Phenilin - description of an indirect anticoagulant. Phenilin-health: instructions for use Use during pregnancy and lactation

Increased synthesis of prothrombin in the liver occurs as a result of some injuries, when the body tries to stop excessive blood loss. Unfortunately, the well-functioning mechanism sometimes malfunctions, and an increase in prothrombin in the blood occurs when there is no danger of blood loss.

Situations like this lead to increased thrombosis, which can lead to stroke, heart attack or blockage of peripheral blood vessels.

Drugs called indirect anticoagulants, which include Fenilin. This drug has a pronounced cumulative effect and overcomes the hematic and histological barrier well.

The main property due to which the anticoagulation effect is achieved is to reduce the formation of certain blood clotting factors and prothrombin itself.

Instructions for use

The active compound Phenilin is metabolized primarily in the liver and excreted through the kidneys.

While in the body, this component of the drug is found in almost all tissues of the human body. As a result, Phenilin can change the functional component of internal organs, that is, influence their activity. All this requires taking into account many factors when prescribing medicine to patients. They are described in detail in the official instructions for use of the drug.

Release form and composition

The drug Phenilin is available in the form of white or creamy-beige tablets in the usual form for this form of medication - a flat cylinder with bevels.

The tablets contain active compound phenindione in the amount of 0.03 g per tablet, as well as a complex of additional components: starch, talc, lactose and citric acid.

The tablets are packaged in contour packs of 20 pieces each, or in opaque jars made of polymer material, 20 or 50 pieces each.

Video: "Pharmacology of anticoagulants"

Indications for use

  • thrombophlebitis;
  • thrombosis;
  • myocardial infarction with thromboembolic complications;
  • embolism of large vessels of internal organs;
  • ischemic stroke.

In addition, the drug Phenilin is used to prevent thrombosis in the postoperative period (but only if there is a risk of thrombosis or thromboembolism).

Mode of application

Phenilin tablets are intended for oral administration, and the dosage of the drug depends on the patient’s index prothrombin at the time of calculation, as well as on the existing diagnosis and purpose of admission - prevention or treatment of the condition.

To maintain prothrombin levels in the blood(optimal indicators 50-40%) on the first day of use, the medicine is prescribed in a dosage of 4 to 6 tablets per day, divided into 3-4 doses, depending on the existing blood picture. On the second day of therapy, the dosage is slightly reduced - to 3-5 tablets. On the third day, the dosage is reduced to 1-2 tablets.

As a prophylactic if there is a risk of developing thromboembolism, the drug is prescribed in a dosage of 0.03 or 0.06 g per day. If it is necessary to take a large dose, it is divided into two doses.

For thrombosis in acute form, heparin is added to the treatment regimen described above. The dosage of the latter is calculated empirically, gradually increasing or decreasing the amount of the administered drug.

It is strictly forbidden to stop taking Phenilin. This should be done by gradually reducing the dosage of the medication.

Throughout the entire therapy, the patient should be under the supervision of a doctor who will monitor the amount of prothrombin in the blood, as well as other factors of its coagulation.

Drug interactions

When used together with other drugs, Phenylin can increase or decrease the effect on the body. This must be taken into account when prescribing the drug in combination with certain medications.

The following drugs enhance the anticoagulant effect of Phenilin to varying degrees:

  • preparations with salicylate;
  • sulfa drugs;
  • cimetidine;
  • anabolic agents;
  • narcotic analgesics;
  • tricyclic antidepressants;
  • glucocorticosteroid drugs;
  • medications with hormones (especially androgens);
  • saline solutions.

Preparations containing ascorbic acid, vitamin K, female sex hormones, diuretics, antacids and barbiturates can reduce the effectiveness of Phenilin.

Side effects

When taking the drug, unwanted symptoms may appear. Most often, the active ingredient in tablets has a negative effect on the liver, as a result of which the patient’s palms may turn yellow.

Also, some patients experience the occurrence of allergic dermatitis and stool disorders in the form of diarrhea. In rare cases, it is possible to develop a febrile state that occurs against a background of elevated body temperature.

If the recommended dosages are exceeded, the manifestations of the disorders listed above are aggravated. The risk of bleeding also increases significantly. Treatment of overdose is symptomatic. Patients are prescribed vitamins K and C, Vikasol and calcium chloride.

