How can you replace pradaxa cheaper, the best analogues and substitutes

Description of the drug

The capsules are oblong in shape with a soft creamy shell. The main active ingredient is dabigatran etexilate. You can buy it in any dosage - 75; 100; 150 mg. Excipients are hypromellose, tartaric acid, gum arabic, carrageenan, potassium chloride.

The main element of Pradaxa reduces blood clotting. The mechanism of action occurs through the suppression of thrombin, which involves a strain in the form of a serine protease, which initiates the process of blood clotting with modification of soluble fibrinogen. After taking the medication, the active substance is instantly absorbed from the intestine into the plasma. Its pharmaceutical concentration in the circulatory system is achieved 2 hours after consumption.

The drug is excreted unchanged in the urine by the kidneys after about 14 hours. In elderly people or with kidney pathologies with low activity, the half-life may increase (this must be taken into account when prescribing the dosage of the drug).

Description of the drug PRADAXA® (PRADAXA)

Concomitant use with drugs that affect hemostasis or coagulation processes, including vitamin K antagonists, can significantly increase the risk of bleeding.

The substrate for the transport molecule P-glycoprotein is dabigatran etexilate. The simultaneous use of P-glycoprotein inhibitors (amiodarone, verapamil, quinidine, ketoconazole for systemic use or clarithromycin) leads to an increase in the concentration of dabigatran in the blood plasma.

With simultaneous use of dabigatran etexilate with a single dose of amiodarone (600 mg) taken orally, the degree and rate of absorption of amiodarone and its active metabolite, desethylamiodarone, did not change. The AUC and Cmax values of dabigatran increased approximately 1.6 and 1.5 times (60% and 50%), respectively. In a study in patients with atrial fibrillation, dabigatran concentrations increased by no more than 14%, and no increased risk of bleeding was observed.

After simultaneous use of dabigatran etexilate and dronedarone at a single dose of 400 mg, the AUC0-∞ and Cmax of dabigatran increased by 2.1 and 1.9 times (by 114% and 87%), respectively, and after repeated use of dronedarone at a dose of 400 mg/day - by 2.4 and 1.9 times. 2.3 (by 136% and 125%), respectively. After single and multiple doses of dronedarone, 2 hours after administration of dabigatran etexilate, AUC0-∞ increased by 1.3 and 1.6 times, respectively. Dronedarone did not affect the final T1/2 and renal clearance of dabigatran.

When dabigatran etexilate was co-administered with verapamil administered orally, the Cmax and AUC values of dabigatran increased depending on the time of administration and the dosage form of verapamil. The greatest increase in the effect of dabigatran was observed with the first dose of immediate-release verapamil, administered 1 hour before dosing with dabigatran etexilate (Cmax increased by 180% and AUC increased by 150%). When using the sustained release formulation of verapamil, this effect was progressively reduced (Cmax increased by 90% and AUC by 70%), as well as when using multiple doses of verapamil (Cmax increased by 60% and AUC by 50%), which may be explained by the induction of P-glycoprotein in the gastrointestinal tract with long-term use of verapamil. When verapamil was used 2 hours after taking dabigatran etexilate, no clinically significant interaction was observed (Cmax increased by 10% and AUC by 20%), since dabigatran was completely absorbed after 2 hours. In a study in patients with atrial fibrillation, dabigatran concentrations increased by no more than 21%, and no increased risk of bleeding was observed.

Ketoconazole for systemic use after a single dose of 400 mg increases the AUC0-∞ and Cmax of dabigatran by approximately 2.4 times (by 138% and 135%), respectively, and after repeated administration of ketoconazole at a dose of 400 mg/day - by approximately 2.5 times (by 153% and 149%) respectively. Ketoconazole did not affect Tmax and final T1/2. The combination of dabigatran etexilate and ketoconazole for systemic use is contraindicated.

With simultaneous use of clarithromycin at a dose of 500 mg 2 times / day with dabigatran etexilate, no clinically significant pharmacokinetic interaction was observed (Cmax increased by 15% and AUC by 19%).

