FTORURACIL-TEVA

Active material: Ftoruracil
When ATH: L01BC02
CCF: Anticancer drug. Antimetaʙolit
When CSF: 22.02.03
Manufacturer: TEVA Pharmaceutical Industries Ltd. (Israel)

DOSAGE FORM, STRUCTURE AND PACKAGING

Solution for injection clear, colorless to slightly yellow, free of mechanical impurities.

Excipients: Sodium hydroxide, water d / and.

5 ml – bottles (1) – packs cardboard.

Solution for injection clear, colorless to slightly yellow, free of mechanical impurities.

Excipients: Sodium hydroxide, water d / and.

10 ml – bottles (1) – packs cardboard.

Pharmacological action

Group of antimetabolites antineoplastic. Is antimetabolitom uracil, competes with it for timidilatsintetazu, blocking DNA synthesis, raises education structurally imperfect RNA (by introducing in its synthesis), oppressing Division of tumor cells. A few hours later the concentration in tumor tissue above, than in healthy tissue.

Testimony

• cancer of the colon and rectum,
• mammary cancer,
• esophagus,
• stomach,
• pancreas,
• primary liver cancer,
• ovarian cancer,
• cervical cancer,
• Bladder,
• Malignant tumors of the head and neck,
• prostate cancer,
• Adrenal Cancer,
• cancer vulyvы,
• penile cancer,
• carcinoid,
• skin cancer (ointment)

Dosage regimen

Ftoruacil is a part of many schemes to cytostatic treatment, Therefore when choosing a route, regime and doses in each individual case data should guide literature.

Misleading in/in struino or drip, B / A (It is recommended that you use the appropriate infusion pump to ensure constant infusion rate), intracisternally.

B / drip, for any of the following schemes (the introduction is stopped when side effects appear – stomatitis, diarrhea, leukopenia or thrombocytopenia; resume after an increase in the number of leukocytes to 3-4 thousand / μl and platelets up to 80-100 thous. / ul): 1) 1 g/m2/day/drip constantly over 96-120 no; 2) 600 mg/sq ft/in 1 and 8 days of the course, in combination with other. PM.

When used in combination with calcium folinatom dose fluorouracil is usually reduced by 25-30%; 3) 500 mg/m2 or 12-13.5 mg/kg each day for 3-5 days, the interval between courses – 4 Sun; 4) 600 mg/m2 or 15 mg / kg (The highest single dose 1 g) 1 Once a week for 6-10 Sun.

When used in combination with calcium folinatom dose fluorouracil is usually reduced by 25-30%. In obese patients or patients with elevated body mass due to edema, ascites, etc. causes of fluid retention, it is recommended to estimate body mass without taking them into account (“dry” weight).

Side effect

From the digestive system: decreased appetite, nausea, vomiting, heartburn, taste disturbance, esophagitis, inflamed and ulcerated mucous membrane syndrome, ulcerative stomatitis, diarrhea, bleeding from the gastrointestinal tract, abnormal liver function.

From the CCC: myocardial ischemia (angina, LV failure, breathlessness), which can be observed for a few hours later the introduction; usually develops in the second or later posledstviiduûŝih introductions; myocardial infarction, thrombophlebitis at the injection site.

From the central nervous system: acute cerebellar syndrome (ataxia, nistagmo), headache, disorientation, confusion, euphoria.

From the side of hematopoiesis: leukopenia (usually via 9-14 days later each course; the lowest level is a 9-14, less often – 20 days; restored after about 30 days), neutropenia, anemia, thrombocytopenia.

From the senses: optic neuritis, lacrimation, sleznыh ducts stenosis, blurred vision, photophobia, Cataract, korkovaya blindness (at higher doses). Allergic reactions: skin rash, dermatitis, hives, photosensitivity, bronchospasm, anaphylactic shock.

For the skin: dermatomelasma, dry and cracked skin, hand-foot syndrome eritrodizestezii (tingling sensation in hands and feet with the advent of posledstviiduûŝim pain, hyperemia and swelling), alopecia, teleangiэktaziya, nail changes (incl. the destruction of).

Other: azoospermia, amenorrhea, hyperuricemia, pneumopathy (cough, breathlessness), epistaxis (nose bleed), weakness (usually occurs immediately afterwards introduction and kept for 12-36 no), development of secondary infections.

Contraindications

• gipervospriimčivost′,
• suppressing kostnomozgovy blood (white blood cell count less than 5 thous. / ul, platelets less 100 thous. / ul),
• pregnancy,
• lactation.

C care. Renal and / or hepatic insufficiency, acute infectious viral disease, fungal or bacterial origin (incl. tuberculosis, enable vetryanaya, shingles), bone marrow infiltration of tumor cells, previously carried out intense radiation or chemotherapy, kaxeksija.

Pregnancy and lactation

The reception of the product contraindicated.

Cautions

With the emergence of stomatitis or diarrhea treatment product must stop until these symptoms.

With the development of the syndrome, Palmar-Plantar èritrodizestezii appointment inside pyridoxine dose 100-150 mg / day.

During treatment should monitor the total number of leukocytes and platelets, determine the hematocrit and Hb, activity of AST, GOLD, LDH, bilirubin, inspect the oral cavity of the ill to detect ulcers (before each product introduction).

Patients with advanced lakopenia should be carefully observed for signs of infection.

Overdose

Data on overdose are not represented.

Drug Interactions

The efficacy and/or toxicity increase etc. antineoplastic HP (Interferon al′fa2a, cyclophosphamide, vynkrystyn, methotrexate, cisplatin, adriamycin), calcium folinate.

Radiation therapy – additive oppression bone marrow. When duty coupled with mitomycine c observed the emergence of haemolytic uraemic syndrome.

Together with the admission sorivudinom noted the expressed lakopenia, in some cases leading to death.

Fluorouracil not be used later, in conjunction with therapy aminofenazonom, fenilbutazonom and sul′fonamidom. Hlordiazeopoksid, disulьfiram, griseofulvin and isoniazid may increase the activity of fluorouracil.

In connection with the Suppression of natural protective mechanisms in the treatment of fluorouracil possible vaccine virus replication process intensification or reduction of the production of antibodies in response to the introduction of the vaccine in the vaccination of live or inactivated vaccines, Therefore, the interval between the end of the product application and vaccinating live or inactivated vaccines is from 3 to 12 Months.

Conditions and periodic store

At a temperature of 15-30° c.

Shelf life – 2 year.