From the digestive tract: stomatitis, bleeding gums, anorexia, nausea, vomiting, diarrhea / constipation, ulceration of the gastrointestinal mucosa. increased activity of liver enzymes.
With the genitourinary system: interstitial nephritis, uremia, hyperuricemia, painful or difficult urination, impairment of fertility (azoospermia, cessation of menstruation).
For the skin: maculo – papular rash, itching, redness of the skin, hair loss, sores, skin hyperpigmentation, exacerbation of post-radiation erythema, brittle nails.
Other: fever, chills, malaise, increased erythrocyte sedimentation rate.
On the background of uricosuric agents increase the risk of developing nephropathy. Drugs that cause pathological changes in the blood, increase leukopenia and / or thrombocytopenia, if these drugs have the same effect as hydroxycarbamide in leukocytes and platelets. Other drugs that cause 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 ; decrease in production of antiviral antibodies.
Increase in toxicity while the use of antiretroviral drugs
Pancreatitis in patients with HIV -. Infection during therapy with hydroxyurea and ddI with / without stavudine were cases of fatal and nonfatal pancreatitis. If patients with HIV – infection used hydroxyurea in combination with didanosine and / or stavudine, close monitoring is recommended for early detection of symptoms of pancreatitis. If signs of pancreatitis hydroxyurea therapy should be discontinued.
Hepatotoxicity During postmarketing surveillance in patients with HIV -. Infection treated with hydroxyurea and other antiretroviral medicines. Cases of hepatic failure have been reported, leading to death. Most of these cases were associated with the treatment combination of hydroxyurea, didanosine and stavudine. Applications of this combination should be avoided.
Peripheral neuropathy. There are reports of peripheral neuropathy, which in some cases was severe, in patients with HIV. treated with hydroxyurea in combination with antiretroviral agents, including ddI with / without stavudine.
Symptoms: in the appointment of high doses (greater than 60 mg / kg / day) may increase adverse effects, including with severely impaired bone marrow function.
Treatment: symptomatic, preventive anti-infective therapy, transfusion of blood components indicated. A specific antidote is not known.
Dosing and Administration
Inside, , if necessary (the impossibility of swallowing capsules) capsule contents are poured into a glass of water and taken immediately. Used as a single agent (palliative chemotherapy III – IV line), or in combination with other cytotoxic drugs or radiotherapy. Dosage is determined individually. In monotherapy (including the purpose radiosensitization): 20 – 30 mg / kg daily for 3 weeks. daily dose of ; 2000 mg; or 80 mg / kg, 1 to 3 times of the day (6 – 7 doses). If, after 4 weeks of therapy continues to be observed a pronounced progression of the disease, treatment should be stopped. For radiosensibilization recommended taking the drug in the last 7 days prior to radiation therapy.
When a sufficient effectiveness of the treatment is administered for an unlimited time. The average maintenance dose ; 500 – 2000 mg. Development of anemia does not require interruption of treatment course provided adequate therapy.
Precautions substance Hydroxycarbamide
The use of hydroxyurea is conducted under strict medical supervision.
Be wary appoint elderly and children (requires a reduction in dose) in patients who have previously held radiation or chemotherapy, patients with tumors of the kidney, renal and liver failure. Before treatment is a deep correction of anemia (a transfusion of whole blood preparations). Before and during treatment (at least 1 time per week) requires regular blood tests; with a decrease in white blood cell counts below 2,5 · 10 9 / L and platelet count below 100 · 10 9 / L treatment is interrupted until a clear trend towards normalization of hematological parameters. It is also recommended dynamic control over the level of uric acid, creatinine, transaminases; while reducing Cl creatinine less than 10 ml / min, the dose is reduced to 2 times.
Dental procedures should be completed before the start of therapy or to defer to the normalization of the blood picture (possibly increasing the risk of microbial infections, slow healing process, bleeding gums). In the course of treatment to be careful when using the toothbrush filaments or toothpicks.
In the period of treatment is not recommended vaccination viral vaccines, should avoid contact with people who have received the polio vaccine, patients with bacterial infections. Apply live virus vaccine in patients with leukemia in remission should not be at least 3 months after the last course of chemotherapy. Immunization of oral polio vaccine people who are 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 bleeding, black tarry stools, blood in the urine or feces point, or red spots on the skin requires immediate medical advice.
Be careful to avoid accidental cuts with sharp objects (safety razor, scissors), Avoid contact sports or other situations that may hemorrhage or injury.
In the course of treatment it is important to the consumption of adequate amounts of fluid and the subsequent increase in urine output to ensure the elimination of uric acid.
Be careful when combination therapy; you need to take each medication at the scheduled time.
In the absence of the patient’s clinical response after 6 weeks of treatment, the use of the drug should be discontinued; in the case of the effectiveness of the drug therapy can be continued indefinitely.
Patients who develop leukopenia should be carefully monitored for signs of infection if necessary ; prescribe antibiotics. Patients with neutropenia with fever broad spectrum antibiotics prescribed empirically before the results of bacteriological examinations and related diagnostic tests.
In patients who develop as a result of the use of hydroxyurea thrombocytopenia recommended to take special precautions (frequency limit venipuncture, the rejection of the / m injection, regular inspection of places on / in the preparations, skin and mucous membranes, the rejection of the use of acetylsalicylic acid, etc. .d.).
During the 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 gastrointestinal ulcerative lesion development).
In the period of treatment to the use of contraceptives.