The AUCt,ss and Cmax,ss values of dabigatran when used 2 times a day in the case of simultaneous administration with quinidine at a dose of 200 mg every 2 hours until a total dose of 1000 mg increased on average by 53% and 56%, respectively.

Concomitant use of dabigatran etexilate and P-gp inducers should be avoided as concomitant use will result in decreased exposure to dabigatran.

Pretreatment with the test inducer rifampicin at a dose of 600 mg/day for 7 days resulted in a decrease in exposure to dabigatran. After discontinuation of rifampicin, this inductive effect decreased; on day 7, the effect of dabigatran was close to the initial level. Over the next 7 days, no further increase in the bioavailability of dabigatran was observed.

It is assumed that other P-glycoprotein inducers, such as St. John's wort or carbamazepine, are also capable of reducing plasma concentrations of dabigatran; such combinations should be used with caution.

When studying the simultaneous use of dabigatran etexilate at a dose of 150 mg 2 times / day and acetylsalicylic acid in patients with atrial fibrillation, it was found that the risk of bleeding may increase from 12% to 18% (with a dose of acetylsalicylic acid 81 mg) and up to 24% (when using acetylsalicylic acid at a dose of 325 mg). It has been shown that acetylsalicylic acid or clopidogrel, used simultaneously with dabigatran etexilate at a dose of 110 mg or 150 mg 2 times a day, may increase the risk of major bleeding. Bleeding is also observed more often with the simultaneous use of warfarin with acetylsalicylic acid or clopidogrel.

It was found that the simultaneous use of dabigatran etexilate and clopidogrel does not lead to an additional increase in capillary bleeding time compared to clopidogrel monotherapy. In addition, it was shown that the AUCt,ss and Cmax,ss values of dabigatran, as well as the coagulation parameters that were monitored to evaluate the effect of dabigatran (aPTT, ecarin clotting time or thrombin time (anti FIIa), as well as the degree of inhibition of platelet aggregation (main the effect index of clopidogrel) during combination therapy did not change compared with the corresponding indicators in monotherapy. When using a “loading” dose of clopidogrel (300 or 600 mg), the AUCt,ss and Cmax,ss values of dabigatran increased by 30-40%.

When dabigatran etexilate and pantoprazole were co-administered, a 30% decrease in the AUC of dabigatran was observed. Pantoprazole and other proton pump inhibitors were used with dabigatran etexilate in clinical studies and no effect on bleeding risk or efficacy was observed.

Indications and contraindications

Pradaxa should be used to eliminate thromboembolic disorders caused by the intravascular appearance of blood clots. Indications for use are as follows:

atrial arrhythmia;
deep vein thrombosis;
stroke and myocardial infarction;
prevention of cardiovascular damage in people with atrial fibrillation;
to prevent thromboembolism after orthopedic surgery.

Prescribing the drug is possible only after the approval of a vascular surgeon, since this is a very serious medication with a lot of contraindications. Even a slight overdose or violation of the therapeutic course can cause irreversible consequences.

During pregnancy, Pradaxa is prescribed in extreme, life-threatening cases, and stopping breastfeeding is also a precautionary measure.

Contraindications to the use of the medicine:

personal intolerance to the constituent components;
severe kidney dysfunction;
stomach and duodenal ulcers;
liver disorder;
venous expansion of the lower region of the esophagus;
severe bleeding.

Pradaxa should not be used for gastritis, esophagitis, bacterial endocarditis, thrombocytopenia, chronic recurrent pathology of the esophagus, congenital or acquired disorder of the circulatory system affecting coagulation. These diseases can cause bleeding.

Instructions for use

Pradaxa is indicated exclusively for adult patients. The capsule is taken orally with water 1-2 times a day, regardless of meals. The dose and mode of use of the drug depends on the pathology and certain conditions. Method of using the anticoagulant:

as a preventive measure for thromboembolic complications after orthopedic surgery, 220 mg per day is prescribed; in case of relative renal failure - 75 mg twice a day;
to prevent stroke, myocardial infarction - the dose is 150 mg 2 times a day throughout life;
in order to eliminate acute venous thrombosis and to prevent the formation of pulmonary embolism, the daily dose is 300 mg (i.e. 150 mg twice a day); Duration of treatment - 6 months.

