Fluorouracil

Brand Teva

In stock 798 Items

Available since: 2019-09-19

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Clinical Pharmacology

Antitumor (cytostatic). Antitumor activity is caused by the transformation of fluorouracil in the tissues into active metabolites, their action leads to a deficiency of thymidine and inhibition of DNA synthesis and disruption of RNA processing and protein synthesis. Histohematic barriers easily pass, including the BBB, and are distributed among tissues (tumors, bone marrow, liver, etc.) and body fluids (cerebrospinal, extracellular). The concentration in the tumor tissue several hours after the administration is higher than in the healthy one. Active metabolites are localized inside the cell. Catabolic degradation occurs predominantly in the liver. With a / in the introduction of the half-life of fluorouracil from plasma is about 16 minutes (in the range of 8-20 minutes), depending on the dose administered. Excreted through the respiratory tract and kidneys. A very small amount of fluorouracil may be excreted in the bile. It has high myelotoxicity and gastrointestinal toxicity.

Indications

Malignant tumors of the breast, stomach, pancreas, rectum and other parts of the large intestine, cancer of the bladder, prostate, ovary, cervix, liver, malignant head and neck tumors.

Composition

The active ingredient is fluorouracil.

Fluorouracil is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Fluorouracil-Teva	Teva	Israel	solution
Fluorouracil	Ebeve Pharma	Austria	solution concentrate

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Dosage and Administration

The route of administration, mode and dose in each case are determined individually and depend on the evidence, the stage of the disease, the state of the hematopoietic system, the chemotherapy regimen. They are administered intravenously in a stream or drip, intraarterially, intracavitary. IV drip, 1 g / m2 / day, constantly for 96-120 hours; in combination with other drugs - 600 mg / m2 IV by 1 and 8 days of the course. When used in combination with calcium folinate, doses of fluorouracil are usually reduced by 25–30%.

Adverse reactions

Dizziness, ataxia, dysarthria, nystagmus, disturbance of spatial orientation, confusion, euphoria, optic neuritis, photophobia, excessive tearing, stenosis of the lacrimal canaliculi; leukopenia (usually occurs after 9–14 days after each course, the number of leukocytes recovers in about 30 days), neutropenia, thrombocytopenia, arrhythmia, angina, ischemia, myocardial infarction, cardiomyopathy, heart failure, thrombophlebitis; pulmonitis (cough, shortness of breath), bronchospasm; nausea, vomiting, mucositis (ulcerative stomatitis, ulcerative lesions of the gastrointestinal mucosa, esophagitis, proctitis), diarrhea, loss of appetite; dermatitis (itching and skin rash usually on the limbs and less often on the body), dryness and cracks of the skin; in some cases - alopecia (reversible), partial loss of nails, hyperpigmentation in the area of the nail bed and other parts of the body, palmar and plantar erythrodisesthesia, photosensitization; infections (usually asymptomatic, less often - increased body temperature or chills, cough or hoarseness, pain in the lower back or side, painful or difficult urination), muscle weakness, generalized allergic reactions, anaphylactic shock, nasal bleeding.

Contraindications

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

- pregnancy and lactation period;

- severe leukopenia, neutropenia, thrombocytopenia, stomatitis, gastrointestinal mucosa (GIT), pseudomembranous enterocolitis.

With care: renal and / or liver failure; acute infectious diseases of viral, fungal or bacterial nature (including tuberculosis, chicken pox, shingles); bone marrow infiltration by tumor cells; previous intensive radiotherapy or chemotherapy.

Drug interactions

The efficacy and / or toxicity of fluorouracil modulate interferon alfa-2a, methotrexate, calcium folinate. Mitomycin with long-term use potentiates the occurrence of hemolytic-uremic syndrome. Drugs + radiation therapy, causing myelosuppression, increase fluorouracil-induced leukopenia and / or thrombocytopenia. With the introduction of live viral vaccines, it is possible to intensify the replication of the vaccine virus and increase side effects or reduce the production of antibodies in the patient's body in response to the introduction of the vaccine; inactivated vaccines - reducing the production of antiviral antibodies.

Special instructions

The use of fluorouracil should be carried out under the supervision of a qualified physician with experience in antitumor therapy, patients should be in a hospital. During treatment, blood is examined at least 3 times a week. After radiation therapy or the use of other antitumor agents, the administration of fluorouracil is permissible after 1-1.5 months, provided that the blood picture is fully restored. You should also not prescribe the drug earlier than 3-4 weeks after complex surgical interventions. It is not recommended to inject the drug in case of extensive metastases in the bone marrow. Dental interventions should be completed before the start of therapy or postponed until the blood picture is normalized.Since there are no data on the safety of the prescription during pregnancy, women with preserved fertility should be used only in combination with adequate contraception. The use of fluorouracil is immediately stopped at the first signs of complications. With the resolution (disappearance) of side effects, treatment is continued at a lower dose. Take care to avoid accidental cuts with sharp objects, avoid contact sports or other situations in which hemorrhage or injury is possible. During treatment, avoid contact with people who have received a polio vaccine, patients with bacterial infections. Use caution in combination therapy; take each drug at the scheduled time. It is necessary to observe the necessary rules for the use and destruction of the drug. Dilution of fluorouracil should be carried out by trained personnel in a specially equipped place (in special cabinets with a hood), using protective clothing (disposable gloves, goggles, masks), taking precautions when preparing injection solutions and destroying needles, syringes, ampoules and the remainder of unused drug.

Overdosage

Hypersensitivity, terminal stages of the disease, cachexia, bone marrow aplasia, gastric ulcer and duodenal ulcer, ulcerative colitis, severe liver and kidney failure, severe systemic infections (or the threat of their development), pregnancy and lactation.