24 September

Hydrea - instructions for use , indications, dosage

Hydrea - anticancer drug.

Product form and composition

Hydrea is produced in the form of capsules: gelatin solid, opaque, size №0, with an inscription in black «BMS 303" housing - matte, pale pink cap - matt, green;contents of capsules - a white powder or compacted mass (100 pieces in dark glass bottles, 1 bottle in a cardboard package, 10 pieces in blister, 2 blisters in a carton box..).

The structure of the capsule 1 includes:

  • Active substance: hydroxyurea - 500 mg;
  • Auxiliary components: lactose monohydrate - 42.2 mg Citric Acid - 12.8 mg magnesium stearate - 9 mg, sodium hydrogen phosphate - 36 mg.

capsule shell composition: Titanium dioxide - 2,016 mg gelatine - 93.743 mg Iron oxide yellow dye - 0.110 mg iron oxide red dye - 0,115 mg, indigo dye FD & amp;C Blue 2 - 0,017 mg.

ink composition: iron oxide black, shellac, propylene glycol, N-butyl alcohol, isopropyl alcohol, industrial methylated spirit, purified water.

Indications

  • Malignant tumors of the head and neck, except f
    or lip cancer (along with radiation therapy);
  • polycythemia vera (erythremia);
  • Chronic myelogenous leukemia;
  • osteomyelofibrosis;
  • Essential thrombocythemia;
  • Cervical cancer (along with radiation therapy);
  • Melanoma.

Contraindications Absolute:

  • Thrombocytopenia below 100,000 / uL, leukopenia below 2500 cells / mm;
  • Pregnancy and lactation;
  • Children's age (efficacy and safety of Hydrea for patients in this age group have not been established);
  • hypersensitivity to the drug.

Relative (Hydrea prescribed with caution in the presence of the following diseases / conditions):

  • Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
  • Severe anemia (must be compensated before the start of therapy);
  • renal and / or hepatic impairment;
  • condition after undergoing chemotherapy or radiotherapy (due to the probability of acute radiation erythema, myelosuppression development).

Dosage and Administration

Hydrea is taken orally.When swallowing difficulties may be available to open the capsule, pour the contents into a glass of water and drink immediately.Thus some of the insoluble auxiliary components may remain on the surface of the solution.

Dosage doctor determines individually, based on technical literature data.

During therapy need to take the liquid in sufficiently large quantities.

Depending on the indication, Hydrea is usually prescribed as follows:

  • Resistant CML: 1 times a day for 20-30 mg / kg daily (continuous therapy).Evaluation of the effectiveness of Hydrea should be carried out after 1.5 months of treatment.If there is an acceptable clinical response, treatment can be performed for an unlimited time.Treatment is suspended if the white blood cell count is less than 2500 / mm3 or platelets - less than 100,000 / mm3.After 3 days the blood test is conducted repeatedly.Therapy can be resumed after the increase in the number of red blood cells and white blood cells to acceptable.Recovery typically is rapid enough to otherwise while applying Hydrea with radiotherapy, the latter can also be suspended.Anemia, even hard to interrupt the course of treatment usually does not, subject to adequate therapy (transfusion of packed red blood cells);
  • polycythemia vera: use Hydrea begin with 15-20 mg / kg per day.The dose is determined individually, it is desirable to maintain the number of platelets - less than 400,000 / L, hematocrit - at a level below 45%.In most cases it is possible to use a constant hydroxycarbamide in a daily dose 500-1000 mg;
  • Essential thrombocythemia: Hydrea administered in an initial dose of 15 mg / kg per day.Thereafter, the dosage is selected so as to maintain the platelet count at a level below 600,000 / microliter, without leading to a decrease in the number of counts below 4000 / mm.When solid tumors and melanoma performed discontinuously (1 time per day to 80 mg / kg every three days; 6-7 doses) or continuous (every day for three weeks at 20-30 mg / kg 1 time a day) therapy;
  • cervix carcinoma, head and neck carcinoma, 1 times a day to 80 mg / kg every three days in combination with radiation therapy.Hydrea appoint not less than 7 days before the start of radiation therapy and do not interrupt taking the drug during the entire course.In the absence of the patient's severe or unusual toxicity after radiotherapy use of the drug should continue indefinitely under strict medical supervision.

In patients with impaired hepatic function should be carried out careful monitoring of blood parameters.Data on the need to change the dose in this group of patients there.

the appointment of Hydrea in patients with impaired renal function should be carried out correction dose.If creatinine clearance up to 60 ml per minute to a drug usually administered in a dose of 15 mg / kg.Patients with end-stage renal failure Hydrea should be used at the same dose twice, with an interval of 7 days: the first time - at the end of the four-hour hemodialysis session, the second - before the hemodialysis session.

Older patients are encouraged to nominate a drug in doses not exceeding 60 mg / kg per day.