Depending on the prescriptions and the degree of manifestation of the functional capacity of the kidneys, the dose of the drug will range from 150-300 mg per day. When a conjugate lesion appears with possible bleeding, the norm is reduced to 220 mg. Patients weighing less than 50 kg are treated under medical supervision.

Dabigatran etexilate, if taken incorrectly, can provoke negative reactions: anemia, dyspepsia, bronchospasm, bleeding from the nasal passage, pain in the epigastric region, various allergic manifestations (urticaria, rash), anaphylactic shock, expectoration of blood, hemartosis, hematomas.

Pradaxa®

Concomitant use with drugs that affect hemostasis or coagulation processes, including vitamin K antagonists, can significantly increase the risk of bleeding.

Pharmacokinetic interactions

In vitro studies have not established an inducing or inhibitory effect of dabigatran on cytochrome P450. In in vivo studies in healthy volunteers, no interaction was observed between dabigatran etexilate and atorvastatin (CYP3A4 substrate) and diclofenac (CYP2C9 substrate).

Interaction with inhibitors/inducers of P-

glycoprotein:

Concomitant use with P-glycoprotein inhibitors:

Dose selection in the case of using the listed P-glycoprotein inhibitors for the prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation is not required. If used for the prevention of venous thromboembolism in patients after orthopedic surgery, see sections “Dosage regimen” and Drug interactions.”

Amiodarone

. With simultaneous use of dabigatran etexilate with a single dose of amiodarone (600 mg) taken orally, the degree and rate of absorption of amiodarone and its active metabolite, desethylamiodarone, did not change. The AUC and Cmax values of dabigatran increased approximately 1.6 and 1.5 times (60% and 50%), respectively. In a study in patients with atrial fibrillation, dabigatran concentrations increased by no more than 14%, and no increased risk of bleeding was observed.

Dronedarone.

Verapamil.

Ketoconazole.

Ketoconazole for systemic use after a single dose of 400 mg increases the AUC0-∞ and Cmax of dabigatran by approximately 2.4 times (by 138% and 135%), respectively, and after repeated administration of ketoconazole at a dose of 400 mg/day - by approximately 2.5 times (by 153% and 149%) respectively. Ketoconazole did not affect Tmax and final T1/2. The simultaneous use of Pradaxa® and ketoconazole for systemic use is contraindicated.

Clarithromycin.

Quinidine.

Concomitant use with P-glycoprotein substrates:

Digoxin.

With simultaneous use of dabigatran etexilate with digoxin, which is a substrate of P-glycoprotein, no pharmacokinetic interaction was observed. Neither dabigatran nor the prodrug dabigatran etexilate are clinically significant P-gp inhibitors.

Concomitant use with P-glycoprotein inducers:

The simultaneous use of Pradaxa® and P-glycoprotein inducers should be avoided, since combined use leads to a decrease in the exposure of dabigatran.

Rifampicin.

It is expected that other P-glycoprotein inducers, such as St. John's wort or carbamazepine, may also reduce plasma concentrations of dabigatran and should be used with caution.

Concomitant use with antiplatelet agents

Acetylsalicylic acid (ASA).

When studying the simultaneous use of dabigatran etexilate at a dose of 150 mg 2 times / day and ASA in patients with atrial fibrillation, it was found that the risk of bleeding may increase from 12% to 18% (when using ASA at a dose of 81 mg) and up to 24% (when using ASA at a dose of 325 mg). It has been shown that ASA or clopidogrel, used simultaneously with dabigatran etexilate at a dose of 110 mg or 150 mg 2 times a day, may increase the risk of major bleeding. Bleeding is also observed more often with the simultaneous use of warfarin with ASA or clopidogrel.

NSAIDs.

