Hydrea, 500 mg capsules, 20 pcs.

Pharmacodynamics

Antitumor agent. The presumed mechanism of action is inhibition of DNA synthesis. It has no effect on the synthesis of protein and RNA.

Pharmacokinetics

After oral administration it is well absorbed from the gastrointestinal tract. It penetrates through the HEB. It is metabolized in the liver. It is excreted mainly by the kidneys (80%). T_1/2 is 3-4 hours.

Indications

Active ingredient

Composition

1 capsule contains:

Active substances:

Hydroxycarbamide 500 mg.

How to take, the dosage

It is set individually, depending on the indication and stage of the disease, the state of the hematopoiesis system, the scheme of anti-tumor therapy.

Interaction

Myelodepression may worsen in case of previous therapy with cytotoxic drugs.

Special Instructions

Caution should be exercised in patients with significant renal dysfunction.

The use of hydroxycarbamide is not recommended in patients with varicella (including those who have recently had or have been exposed to chickenpox), herpes zoster and other acute infectious diseases.

The dosing regimen may need to be adjusted for elderly patients.

The use of hydroxycarbamide in patients with gout or nephrolithiasis increases the risk of hyperuricemia.

Combination with radiation therapy may lead to increased side effects that are associated with myelodepression and gastric mucosal damage. Erythema caused by radiation may worsen. Nausea, vomiting, and anorexia caused by combined use with radiation therapy may disappear as a result of temporary withdrawal of hydroxycarbamide.

Before and during treatment, a complete blood count should be performed, including bone marrow, and renal and hepatic function tests. Blood tests should be repeated at least once a week. If leukocyte count is lower than 2500/μL and platelet count is lower than 100,000/μL, the treatment should be stopped until normal values are restored. There may be changes in red blood cell count (often increasing).

If anemia develops, it should be treated without interrupting the course of hydroxycarbamide with replacement transfusions of red cell mass.

Possible changes in biochemical parameters: increased blood concentrations of urea, creatinine, uric acid, increased activity of hepatic transaminases.

Vaccination of patients and their families is not recommended.

Contraindications

Side effects

Blood system disorders: leukopenia, thrombocytopenia, anemia.

Digestive system disorders: stomatitis, anorexia, nausea, vomiting, diarrhea, constipation; rarely – liver function disorders.

CNS disorders: feeling of fatigue, headache, drowsiness, dizziness, hallucinations, seizures.

Respiratory system disorders: in some cases – diffuse pulmonary infiltrates accompanied by fever and shortness of breath.

Urinary system disorders: difficulty in urination; rarely – renal dysfunction.

Dermatological reactions: alopecia, maculopapular rash, erythema.

Others: fever and chills.

Overdose

Treatment is symptomatic because there is no specific antidote; not susceptible to dialysis.

Pregnancy use

Hydroxycarbamide is contraindicated in pregnancy. Breastfeeding should be stopped if it is necessary to use during lactation.

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

The teratogenic and embryotoxic effects of hydroxycarbamide have been established in experimental studies.