Side effects

  • Nervous system: with unknown frequency - drowsiness, dizziness, disorientation, headache, seizures, hallucinations, peripheral neuropathy (HIV-infected patients, while receiving antiretroviral therapy, such as stavudine and didanosine), fatigue;
  • urinary system: with unknown frequency - interstitial nephritis, urinary retention, increased levels of uric acid in the blood serum urea nitrogen and creatinine in the blood plasma;rarely - dysuria;
  • Respiratory system: with unknown frequency - diffuse infiltration of the lungs, pulmonary fibrosis, shortness of breath;
  • skin and skin appendages: unknown frequency - cutaneous vasculitis, makulezno-papular rash, ulcers on the skin, peripheral erythema, and facial erythema, dermatomiozitopodobnye changes and skin exfoliation, erythema, hyperpigmentation, scaling, papules purple, atrophy of skin and nails,toxic skin vasculitis (including gangrene and ulceration, vasculitis);rarely - skin cancer, alopecia;
  • Ingestion: unknown frequency - hepatotoxicity, pancreatitis (in some cases with fatal outcome) (in HIV-infected patients, while receiving antiretroviral therapy, such as stavudine and didanosine), dyspepsia, stomatitis, diarrhea, anorexia, vomiting, nauseaconstipation, mucositis, ulceration of the mucosa of the gastrointestinal tract, irritation of gastric mucosa, increasing the concentration of bilirubin in plasma and liver enzymes;
  • Agencies blood: with unknown frequency - myelosuppression (anemia, leukopenia, thrombocytopenia);
  • infection: unknown frequency - gangrene;
  • Other: with unknown frequency - asthenia, allergic skin reactions, chills, malaise, fever, increased erythrocyte sedimentation rate (ESR);rarely - dyspnea, diffuse infiltration of the lungs.

Cases of hepatotoxicity and pancreatitis (with possible fatal outcome), and severe peripheral neuropathy observed in patients with HIV who were taking Hydrea simultaneously with antiretroviral drugs, in particular, together with didanosine or stavudine without him.

most private violations observed in the combined use Hydrea and radiation therapy are the same as for monotherapy - suppression of bone marrow function (anemia, leukopenia) and irritation of the gastric mucosa.Additionally, hydroxycarbamide reception can lead to an enhancement of certain side effects commonly seen when radiation therapy (mucositis, stomach discomfort).

Cautions

Hydrea may be used only under the supervision of a physician who has experience in anticancer therapy.

Before the start of each course and periodically during therapy need to control the function of bone marrow, liver and kidney.Determination of white blood cells, platelets and hemoglobin should be carried out at least 1 time in 7 days, throughout the period of use of Hydrea.The therapy is prescribed only in cases where the white blood cell count above 2500 / mm, and platelets - 100,000 / microliter.By reducing the level of their therapy discontinued prior to normalization.

should compensate Prior to treatment in severe anemia.

When using Hydrea may develop myelosuppression, most often - leukopenia.Anemia and thrombocytopenia develop less frequently and in very rare cases - without prior leukopenia.The most likely development of myelosuppression in patients after recent chemotherapy other medications or radiation therapy.

Following the recent time, radiation or chemotherapy Hydrea should be used with caution because of the probability of acute post-irradiation erythema and increase the severity of side effects (ulceration of the gastrointestinal tract, dyspepsia, bone marrow aplasia).With the development of severe violations of the digestive organs, such as nausea, vomiting, anorexia, treatment is usually suspended.

When the pain and discomfort with local anesthetics and analgesics for oral mucositis occurs in the field of radiation are usually prescribed.In severe cases, treatment temporarily suspended, with very severe temporarily cancel concomitant radiotherapy.

Hydrea may delay plasma iron clearance and reduce the rate of iron utilization by erythrocytes, but it does not affect the red blood cells during life.

In the early stages of application Hydrea is often observed moderate megaloblastic erythropoiesis.Morphological changes are generally resemble pernicious anemia, but they are not associated with deficiency of folic acid or vitamin B12.Due to the fact that macrocytosis may mask a lack of folic acid, it is necessary to consider its preventive appointment the patient.

Against myeloproliferative disorders during use Hydrea observed toxic dermal vasculitis, including gangrene and ulceration of the vasculitis.The most common reported toxic vasculitis in patients treated in the past or currently receiving interferon.Taking the drug with the progression of vasculitic ulcerations should be stopped.

Prolonged use of Hydrea in patients with myeloproliferative diseases, such as polycythemia vera and thrombocythemia, secondary leukemia cases were observed.The reason for the development of secondary leukemia (receiving hydroxyurea or underlying disease) is unknown.Also, prolonged therapy may lead to the development of skin cancer, so at the time of treatment is recommended to protect the skin from sunlight and systematically self-control of its condition.When planning visits to the doctor should monitor the patient's skin covers for possible malignant change.

Since Hydrea has a cytotoxic effect at the opening of the capsules need to be careful and avoid inhalation or contact with the drug powder to the mucous membranes and skin.

Hydrea can lead to dizziness and other adverse events in the nervous system that need to be considered when managing road.

Drug Interactions

With simultaneous use of Hydrea with some drugs may cause the following effects:

  • other myelosuppressive drugs or radiation therapy: an increase in the degree of suppression of bone marrow function or the risk of other side effects;
  • Cytarabine: increase in its cytotoxic effect;
  • uricosuric agents: increased risk of developing nephropathy.

If, during the combined treatment occurs severe indigestion, nausea, anorexia, or vomiting, they can usually be cut short interruption receiving Hydrea.

Mucositis (discomfort and soreness of the mucous membranes at the site of exposure) can facilitate local anesthetic and analgesic drugs (oral).In severe mucositis use Hydrea is temporarily interrupted;in very severe cases - suspended radiotherapy.

drug can increase the content of uric acid in blood serum, which may require adjusting the dose of drugs that increase the excretion of uric acid.

The interaction of enzymes and hydroxycarbamide (uricase, urease, LDH) during use Hydrea sightings false positive test results were noted when determining uric acid, urea and lactic acid.

Terms and conditions of storage

Store protected from light, out of reach of children at a temperature of 15-25 ° C.

Shelf life - 5 years.

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