Description overdue on 07/11/2014
- Latin name: Pradaxa
- ATC code: B01AE07
- Active substance: Dabigatran etexilate (Dabigatran etexilate)
- Manufacturer: GmbH & Co. KG. Boehringer Ingelheim Pharma KG, Germany
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications Pradaksy
- Contraindications
- Side effects
- Instructions for use Pradaksy (method and dosage)
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Analogs
- Reviews
- Price, where to buy
Composition
The composition of one capsule of the drug are: dabigatran etexilate mesylate 172, 95 mg (150 mg calculated as dabigatran etexilate ) + Additional agents ( tartaric acid, dimethicone, acacia gum, hypromellose, talc, hydroxypropyl cellulose, potassium chloride, E407, E171, E132, E110, water, butanol, ethanol, isopropanol, shellac, pripilenglikol, E172 ).
There is also a dosage form containing dabigatran etexilate 75 and 110 mg.
Product form
Opaque capsule, oblong. Creamy yellow color (the inscription R150) and blue (the inscription - a symbol of the company). Inside the capsule, pellets pale yellow.
Blisters 10 capsules in packs of 10, 30, 60 pieces (1, 3, 6 blisters respectively). Bottles of 60 capsules.
INN: dabigatran etexilate .
Pharmacological action
Medicine Pradaksa - straight anticoagulant . Thrombin inhibitor .
Pharmacodynamics and pharmacokinetics
The active ingredient tablets, after conversion to the dabigatran It inhibits the activity of the enzyme Thrombin Which in turn is responsible for the conversion process fibrinogen at fibrin and the emergence of thrombus . Also dabigatran It has the ability to reduce the activity of the already formed thrombus free thrombin fibrinosvyazannogo thrombin , Subsequent platelet aggregation not happening.
The active ingredient is effective in reducing prothrombin index In direct proportion to its concentration in the blood plasma reached in the process of taking the drug.
Almost immediately after taking the drug reaction occurs hydrolysis , Dabigatran etexilate in the transformation of dabigatran. The bioavailability of dabigatran is about 6%, the maximum concentration of active ingredient will occur in one hour or two after administration. Regardless of the dose, half-life is 11 to 14 hours. In patients with renal failure is a change of some pharmacokinetic parameters .
Indications Pradaksy
Typically, the drug is prescribed for the prevention of:
- venous thromboembolism and system ;
- stroke .
It is also an indication for the use of a Atrial fibrillation (to reduce the percentage of mortality after fibrillation).
Contraindications
The drug Pradaxa is contraindicated:
- at drug allergy on the active ingredient, its derivatives and other components;
- in disorders of the liver;
- severe renal failure;
- high probability of bleeding due to stomach ulcers . malignancy , Injury of brain or spinal cord aneurysm and other pathologies;
- artificial valve in heart;
- when combined with other anticoagulants, ketoconazole, cyclosporine, itraconazole .
Side effects
FEATURES:
- thrombocytopenia and anemia . intracranial bleeding ;
- education hematomas , The occurrence of bleeding of different origin and location, including the post-operative wounds, nose, stomach and intestines;
- bronchospasm Reactions hypersensitivity , such as hives, itching and rash ;
- diarrhea , stomach ache, indigestion . nausea . dysphagia , Disorders of the liver;
- hemarthrosis, hematuria;
- bleeding Bad happening healing, education hematomas and discharge from the wounds drainage from the wounds.
Instructions for use Pradaksy (method and dosage)
The dosage and duration of administration must appoint a physician.
According to the instructions on Pradaksu, the daily dosage is about 100-300 mg. The medicament of twice a day.
The specialist must adjust the dosage if there is kidney disease, bleeding, the elderly, and when combined with the drug P-glycoprotein inhibitors .
Overdose
Significantly increases the risk of bleeding.
In case of overdose should be made test coagulation . The positive effect gives conduct Hemodialysis Should eliminate the bleeding, to identify the place of their origin. As a rule, it is effective blood transfusion .
Cooperation
Do not combine with drugs that affect hemostasis . antagonists of vitamin K . P-glycoprotein inhibitors ( verapamil . ketoconazole . clarithromycin . amiodarone . quinidine ).
With care to apply in conjunction with dronedarone . Hypericum perforatum . carbamazepine and pantoprazole .
Acetylsalicylic acid In combination with Pradaksoy can significantly increase the risk of bleeding.
Terms of sale
It requires a prescription.
Storage conditions
In the reach of children. The temperature is not above 25 degrees.
Shelf life
3 years. After opening a bottle of pills, they should be used within 4 months.
Analogs Pradaksy
Analogues Pradaksy virtually no effect on the closest to the drug are warfarin and ksarelto .
Which is better: Pradaksa or Warfarin?
Warfarin is the most widely used vitamin K antagonist And has a lot of restrictions to use. Continuous monitoring INR , A drug is combined not with all Food and Drug Administration. Not at all, it turns out to maintain the desired level INR Which leads to undesirable side effects, or decrease the effectiveness of the drug. Unlike warfarin , Pradaksa is a means of the new generation, the risk of bleeding in the drug less restrictions applying smaller.,
In any case, some of the drugs to be used, or warfarin Pradaksa must decide physician.
Reviews on Pradaksu
Reviews on Pradaksu good. Particularly flattering about the drug, doctors speak, compared with a medicine Warfarin and say a lot of advantages over other anticoagulants . Given that it is a means to prevent and drink it is necessary for a long time, many people confuse the high price of the drug, and some of the emerging adverse effects.
Price Pradaksy (Where to buy)
Price Pradaksy 110 mg is about 2700 rubles per 60 pieces.
Buy Pradaksu in Moscow is available at 1000 rubles for 10 capsules of 75 mg.
Price Pradaksa 150 mg within 1400 rubles per 30 pieces.
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