NSAIDs used for short-term analgesia after surgery did not increase the risk of bleeding when used simultaneously with dabigatran etexilate. Experience with long-term use of NSAIDs with a half-life of less than 12 hours with dabigatran etexilate is limited, and there is no evidence of an additional increase in the risk of bleeding.

Clopidogrel.

Concomitant use with drugs that increase the pH of the gastric contents

Pantoprazole.

Ranitidine.

Ranitidine, when used concomitantly with dabigatran etexilate, did not have a significant effect on the degree of absorption of dabigatran. The changes in the pharmacokinetic parameters of dabigatran identified during the population analysis under the influence of proton pump inhibitors and antacid drugs turned out to be clinically insignificant, since the severity of these changes was small (the decrease in bioavailability was not significant for antacids, but for proton pump inhibitors it was 14.6%). It was found that the simultaneous use of proton pump inhibitors is not accompanied by a decrease in the concentration of dabigatran and, on average, only slightly reduces the concentration of the drug in the blood plasma (by 11%). Therefore, concomitant use of proton pump inhibitors does not appear to lead to an increased incidence of stroke or systemic thromboembolism, especially when compared with warfarin, and therefore the decrease in dabigatran bioavailability caused by concomitant use of pantoprazole is probably not clinically significant.

Cheap analogues of Pradaxa

Pradaxa is available in Austria and Germany. The capsules are very effective, but the only drawback is the price of the medicine. A pack of 10 tablets. You can buy it for 670 rubles, and a package with 180 capsules for 9500 rubles. Below is a table with cheaper anticoagulant substitutes:

A drug	Active substance	Manufacturer	Price
Warfarin	warfarin sodium	Denmark	90-190 rub.
Fraxiparine Forte	nadroparin calcium	France	475-680 rub.
Magnicor	magnesium hydroxide, acetylsalicylic acid	Ukraine, Kyiv	60-120 rub.
Atherocardium	clopidogrel	Ukraine, Kyiv	90-370 rub.
Fenilin Health	phenindione	Ukraine, Kharkov	40-55 rub.
Clopidogrel	clopidogrel	Izvarino Pharma LLC (Russia)	280-320 rub.
Heparin	heparin sodium	Yugoslavia; Belarus; Russia	330-490 rub.
Xarelto	rivaroxaban	Germany	From 1315-10000 rub.
Sinkumar	acenocoumarol	Hungary; Germany	365-390 rub.
Warfarex	warfarin	Latvia	115-215 rub.
Warfarin Orion	warfarin	Finland	150-390 rub.

Pradaxa and its substitutes belong to the group of medications that should be used in cases of extreme health risk.

Xalerto

Xarelto is an effective analogue of Pradaxa and is also an anticoagulant. The main substance is rivaroxaban, which inhibits clotting factor 10, eliminating the thrombin burst, which prevents the formation of blood clots.

Indications for use: the component is used to prevent the appearance of blood clots during surgery on the lower extremities; prevention of secondary pulmonary embolism or deep vein thrombosis.

Instructions for use: the dosage of the drug is prescribed - from 10-30 mg, once. It is allowed to divide a large dose into 2 doses. Contraindications for taking Xarelto:

During pregnancy and breastfeeding;
children under 18 years of age;
tendency to allergies;
severe disorders of the liver and kidneys;
changes in carbohydrate metabolism;
severe bleeding.

Rivaroxaban is not used in combination with other drugs of similar action. Negative reactions: hemorrhage, decreased blood pressure, anemia, increased heart rate, increased activity of liver enzymes, pain in the legs.

Which is better than Pradaxa or Xarelto depends on the presence and severity of the disease. The second drug has an immediate effect on thrombus formation. Therefore, it is advisable to prescribe it for acute thrombosis and blockage of large capillaries. Xarelto is effective for atrial fibrillation. But in terms of price category, Pradaxa is slightly lower than Xarelto.

Warfarin

Warfarin, an analogue of Pradaxa, has indirect anticoagulant activity. The effect is formed by blocking clotting enzymes, caused by the amount of vitamin K. The indications for both medications are identical:

thrombophlebitis of veins;
preventive measures for secondary myocardial infarction;
recurrent strokes;
TELA.

