5-Fluorouracil-Ebeve, 50 mg/ml 20 ml

– colorectal and rectal cancer;

– breast cancer;

– esophageal cancer;

– stomach cancer;

– pancreatic cancer;

– primary liver cancer;

– ovarian cancer;

– cervical cancer;

– bladder cancer;

– malignant tumors of the head and neck;

– prostate cancer;

– adrenal cancer;

– penile cancer;

– carcinoid.

Active ingredient

Composition

Associates:

sodium hydroxide,

water d/i.

Interaction

Calcium folinate enhances the therapeutic and toxic effects of fluorouracil.

When used in combination with other cytostatics and interferon-alfa an increase in both antitumor effects and toxicity of fluorouracil may also be observed.

Hemolytic uremic syndrome has been observed with long-term co-administration with mitomycin C.

When concomitantly administered with sorivudine severe leukopenia was observed, in some cases leading to death.

Fluorouracil should not be used after and together with therapy with aminophenazone, phenylbutazone and sulfonamide.

Chlordiazopoxide, disulfiram, griseofulvin and isoniazid can increase the activity of fluorouracil.

Fluorouracil may decrease the immunological response to vaccination. Severe antigenic reactions may develop if administered concomitantly with live vaccine.

Directions for use

Fluorouracil is part of many chemotherapeutic treatment regimens; therefore, the data from specific literature should be used to guide the choice of route of administration, regimen and doses in each individual case.

The drug is administered by IV fluids or by slow infusion, intraarterially, intracavitary.

The following doses and regimens are recommended:

500 mg/m2 or 12-13.5 mg/kg daily for 3-5 days, 4 weeks interval between courses;

600 mg/m2 or 15 mg/kg (highest single dose of 1 g) once a week, 6-10 doses;

600 mg/m2 on days 1 and 8 v/v in combination with other cytostatics;

1 g/m2 /day by IV drip as a continuous infusion for 96-120 h;

When used in combination with calcium folinate, the dose of fluorouracil is usually reduced by 25-30%.

Special Instructions

Fluorouracil is a cytotoxic drug, so care should be taken when handling it.

If stomatitis or diarrhea occurs, treatment with the drug should be stopped until these symptoms disappear.

The initial dose should be reduced by 1/3 or 1/2 in the following cases: weight loss, postoperative period of at least 30 days after major surgery, insufficient bone marrow function, impaired liver or kidney function.

Caution should be used when prescribing in patients who have previously been exposed to high doses of radiation on the pelvic area or have received alkylating drugs.

When treating, the total number of leukocytes, the absolute number of neutrophils, platelets should be monitored; hematocrit, hemoglobin, liver function tests and bilirubin levels should be determined; the patient’s mouth should be examined for signs of stomatitis.

Men and women of childbearing age should use reliable contraceptive methods during treatment with fluorouracil and for at least 3 months after.

Impact on driving and operating ability

The side effects caused by taking fluorouracil may adversely affect driving.

Contraindications

– hypersensitivity to fluorouracil and/or any other component of the drug;

– pregnancy;

– breast-feeding;

– Severe leukopenia, neutropenia, thrombocytopenia;

– stomatitis;

– gastrointestinal mucosal ulceration;

– pseudomembranous enterocolitis.

With caution: renal and/or hepatic failure; acute infectious diseases of viral, fungal or bacterial nature (including tuberculosis, varicella, shingles); bone marrow infiltration with tumor cells; previous radiation therapy or chemotherapy.

Side effects

Blood organs: leukopenia, neutropenia, rarely – thrombocytopenia, anemia. The most significant drop in the number of leukocytes is usually observed from day 9 to 14 (up to day 25), platelets – from day 7 to 17 of treatment.

Digestive system disorders: decreased appetite, nausea, vomiting, inflammation and or ulceration of gastrointestinal mucosa (including stomatitis), diarrhea, gastrointestinal bleeding, heartburn and change of taste, liver function disorders.

Cardiovascular system disorders: very rarely – heart pain, arrhythmia, ischemia, myocardial infarction, angina pectoris, heart failure.

Nervous system disorders: rarely – cerebellar ataxia, sensory disorders, disorientation, confusion, euphoria, nystagmus, retrobulbar neuritis, headache.

Sense organs: eye mucosa irritation, excessive tearing due to duct stenosis (10-25%), photophobia, cataract, cortical blindness (in high doses), vision disorders.

Reproductive system disorders: reversible suppression of gland function leading to amenorrhea or azoospermia.

Skin and skin appendages: alopecia (rare), hyperpigmentation of skin, dry and cracked skin, telangiectasia, palmar and plantar erythrodysesthesia syndrome (tingling sensation in hands and feet followed by pain, hyperemia and swelling), changes and falling of nail plates (rare), photosensitization.

Allergic reactions: skin rash, dermatitis, urticaria, skin hyperemia of the palms and soles, bronchospasm, anaphylaxis (rare).

Others: fever (rare), thrombophlebitis at the injection site, nasal bleeding, cough, shortness of breath, hyperuricemia, weakness, development of secondary infections.

Overdose

Symptoms: nausea, vomiting, diarrhea, ulcerative stomatitis and gastric bleeding, suppression of bone marrow function (thrombocytopenia, leukopenia and agranulocytosis).

In case of overdose the patients’ hematopoietic function should be monitored for at least 4 weeks, in case of occurrence of disorders symptomatic therapy is carried out. A specific antidote to fluorouracil is not known.

Pregnancy use