Description
Release form
Capsules.
Packing
100 pcs.
Indications
Chronic myelogenous leukemia
true polycythemia (erythremia)
essential thrombocythemia
osteomyelofibrosis
melanoma
malignant tumors of the head and neck with cancer, except for cancer, with cancer
Contraindications
Hypersensitivity to hydroxycarbamide or any other excipient that is part of the
preparation pregnancy and lactation period
leukopenia below 2500 / μl, thrombocytopenia below 100000 / μl.
Caution: hepatic and / or renal failure, anemia (should be corrected before starting treatment).
Use during pregnancy and lactation
Contraindicated in pregnancy and during breastfeeding.
Composition
1 capsule contains:
Active substances: hydroxycarbamide 500 mg.
Excipients: lactose, calcium citrate, sodium citrate, magnesium stearate.
Shell composition: gelatin, titanium dioxide.
Dosage and administration
When choosing a regimen and doses in each individual case, one should be guided by the data of the specialized literature.
The drug is administered orally.
If it is difficult to swallow, the capsule can be opened, Dissolve the contents in a glass of water and drink the whole. However, some water-insoluble excipients may float on the surface of the solution.
During treatment with the drug, a sufficiently large amount of liquid should be taken.
Solid tumors
80 mg / kg once a day every three days (6-7 doses).
20-30 mg / kg daily for 3 weeks.
Head and neck carcinoma, cervical carcinoma
80 mg / kg once daily, every third day in combination with radiation therapy.
Treatment with the drug is started at least 7 days before the start of radiation therapy and continued during radiation therapy. After radiation therapy, the drug continues to be taken for an unlimited time with strict monitoring of the patient and in the absence of unusual or severe toxicity reactions.
Resistant chronic myeloid leukemia
Continuous therapy. From 20 to 30 mg / kg daily once a day.
Evaluation of the effectiveness of the drug is carried out after 6 weeks of treatment. With severe clinical remission, treatment can be continued indefinitely. Treatment should be suspended if the white blood cell count is less than 2500 / mm3 and the platelet count is less than 100000 / mm3. After 3 days, a blood test is repeated. Treatment is resumed when the content of white blood cells and red blood cells begins to increase markedly.
True polycythemia
Treatment begins with a daily dose of 15-20 mg / kg. The dose is set individually, trying to maintain the hematocrit at a level below 45%, and the platelet count is below 400,000 / μl. In most patients, these indicators can be achieved by constantly using hydroxycarbamide in a daily dose of 500 to 1000 mg.
Essential thrombocythemia
Typically, a drug is prescribed at an initial daily dose of 15 mg / kg, then a dose is selected that maintains the platelet count below 600,000 / μl, without leading to a decrease in white blood cell count below 4000 / μl.
Side effects
From the hemopoietic organs: leukopenia, anemia, thrombocytopenia.
From the digestive system: stomatitis, anorexia, nausea, vomiting, diarrhea or constipation, ulceration of the mucous membrane of the gastrointestinal tract. Increased activity of liver enzymes.
On the part of the skin and skin appendages: maculopapular rashes, erythema of the face and peripheral erythema, dermatomyositis changes in the skin. In some cases, as a result of daily use of the drug for several years, patients had hyperpigmentation, erythema, atrophy of the skin and nails, peeling, and purple papules. In rare cases, alopecia, skin cancer is noted.
From the nervous system: headache, dizziness, fatigue, drowsiness, disorientation rarely – hallucinations and cramps.
From the urinary system: increased levels of uric acid, blood urea nitrogen and creatinine in blood plasma, urinary retention, interstitial nephritis. In rare cases, dysuria is noted.
Other: chills, general malaise, increased ESR, allergic skin reactions. In rare cases, acute pulmonary reactions associated with the use of the drug, diffuse pulmonary infiltration, fever and shortness of breath have been reported.
Drug Interaction
When co-administered with other myelosuppressive drugs or radiation therapy, the degree of bone marrow function suppression or the development of other side effects may increase.
The drug may increase the content of uric acid in the blood, so it may be necessary to adjust the dose of drugs that increase the excretion of uric acid from the body. Uricosuric agents increase the risk of nephropathy.
Overdose
When using the drug in doses several times higher than the recommended, patients develop symptoms of acute dermatological toxicity: soreness, purple erythema, edema with subsequent peeling of the palms of the hands and feet feet, intensi. The specific antidote is unknown. Treatment is symptomatic.
Storage conditions
Store under normal conditions.
Keep out of the reach of children.
Expiration
4 years.
Deystvuyuschee substances
Hydroksykarbamyd
dosage form
dosage The shape of the capsule
Medak GmbH, Germany
