Pradaksa

Pradaksa is a highly effective drug in the form of capsules for oral administration.

The manufacturer of this medicine is the famous German pharmaceutical company Boehringer Ingelheim Pharma. It belongs to the category of anticoagulants and direct inhibitors of thrombin and therefore is often prescribed for the prevention of strokes, as well as the prevention and treatment of deep vein thrombosis.

This drug is intended exclusively for adults. Its daily dosage is 1-2 capsules, which should be taken with a small amount of water.

Clinico-pharmacological group

Anticoagulant. Direct inhibitor of thrombin.

Pharmacy sales terms

It is released on prescription.

Prices

How much does Pradax cost in pharmacies? The average price is at the level of 2 000 rubles.

Release form and composition

Available in dosage form capsules for oral administration. They have an oblong shape, a relatively soft texture, as well as a cream-colored shell. Inside the capsule contains small yellow pellets.

Ingredients 1 capsules:

  • Active ingredient: dabigatran etexilate - 75, 110 or 150 mg (dabigatran etexilate mesylate - 86.48 / 126.83 / 172.95 mg);
  • Auxiliary components (75/110/150 mg): acacia gum - 4.43 / 6.5 / 8.86 mg, coarse-grained tartaric acid - 22.14 / 32.48 / 44.28 mg, tartaric acid powder - 29, 52 / 43.3 / 59.05 mg, crystalline tartaric acid - 36.9 / 54.12 / 73.81 mg, hypromellose - 2.23 / 3.27 / 4.46 mg, dimethicone - 0.04 / 0 , 06 / 0.08 mg, talc - 17.16 / 25.16 / 34.31 mg, hydroxypropylcellulose (hyprolosis) - 17.3 / 25.3734.59 mg;
  • Capsule shell (75/110/150 mg): Hypromellose capsule (HPMC) - 60/70/90 mg;
  • HPMC capsules (75/110/150 mg): carrageenan (E407) - 0.2 / 0.22 / 0.285 mg, potassium chloride - 0.27 / 0.31 / 0.4 mg, titanium dioxide (E171) - 3 , 6 / 4.2 / 5.4 mg, indigo carmine (E132) - 0.036 / 0.042 / 0.054 mg, yellow sunset dye (E110) - 0.002 / 0.003 / 0.004 mg, hydroxypropylmethylcellulose (hypromellose) - 52.9 / 61, 71 / 79.35 mg, purified water - 3 / 3.5 / 4.5 mg;
  • Black ink (%, mass.): Potassium hydroxide - 0.5-0.1%, shellac - 24-27%, butanol - 1-3%, isopropanol - 1-3%, propylene glycol - 3-7%, ethanol - 23-26%, aqueous ammonia - 1-2%, black iron oxide dye (E172) - 24-28%, purified water - 15-18%.

Pradaks capsules are packaged in foil blisters of 10 pieces or in a polyethylene bottle of 60 pieces. One package can contain 1, 3 or 6 blisters, as well as 1 polyethylene bottle with capsules. It necessarily contains instructions.

Pharmacological effect

Pradaksa helps to suppress the activity of thrombin. The low molecular weight substance Dabigatran etexilate does not possess pharmacological activity. Once inside the body, this compound is rapidly absorbed and as a result of hydrolysis, it is converted into dabigatran, a competitive, active, direct, reversible inhibitor of thrombin. This substance helps to inhibit the activity of thrombin, which binds fibrin, as well as free thrombin and inhibits platelet aggregation, which caused thrombin.

According to the medical reviews about Pradax, the effectiveness of this drug becomes lower by 20% if the patient's body weight exceeds 120 kilograms. Conversely, with a body weight of 48 kilograms, the drug begins to act more efficiently, by about 25% (if compared with patients with average body weight).

Indications for use

The drug Pradaksa has several indications for use. These capsules are usually prescribed:

  1. In order to prevent venous thromboembolism in patients who have undergone orthopedic surgery;
  2. In order to prevent the onset of stroke and thromboembolism of a systemic nature, as well as to reduce the risk of mortality in cardiovascular diseases among patients who have atrial fibrillation;
  3. For the treatment of acute forms of deep vein thrombosis and pulmonary thromboembolism, as well as to prevent deaths as a result of these diseases;
  4. To prevent the recurrence of deep vein thrombosis and pulmonary thromboembolism, as well as to reduce the risk of mortality as a result of these pathologies.

