Pradaxa capsules 150mg №60

Packaging

Indications and usage

Prevention of venous thromboembolism in patients after orthopedic surgery.

Contraindications

- renal failure severe (CC less than 30 ml / min);
- hemorrhagic disorders, hemorrhagic diathesis, spontaneous or pharmacologically induced impairment of hemostasis;
- active clinically significant bleeding;
- abnormal liver function and liver diseases that may affect survival;
- simultaneous administration of quinidine;
- damage to the organs as a result of clinically significant bleeding, including hemorrhagic stroke during the previous 6 months before the start of therapy;
- age less than 18 years;
- known hypersensitivity to dabigatran or dabigatran etexilate or to one of the excipients.

Pregnancy and Breastfeeding

In experimental animal studies, reproductive toxicity was identified. Clinical data on the use of dabigatran etexilate during pregnancy is not available. The potential risk to humans is not known.
Women of reproductive age should avoid pregnancy when treating Pradaxa. In pregnancy, the use of dabigatran etexilate is not recommended, except in cases where the expected benefit outweighs the possible risk.
In the case of dabigatran etexilate, breastfeeding should be discontinued. Clinical data on the use of the drug during breastfeeding is not available.

Dosage and administration

Pradaxa is prescribed inside.
Adults for the prevention of venous thromboembolism (BT) in patients after orthopedic surgery recommended dose is 150 mg / day. once.

Adverse reactions

In controlled studies, some patients received the drug at 150-220 mg / day, some less than 150 mg / day, and some more than 220 mg / day.
Possible bleeding of any localization. Extensive bleeding is rare. The development of undesirable reactions was similar to the reactions in the case of the use of enoxaparin sodium.
From the hematopoietic system: anemia, thrombocytopenia.
From the blood coagulation system: hematoma, bleeding of wounds, nose bleeding, Gastrointestinal bleeding, rectal bleeding, hemorrhoidal bleeding, skin hemorrhagic syndrome, hemarthrosis, hematuria.
From the digestive system: dysfunction of the liver, increased activity of hepatic transaminases, hyperbilirubinemia.
From the laboratory indicators: reduction of hemoglobin and hematocrit
Local reactions: bleeding from the injection site, bleeding from the injection site of the catheter.
Complications associated with the procedures and surgical interventions: bloody wound discharge, hematoma after procedures, bleeding after procedures, postoperative anemia, post-traumatic hematoma, bloody discharge after procedures, bleeding from the incision site, drainage after the procedure, drainage of the wound.
The frequency of the observed undesirable reactions when taking dabigatran etexilate did not go beyond the range of the frequency of undesirable reactions developing when using enoxiparin sodium. In controlled studies, some patients received the drug at 150-220 mg /, part - less than 150 mg /, part - more than 220 mg /
Possible bleeding of any localization. Extensive bleeding is rare. The development of undesirable reactions was similar to the reactions in the case of the use of enoxaparin sodium.
From the hematopoietic system: anemia, thrombocytopenia.
From the blood coagulation system: hematoma, bleeding of wounds, nose bleeding, gastrointestinal bleeding, rectal bleeding, hemorrhoidal bleeding, skin hemorrhagic syndrome, hemarthrosis, hematuria.
From the digestive system: dysfunction of the liver, increased activity of hepatic transaminases, hyperbilirubinemia.
From the laboratory indicators: reduction of hemoglobin and hematocrit
Local reactions: bleeding from the injection site, bleeding from the injection site of the catheter.
Complications associated with the procedures and surgical interventions: bloody wound discharge, hematoma after procedures, bleeding after procedures, postoperative anemia, post-traumatic hematoma, bloody discharge after procedures, bleeding from the incision site, drainage after the procedure, drainage of the wound.
The frequency of the observed undesirable reactions when taking dabigatran etexilate did not go beyond the range of the frequency of undesirable reactions developing when using enoxiparin sodium.

