Fluorouracil-LENS vials 50mg/ml 20ml, 10pcs

Composition

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1 ml of the solution contains:

Active ingredient:  fluorouracil 50 mg

Auxiliary substances:  sodium hydroxide – 15.37 mg, water for injection-up to 1 ml

Pharmacological action

Antitumor agent from the group of antimetabolites. Inhibits the process of cell division by blocking DNA synthesis (due to inhibition of the activity of the thymidylate synthetase enzyme) and the formation of structurally imperfect RNA (due to the introduction of fluorouracil into its structure).

Indications

Colon and rectal cancer, breast cancer, esophageal cancer, stomach cancer, pancreatic cancer. breast cancer, primary liver cancer, ovarian cancer, cervical cancer, uterine cancer, bladder cancer, head and neck cancer, prostate cancer, adrenal cancer, penile cancer, carcinoid.

Contraindications

• Hypersensitivity to fluorouracil and / or any other component of the drug.

• Pregnancy and lactation.

• Severe leukopenia, neutropenia, thrombocytopenia, stomatitis, ulceration of the gastrointestinal mucosa, pseudomebranous enterocolitis.

With caution:

kidney and / or liver failure, acute infectious diseases of a viral, fungal or bacterial nature (including tuberculosis, chickenpox, shingles), infiltration of the bone marrow with tumor cells, previously performed radiation therapy or chemotherapy.

Side effects

From the side of hematopoietic organs:  leukopenia, neutropenia, rarely-thrombocytopenia, anemia. The most significant drop in the number of white blood cells 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 gastrointestinal mucosa (including stomatitis), diarrhea, bleeding from the gastrointestinal tract, heartburn and taste changes, impaired liver function.

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

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

From the side of the senses:  Irritation of the eye mucosa, excessive lacrimation due to ductal stenosis (10% -25%), photophobia, cataracts, cortical blindness (at high doses), visual impairment.

From the side of the reproductive system:  reversible suppression of the function of the gonads, leading to amenorrhea or azoospermia.

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

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

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

Interaction

of Calcium folinate enhances the therapeutic and toxic effects of fluorouracil. Use in combination with other cytostatics and interferon-alpha may also increase both the antitumor effect and the toxicity of fluorouracil. Long-term concomitant use with mitomycin C resulted in the appearance of hemolytic uremic syndrome. When taking sorivudine concomitantly, severe leukopenia was observed, in some cases leading to a fatal outcome. Fluorouracil should not be used after or in combination with aminophenazone, phenylbutazone, or sulfonamide therapy. Chlordiazopoxide, disulfiram, griseofulvin, and isoniazid may enhance the activity of 5-fluorouracil. Fluorouracil may reduce the immunological response to vaccination. When administered concomitantly with a live vaccine, severe antigenic reactions may develop. Influence on the ability to drive vehicles and mechanisms: Side effects caused by taking fluorouracil can negatively affect the ability to drive a vehicle and perform work that requires a high rate of psychomotor reactions.

How to take, course of use and dosage

Fluorouracil is included in many chemotherapeutic treatment regimens, and therefore, when choosing the route of use, regimen and doses in each individual case, you should be guided by the data of the specialized literature.

The drug is administered intravenously by jet or by slow infusion intraarterially, intracavitarily

The following doses and regimens are recommended:

• 500 mg/m 2 or 12-13,5 mg/kg daily for 3-5 days, the interval between courses – 4 weeks;

• 600 mg/m 2 or 15 mg/kg (maximum single dose 1 g) 1 time in a week,6-10 doses;

• 600 mg/m 2 at 1 and 8 days intravenously in combination with other cytostatics;

• 1 g/m2 /day intravenously 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%.

Precautions for use:

Fluorouracil-LANCE® is a cytotoxic drug, so caution should be exercised when handling it.

If stomatitis or diarrhea occurs, treatment with the drug should be discontinued 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 extensive surgery, insufficient bone marrow function, impaired liver or kidney function.

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

During treatment, it is necessary to monitor the total number of white blood cells, the absolute number of neutrophils, platelets, determine hematocrit, hemoglobin, the activity of “liver” tests and the level of bilirubin, examine the patient’s oral cavity for signs of stomatitis.

Men and women of childbearing age should use reliable methods of contraception during treatment with Fluorouracil-LANCE and for at least 3 months thereafter.

Overdose

Signs and symptoms of overdose include nausea, vomiting, diarrhea, ulcerative stomatitis and gastric bleeding, and bone marrow suppression (thrombocytopenia, leukopenia, and agranulocytosis). In case of overdose, the hematopoietic function of patients should be monitored for at least 4 weeks, and if violations occur, symptomatic therapy is carried out.

A specific antidote to fluorouracil is not known.

Storage conditions

At a temperature of 15 to 25 °C.

Keep out of the reach of children!

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Fluorouracil

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

For adults as directed by your doctor

Indications

Cancer