Fluorouracil bottles 5%, 5 ml, 10 pcs. (Fluorouracil)

Latin name

FLUOROURACIL-LENS

Release form

Solution for intravascular and intracavitary administration.

Packing

in an ampoule of 5 ml. In a cardboard box of 10, 25, 35 or 50 ampoules.

Pharmacological action

Fluorouracil - antimetabolite uracil. The mechanism of action is due to the transformation of the drug in the tissues into an active metabolite of fluoruridine monophosphate, which is a competitive inhibitor of the enzyme thymidylate synthetase, which is involved in the synthesis of nucleic acids. Fluorouracil disrupts DNA synthesis and causes the formation of structurally imperfect RNA, inhibiting the division of tumor cells. Active metabolites are localized inside the

Indications

Colorectal cancer, breast cancer, esophageal cancer, stomach cancer, pancreatic cancer, primary liver cancer, ovarian cancer, cervical cancer, bladder cancer, cancer of the head and neck, prostate cancer, adrenal cancer, penile cancer, carcinoid.

Contraindications

Hypersensitivity to fluorouracil and / or any other component of the

preparation pregnancy and lactation

severe leukopenia, neutropenia, thrombocytopenia

stomatitis

ulceration of the gastrointestinal tract, pseudomonas pyloric ulcer,

Precautions: use in case of renal and / or liver failure, acute infectious diseases of a viral, fungal or bacterial nature (including tuberculosis, chickenpox, shingles), bone marrow infiltration with tumor cells, previous radiation therapy or chemotherapy.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Composition

1 ml of solution contains:

Active ingredient: fluorouracil 50 mg

Excipients: sodium hydroxide - 15.37 mg, water for injection - up to 1 ml.

Dosage and administration of

Fluorouracil is part of many chemotherapeutic regimens, and therefore, when choosing the route of administration, regimen and dose in each individual case, one should be guided by the data of the specialized literature.

The drug is administered intravenously in a jet or by slow infusion, in / a, intracavitary.

The following doses and regimens are recommended:

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

600 mg / m2 or 15 mg / kg (highest single dose 1 d) 1 time / week, 6-10 doses of

600 mg / m2 on days 1 and 8 in iv in combination with other

cytostatics 1 g / m2 / day iv in the form of a continuous infusion for 96-120 hours

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

Side effects

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

From the digestive system: decreased appetite, nausea, vomiting, inflammation and / or ulceration of the mucous membranes of the gastrointestinal tract (including stomatitis), diarrhea, bleeding from the gastrointestinal tract, heartburn and taste change, impaired liver function.

From the cardiovascular system: very rarely - pain in the heart, arrhythmias, ischemia, myocardial infarction, angina pectoris, heart failure.

From the nervous system: rarely - cerebellar ataxia, impaired sensitivity, disorientation, confusion, euphoria, nystagmus, retrobulbar neuritis, headache.

On the part of the sensory organs: irritation of the mucous membrane of the eyes, excessive lacrimation due to stenosis of the ducts (10% -25%), photophobia, cataracts, cortical blindness (at high doses), visual impairment.

From the reproductive system: reversible inhibition of the function of the sex glands, leading to amenorrhea or azoospermia.

From the skin and skin appendages: alopecia (rarely), hyperpigmentation of the skin, dryness and cracking of the skin, telangiectasia, palm-plantar erythrodysesthesia syndrome (tingling sensation in the hands and feet, followed by the appearance of pain, hyperemia and swelling), change and convergence of the nail plates (rarely), photosensitivity.

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

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

Overdose

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

Treatment: symptomatic therapy. The specific antidote to fluorouracil is unknown. In case of overdose, hematopoiesis should be monitored for at least 4 weeks.

Storage conditions

Keep out of the reach of children at a temperature of 15 to 25 ° C.

Note: Precipitation may occur when storing the drug at lower temperatures. In this case, the vial should be heated to a temperature of 60 ° C with vigorous shaking, after which the drug must be cooled to a temperature of 35 ° C. If the precipitate dissolves and the solution becomes clear, the drug is suitable for use.

Expiration

2 years.

active ingredient Deystvuyuschee substances

Fluorouracil

dosage form

dosage form

infusion solution



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