Special notes

Unfractionated Heparin can be applied in order to preserve the functioning of the central venous or arterial catheter. It should not be used simultaneously with the drug Pradaxa nefractionated heparins or its derivatives, low molecular weight heparins, fondaparinux sodium, desirudin, thrombolytic agents, GPIIb / IIIa receptor antagonists, Clopidogrel, ticlopidine, dextran, sulfinpyrazone and vitamin K antagonists, common K. deep vein doses and Acetylsalicylic acid in doses of 75-320 mg increase the risk of bleeding. Evidence of an increased risk of bleeding associated with dabigatran when taking Pradaxa in the recommended dose, patients receiving small doses of acetylsalicylic acid to prevent cardiovascular diseases are not available. However, the available information is limited, therefore, with the combined use of acetylsalicylic acid in a low dose and Pradaxa, it is necessary to monitor the condition of the patients in order to timely diagnose bleeding.

Combined use with drugs that affect hemostasis or coagulation processes, including vitamin K antagonists, can significantly increase the risk of bleeding. Dabigatran etexilate and dabigatran are not metabolized with the participation of the cytochrome P450 system and do not affect in vitro the human cytochrome P450 enzymes.Therefore, when used together with Pradaxa, drug interactions are not expected. When combined with Atorvastatin interaction is not observed. With the combined use of the pharmacokinetics of Diclofenac and dabigatran etexilate does not change, indicating a slight interaction. The use of NSAIDs for a short time to reduce pain after surgery did not increase the risk of bleeding. There is limited experience in the use of Pradaxa in combination with long-term systematic administration of NSAIDs, and therefore requires careful monitoring of the patients. Pharmacokinetic interaction with Digoxin was not detected. In clinical studies, no effect of the combination of pantoprazole or other proton pump inhibitors and Pradaxa on the development of bleeding or pharmacological effects was detected. When combined with Ranitidine, the degree of absorption of dabigatran does not change. With the combined use of Pradaxa and Amiodarone, the rate and extent of absorption of the latter and the formation of its active metabolite, deethylamidarodon, does not change. AUC and Cmax increases by 60% and 50%, respectively. With the combined use of dabigatran etexilate and amiodarone, it is necessary to reduce the dose of Pradaxa to 150 mg / day. In connection with the prolonged T1 / 2 of amiodarone, the potential drug interaction may persist for several weeks after discontinuation of amiodarone. Care should be taken when using Pradaxa with the active inhibitors of P-glycoproteins (verapamil, clarithromycin). Repeated administration of Verapamil over several days led to an increase in the concentration of dabigatran by 50-60%. This effect can be reduced by prescribing dabigatran at least 2 hours before taking verapamil. Simultaneous use of Pradaxa with quinidine is contraindicated. Potential inductors, such as rifampicin and St. John's wort herb extract, can reduce the effect of dabigatran. Care should be taken when sharing dabigatran with similar drugs. When combined use of dabigatran with antacids and agents that inhibit gastric secretion, changes in the dose of dabigatran is not required.No interaction of dabigatran with opioid analgesics, diuretics, Paracetamol, NSAIDs (including COX-2 inhibitors), inhibitors of HMC-CoA reductase, cholesterol / triglyceride reducing drugs (not related to statins), angiotensin II receptor blockers, ACE inhibitors, beta-blockers, Calcium channel blockers, prokinetics, benzodiazepine derivatives.

There is no antidote to dabigatran etexilate or dabigatran. The use of doses of the drug in excess of the recommended, increases the risk of bleeding. If bleeding develops, treatment should be stopped to determine the causes of bleeding. Given the main route of elimination of dabigatran through the kidneys, it is recommended to ensure adequate diuresis. If necessary, surgical hemostasis or transfusion of fresh frozen plasma is possible. Dabigatran is removed during dialysis, but there is no clinical experience with this method.

In the dark place at a temperature of no higher than 25 ° C.