Warfarin should not be used during pregnancy, lactation, allergic reactions, kidney and liver disorders, capillary aneurysm, esophageal varicose veins. Adverse consequences if the medication is taken incorrectly are bleeding, increased dynamics of liver enzymes, and soft tissue necrosis.

The doctor will tell you which of the 2 drugs is better and how long to treat them. For example, many experts recommend Warfarin, since it is quite popular and has been used for a long time, released more than 60 years ago. The product has been well studied and is accessible due to its inexpensive price. You can buy it for only 90 rubles. Since preventive measures require constant use of medication, and not everyone is able to purchase expensive Pradaxa.

Eliquis

Eliquis is a direct anticoagulant, the main substance is apixaban. The result of the drug is based on the inhibition of the tenth factor of blood clotting, helping to prevent the occurrence of thrombosis. The analogue is effective in preventing the occurrence of blood clots after joint replacements performed in people with atrial fibrillation, pulmonary embolism. Eliquis is not prescribed:

up to 18 years old;
pregnant and lactating women;
for kidney and liver diseases;
when carbohydrate metabolism changes;
at the time of severe hemorrhage;
simultaneously with additional anticoagulants.

Apixaban is indicated for oral administration. Dosage: 1 tablet. twice a day. Negative phenomena include the formation of blood in urine, anemia, and a high likelihood of injury. A package of Eliquis costs from 800-2500 rubles.

Eliquis or Pradaxa, which is better to choose is difficult to say. Both drugs have the same indications and contraindications, but the first medication is cheaper than the second. Eliquis very rarely provokes adverse reactions.

Fraxiparine

Fraxiparine is a direct anticoagulant, meaning low molecular weight heparin. The medication is available in the form of a solution for subcutaneous administration in a disposable syringe; it can also be purchased in blisters of 2-5 strips.

The dosage of the Pradaxa analogue and the duration of treatment are determined by the physician in accordance with the characteristics of the patient’s body. To prevent thromboembolism, 0.3 ml of the drug is administered 2-4 hours before surgery, then once a day for a week. Fraxiparine should not be used during pregnancy. The price of the medicine is 3000 rubles.

Clopidogrel

Clopidogrel is a synthetic tablet used to prevent pathologies of the heart and blood vessels. Available in the form of pink capsules. Each pill contains 75 mg of the active ingredient clopidogrel hydrogen sulfate. In case of a high risk of bleeding after injuries, operations should be taken with caution. The price ranges from 600-800 rubles. When treating with the drug, alcohol intake should be avoided.

Sinkumar

The main substance of Sinkumar is acenocoumarol, which suppresses the dynamics of prothrombin. In 1 tab. - 2 mg of component. Helps with embolism and thrombosis. The maximum effect is observed 2-4 days after use. After discontinuation of the substance, the previous prothrombin level resumes after 24-48 hours. During the period of therapy with the drug, the patient’s general well-being and changes in blood clotting must be carefully monitored.

If bleeding occurs during treatment, acenocoumarol should be discontinued.

List of contraindications:

complex liver disorders;
hemorrhages, hemorrhagic diathesis;
ulcerative pathology of the duodenum and stomach.

Sinkumar can provoke dyspeptic disorders, the risk of hemorrhages increases, nausea, diarrhea, skin rash, and headache are possible. You need to take 4-8 mg tablets once. The drug is produced in Germany and sold for 500-700 rubles. per package. Compatibility with sulfonamides, non-steroidal, and certain antibiotics increases the effect of Sinkumar. And contraceptive and diuretic medications weaken its effectiveness.

PRADAXA

Directions for use and doses

Capsules should be taken orally, 1 or 2 times a day, regardless of meal time, with a glass of water to facilitate the passage of the drug into the stomach.
The capsule should not be opened. Special instructions when removing capsules from the blister:

— tear off one individual blister from the blister pack along the perforation line;

- remove the capsule from the blister, peeling off the foil;

— do not squeeze capsules through the foil.

PRADAXA is available in 75 mg, 110 mg and 150 mg capsules.

