Universal reference book for medicines
Name of the preparation: FTORAFUR ® (FTORAFUR)

Active substance: tegafur

Type: Antitumor drug.
Antimetabolite
Manufacturer: GRINDEX (Latvia)
Composition, form of production and packaging
Capsules are
hard gelatinous, with a yellow hull and an orange lid;
contents of capsules - a powder of white color without a smell.
1 caps.

tegafur 400 mg

Excipients: stearic acid.

The composition of the capsule shell: gelatin, titanium dioxide (E171), Quinoline yellow (E104), Ponceau 4R (E124).

100 pieces.
- polyethylene cans with a capacity of 150 ml (1) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antitumor drug, the effect of which is due to a violation of the synthesis of DNA and RNA.
The fluorouracil formed as a result of hydrolysis inhibits the enzyme thymidylate synthetase and DNA synthesis, is incorporated into the RNA structure instead of uracil, making it defective, and inhibiting cell proliferation.
In tumor cells, it is converted to 5-fluoro-deoxyuridine-5-monophosphate, which is then phosphorylated into triphosphate and incorporated into RNA, and floxuridine monophosphate, which inhibits thymidylate synthetase.
Less toxic and better tolerated by patients than 5-fluorouracil.
PHARMACOKINETICS

Suction

When ingested tegafur is rapidly absorbed from the gastrointestinal tract and is found in the blood, at least 24 hours after a single application.
C max of tegafur in blood plasma is achieved within 4-6 hours after administration. Bioavailability is almost complete.
Distribution

Has a high lipophilicity (200 times higher than fluorouracil), while remaining a water-soluble compound.
High lipophilicity ensures rapid passage through biological membranes, distribution in the body and penetration through the BBB.
Metabolism

Metabolised in the liver with the formation of metabolites, among which the central place is occupied by pharmacologically active 5-fluorouracil.
Bioactivation occurs not only in the liver, but can also be local in a tumor tissue that is characterized by an increased content of cytosolic hydrolytic enzymes.
INDICATIONS

- cancer of the colon and rectum;

- stomach cancer;

- mammary cancer;

- diffuse neurodermatitis;

- Skin lymphomas.

DOSING MODE

Assign inside.
The daily dose of the drug Fltorafur ® is 800-1000 mg / m 2 (20-30 mg / kg body weight) in 2-4 doses, but not more than 2 g / day. The course dose for oral administration is 30-40 g. The interval between courses is 4 weeks. The dose of Ftorafur ® can be reduced in elderly patients and in the late stage of the disease.
SIDE EFFECT

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, anemia.

On the part of the digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea;
rarely - stomatitis, esophagitis, ulcerative lesions of the mucous membrane of the gastrointestinal tract, gastrointestinal bleeding, violations of liver function, acute hepatitis, acute pancreatitis.
From the side of the central nervous system: dizziness, confusion, drowsiness, ataxia, euphoria, symptoms of leukoencephalitis.

From the cardiovascular system: cardialgia, angina pectoris, myocardial ischemia, myocardial infarction.

From the senses: diplopia, lacrimation, fibrosis of lacrimal ducts, loss of smell.

Dermatological reactions: alopecia, violation of skin regeneration, nails.

Other: pharyngitis, allergic reactions (including anaphylactic shock), impaired renal function, dehydration of the body, interstitial pneumonia.

CONTRAINDICATIONS

- terminal stage of the disease;

- Acute profuse bleeding;

severe hepatic impairment;

- severe renal dysfunction;

- leukopenia (less than 3000 / μl);

- thrombocytopenia (less than 100 000 / μl);

- Anemia (hemoglobin level less than 65 g / l);

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution should be used in patients with impaired hematopoiesis, liver and kidney function, glucose metabolism, gastric ulcer and duodenal ulcer, propensity to bleed, with infectious diseases.

PREGNANCY AND LACTATION

Ftorafur ® is contraindicated in pregnancy and lactation (breastfeeding).

It should be noted that the drug depresses the reproductive function of the patient.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in severe impairment of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe violations of liver function.

APPLICATION FOR CHILDREN

The safety of the drug in children is not established.

APPLICATION IN ELDERLY PATIENTS

The dose of Ftorafur may be reduced in elderly patients and in the late stage of the disease.

SPECIAL INSTRUCTIONS

If a Ftorafur® drug is to be prescribed for patients with hematopoiesis, liver and kidney function, glucose metabolism, gastric ulcer and duodenal ulcer, a penchant for hemorrhages, and infectious diseases, the potential risk of adverse reactions should be considered.
During the treatment period, the picture of peripheral blood, the functional state of the liver and kidneys should be monitored regularly. With prolonged use of the drug, its side effect is enhanced.
Dizziness, nausea and vomiting decrease when fractionating the daily dose.

If serious side effects develop, discontinue use.

Use in Pediatrics

The safety of the drug in children is not established.

OVERDOSE

Symptoms: increased toxic effects from the gastrointestinal tract, central nervous system and suppression of hemopoiesis.

Treatment: monitoring the function of hematopoies for at least 4 weeks, if necessary, conduct symptomatic therapy.
The specific antidote to tegafur is unknown.
DRUG INTERACTION

With the simultaneous use of the drug Ftorafur ® and phenytoin, the effect of the latter is possible.

Fluorofur ® increases the effectiveness of other chemotherapeutic agents and radiotherapy (side effects also increase).

When used simultaneously with inhibitors of microsomal oxidation in the liver, the toxicity of the preparation Ftorafur ® increases.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List A. The drug should be stored out of the reach of children, in a dark place at a temperature of no higher than 25 ° C.
Shelf life - 4 years.
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