Contraindications

The use of the drug Phenilin can have an adverse effect on the body and, therefore, be dangerous in the presence of the following diseases and conditions:

  • hemorrhagic diathesis;
  • first trimester of pregnancy;
  • severe dysfunction of the liver and kidneys;
  • oncology;
  • ulcerative lesions of the gastric or intestinal mucosa;
  • inflammation of the pericardium.

Prescribe medication with extreme caution for pulmonary embolism in elderly patients, as well as during menstruation and in the period after childbirth.

During pregnancy

The drug is contraindicated for use in women at the initial stage of pregnancy, especially in the first third, as well as shortly before childbirth. During breastfeeding, you can take the medicine only after transferring the child to artificial feeding.

Storage conditions and periods

A dark and not too humid place with a temperature of up to 25 degrees Celsius is suitable for storing Phenilin tablets. It is important to ensure that the medication is not available to young children or pets.

The period during which the tablets can be used is 2 years from the date of manufacture. After its expiration, it is recommended to dispose of the drug in its original packaging.

Price

Phenilin tablets belong to the category of drugs available to a wide range of consumers. It can be purchased for a fairly modest price (compared to other drugs with similar effects).

Cost in Russia

In Russian pharmacies, Phenilin can be purchased at a price from 139 to 172 rubles per pack of 20 tablets.

Cost in Ukraine

In Ukrainian pharmacies, a package of 20 tablets costs on average from 20 to 27 hryvnia.

Analogues

Phenilin tablets do not have many analogues, although the pharmaceutical industry produces enough indirect anticoagulants.

The medications closest to the drug described are:

and some others.

However, using them instead of Phenilin is strictly prohibited, since they have a different list of indications and contraindications, as well as modes of action on the hematopoietic system that are different from Phenilin.

Video: "Pharmacology of Warfarin"

The heart is the engine of the human body. Modern life, environmental disaster, unhealthy diet, as well as high levels of stress daily lead to disruption of the functioning of a vital organ.

In most cases, heart diseases lead to a sharp deterioration in a person’s standard of living, less often to disability, and in severe situations to death.

To treat them, a cardiologist may prescribe a drug, for example, the drug Phenilin.

Phenylin is a drug that prevents blood clotting. How should it be taken correctly so that the product has only benefits?

There is a wide range of reviews on the Internet. They can be found in this article.

Instructions for use of this product

In this article you can find information about when exactly the drug can be prescribed, what composition it has, how the drug should be taken, what contraindications it has, what side effects can be identified, how the drug should be stored, and also with which drugs it should not be used in any case. The drug is not recommended to be taken, what actions should be taken in case of an overdose, and also in what form can it be produced?

In addition, here you can also find information such as price, as well as possible analogues.

Pharmacology

To begin to function in the human body, Phenilin must accumulate in the required concentration, therefore its effect does not appear immediately - it begins after 10 hours, and the maximum effect is achieved after a day or two.

The drug Phenilin is absorbed quite well from the gastrointestinal tract. Its further transformation occurs in the liver. It is excreted from the body through the kidneys.

For what conditions is the drug prescribed?

This remedy can be prescribed:

  1. For the treatment of thrombophlebitis or thrombosis;
  2. For the prevention of myocardial infarction;
  3. For embolic strokes.

In addition, the drug can be prescribed for blood clots after surgery.

How to take the product correctly?

Elderly patients should adjust the dosage.

The drug Finilin is prescribed orally to patients over 14 years of age (whose body weight is more than 45 kg). The drug should be taken after meals. The optimal dosage is selected individually in each case. The dosage is influenced by the severity of the disease, the individual characteristics of the patient’s body, nutritional characteristics and the treatment that the patient is already receiving.

Adults are prescribed 4-6 tablets on the first day. The dose is divided into 3-4 times. On the second day, the dosage is reduced to 3-5 days, then it should not exceed two tablets. The duration of receptions per day is several times.

In the first few days, adolescents should take 3-5 tablets in three or four doses, then the dosage is reduced to one or two tablets in one or two doses.

To prevent thromboembolic complications, the drug is prescribed in a dosage of one tablet, which should be taken once or twice a day.

The highest dosage for an adult: single - 50 mg, daily - 200 mg.

Compound

This product can be found in the form of white tablets with a creamy tint.