Use in adults:

Prevention of venous thromboembolism (VTE) in patients after orthopedic surgery:

The recommended dose is 220 mg 1 time per day (2 capsules of 110 mg each).

In patients with moderate renal impairment

due to the risk of bleeding, the recommended dose is 150 mg 1 time per day (2 capsules of 75 mg).

Prevention of VTE after knee replacement:

The use of PRADAXA should begin 1-4 hours after completion of the operation with 1 capsule (110 mg), followed by an increase in dose to 2 capsules (220 mg) once a day over the next 10 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 2 capsules (220 mg) once a day.

Prevention of VTE after hip replacement:

The use of PRADAXA should begin 1-4 hours after completion of the operation with 1 capsule (110 mg), followed by an increase in dose to 2 capsules (220 mg) once a day over the next 28-35 days. If hemostasis is not achieved, treatment should be delayed. If treatment has not started on the day of surgery, therapy should begin with 2 capsules (220 mg) once a day.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy should continue for life.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day) after parenteral anticoagulant treatment for at least 5 days. Therapy should continue for up to 6 months.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

It is recommended to use PRADAXA in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day). Therapy can be continued for life, depending on individual risk factors.

Use in special patient groups

Use in children

The effectiveness and safety of PRADAXA have not been studied in patients under 18 years of age, therefore use in children is not recommended (see section “Contraindications”).

Renal dysfunction

Before therapy, to avoid prescribing the drug to patients with severe renal impairment

(creatinine clearance less than 30 ml/min), it is necessary to first evaluate creatinine clearance. Due to the lack of data on the use of the drug in patients with severely impaired renal function (creatinine clearance less than 30 ml/min), the use of PRADAXA is contraindicated (see section “Contraindications”).

Renal function should be assessed during treatment when there is a suspicion of a possible decrease or deterioration in renal function (for example, with hypovolemia, dehydration, simultaneous use of certain medications, etc.).

During the clinical development of PRADAXA, the Cocroft-Gault method was used to assess renal function.

Dabigatran is eliminated by hemodialysis; however, clinical experience with hemodialysis patients is limited.

When using PRADAXA for the prevention of venous thromboembolism
in patients after orthopedic surgery
with moderate renal impairment (creatinine clearance 30 - 50 ml/min), the daily dose of the drug should be reduced to 150 mg (2 capsules of 75 mg 1 time per day).

When using PRADAXA to prevent stroke, systemic thromboembolism and reduce cardiovascular mortality in patients with atrial fibrillation

for
moderate
renal dysfunction (creatinine clearance 30 - 50 ml/min), no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Kidney function should be assessed at least once a year.

When using PRADAXA to treat acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevent deaths caused by these diseases

with CC ˃30 ml/min, no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

When using PRADAXA to prevent recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases,

for
moderate
renal dysfunction (creatinine clearance 30-50 ml/min), no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day). Kidney function should be assessed at least once a year.

Use in elderly patients

Due to the fact that increased drug exposure in elderly patients (over 75 years of age) is often due to decreased renal function, renal function should be assessed before prescribing the drug. Renal function should be assessed at least once a year or more frequently depending on the clinical situation. Dose adjustment of the drug should be carried out depending on the severity of renal dysfunction (see “Renal dysfunction”).

Prevention of venous thromboembolism in elderly patients (over 75 years of age) after orthopedic surgery:

Application experience is limited. The recommended dose is 150 mg (2 capsules of 75 mg once).

When using PRADAXA in elderly patients over 80 years of age to prevent stroke, systemic thromboembolism and reduce cardiovascular mortality in patients with atrial fibrillation

PRADAXA should be taken in a daily dose of 220 mg (1 capsule of 110 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases in patients over 75 years of age:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases in patients over 75 years of age:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Effect of body weight

Prevention of venous thromboembolism (VTE) in patients after orthopedic surgery:

in patients weighing less than 50 kg and more than 110 kg, experience with use is limited. In accordance with pharmacokinetic and clinical data, no dose adjustment is required. However, it is recommended to monitor such patients.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

According to pharmacokinetic and clinical data, no dose adjustment is required. However, patients weighing less than 50 kg are recommended to be monitored.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

no dose adjustment is required depending on body weight.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

no dose adjustment is required depending on body weight.

