PRADAXA CAPSULES 110MG

Indications and usage

- prevention of venous thromboembolism in patients after orthopedic operations;

- prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation;

- treatment of acute deep vein thrombosis and / or thromboembolism
pulmonary artery disease and the prevention of deaths caused by these diseases;

- prevention of recurrent deep vein thrombosis and / or thromboembolism of the pulmonary artery and deaths,
caused by these diseases.

Capsules should be taken orally, 1 or 2 times / day, regardless of the time of meals, with a glass of water to facilitate the passage of the drug in the stomach. Do not open the capsule.

For the removal of capsules from the blister:

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

- do not squeeze the capsules through the foil;

- it is necessary to remove the foil so that it is convenient to remove the capsules.

Drug is prescribed for adults.

Prevention of venous thromboembolism (VTE) in patients after orthopedic operations: The recommended dose is 220 mg 1 time / day (2 capsules. 110 mg each).

Have patients with moderate renal impairment due to the risk of bleeding, the recommended dose is 150 mg 1 time / day (2 capsules, 75 mg each).

Prevention of VTE after knee arthroplasty: use of the drug Pradaxa ® should begin after 1-4 hours after completion of the operation with receiving 110 mg (1 caps.), followed by increasing the dose to 220 mg (2 caps.) / day 1 time / day for the next 10 days. If hemostasis is not achieved, treatment should be postponed. If treatment has not begun on the day of surgery, therapy should begin with taking 220 mg (2 capsules) / day 1 time / day.

Prevention of VTE after hip arthroplasty use of the drug Pradaxa® should begin after 1-4 hours after completion of the operation with a dose of 110 mg (1 capsule), followed by increasing the dose to 220 mg (2 capsules) / day 1 time / day for the next 28-35 days. If hemostasis is not achieved, treatment should be postponed. If treatment has not begun on the day of surgery, therapy should begin with taking 220 mg (2 capsules) / day 1 time / day.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the use of the drug Pradaxa is recommended® in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day). Therapy must be continued for life.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: the use of the drug Pradaxa is recommended® in a daily dose of 300 mg (1 caps. 150 mg 2 times / day) after parenteral treatment with an anticoagulant for at least 5 days. Therapy should be continued until 6 months.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: the use of the drug Pradaxa is recommended® in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day). Therapy can continue for life, depending on individual risk factors.

Application of patients with impaired renal function

Before therapy, in order to avoid the appointment of the drug to patients with severe renal impairment (CC <30 ml / min), you must first assess the QC. Due to the lack of data on the use of the drug in patients with severe impaired renal function (CC less than 30 ml / min) use of the drug Pradaxa® Not recommended.

Renal function should be assessed in the course of treatment when there is a suspicion of a possible decrease or deterioration of renal function (for example, in case of hypovolemia, dehydration, simultaneous use of certain drugs).

During clinical trials of the drug Pradaxa® As a method for assessing the function of the kidneys, the calculation of QC using the Cocroft-Gault method was used.

Dabigatran is eliminated by hemodialysis; however, clinical experience with patients who are being treated hemodialysislimited

When using the drug Pradaxa® with the aim of prevention of venous thromboembolism in patients after orthopedic surgery at moderate impaired renal function (CC 30-50 ml / min) the daily dose should be reduced to 150 mg (2 capsules. 75 mg 1 time / day).

When using the drug Pradaxa® with the aim of prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation at moderate impaired renal function (CC 30-50 ml / min) dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day). Renal function should be assessed at least once a year.

When using the drug Pradaxa® with the aim of treating acute DVT and / or PEH and preventing deaths caused by these diseases, in patients with QC> 30 ml / min dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day).

When using the drug Pradaxa® with the aim of prevention of recurrent TB and / or pulmonary embolism and death caused by these diseases, in patients with moderate renal dysfunction (CC 30-50 ml / min) dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day). Renal function should be assessed at least once a year.

