Pradaxa® [Dabigatran etexilate]

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Dosage and Administration

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 hemopoietic 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 that develop when using enoxiparin sodium.

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.

Drug interactions

Combined use of PRADAXA® 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 combined with PRADAXA®, drug interactions are not expected.
Atorvastatin: when used together with atorvastatin, the interaction is not observed.
Diclofenac: with the combined use of the pharmacokinetics of diclofenac and dabigatran etexilate does not change, indicating that their interaction is insignificant.
The use of NSAIDs to reduce pain after surgery for a short time did not increase the risk of bleeding.
There is limited experience with the use of PRADAXA® in combination with the long-term systematic administration of nonsteroidal anti-inflammatory drugs (NSAIDs), and therefore careful monitoring of the condition of the patients is required.
Digoxin: pharmacokinetic interaction of this combination was not detected.
Pantoprazole: AUC reduction of approximately 30% has been established. 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.
Ranitidine: when combined with PRADAXA®, the degree of absorption of dabigatran does not change.
Interaction at the conveyor level:
Amiodarone: when PRADAXA® and amiodarone are used together, the rate and extent of absorption of the latter and the formation of its active metabolite, dezethylamodarone, does not change. AUC and Cmax increased by 60% and 50%, respectively.
With the joint use of dabigatran etexilate and amiodarone, it is necessary to reduce the dose of PRADAXA® to 150 mg per day. Due to the long half-life of amiodarone, potential drug interactions may persist for several weeks after discontinuation of amiodarone.
P-glycoprotein inhibitors:
Care should be taken when using PRADAXA® together with active P-glycoprotein inhibitors, such as, for example, 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 two hours before taking verapamil.
Simultaneous use of PRADAXA® with quinidine is contraindicated.
Inductors P-glycoprotein:
Potential inducers such as rifampicin and St. John's wort herb extract may reduce the effect of dabigatran. Care should be taken when sharing dabigatran with similar drugs.
When combined use of dabigatran with antacids and means that inhibit gastric secretion, changes in the dose of dabigatran is not required.
No interaction of dabigatran with the most commonly used drugs was found: opioid analgesics, diuretics, paracetamol, nonsteroidal anti-inflammatory drugs, cyclooxygenase 2 inhibitors, hydroxymethylglutaryl-coenzyme A reductase inhibitors; drugs that reduce cholesterol / triglycerides (not related to statins), angiotensin II receptor blockers, ACE inhibitors, beta-adrenergic receptor blockers; calcium channel blockers; prokinetics; benzodiazepine derivatives.

Special instructions

Overdosage

• Brand name: Pradaxa®
• Active ingredient: Dabigatran etexilate
• Dosage form: Capsules
• Manufacturer: Krasnogorskleksredstva