Concomitant use of PRADAXA with active P-glycoprotein inhibitors (amiodarone, quinidine, verapamil) for the prevention of venous thromboembolism in patients after orthopedic surgery:

When used concomitantly with amiodarone, quinidine or verapamil, the dose of PRADAXA should be reduced to 150 mg once a day (2 capsules of 75 mg) (see section “Interaction with other drugs”). Patients taking PRADAXA after orthopedic surgery are not recommended to start using verapamil at the same time and connect it to therapy in the future.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

no dose adjustment is required; patients are recommended to use the drug in a daily dose of 300 mg (1 capsule of 150 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

no dose adjustment is required. It is recommended to use the drug in a daily dose of 300 mg (1 capsule 150 mg 2 times a day).

Use in patients at increased risk of bleeding

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

the presence of factors such as age 75 years or older, moderate decrease in renal function (creatinine clearance 30-50 ml/min), simultaneous use of P-glycoprotein inhibitors, antiplatelet agents, or a history of gastrointestinal bleeding may increase the risk of bleeding (see "Special Concerns" instructions"). In patients with one or more of these risk factors, at the discretion of the physician, the daily dose of PRADAXA may be reduced to 220 mg (take 1 capsule 110 mg 2 times a day).

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

the presence of factors such as age 75 years or older, moderate reduction in renal function (creatinine clearance 30-50 ml/min) or a history of gastrointestinal bleeding may increase the risk of bleeding (see "Special Instructions"). In patients with one risk factor, no dose adjustment is required. For patients with multiple risk factors, clinical data are limited. In such patients, the drug should be used only in cases where the expected benefit outweighs the risk of bleeding.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

Transition from the use of PRADAXA to parenteral use of anticoagulants

Prevention of venous thromboembolism in patients after orthopedic surgery:

Parenteral administration of anticoagulants should begin 24 hours after taking the last dose of PRADAXA.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

Parenteral use of anticoagulants should be started 12 hours after taking the last dose of PRADAXA.

Transition from parenteral anticoagulants to PRADAXA

The first dose of PRADAXA is prescribed instead of the discontinued anticoagulant in the interval 0-2 hours before the next injection of alternative therapy or simultaneously with the cessation of a continuous infusion (for example, intravenous use of unfractionated heparin, UFH).

Switching from vitamin K antagonists to PRADAXA

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

the use of vitamin K antagonists is discontinued; the use of PRADAXA is possible when the INR is <2.0.

Switching from PRADAXA to vitamin K antagonists

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

with creatinine clearance ≥50 ml/min, the use of vitamin K antagonists is possible 3 days, and with creatinine clearance 30-50 ml/min - 2 days before discontinuation of PRADAXA.

Cardioversion

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation

Planned or emergency cardioversion does not require discontinuation of PRADAXA therapy.

Missed dose

Prevention of venous thromboembolism in patients after orthopedic surgery:

It is recommended that you take your usual daily dose of PRADAXA at your usual time the next day. If you miss individual doses, you should not take a double dose of the drug.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation:

a missed dose of PRADAXA can be taken if there are 6 hours or more left before taking the next dose of the drug; If the period is less than 6 hours, the missed dose should not be taken. If you miss individual doses, you should not take a double dose of the drug.

Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of deaths caused by these diseases:

Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and deaths caused by these diseases:

Pradaxa and its best analogues

Pradaxa is a serious medication from the group of anticoagulants. The active substance prevents the formation of blood clots by inhibiting thrombin activity. Taking the medicine incorrectly can lead to hemorrhagic disorders and bleeding.

If Pradaxa is not suitable for some reason, it can be replaced with a domestic or imported analogue, which will help prevent the occurrence of thrombosis. Medicines have different prices, but similar effects. The list of indications and contraindications and negative consequences is almost the same.