Gidroksiurea

General characteristics. Structure:

Active agent: hydroxycarbamide of 500 mg
excipients: potato starch — 300 mg  
in banks on 100 pieces; in a package of PE of 1 bank.

Description of a dosage form: The solid gelatin capsule with a lime lid and a pink bottom containing white crystal powder.

Pharmacological properties:

The drug operating antimitotically. The estimated mechanism consists in braking of synthesis of DNA without influence on synthesis of RNA and protein. After intake the maximum concentration is found in plasma in 2 hours. Гидроксиуреа® it is quickly distributed on body tissues: in cerebrospinal fluid there are 10–20%, in ascitic liquid - 15–50% of concentration in plasma. The elimination half-life makes 3–4 hours, 80% are allocated with kidneys within 12 hours. In 24 hours in a blood plasma is not defined. It is applied at some malignant new growths. Yields also good results at treatment of psoriasis, allowing to limit or to completely stop use of corticosteroids.

Indications to use:

- chronic miyeloblastny leukosis;
- melanoma;
- ovarian cancer;
- uterus choriocarcinoma;
- tumor of the head and neck;
- acute miyeloblastny leukosis;
- an acute lymphoblastoid leukosis at children;
- osteomyelofibrosis;
- idiopathic thrombocytopenia;
- true erythremia.

Route of administration and doses:

Inside at cancer therapy of the head and neck, ovarian cancer, melanoma appoint with breaks according to the scheme: within 3 weeks each three days in a dose of 80 mg/kg of body weight (3200 mg/m ²), or daily on 800–1200 mg/m ² in days. At treatment of a myelosis use the scheme with daily reception: a daily dose - 20–30 mg/kg (to 1600 mg/m ²) at one time. At decrease in leukocytes lower than 20 000/mm ³ reduce a dose to 600 mg/m ², lower than 5000/mm ³ cancel drug. Doses are calculated on actual or on due weight depending on what of them is smaller. Aged patients can be more sensitive to a hydroxycarbamide.

The term during which it is possible to estimate efficiency of treatment, - 6 weeks.

If after 4 weeks of therapy the expressed progressing of a disease continues to be observed, treatment is stopped.

At sufficient efficiency treatment is carried out during unlimited time. An average maintenance dose - 0,5–2 g a day. Development of anemia does not demand interruption of a course of treatment on condition of performing adequate therapy.

Features of use:

• therapy should be carried out in the conditions of careful medical observation;
• the combination with radiation therapy can lead to strengthening of expressiveness of side effects (a marrow aplasia, dyspepsia and development of a canker of digestive tract);
• can strengthen the erythema caused by radiation;
• the nausea, vomiting and anorexia which are especially often found against the background of similar treatment as a result of temporary cancellation of a hydroxycarbamide can disappear;
• before and during treatment it is necessary to define a condition of a hemogenesis (clinical blood test, a marrow research), and also functions of a liver and kidneys;
• to repeat blood test at least 1 time a week. At decrease in number of leukocytes less than 2500/mm ³, and thrombocytes less than 100 000/mm ³, treatment should be stopped.

Side effects:

• leukopenia, thrombocytopenia, anemia;
• stomatitis, anorexia;
• nausea, vomiting, diarrhea, lock;
• development of ulcers in digestive tract;
• difficulty of an urination;
• alopecia;
• makulezno-papular rashes;
• erubescence of the person;
• feeling of fatigue, headache;
• drowsiness, dizziness;
• hallucinations, spasms;
• uraemia;
• giperkreatininemiya;
• hyperuricemia;
• increase in SOE;
• increase in activity of enzymes of a liver.

Seldom - a renal failure, a hyperthermia, a fever.

Interaction with other medicines:

At simultaneous use of drug with other myelosuppressive drugs or radiation therapy extent of suppression of functions of marrow or development of other side effects can increase.
 
Drug can increase the content of uric acid in blood therefore correction of a dose of the drugs increasing removal of uric acid from an organism can be required. Uricosuric means increase risk of development of a nsfropatiya.

Gidroksikarbamid weakens immune system of an organism therefore for receiving a desirable immune response purpose of vaccines is recommended in 3-12 months after the end of treatment.

Contraindications:

• hypersensitivity, a leukopenia is lower 2500-3000/mm ³, thrombocytopenia lower than 100 000/mm ³, the expressed anemia;
• it is applied with care at patients with the expressed liver and/or renal failure;
• at pregnancy and a lactation appoint only in the presence of vital indications. Feeding by a breast is not allowed.

Overdose:

At use of drug in the doses several times exceeding recommended at patients signs of acute dermatological toxicity develop: morbidity, a violet erythema, hypostasis with the subsequent peeling of palms of hands and feet of legs, an intensive generalized hyper xanthopathy and heavy acute stomatitis, and also can amplify also other side effects.
 
The specific antidote is unknown. Symptomatic treatment.

Storage conditions:

Period of validity of 5 years. List B.: In the dry place, at a temperature of 15-25 °C.

Issue conditions:

According to the recipe

Packaging:

Banks: 100 capsules on 500 mg.