Contraindications

The drug Pradaksa has a number of contraindications, such as:

  • co-administration of ketoconazole for systemic use;
  • abnormal liver function and liver disease that may affect survival;
  • age up to 18 years (no clinical data);
  • severe renal failure (CC less than 30 ml / min);
  • active clinically significant bleeding, hemorrhagic diathesis, spontaneous or pharmacologically
  • induced disturbance of hemostasis;
  • organ damage as a result of clinically significant bleeding, including hemorrhagic stroke during
  • previous 6 months before the start of therapy;
  • known hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients.

Relative (taken with caution, increased likelihood of adverse reactions):

  • acquired or congenital coagulation disorders;
  • gastritis, esophagitis, gastroesophageal reflux disease;
  • extensive injury or recent biopsy;
  • moderate decrease in kidney function (creatinine clearance 30-50 ml / min);
  • patient body weight less than 50 kg;
  • age over 75 years;
  • functional defects of platelets or thrombocytopenia;
  • bacterial endocarditis;
  • simultaneous use of clopidogrel, nonsteroidal anti-inflammatory drugs, selective norepinephrine and serotonin reuptake inhibitors, as well as other drugs, which may result in impaired hemostasis;
  • simultaneous use of P-glycoprotein inhibitors.

Use during pregnancy and lactation

Data on the use of dabigatran etexilate during pregnancy are not available. The potential risk in a person is unknown.

In experimental studies have not established adverse effects on fertility or postnatal development of newborns. Women of reproductive age should avoid becoming pregnant while being treated with Pradax. When pregnancy occurs, the use of the drug is not recommended, except in cases where the expected benefit exceeds the possible risk.

If you need to use the drug during breastfeeding, due to the lack of clinical data, breastfeeding is recommended to stop (as a precautionary measure).

Dosage and method of use

The instructions for use indicated Pradaksa is assigned only to adults. 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:

  • tear off one individual blister from the blister-packaging along the perforation line;
  • remove the capsule from the blister, peeling off the foil;
  • Do not squeeze the capsules through the foil.

The dosage of the drug depends on the evidence and is determined by the doctor. Average dosages:

  1. Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: 300 mg (1 capsule. 150 mg 2 times a day). The course of treatment: for life.
  2. Prevention of venous thromboembolism (VTE) after orthopedic operations: 220 mg 1 time per day (2 capsules. 110 mg each). With moderate renal dysfunction: 150 mg 1 time per day (2 capsules, 75 mg each), since there is a risk of bleeding.
  3. Prevention of VTE after hip arthroplasty: the course starts 1 to 4 hours after the operation is completed. The first dose: 110 mg (1 caps.). Further, the dose is increased to 220 mg (2 caps.) 1 time per day for the next 28 to 35 days. In the absence of hemostasis, treatment should be postponed. If the treatment started several days after the operation, the therapy should be started with a dose of 220 mg (2 capsules) 1 time per day.
  4. Prevention of VTE after knee arthroplasty: the course starts 1 to 4 hours after the operation is completed. The first dose: 110 mg (1 caps.). Further, the dose is increased to 220 mg (2 caps.) 1 time per day over the next 10 days. In the absence of hemostasis, treatment should be postponed. If the treatment started several days after the operation, the therapy should be started with taking 220 mg (2 capsules) 1 time per day.
  5. Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: 300 mg (1 capsule. 150 mg 2 times a day) after parenteral treatment with an anticoagulant for at least 5 days. The course of treatment: up to 6 months.
  6. Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases: 300 mg (1 capsule. 150 mg 2 times a day). Therapy can continue for life, depending on the individual risk factors.

In case of impaired renal function

Before starting treatment with Pradaksa, it is necessary to first assess the CC.

Drug treatment is contraindicated in severe renal impairment.

During treatment, renal function should be evaluated periodically.