The product contains phenindione. Auxiliary components are components such as talc, milk sugar, starch, citric acid.

Combination of funds

When combined with ACTH, the anticoagulant effect of the drug Phenilin is enhanced.

When combined with dopyridamole, cases of increased bleeding were observed. This is due to a decrease in adhesiveness, as well as platelet aggregation under the influence of dopyridamole.

When combined with clofibrate, the anticoagulant effect of the drug is enhanced. When combined with liothyronine, the anticoagulant effect of phenindione is enhanced.

When combined with cimetidine, the anticoagulant effect of phenindione increases due to a slowdown in its metabolism in the liver under the influence of cimetidine, which is an inhibitor of liver enzymes.

When taken with ethylestrenol, the anticoagulant effect increases and the risk of bleeding increases.

Adverse reactions

Sometimes the patient's body may malfunction. As a result, the patient may experience symptoms such as:

  1. Vomiting, nausea, diarrhea, constipation, toxic form of hepatitis. Sometimes a person may experience flatulence, bloating, and liver problems.
  2. Arganulocytosis, leukopenia.
  3. Impaired kidney function.
  4. Sleep disturbance, headache.
  5. Change in urine color, fever.
  6. Eosinophilia, skin rash, sudden increase in body temperature, dermatitis, urticaria, skin peeling, itching.

If during treatment you begin to experience these conditions, then in this case you should stop taking this medication, because This drug may harm your health.

Overdose

If a person takes a medicine in a large dosage, the person may experience an overdose.

This condition is evidenced by such manifestations as depression, pain in the abdomen/back/chest, excitability, nausea, vomiting, constipation, diarrhea, bloating, flatulence, sleep disturbance, eosinophilia, hepatitis, disturbances in the liver, disturbances in the functioning of the kidneys , headache, as well as any other manifestations of an overdose.

For treatment, the stomach should be rinsed, and all measures should be taken to eliminate the symptoms that appear in a person.

Contraindications

  1. Disturbances in the functioning of the kidneys and liver (if the disease is serious). If the lesion is mild, then you should not stop taking the drug.
  2. Ulcerative lesions of the gastrointestinal tract, gastritis.
  3. Malignant neoplasms.
  4. Increased vascular permeability.

With increased caution, the drug can be prescribed for gynecological diseases, as well as erosion in the gastrointestinal tract.

Taking medication during pregnancy

If you still need to take this drug, the doctor can prescribe the drug in late pregnancy, but he must carefully monitor the patient.

When breastfeeding, it is also better to refrain from taking this drug, because this is due to the fact that the drug has a negative effect on a small organism.

Moreover, if it is necessary to take the drug during this period of time, then it can only be carried out if natural feeding is abandoned.

Storage

The medicine should be placed in a room where the temperature does not exceed 25 degrees. It should be borne in mind that the chosen place should be sufficiently dark, cool, and also dry.

If you do not comply with these requirements, the service life of the medicine will be sharply reduced. The drug must be removed to a place where children and beloved pets will not have access under any circumstances.

Price

Prices may vary significantly in different countries. For example, we will consider two states - Ukraine and Russia.

The article presents average price data.

Price in Russia is 120 rubles.

In Ukraine for a package of this drug you will have to pay 65.49 hryvnia.

Analogues

Drugs with similar effects are drugs such as Plestasol, Sinkumar, Atrombone, Atherocard, Warfarin, Gedulin, Atrogrel, Acecardine, Diofindal, Agrelide, Pindion, Tromazal, Thrombozol, Phenindione, Trombantine, Phenylindandione and other drugs.

It is worth considering that all these drugs may have different effects on the body, as well as costs. That is why the selection of an analogue should only be carried out by a specialist.


A drug Fenilin- antithrombotic agent.
A drug that affects blood clotting and platelet function. Indirect anticoagulant.
The mechanism of action is due to competitive antagonism with vitamin K. Phenindione blocks vitamin K reductase, disrupts the formation in the liver of the active form of vitamin K, necessary for the synthesis of prothrombin and other blood coagulation factors (VII, IX and X). Causes hypoprothrombinemia.
Reduces plasma tolerance to heparin, blood lipid levels and increases vascular permeability.
The hypocoagulant effect (decrease in the concentration of coagulation factors in the blood) develops gradually (previously synthesized factors of the blood coagulation system continue to act), begins to appear after 8-10 hours and reaches a maximum 24-36 hours after administration. Duration of action is 1 - 4 days after discontinuation of the drug.