Use in elderly patients

Due to the fact that the increase in drug exposure in elderly patients (older than 75 years) is often due to a decrease in renal function, it is necessary to evaluate renal function before prescribing the drug. Renal function should be assessed at least once a year or more often, depending on the clinical situation. Dose adjustment of the drug should be carried out depending on the severity of renal dysfunction.

Prevention of venous thromboembolism after orthopedic surgery at patients older than 75 years: application experience is limited. The recommended dose is 150 mg (2 caps. 75 mg in a single dose).

When using the drug Pradaxa® at patients over 80 for the prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation drug Pradaxa® should be taken in a daily dose of 220 mg (1 capsule. 110 mg 2 times / day).

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases in patients older than 75 years: dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day).

Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases in patients older than 75 years: dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day).

Patients with different body weight

Prevention of venous thromboembolism after orthopedic surgery at patients with a body weight <50 kg and more than 110 kg application experience is limited. In accordance with the pharmacokinetic and clinical data dose adjustment is not required. However, observation of such patients is recommended.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: In accordance with the pharmacokinetic and clinical data dose adjustment is not required. However for patients weighing <50 kg observation is recommended.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: no dose adjustment required for body weight.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: no dose adjustment required for body weight.

Simultaneous use of the drug Pradaxa® with active inhibitors of P-glycoprotein (amiodarone, quinidine, verapamil)

Prevention of venous thromboembolism after orthopedic operations: with simultaneous use with Amiodarone , quinidine or Verapamil dose of the drug Pradaxa® should be reduced to 150 mg 1 time / day (2 capsules. 75 mg).

Patients taking the drug Pradaxa® after orthopedic operations, it is not recommended to simultaneously begin the use of verapamil and connect it to therapy in the future.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: dose adjustment is not required, it is recommended to use the drug in a daily dose of 300 mg (1 caps. 150 mg 2 times / day).

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day).

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: dose adjustment is not required. The use of the drug is recommended in a daily dose of 300 mg (1 capsule. 150 mg 2 times / day).

Use in patients with an 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, a moderate decrease in kidney function (CC 30-50 ml / min), simultaneous use of P-glycoprotein inhibitors, or an indication of a history of Gastrointestinal bleeding may increase the risk of bleeding. In patients with one or more of these risk factors, at the discretion of the physician, a decrease in the daily dose of Pradaxa may be possible.® up to 220 mg (1 capsule. 110 mg 2 times / day).

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: the presence of factors such as age 75 years or older, a moderate decrease in kidney function (CC 30-50 ml / min) or an indication of a history of gastrointestinal bleeding may increase the risk of bleeding. In patients with a single risk factor, dose adjustment is not required. For patients with multiple risk factors, clinical data are limited. In these patients, the drug should be used only in cases where the expected benefit exceeds the risk of bleeding.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: the presence of factors such as age 75 years or older, a moderate decrease in kidney function (CC 30-50 ml / min) or an indication of a history of gastrointestinal bleeding may increase the risk of bleeding.In patients with a single risk factor
dose adjustment is not required. For patients with multiple risk factors, clinical data are limited. In such
Patients should use the drug only in cases where the expected benefit exceeds the risk of bleeding.

The transition from the use of the drug Pradaxa® to parenteral use of anticoagulants

Prevention of venous thromboembolism in patients after orthopedic operations: parenteral administration of anticoagulants should be started 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 anticoagulants should be started 12 hours after taking the last dose of Pradaxa®.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: parenteral anticoagulants should be started 12 hours after taking the last dose of Pradaxa®.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: parenteral anticoagulants should be started 12 hours after taking the last dose of Pradaxa®.

The transition from parenteral use of anticoagulants to the use of the drug Pradaxa®

The first dose of the drug Pradaxa® appointed instead of the canceled anticoagulant in the range of 0-2 hours before the next injection of alternative therapy, or simultaneously with the cessation of continuous infusion (for example, in / in the use of unfractionated heparin).

