Hydroxycarbamide capsules 500mg, No. 30

• Chronic myeloid leukemia,

• melanoma,

• ovarian cancer,

• cervical cancer,

• choriocarcinoma of the uterus,

• tumors of the head and neck,

• brain tumor,

• erythremia,

• essential thrombocythemia with the risk of thromboembolic complications.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Set individually, depending on the indications and stage of the disease, the state of the hematopoietic system, the scheme of anticancer therapy.

Active ingredient: hydroxycarbamide - 500 mg

Excipients: citric acid monohydrate - 25 mg, sodium hydrogen phosphate - 10 mg, calcium stearate - 3 mg, sodium lauryl sulfate - 3 mg, sodium citrate pentasesquihydrate - up to 600 mg capsule contents.

The composition of the hard gelatin capsule: gelatin - 95.3041 mg, titanium dioxide E171 - 0.6348 mg, quinoline yellow dye E-104 - 0.0601 mg, sunset yellow dye E-110 - 0.001 mg.

• Leukopenia less than 2500 / ?l,

• thrombocytopenia less than 100,000 / ?l,

• severe anemia,

• pregnancy,

• hypersensitivity to hydroxycarbamide.

Hard gelatin capsules No. 0, yellow; the contents of the capsules are white or white with a yellowish tinge powder; the presence of a compacted capsule mass in the form of a column or a tablet is allowed, which crumbles when pressed with a glass rod.

Clinical and pharmacological group: Antineoplastic drug

Pharmaco-therapeutic group: Antineoplastic agent, antimetabolite

pharmachologic effect

Antineoplastic agent. The proposed mechanism of action is to inhibit DNA synthesis. Does not affect protein and RNA synthesis.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Penetrates the BBB. It is metabolized in the liver. It is excreted mainly by the kidneys (80%). T1 / 2 - 3-4 hours

Indications

• Chronic myeloid leukemia,

• melanoma,

• ovarian cancer,

• cervical cancer,

• choriocarcinoma of the uterus,

• tumors of the head and neck,

• brain tumor,

• erythremia,

• essential thrombocythemia with the risk of thromboembolic complications.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Set individually, depending on the indications and stage of the disease, the state of the hematopoietic system, the scheme of anticancer therapy.

Side effect

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: stomatitis, anorexia, nausea, vomiting, diarrhea, constipation; rarely - liver dysfunction.

From the side of the central nervous system: a feeling of fatigue, headache, drowsiness, dizziness, hallucinations, convulsions.

From the respiratory system: in some cases - diffuse pulmonary infiltrates, accompanied by fever and shortness of breath.

From the urinary system: difficulty urinating; rarely - impaired renal function.

Dermatological reactions: alopecia, maculopapular rash, erythema.

Others: fever, chills.

Contraindications for use

• Leukopenia less than 2500 / ?l,

• thrombocytopenia less than 100,000 / ?l,

• severe anemia,

• pregnancy,

• hypersensitivity to hydroxycarbamide.

Application during pregnancy and lactation

Hydroxycarbamide is contraindicated in pregnancy. If necessary, use during lactation should stop breastfeeding.

Women of childbearing age receiving hydroxycarbamide therapy should use reliable contraceptive methods.

In experimental studies established teratogenic and embryotoxic action of hydroxyurea.

Application for impaired renal function

Care must be taken in patients with severe renal impairment.

Use in elderly patients

Elderly patients may require a dosage adjustment.

special instructions

Care must be taken in patients with severe renal impairment.

It is not recommended to use hydroxycarbamide in patients with chickenpox (including recently transferred or after contact with sick), herpes zoster and other acute infectious diseases.

Elderly patients may require a dosage adjustment.

When using hydroxycarbamide in patients with gout or nephrolithiasis, the risk of hyperuricemia increases.

The combination with radiation therapy can lead to increased side effects that are associated with myelodepression and damage to the gastric mucosa. Radiation-induced erythema may increase. Nausea, vomiting, anorexia caused by combined use with radiation therapy may disappear as a result of temporary withdrawal of hydroxycarbamide.

Before starting and during treatment, a complete blood picture should be determined, including an examination of the bone marrow, as well as kidney and liver function. Repeat the blood test at least 1 time / week. With a decrease in the number of leukocytes less than 2500 / ?l, and platelets less than 100,000 / ?l, treatment should be discontinued until the normal values ??of these indicators are restored. Changes in ESR are possible (more often an increase).

With the development of anemia, it should be treated without interrupting the course of hydroxycarbamide, with the help of substitute transfusions of erythrocyte mass.

Changes in biochemical parameters are possible: an increase in the concentration of urea, creatinine, uric acid in the blood, an increase in the activity of hepatic transaminases.

It is not recommended to vaccinate patients and their families.

Drug interactions

It is possible to increase myelodepression in the case of previous therapy with cytotoxic drugs.