Pharmacokinetics

.
After oral administration, it is quickly and almost completely absorbed. The connection with proteins is fragile. Passes through histohematic barriers (including placental) and accumulates in tissues. Metabolized in the liver with the participation of cytochrome P-450. It is excreted by the kidneys unchanged and in the form of metabolites. Can accumulate.

Indications for use

A drug Fenilin used for the prevention and treatment of thrombosis (especially deep veins of the lower extremities), thromboembolic complications (pulmonary embolism, embolic strokes, myocardial infarction, etc.) and thrombus formation in the postoperative period; mechanical prosthetic heart valves (permanent use).

Mode of application

Fenilin prescribed to adults and adolescents (over 14 years of age with a body weight of at least 45 kg; rarely prescribed) orally after meals.
The optimal dose in different patients can vary significantly and depends on individual sensitivity, the nature of the disease, dietary habits and concomitant treatment, as a result of which the selection of the dose is individual.
Adults are prescribed on the first day of treatment in a daily dose of 120 - 180 mg (4 - 6 tablets) in 3 - 4 doses, on the second day - in a daily dose of 90 - 150 mg (3 - 5 tablets), then - 30 -
60 mg (1 - 2 tablets) in 1 - 2 doses, depending on the level of prothrombin in the blood.
Adolescents over 14 years of age (body weight at least 45 kg) are prescribed (rarely) on the first and second days of treatment at a daily dose of 90 - 150 mg (3 - 5 tablets) in 3 - 4 doses, then - 30 - 60 mg (1 - 2 tablets) in 1 - 2 doses, depending on the level of prothrombin in the blood.
The single dose, frequency and duration of use are set individually by the doctor depending on the value of the prothrombin index in the blood, which is maintained at 40 - 60%. If the prothrombin level is less than 40 - 50%, the drug should be discontinued immediately.
To prevent thromboembolic complications, 30 mg (1 tablet) is prescribed 1 to 2 times a day.
Higher doses for adults: single - 50 mg, daily - 200 mg.
The drug should be discontinued gradually.

Side effects

From the blood coagulation system: with long-term use - micro- and macrohematuria, bleeding from the oral cavity and nasopharynx, gastrointestinal bleeding, hemorrhage into the muscles. From the blood system: inhibition of bone marrow hematopoiesis (agranulocytosis, leukopenia, leukemoid reactions). From the digestive system: nausea, diarrhea, toxic hepatitis. From the cardiovascular system: myocarditis. Allergic reactions: skin rash (erythematous, macular, papular), exfoliative dermatitis, eosinophilia, hyperthermia. From the urinary system: impaired renal function, pink colored urine. Other: headache, orange discoloration of palms.

Contraindications

Contraindications to the use of the drug Fenilin are: increased individual sensitivity to the components of the drug, hemophilia, severe liver and/or renal failure, hemorrhagic diathesis, hypocoagulation (initial prothrombin level less than 70%), malignant neoplasms, erosive and ulcerative lesions of the gastrointestinal tract, pregnancy (especially the first trimester and the second half of the third trimester), the period of breastfeeding, childhood.

Pregnancy

A drug Fenilin contraindicated during pregnancy (especially in the first trimester and the second half of the third trimester). The drug should not be used in the first days after childbirth. If use is necessary during lactation, breastfeeding should be discontinued.

Interaction with other drugs

Effect of the drug Fenilin enhance thrombolytic, antiaggregation agents, anticoagulants, adrenocorticotropic hormone, anabolics, azathioprine, allopurine, amiodarone, narcotic analgesics, androgens, antibiotics, tricyclic antidepressants, urinary oxidizing agents, glucocorticosteroids, diazoxide, disopyramide, nalidixic acid, isoniazid, clofibrate, metronidazole , paracetamol, reserpine, vitamin E, butadione, sulfonamides, disufiram, quinidine, cyclophosphamide, thyroid hormones, cimetidine and other microsomal oxidation inhibitors.

