Ftorafur, 400mg capsules, 100pcs

Composition

1 capsule contains:

Active ingredients:

tegafur 400 mg.

Auxiliary substances:

stearic acid.

Capsule shell composition:

gelatin,

titanium dioxide (E 171),

Quinoline yellow (E 104),

Ponceau 4R (E 124).

There are 100 capsules in a plastic jar.

In a cardboard box 1 plastic jar.

Pharmacological action

Pharmacodynamics

Antitumor drug, the action of which is caused by a violation of the synthesis of DNA and RNA. The resulting hydrolysis of fluorouracil inhibits the enzyme thymidylate synthetase and DNA synthesis, is introduced into the RNA structure instead of uracil, making it defective, and inhibits cell proliferation.

In tumor cells, it is converted to 5-fluoro-deoxyuridine-5-monophosphate, which is then phosphorylated to triphosphate and incorporated into RNA, and phloxuridine monophosphate, which inhibits thymidylate synthetase. It is less toxic and better tolerated by patients than 5-fluorouracil.

Pharmacokinetics

Suction

When taken orally, tegafur is rapidly absorbed from the gastrointestinal tract and is detected in the blood, at least within 24 hours after a single application. _{Cmax of}tegafur in blood plasma is reached within 4-6 hours after use. Bioavailability is almost complete.

Distribution

It 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

It is metabolized in the liver with the formation of metabolites, among which the pharmacologically active 5-fluorouracil occupies a central place. Bioactivation is carried out not only in the liver, but can also be local in the tumor tissue, characterized by an increased content of cytosolic hydrolytic enzymes.

Indications

• Cancer of the colon and rectum;
• stomach cancer;
• breast cancer;
• diffuse neurodermatitis;
• cutaneous lymphomas.

Use during pregnancy and lactation

Ftorafur® is contraindicated for use during pregnancy and lactation (breastfeeding).

It should be borne in mind that the drug inhibits the patient’s reproductive function.

Contraindications

• End-stage disease;
• acute profuse bleeding;
• severe hepatic impairment;
• severe renal impairment;
• 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: the drug should be used in patients with impaired hematopoiesis, liver and kidney function, glucose metabolism, peptic ulcer of the stomach and duodenum, a tendency to bleeding, with infectious diseases.

Side effects

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea; rarely-stomatitis, esophagitis, ulcerative lesions of the gastrointestinal mucosa, gastrointestinal bleeding, liver function disorders, acute hepatitis, acute pancreatitis.

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

Dermatological reactions: alopecia, impaired regeneration of the skin, nails.

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

Interaction

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

Ftorafur ® increases the effectiveness of other chemotherapeutic agents and radiation therapy (the side effect also increases).

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

How to take, course of use and dosage

Assign inside.

The daily dose of Ftorafur® is 800-1000 mg / m2 (20-30 mg / kg body weight) in 2-4 doses, but not more than 2 g / day.

The course dose when taken orally is 30-40 g.

The interval between courses is 4 weeks.

The dose of Ftorafur® can be reduced in elderly patients and at a late stage of the disease.

Overdose

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

Treatment: monitoring of hematopoietic function for at least 4 weeks, if necessary, conduct symptomatic therapy.

The specific antidote to tegafur is unknown.

Special instructions

When prescribing Ftorafur® to patients with impaired hematopoiesis, liver and kidney function, glucose metabolism, peptic ulcer of the stomach and duodenum, a tendency to hemorrhage, and infectious diseases, the potential risk of adverse reactions should be taken into account. During treatment, the picture of peripheral blood, the functional state of the liver and kidneys should be regularly monitored. With prolonged use of the drug, its side effect increases.

Dizziness, nausea, and vomiting are reduced by fractionating the daily dose.

If serious side effects develop, the drug should be discontinued.

Use in pediatrics

The safety of using the drug in children has not been established.

Form of production

Capsules

Storage conditions

Keep out of reach of children in a dark place at a temperature not exceeding 25°C.

Shelf

life is 4 years.

Active ingredient

Tegafur

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Description

For adults as directed by your doctor

Indications

Cancer