Fluorouracil-LENS, 50 mg/ml 5 ml 10 pcs

Fluorouracil is an antimetabolite of uracil.

The mechanism of action is due to the conversion of the drug in the tissues into the active metabolite fluoruridinmonophosphate, which is a competitive inhibitor of the enzyme thymidylate synthetase, taking part in the synthesis of nucleic acids.

Fluorouracil disrupts DNA synthesis and causes formation of structurally imperfect RNA, inhibiting tumor cell division. Active metabolites are localized inside the cell

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Indications

Active ingredient

Composition

1 ml of the solution contains:

Active substance:

fluorouracil 50 mg

Ancillary substances:

Sodium hydroxide – 15.37 mg,

water for injection – up to 1 ml.

How to take, the dosage

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, w/a, intracavitary.

The following doses and regimens are recommended:

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

Interaction

Calcium folinate enhances the therapeutic and toxic effects of fluorouracil. When used in combination with other cytostatics and interferon-alpha an increase in both antitumor effect and toxicity of fluorouracil may also be observed. In long-term co-administration with mitomycin C the appearance of hemolytic uremic syndrome was observed.

When concomitantly administered with Sorivudine, pronounced leukopenia was observed, which in some cases was fatal.

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

Chlordiazopoxide, disulfiram, griseofulvin and isoniazid may increase the activity of 5 fluorouracil. Fluorouracil may decrease the immunological response to vaccination. Severe antigenic reactions may develop if administered concomitantly with live vaccine.

Special Instructions

Fluorouracil-LENS® is a cytotoxic drug, so caution should be exercised 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.

At the time of treatment, it is necessary to monitor the total number of leukocytes, the absolute number of neutrophils, platelets, to determine hematocrit, hemoglobin, the activity of “liver” tests and bilirubin level, to examine the patient’s mouth for signs of stomatitis.

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

Impact on ability to drive vehicles and other mechanisms requiring high concentration

The side effects caused by taking fluorouracil may adversely affect the ability to drive and perform activities requiring high speed psychomotor reactions.

Features

Contraindications

With caution: use with renal and/or hepatic failure, acute infections of viral, fungal or bacterial nature (including tuberculosis, varicella, herpes zoster), 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, bleeding from gastrointestinal tract, 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), visual impairment.

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).

Treatment: symptomatic therapy. No specific antidote to fluorouracil is known. In case of overdose, hematopoiesis function of patients should be monitored for at least 4 weeks.

Pregnancy use

The drug is contraindicated during pregnancy and lactation.