The effect of the drug is weakened by vitamin K, propranolol, urine alkalinizers, antacids, cholestyramine, phenazone, haloperidol, diuretics, carbamazepine, barbiturates, oral contraceptives, rifampicin.

Overdose

Overdose symptoms Fenilina: hemorrhagic syndrome (gastrointestinal, uterine, nosebleeds, hematuria, hemorrhages in the skin, muscles, parenchymal organs). Treatment: drug withdrawal; taking vitamin K orally (5 - 10 mg). If serious bleeding develops, 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). In case of massive bleeding or in patients with liver failure, fresh frozen plasma is simultaneously prescribed. It is possible to use aminocaproic acid, vitamins C and P.

Storage conditions

Store in a place protected from light at temperatures from 8 °C to 25 °C. Keep out of the reach of children.
Shelf life - 3 years.

Release form

Phenilin - tablets 30 mg.
No. 20 in a blister in a box.

Compound:
1 tablet Fenilin contains phenyline (phenindione) 30 mg.
Excipients: lactose monohydrate, potato starch (in terms of starch with a moisture content of 10%), talc, citric acid monohydrate.

Additionally

Prescribe the drug with caution Fenilin in old age (increased risk of bleeding, especially intracranial), with liver and/or renal failure, increased vascular permeability, pericarditis, in the postpartum period, with gynecological diseases.
For acute thrombosis, it is prescribed together with heparin.
During the course of treatment with the drug, systematic monitoring of the prothrombin ratio (normal values ​​are 2.0 - 4.0), regular extended coagulation blood tests (coagulogram, thromboelastogram, platelet count), and urine analysis for early detection of hematuria are necessary.
To monitor anticoagulation activity, the prothrombin time indicator is used: reliable prevention of venous thrombosis is achieved by increasing the prothrombin time by 2 times, the arterial time by 3-4 times (the norm is 11-14 sec).
The drug should not be prescribed during menstruation (stop taking it 2 days before it starts) and in the first days after childbirth.
The coloring of urine pink and the palms orange is due to the metabolism of phenindione (transition to the enol form) and is not dangerous. When urine is acidified, the pink color disappears, which can be used to differentiate urine staining from hematuria. If the palms are stained and the color of urine changes, it is recommended to replace the drug with another anticoagulant, with the exception of omefin.
Impact on the ability to drive vehicles and machinery. During the treatment period, you should refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Main settings

Name: PHENILIN
ATX code: B01AA02 -

Anticoagulant therapy in the prevention of systemic embolization in patients with rheumatic heart disease and atrial fibrillation. Prevention after heart valve replacement. Prevention and treatment of venous thrombosis and pulmonary embolism.

Contraindications

Hypersensitivity to phenindione and other components of the drug; hemorrhagic stroke; clinically significant bleeding; within 72 hours after surgery with a risk of severe bleeding, within 48 hours after childbirth; pregnancy; lactation; children under 14 years of age; simultaneous use with medications that increase the risk of bleeding. Phenindione should not be prescribed to patients with severe renal or hepatic impairment, bacterial endocarditis, uncontrolled hypertension, actual or potential hemorrhagic conditions, or to patients with hereditary galactose intolerance, lactase deficiency or glucose-galactase malabsorption.

Cautions for use

Most adverse events associated with phenindione are the result of allergic reactions or anticoagulant effects, so it is important that the need for therapy is reviewed by a physician on a regular basis and should be discontinued when it is no longer required. Patients should be aware of the symptoms of adverse reactions and that they should contact their physician if any signs of adverse events are observed.

Conditions in which the effect of phenindione may be enhanced, requiring dosage reduction, include weight loss, old age, acute illness, impaired renal function, reduced dietary intake of vitamin K, and taking certain medications (see Interactions section).

Conditions that may reduce the effect of phenindione and may require increased dosage include weight gain, diarrhea and vomiting, increased intake of vitamin K, fats or oils, and certain medications (see Interactions section).

When treating phenindione using a standard dosage regimen, the INR should be determined daily or every other day in the first days of treatment. Once the INR has stabilized in the target range, the INR can be determined at longer intervals. INR should be monitored more frequently in patients at increased risk, such as patients with severe hypertension, hepatic or renal impairment, and in patients for whom dosage compliance may be difficult.

Thrombophilia. Patients with protein C or protein S deficiency are at risk; it is advisable to select the dose of phenindione for them individually.