The transition from the use of vitamin K antagonists to the use of the drug Pradaxa®

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the use of vitamin K antagonists is stopped, the use of the drug Pradaxa® possible with MHO <2.0.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: the use of vitamin K antagonists is stopped, the use of the drug Pradaxa® possible with MHO <2.0.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: the use of vitamin K antagonists is stopped, the use of the drug Pradaxa® possible with MHO <2.0.

The transition from the use of the drug Pradaxa® to the use of vitamin K antagonists

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: with QC ≥50 ml / min, use of vitamin K antagonists is possible in 3 days, and in QC 30-50 ml / min - 2 days before discontinuation of the drug Pradaxa®.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: with QC ≥50 ml / min, use of vitamin K antagonists is possible in 3 days, and in QC 30-50 ml / min - 2 days before discontinuation of the drug Pradaxa®.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: with QC ≥50 ml / min, use of vitamin K antagonists is possible in 3 days, and in QC 30-50 ml / min - 2 days before discontinuation of the drug Pradaxa®.

Cardioversion

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

Conducting a planned or emergency cardioversion does not require discontinuation of therapy with Pradaxa®.

Missed dose

Prevention of venous thromboembolism in patients after orthopedic operations: It is recommended to take the usual daily dose of Pradaxa.® at the usual time the next day. In case of missing 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: missed dose of Pradaxa® can be taken if 6 hours or more remains before taking the next dose; If the period is less than 6 hours, the missed dose should not be taken. In case of missing individual doses, you should not take a double dose of the drug.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: missed dose of Pradaxa® can be taken if 6 hours or more remains before taking the next dose; If the period is less than 6 hours, the missed dose should not be taken. In case of missing individual doses, you should not take a double dose of the drug.

Prevention of recurrent DVT and / or PATE and deaths caused by these diseases: missed dose of Pradaxa® can be taken if 6 hours or more remains before taking the next dose; If the period is less than 6 hours, the missed dose should not be taken. In case of missing individual doses, you should not take a double dose of the drug.

Determination of the frequency of side effects (number of registered cases / number of patients): very often (up to 1/10), often (from 1/100 to 1/10), rarely (from 1/1000 to 1/100), is unknown (side effects can not be estimated based on available data), not applicable (side effect was not detected when applied for this indication).

Contraindications

- renal failure severe (CC <30 ml / min);

- active clinically significant bleeding, hemorrhagic diathesis, spontaneous or pharmacologically induced impairment of hemostasis;

- damage to the organs as a result of clinically significant bleeding, including hemorrhagic stroke during the previous 6 months before the start of therapy;

- significant risk of major bleeding from existing or recent ulceration of the gastrointestinal tract, the presence of malignant tumors with a high risk of bleeding, recent damage to the brain or spinal cord, recent surgery on the brain or spinal cord or ophthalmic surgery, recent intracranial hemorrhage, the presence or suspicion of varicose veins veins of the esophagus, congenital arteriovenous defects, vascular aneurysms or large intravertebral or intracerebral vascular disorders;

- simultaneous administration of any other anticoagulants, incl.
unfractionated Heparin , low molecular weight heparins (including enoxaparin, dalteparin), heparin derivatives
(including fondaparinux), oral anticoagulants (including Warfarin , rivaroxaban, apixaban), except when switching treatment with or to Pradaxa® or in the case of using unfractionated heparin in doses necessary to maintain a central venous or arterial catheter;

- simultaneous administration of Ketoconazole for systemic use, cyclosporine, itraconazole, tacrolimus and dronedarone;

- abnormal liver function and liver diseases that may affect survival;

- the presence of prosthetic heart valve;

- children's and teenage age till 18 years (clinical data are absent);

- hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients.

WITH caution the drug should be used in conditions that increase the risk of bleeding:

- age 75 years and older;

- moderate decrease in renal function (CC 30-50 ml / min);

- simultaneous use of P-glycoprotein inhibitors (for a lawsuit