Phenylline (Phenylin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFenindionFenindion
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  • Phenylline
    pills inwards 
    HEALTH PHARMACEUTICAL COMPANY, LTD.     Ukraine
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: phenylin (phenyldione) 30 mg;

    Excipients: lactose monohydrate (sugar milk), starch potato, talc, acid citric monohydrate.

    Description:Tablets are white or white with a creamy shade of color, flat-cylindrical, with a bevel.
    Pharmacotherapeutic group:anticoagulant means of indirect action
    ATX: & nbsp

    B.01.A.A   Antagonists of vitamin K

    B.01.A.A.02   Fenindion

    Pharmacodynamics:Phenylin refers to agents that affect blood coagulability, anticoagulants of indirect action. It causes hypoprothrombinemia, caused by a violation of the formation of prothrombin in the liver, and also reduces the formation of factors VII, IX and X. The cumulative effect of phenylene is greater than that of neodicumarin. When administered orally, a decrease in the concentration of coagulation factors occurs 8-10 hours after the administration of phenylin and reaches a maximum after 24-30 hours.
    Pharmacokinetics:After oral administration, it is quickly and almost completely absorbed. Passes histohematological barriers and accumulates in tissues. Metabolised in the liver. It is excreted by the kidneys in unchanged form and in the form of metabolites.
    Indications:

    - Prevention of thromboembolism (including myocardial infarction, after surgical interventions);

    - coronary thrombosis, thrombophlebitis and deep vein thrombosis of the lower extremities;

    - prophylaxis of thrombosis after surgery for prosthetics of the heart valves (constant reception).

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - hemophilia;

    - hypocoagulation (initial prothrombin content less than 70%);

    - pregnancy and lactation;

    - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

    Carefully:

    - In elderly patients;

    - with increased vascular permeability;

    - Hepatic and / or renal insufficiency;

    - thromboembolism of the pulmonary artery (including in oncology);

    - erosive and ulcerative lesions of the gastrointestinal tract;

    - pericarditis;

    - in the postpartum period.

    Pregnancy and lactation:

    The drug is contraindicated during pregnancy.

    If it is necessary to prescribe the drug during lactation, breast-feeding should be stopped.

    Dosing and Administration:

    Assign adults inside after eating.

    The optimal dose for different patients may vary significantly and depends on individual, sensitivity, the nature of the disease, the characteristics of nutrition and concomitant treatment, so that the choice of dose is individual.

    On the first day of treatment, 120-180 mg (4-6 tablets) are prescribed in 3-4 doses at a daily dose, on the second day at a daily dose of 90-150 mg (3-5 tablets), then 30-60 mg ( 1-2 tablets) in 1-2 doses, under the control of prothrombin time.

    Single dose, frequency and duration of application are set individually by the doctor depending on the prothrombin index in the blood, which is maintained in the range of 50-60%. With a prothrombin content of less than 40-50%, the drug should be immediately discontinued.

    The drug should be discontinued gradually.

    Higher doses for adults: single dose - 60 mg, daily - 210 mg.

    Side effects:

    On the part of the blood system: with long-term use - micro- and macrohematuria, bleeding from the oral cavity and nasopharynx, gastrointestinal bleeding, hemorrhage into the muscles; oppression of bone marrow hematopoiesis (agranulocytosis, leukopenia, leukemoid reactions).

    From the digestive system: nausea, diarrhea, toxic hepatitis.

    Allergic reactions: skin rash (erythematous, macular, papular), exfoliative dermatitis, eosinophilia, fever.

    From the urinary system: staining the urine in pink.

    Other: headache, palms coloration in orange.

    Overdose:

    Symptoms: hemorrhagic syndrome (gastrointestinal, uterine, nasal bleeding, hematuria, hemorrhages in the skin, muscles, parenchymal organs).

    Treatment: drug cancellation; intake of vitamin K inside (5-10 mg). With the development of severe bleeding, vitamin K is administered intravenously slowly (1 mg / min) in a total dose of 10-50 mg (normalizes the increased prothrombin time within 6 hours). With massive bleeding or in patients with hepatic insufficiency, a freshly frozen plasma is simultaneously administered. It is possible to use aminocaproic acid, vitamins C and P.

    Interaction:

    The effect of the drug is enhanced thrombolytic agents, antiaggregants, other anticoagulants, adrenocorticotropic hormone, anabolic, azathioprine, allopurinol, amiodarone, narcotic analgesics, androgens, antibiotics, tricyclic antidepressants, urine oxidizing drugs, glucocorticosteroids, diazoxide, disopyramide, nalidixic acid, isoniazid, clofibrate, metronidazole, paracetamol, reserpine, alpha-tocopherol, butadione, sulfonamides, disulfiram, quinidine, cyclophosphamide, thyroid hormones, cimetidine and other inhibitors of microsomal liver enzymes.

    The effect of the drug weakens vitamin K, propranolol, alkaline urine drugs, antacids, colestramine, phenazone, haloperidol, diuretics, carbamazepine, barbiturates, oral contraceptives, rifampicin and other inducers of microsomal liver enzymes.

    Special instructions:

    The features of the action for the first time

    In acute thrombosis appoint together with heparin.

    During the course of treatment with the drug, systematic monitoring of blood clotting is necessary according to the INR (International Normalized Ratio) index, regular extended coagulologic blood test (coagulogram, thromboelastogram, platelet count), urine analysis for early detection of hematuria.

    To control the anticoagulant activity, the prothrombin time is used: reliable prophylaxis of venous thrombosis is achieved with an increase in prothrombin time by 2 times, arterial - 3-4 times (norm 11-14 sec).

    Do not prescribe the drug during menstruation (stop taking 2 days before it starts) and in the first days after childbirth.

    The coloration of urine in pink and palms in orange is due to the metabolism of phenindione (transition to the enol form) and ns represents a hazard. When urine is acidified, the pink color disappears, which can be used to differentiate the staining of urine from hematuria. When staining the palms and changing the color of urine, the drug should be replaced with another indirect anticoagulant.

    Possibility of use in children

    The use in children is not sufficiently investigated.

    Effect on the ability to drive transp. cf. and fur:

    The drug may cause side effects that affect the ability to drive vehicles and engage in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, so care must be taken when dealing with such activities.

    Form release / dosage:

    Tablets, 30 mg.

    Packaging:For 20 tablets in a contour mesh package, 20 or 50 tablets per can.
    One outline package or one jar in a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of 8 ° C to 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015073 / 01
    Date of registration:12.12.2008
    The owner of the registration certificate:HEALTH PHARMACEUTICAL COMPANY, LTD. HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp19.09.2015
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