Risk of bleeding. The most common side effect of all oral anticoagulants is hemorrhage. Phenindione should be administered with caution to patients at risk of serious bleeding (eg, concomitant use of nonsteroidal anti-inflammatory drugs, ischemic stroke, bacterial endocarditis, history of gastrointestinal bleeding). Risk factors for bleeding include high intensity anticoagulation (INR > 4.0), age ≥ 65, highly variable INR, history of gastrointestinal bleeding, uncontrolled hypertension, cerebrovascular disease, cardiac disease, orthostatic hypotension, anemia, malignancy, trauma, renal failure, concomitant use of drugs (see section “Interaction”).

In patients with a high risk of bleeding, it is necessary to monitor the INR more frequently, carefully adjust the dose of the drug until the desired INR is achieved, and reduce the duration of therapy as much as possible. Patients should be instructed to minimize the risk of bleeding and to immediately report signs and symptoms of bleeding to their physician. Any concomitant antiplatelet drugs should be used with caution due to the increased risk of bleeding.

Bleeding. Bleeding may indicate an overdose of phenindione (see section “Overdose”). In case of unexpected bleeding, INR monitoring is necessary, and a bleeding episode during anticoagulant therapy should be fully investigated and not automatically considered a manifestation of overdose.

Ischemic attack. Anticoagulant therapy; following an ischemic stroke, increases the risk of secondary hemorrhage in the brain with infarction. In patients with atrial fibrillation, long-term use of phenindione is necessary, but there is a small risk of early recurrence of embolism, so a break in treatment after an ischemic stroke is justified. Treatment with phenindione should be resumed 2-14 days after an ischemic stroke, depending on the size of the infarct area and blood pressure. In patients with large embolic strokes or uncontrolled hypertension, treatment should be stopped for 14 days.

Surgery. For surgical interventions without the risk of severe bleeding, the operation can be performed at the INR

Administration of vitamin K may result in the patient developing resistance to the action of phenindione within a few days. Therefore, when bleeding in patients with heart valve prostheses, it is necessary to administer fresh frozen plasma.

Dentistry. Phenindione may not be stopped until after routine dental surgery, such as a tooth extraction.

Active peptic ulceration. Due to the high risk of bleeding, phenindione should be used with extreme caution in patients with active peptic ulcer disease. Such patients should be under regular medical supervision and be taught how to recognize bleeding and what to do if bleeding occurs.

Thyroid diseases. Patients with hyper- or hypothyroidism should be closely monitored, especially when initiating anticoagulation therapy.

Dosage adjustment of phenindione may be required in cases of acquired or hereditary resistance to phenindione, which should be considered if larger than usual daily doses are required to achieve the desired anticoagulant effect.

The effectiveness of phenindione may be significantly influenced by genetic variation especially in relation to VKORC1 (vitamin K reductase). If a patient has a family association with this polymorphism, additional monitoring is necessary for such patients.

Interaction with othershymic drugs

During therapy with phenindione, careful monitoring of all patients taking concomitant therapy is necessary. Any new concomitant therapy should be consulted for specific instructions on dosage adjustments of phenindione. The need for increased coagulation monitoring should be considered with any new treatment regimen if there is any doubt about the extent of the interaction.

.Drugswhich are contraindicated during therapyphenindione

Concomitant use of drugs used in the treatment or prevention of thrombosis, or other drugs with negative effects on hemostasis, may increase the effect of phenindione, which increases the risk of bleeding. Fibrinolytic drugs such as streptokinase and alteplase are contraindicated in patients receiving phenindione.

Drugs that are taken foropportunity should be avoided

The following drugs should be avoided or used with caution with increased clinical and laboratory monitoring: clopidogrel; NSAIDs (including aspirin and COX-2 specific NSAIDs); sulfinpyrazone; thrombin inhibitors such as bivalirudin, dabigatran; dipyridamole; unfractionated heparins and heparin derivatives, low molecular weight heparins; fondaparinux, rivaroxaban; glycoprotein IIb/IIIa receptor antagonists such as epifibatide, tirofiban and abciximab; prostacyclins; antidepressants from the group of serotonin reuptake inhibitors; clofibrate; miconazole; cytostatics; other drugs that inhibit hemostasis, coagulation or platelet action.