For the prevention of venous thromboembolism after orthopedic operations with moderate renal impairment:  the daily dose is reduced to 150 mg (2 capsules. 75 mg 1 time per day).

For the prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation with moderate renal impairment: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day). Once a year, kidney function should be evaluated.

For the treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day).

For the prevention of recurrent THV and / or pulmonary embolism and death caused by these diseases with moderate renal impairment: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day). Once a year, kidney function should be evaluated.

Use in old age

Increasing the exposure of the drug in the elderly (over 75 years) is often due to a decrease in renal function, therefore, before prescribing the drug, it is necessary to evaluate the renal function.

Depending on the clinical situation, it is necessary to evaluate the function of the kidneys (at least once a year). Dose adjustment of the drug should be carried out depending on the severity of renal dysfunction.

Prevention of venous thromboembolism after orthopedic surgeries over the age of 75 years: the recommended dose is 150 mg (2 capsules. 75 mg each time).

At the age of 80 years for the prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: daily dose of 220 mg (1 capsule. 110 mg 2 times a day).

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases in the age of more than 75 years: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day).

Prevention of recurrent THV and / or pulmonary embolism and death caused by these diseases over the age of 75: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day).

Use in individuals with different body weights.

Prevention of venous thromboembolism after orthopedic operations with body weight <50 kg and more than 110 kg: 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: dose adjustment is not required. However, with a body weight of <50 kg, constant medical supervision is recommended.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: dose adjustment is not required.

Prevention of recurrent THV and / or pulmonary embolism and death caused by these diseases: dose adjustment is not required.

The simultaneous use of Pradax with active inhibitors of P-glycoprotein (amiodarone, quinidine, verapamil)

Prevention of venous thromboembolism after orthopedic operations: the dose of the drug should be reduced to 150 mg 1 time per day (2 capsules, 75 mg each).

If the drug is taken 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, daily dose of 300 mg (1 capsule. 150 mg 2 times a day).

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

Prevention of recurrent THV and / or pulmonary embolism and death caused by these diseases: dose adjustment is not required. Daily dose of 300 mg (1 capsule. 150 mg 2 times a day).

Use 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 75 years or older, a moderate decrease in kidney function (CC 30-50 ml / min), simultaneous use of P-glycoprotein inhibitors, or an indication 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, the daily dose may be reduced to 220 mg (1 capsule. 110 mg 2 times a day).

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

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

Transition from the use of Pradax to parenteral use of anticoagulants

Prevention of venous thromboembolism in patients after orthopedic surgeries: it is recommended to begin parenteral administration of anticoagulants 24 hours after the last dose of Pradax.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: it is recommended that parenteral administration of anticoagulants be started 12 hours after the last dose of Pradax.

Treatment of acute DVT and / or pulmonary embolism and prevention of deaths caused by these diseases: it is recommended to begin parenteral use of anticoagulants 12 hours after taking the last dose of the drug.

Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases: it is recommended that parenteral anticoagulants be started 12 hours after the last dose of Pradax.

Transition from parenteral use of anticoagulants to the use of Pradax

The first dose of the drug is prescribed instead of the canceled anticoagulant in the interval of 0 - 2 hours before the next injection of alternative therapy, or simultaneously with the termination of a permanent infusion (for example, in / in using unfractionated heparin).

Transition from the use of Pradax to the use of vitamin K antagonists

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: with CC ≥50 ml / min, vitamin K antagonists may be used for 3 days, and for CC 30-50 ml / min 2 days before Pradaxa is canceled.

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 the withdrawal of Pradax.

Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases: with QA ≥50 ml / min, use of vitamin K antagonists is possible for 3 days, and for QA 30-50 ml / min for 2 days before Praxax is canceled.

The transition from the use of vitamin K antagonists to the use of Pradax

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

Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases: the use of vitamin K antagonists is stopped, the use of Pradaxa is possible with MHO <2.0.

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 drug therapy.

Missed dose

Prevention of venous thromboembolism in patients after orthopedic operations: it is recommended to take the usual daily dose at the usual time the next day. In the case of missing individual doses should not take a double dose of the drug.

