Ftorafur® (Ftorafur®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTegafurTegafur
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  • Ftorafur®
    capsules inwards 
    GRINDEX, JSC     Latvia
    • Dosage form: & nbspcapsules
    Composition:

    1 capsule contains:

    active substance: tegafur - 400 mg;

    auxiliary substance: stearic acid acid 4 mg;

    capsule:

    body: titanium dioxide (E171) - 2%, dye quinoline yellow (E 104) - 0.7139%, iron oxide dye red (Е 172) - 0,0057%, gelatin - up to 100%;

    lid: titanium dioxide (E 171) - 2.5%, dye quinoline yellow (E 104) - 0.1586%, the dye is crimson (Ponso 4R) (Е 124) - 0.1983%, gelatin - up to 100%.

    Description:Solid-gelatin capsules number 0. The capsule body is yellow, the lid is orange. The contents of capsules are white powder odorless.
    Pharmacotherapeutic group:antitumour agent, antimetabolite
    ATX: & nbsp

    L.01.B.C.03   Tegafur

    Pharmacodynamics:

    The antitumor effect is due to a violation of the synthesis of DNA / and RNA. Formed as a result of hydrolysis, fluorouracil inhibits / enzyme thymidylate synthetase and DNA synthesis, is incorporated into the RNA structure instead of uracil, making it defective, and prevents cellular proliferation.

    In tumor cells, it is converted to 5-fluorodeoxyuridine-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 fluorouracil.

    Pharmacokinetics:

    Ingestion tegafur It is rapidly absorbed from the gastrointestinal tract (GIT) and is found in the blood for at least 24 hours after its single administration. The maximum concentration of the drug in the blood is reached within 4-6 hours after administration. Bioavailability is almost complete. Has a high lipophilicity (200 times higher than fluorouracil), while remaining a water-soluble compound. High lipophilicity provides a fast passage through biological membranes, distribution in the body and penetration through the blood-brain barrier.

    Metabolised in the liver with the formation of metabolites, among which the main 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, breast; atopic dermatitis, skin lymphomas.
    Contraindications:

    Hypersensitivity to the drug. Terminal stage of the disease, acute profuse bleeding, severe liver and / or kidney disorders, leukopenia (less than 3x109/ l ), neutropenia (less than 1x109/ l), thrombocytopenia (less than 100x109/ l) and anemia (hemoglobin less than 65 g / l), gastric and duodenal ulcer, infectious diseases, the risk of developing bleeding in the digestive tract, pregnancy and lactation, children under 18 years of age (efficacy and safety not proven).

    Carefully:Carefully used in patients with impaired hematopoiesis, with violations of the liver and kidneys of mild and moderate, as well as with violations of glucose metabolism.
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Inside. The daily dose of the drug Ftorafur® is 20-30 mg / kg body weight (1.2-1.6 g) in 2 to 4 doses, but not more than 2 g / day. The course dose is 30-40. The interval between courses is 4 weeks. The dose can be reduced to elderly patients and at a late stage of the disease.

    The safety of the use of the drug Ftorafur® in children has not been studied.

    Side effects:

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

    From the side of the digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea; stomatitis, pharyngitis, esophagitis, ulceration of the mucous membrane of the gastrointestinal tract, bleeding from the digestive tract, violations of the liver function, acute hepatitis, acute pancreatitis.

    From the nervous system: dizziness, confusion, drowsiness, ataxia, euphoria.

    From the side of the cardiovascular system: cardialgia, stenocardia, myocardial ischemia, myocardial infarction.

    From the side of the organ of vision: diplopia, lacrimation, fibrosis of lacrimal ducts.

    From the skin and skin appendages: alopecia, disorder. regeneration of skin and nails.

    Other: allergic reactions (including anaphylactic shock), impaired renal function, dehydration, leukoencephalitis, interstitial pneumonia, loss of smell.

    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 not known.

    Interaction:

    Tegafur increases the effectiveness of other chemotherapeutic drugs (oxaliplatin, raltitreksida, cyclophosphamide, methotrexate, doxorubicin, mitomycin) and radiation therapy (possibly increasing the risk of adverse events). The tolerance of tegafur improves with the simultaneous administration of calcium folinate.

    With simultaneous use with phenytoin enhances the effect of the latter. Inhibitors of microsomal oxidation in the liver increase the toxicity of tegafur.

    Special instructions:

    Regularly monitor the picture of blood, the functional state of the liver and kidneys. With prolonged use of the drug, its side effect is enhanced. It should be borne in mind that the drug inhibits the reproductive function of the patient. Dizziness, nausea and vomiting decrease when dividing the daily dose into several doses. If serious adverse events develop, stop using the drug.

    The drug is immediately stopped when at least one of the following signs appears: stomatitis, pharyngitis, esophagitis, bleeding, leukopenia (less 3x107l), neutropenia (less than 1x109/ l) thrombocytopenia (less than 100x109/ l). Influence on hematopoiesis can appear and after 8 - 14 days after the end of treatment.

    During the treatment, careful oral care is needed.

    Effect on the ability to drive transp. cf. and fur:The adverse effect of Ftorafur® on the ability to drive and work with machinery has not been reported.However, if side effects such as dizziness and drowsiness occur during the use of the drug, you should not drive the car and do work that requires special attention and quick reactions.
    Form release / dosage:Capsules of 400 mg. For 100 capsules in a polyethylene jar (with a capacity of 150 ml) with a pressurized lid and first opening control. The bank together with the instruction for use is placed in a box of cardboard box.
    Packaging:(100) - polyethylene can (1) / 100 capsules each in a polyethylene can (150 ml capacity) with a pressure cap and first opening control. The bank together with the instruction for use is placed in a box of cardboard box. - box of cardboard box
    Storage conditions:

    Store in a dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    4 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016066 / 01
    Date of registration:06.11.2009
    The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia
    Manufacturer: & nbsp
    Representation: & nbspGrindeks Rus, Open CompanyGrindeks Rus, Open CompanyRussia
    Information update date: & nbsp13.09.2015
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