Low-dose aspirin with phenindione may be therapeutic in some patients but increases the risk of gastrointestinal bleeding.

Drugs that have clinically significant interactions withphenindione

The action of phenindione is potentiated by ACTH, allopurinol, amitriptyline/nortriptyline, cimetidine, dextropoxyphene, glucagon, hepatotoxic drugs, phenformin, thyroid compounds, tolbutamide, disulfiram, amiodarone, propafenone, anabolic steroids, corticosteroids, oral contraceptives, zafirlukast.

The effect of phenindione is reduced by barbiturates, carbamazepine, griseofulvin, and phenytoin. Broad-spectrum antibiotics may enhance the effect of phenindione by inhibiting the intestinal flora that produces vitamin K. In addition, orlistat may reduce the absorption of vitamin K. Cholestyramine and sucralfate potentially reduce the absorption of phenindione.

Increases in INR have been reported in patients taking glucosamine or other anticoagulants (eg, warfarin), and this combination is not recommended. Interaction with plant products

Many herbal products theoretically have an effect on the action of phenindione. Patients should avoid taking any herbal medications or dietary supplements and should tell their doctor immediately if they are taking any herbal medications, as this will require more frequent monitoring.

Interaction with food and food additives

Clinical reports from individual patients suggest a possible interaction between anticoagulants (eg, warfarin) and cranberry juice, in most cases resulting in an increase in INR or bleeding. Increased INR control should be considered for any patient taking phenindione and regularly taking cranberry juice. Certain foods such as liver, broccoli, Brussels sprouts, and green leafy vegetables contain large amounts of vitamin K. Drastic changes in diet may potentially affect anticoagulation control. Patients should be advised (INAUDIBLE) to seek medical advice before undertaking any major dietary changes. Many other dietary supplements have theorized effects of (INAUDIBLE) phenindione, but most of these interactions have not been proven. Patients should avoid taking any dietary supplements while taking phenindione or consult a physician if they are taking any dietary supplements.

Features of the use of medicinal productsby somecategoriespatients

Applicationin elderly patients

In elderly patients, the effect of phenindione may increase with an increased risk of bleeding, which requires a reduction in the dosage of the drug.

Application during pregnancy and breastfeeding

Oral anticoagulant therapy is contraindicated during pregnancy due to possible teratogenic effects and the risk of fetal bleeding. It is suggested that heparin, which does not cross the placenta, can be used during the first trimester and after 37 weeks of pregnancy, however, the use of heparin during pregnancy is not completely safe and the patient should be advised by a specialist who is skilled in its management. pregnant patients requiring anticoagulant therapy. Women of childbearing age who are treated with phenindione should be warned about possible complications during pregnancy.

Phenindione passes into breast milk; breast milk should not be fed to infants of mothers receiving phenindione.

Impact on the ability to drive vehicles andwork with complex mechanisms

Phenindione has no or negligible effect on the ability to drive or use machines.

Directions for use and doses

Setting the dose the doctor individually takes into account the sensitivity to the drug, nature of care levaniya, indicators of condition with blood coagulation systems and concomitant treatments.

Prescribed orally after meals. The initial loading dose is 180 mg, the next day - 90 mg. On the 3rd day of therapy, the dose is adjusted depending on the results of control tests on the state of the body's coagulation system, such as prothrombin time and international normalized ratio (INR). It should be taken into account that concomitant therapy with heparin affects the results of INR, so the prescription of heparin should be discontinued at least 6 hours before determining the INR. Control tests of the state of the body's coagulation system should be carried out regularly, at regular intervals, and the dose of the drug should be adjusted depending on the results obtained;

The maintenance dose of the drug for most patients is 60-150 mg/day; for resistant patients it can be increased to 180 mg or more, for more sensitive patients it can be reduced.

Overdose

Symptoms of overdose may appear within 48-72 hours, during which the effect of the anticoagulant develops; the onset of bleeding may be delayed for several days.

Symptoms: spontaneous bruising, hematomas, hematuria, rectal bleeding and hemorrhage into any internal organ.

Treatment: The benefit of gastric decontamination is uncertain. In a patient within one hour of ingesting more than 0.25 mg/kg or more, the use of activated charcoal (50 g for adults; 1 g/kg for children) may be considered. Prothrombin time should be monitored sequentially every 24-48 hours after oral administration depending on the initial dose and initial INR.