Prevention of stroke, systemic thromboembolism and reduction of cardiovascular mortality in patients with atrial fibrillation: the missed dose can be taken if there is 6 hours or more before taking the next dose of the drug. With a period of less than 6 hours, the missed dose should not be taken. In the case of missing individual doses 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: the missed dose can be taken if there is 6 hours or more before taking the next dose of the drug. With a period of less than 6 hours, the missed dose should not be taken. In the case of missing individual doses should not take a double dose of the drug.

Prevention of recurrent THV and / or pulmonary embolism and deaths caused by these diseases: the missed dose can be taken if there is 6 hours or more before taking the next dose of the drug. With a period of less than 6 hours, the missed dose should not be taken. In the case of missing individual doses should not take a double dose of the drug.

Side effects

Negative reactions to the background of taking Pradax capsules can develop from the various organs and systems, these include:

  • Nervous system - intracranial hemorrhage.
  • Respiratory system - hemoptysis, nasal bleeding.
  • The urinary system - hematuria (the appearance of blood in the urine).
  • The development of bleeding in the skin, joints (hemarthrosis), as well as in the field of medical procedures and manipulations.
  • Blood system - anemia (decrease in the number of red blood cells and hemoglobin level), thrombocytopenia (decrease in the number of platelets).
  • Cardiovascular system - hematomas (formation of a limited cavity in the tissues of different localization due to bleeding from the vessel).
  • The digestive system - abdominal pain, dyspepsia, accompanied by nausea, unstable stool, flatulence (bloating), bleeding from different parts of the digestive tract, the development of ulcerative lesions of the esophagus, stomach or duodenum.
  • Hepatobiliary system - a violation of the functional activity of the liver, increased activity of liver enzymes of transaminases, which indicates damage to liver cells.
  • The immune system - various allergic reactions that may include urticaria (a reaction on the skin that resembles a nettle), angioedema of the skin and subcutaneous tissue (Quincke edema) with predominant localization in the face and genitalia, bronchospasm (an allergic reaction in the form of constriction bronchial lumen with the development of dyspnea), anaphylactic shock with a pronounced decrease in blood pressure and the development of multiple organ failure.

The frequency of side effects after starting to take Pradax capsules depends on the indications for use of the drug, the age and sex of the patient, and the presence of other associated diseases, primarily related to the functional activity of the kidneys.

Overdose

If the dose of the drug is exceeded, then hemorrhagic (with hemorrhages) complications of various localization may occur. In case of overdose, hemostasis is impaired, therefore a coagulation test must be done, showing the rate of blood clotting in clots. Hemodialysis (an extrarenal cleansing method) will also have a positive effect, during which toxic metabolic products are removed from the body.

An effective overdose is blood transfusion. With the development of hemorrhagic complications, drug treatment should be stopped, the search for a source of bleeding is necessary. Often, to accelerate the elimination of the active substance, forced diuresis is carried out using diuretics and surgical hemostasis with the replacement of circulating blood volume.

Special instructions

Combined use with dronedarone is contraindicated.

Prescribing Pradax requires caution in conditions that are characterized by an increased risk of bleeding. The reason for finding the source of bleeding is a decrease in hematocrit and / or hemoglobin in the blood, accompanied by a decrease in blood pressure.

With reduced kidney function (including in elderly patients), an increase in drug exposure may be observed. With the development of acute renal failure, therapy is canceled.

In order to detect excessive anticoagulant activity of dabigatran, it is necessary to use tests to determine ekarinovogo or thrombin clotting time, when they are unavailable - a test to determine the APTT.

With the prevention of VTE after operations on the musculoskeletal system, short-term use of nonsteroidal anti-inflammatory drugs for anesthesia during surgical interventions is not accompanied by an increased risk of bleeding.

If there is an increased risk of bleeding (for example, with bacterial endocarditis, after a recent extensive injury or a biopsy), it is necessary to monitor the patient's condition in order to timely detect signs of bleeding.

After a spinal puncture (repeated or traumatic) and prolonged use of the epidural catheter, the first dose of Pradax can be taken no earlier than 120 minutes after the catheter is removed, monitoring the condition of the patients (to exclude neurological symptoms that may be associated with epidural hematoma or spinal bleeding) .

Due to the high probability of bleeding before surgery or invasive procedures (at least for a day, in some cases for 2-5 days), the drug is canceled. In case of emergency surgical interventions, Pradax should be temporarily interrupted, and the operation should be carried out no earlier than 12 hours after the last dose of the drug. If this is not possible, due to the high risk of bleeding, it is necessary to evaluate the ratio of benefit to risk.

Since taking Pradax can increase the risk of bleeding, it is recommended to use caution when driving and performing potentially hazardous work.

The likelihood of bleeding increases with the combined use of Pradax with ticagrelor, unfractionated heparin (atopic that is necessary to maintain the patency of an arterial or venous catheter) and heparin derivatives, low molecular weight heparins, sodium fondaparinux, thrombolytic drugs, glycoproteins, and glycoprotein-synthesis blockers, glycoproteins, etc. , dextran, rivaroxaban, vitamin K antagonists and P-glycoprotein inhibitors (itraconazole, tacrolimus, cyclospin Rene, ritonavir, nelfinavir and saquinavir). Also, the risk of bleeding may increase due to pharmacological interaction with selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors, antiplatelet agents and other anticoagulants.

Drug interactions

Do not combine with drugs that affect hemostasis, vitamin K antagonists, P-glycoprotein inhibitors (verapamil, ketoconazole, clarithromycin, amiodarone, quinidine).

To be used with caution in combination with dronedarone, perforated hunter, carbamazepine and pantoprazole.

Acetylsalicylic acid, in combination with Pradax, can significantly increase the risk of bleeding.

Reviews

We picked up some reviews of people using the drug Pradaksa:

  1. Helena. This remedy was prescribed to me after surgery on the hip joint. I have been taking it for the fifth month, according to many patients, the drug begins to work after two weeks, it helped me after a month of use. Gone are the pains. It is expensive to treat, though, 2 packs per month, but there is a positive result.
  2. Sasha. After transferring the DVT in the left leg after discharge from the hospital, Prodaks blood thinner 110/2 rd was prescribed to dissolve blood clots. After taking the first pill, blood traces in the urine, after taking the second one in the morning, a strong hematuria. Stopped drinking. A week on cardiomagny. I decided to try Prodax again, the result is the same - the worst hematuria. Bullshit for 3000 p. From acetone probably less harm ...
  3. Maria. I have been taking the drug twice a day because of constant arrhythmia for three years now. I feel good, the medicine supports the body well and prevents blood from clotting. Although the tool is expensive for pensioners, but it is effective. The only thing I want to advise other patients, drink it with food, so as not to hurt the stomach.
  4. Danil. I am familiar with this drug for 5 years and made sure that it is very effective. The drug is not cheap, but it helps well, significant improvements are noticeable. I am very grateful to the doctor who prescribed “Pradaks”. You can buy it in almost every pharmacy, if not, then you can order it. But it is also very important to choose the right dosage. The annotation says that internal bleeding is possible. I have never come across this, but once it is written, it can happen. I recommend using this drug, better than counterparts.

Analogs

The pharmacological industry offers drugs of similar composition and active ingredient, but they should be used only as prescribed by a doctor. To the closest in composition are:

  • Warfarin is an antithrombotic drug from the group of anticoagulants. Allows to reduce the risk of blood clots, is used in the treatment of vascular pathologies.
  • Lavenum - medicine with anti-inflammatory and antithrombotic effect. Appointed with thrombophlebitis of superficial veins, injuries, bruises.
  • Fluxum - the active ingredient of the drug - Parnaparin sodium. It is more often used in the conditions of a hospital for intravenous administration.
  • Emeran - has anti-inflammatory and antithrombotic local effect, can be administered in combination with other drugs for the treatment of diseases of the veins and blood vessels.

Before using analogues consult your doctor.

Storage conditions and shelf life

Store the tool must be in a dry place out of the reach of children. The temperature should be no higher than 25 degrees. Shelf life of the drug is 3 years. After opening the bottle with capsules, they must be used for 4 months.

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