For patients on long-term phenindione therapy, INR monitoring is required for at least 48 hours after overdose (inaudible)

bleeding, but the prothrombin time is dangerous (MHC > 6.0), you should immediately consult a doctor for rehabilitation measures.

For patients not on long-term phenindione therapy, with a normal INR for 24-48 hours and no signs of bleeding, there is no need for further monitoring. If the patient; consumed more than 0.25 mg/kg or the prothrombin time is significantly increased (INR > 6.0), you should immediately consult a doctor for rehabilitation measures.

Side effect

Side effects are classified as very often - ≥1/10, often - ≥1/100 and

From the hematopoietic system: frequency unknown - leukopenia; agranulocytosis; lymphadenopathy; eosinophilia; leukocytosis; pancytopenia.

From the immune system: frequency unknown - hypersensitivity.

From the nervous system: frequency unknown - cerebral hemorrhage, cerebral subdural hematoma.

Vascular disorders: frequency unknown - bleeding.

From the outsiderespiratorysystems: frequency unknown: hemothorax, nosebleeds.

From the digestive system: frequency unknown - gastrointestinal bleeding, rectal bleeding, hematemesis, pancreatitis, diarrhea, nausea, vomiting, melena, dysgeusia, hepatitis, jaundice.

From the skin and subcutaneous tissue: frequency unknown - rash, purpura, blue finger syndrome, ecchymosis, alopecia, skin necrosis, exfoliative dermatitis, exanthema.

From the outsideurinarysystems: frequency unknown - hematuria; kidney damage with tubular necrosis; albuminuria.

Others: frequency unknown - fever.

Laboratory tests: frequency unknown - decrease in hematocrit, decrease in hemoglobin. Metabolites of phenindione often cause pink or orange-colored urine. This effect can be distinguished from the color change caused by hemoglobin by adding a few drops of dilute acetic acid to the urine. If the color change is due to phenindione, the discoloration will disappear immediately.

Phenindione

Composition and release form of the drug

20 pcs. - cans (1) - cardboard packs
20 pcs. - contour cell packaging (1) - cardboard packs
50 pcs. - cans (1) - cardboard packs.

pharmachologic effect

Allergic reactions: skin rash, dermatitis, eosinophilia, fever.

Drug interactions

When used simultaneously with ACTH, the anticoagulant effect is enhanced.

When used simultaneously with, cases of increased bleeding are described, apparently due to a decrease in platelet adhesiveness and aggregation under the influence of dipyridamole.

When used simultaneously with clofibrate, the anticoagulant effect is enhanced. It is believed that fibrates may increase the affinity of oral anticoagulants for the corresponding receptors or possibly interfere with the metabolism of anticoagulants.

When used simultaneously with liothyronine, the anticoagulant effect of phenindione is enhanced. It is believed that thyroid hormones can increase the affinity of oral anticoagulants for the corresponding receptors.

When used simultaneously with miconazole, the anticoagulant effect of phenindione is enhanced. The risk of bleeding increases.

When used simultaneously, the anticoagulant effect of phenindione is enhanced due to a slowdown in its metabolism in the liver under the influence of cimetidine, which is an inhibitor of microsomal liver enzymes.

When used simultaneously with ethylestrenol, the anticoagulant effect is enhanced and there is a risk of bleeding.

special instructions

The drug should be used with caution in elderly patients, with hepatic and/or pulmonary embolism (including in oncology), erosive and ulcerative lesions of the gastrointestinal tract, with pericarditis, in the postpartum period.

Treatment should be carried out under close medical supervision with mandatory systematic testing of prothrombin and other coagulation factors in the blood. General urine tests are systematically performed for early detection of hematuria.

Some patients experience orange discoloration of the palms and pink discoloration of the urine, which is associated with the metabolism of phenindione.

Pregnancy and lactation

Contraindicated during pregnancy. Avoid use in the first days after birth.

Phenindione should not be used during lactation (breastfeeding).

Phenindione should be discontinued 2 days before the start and not used during menstruation.

For impaired renal function

The drug should be used with caution in case of renal failure.

For liver dysfunction

The drug should be used with caution in case of liver failure.

Use in old age

The drug should be used with caution in elderly patients.



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