Pradaxa (dabigatran etexilate) capsules 110 mg. №60

Description

Pradaxa Ingredients
The main active ingredient of the drug is dabigatran etexilate mesylate. The list of auxiliary components includes: tartaric acid (in various forms), hypromellose, dimethicone, talc, hyprollose, etc.

Release form
It is produced in capsules, while 1 capsule contains 110 or 150 mg of the main active ingredient.

Pharmacological properties
This drug Pradaxa is a direct thrombin inhibitor, a drug based on the active ingredient dabigatran etexilate. The specified substance is low molecular weight, has no pharmacological activity, is a precursor of dabigatran in active form.
Dabigatran is a potent competitive reversible direct inhibitor of thrombin, the main active substance in blood plasma, which contributes to the inhibition of thrombin activity, which becomes an obstacle to thrombus formation.
As a result of research, it has been proven and confirmed that dabigatran has anti-thrombotic and anticoagulant activity.
A direct relationship was found between how high the concentration of dabigatran in the patient’s blood plasma and how pronounced the anticoagulant effect was. This substance also has the property of lengthening the activated partial thrombin time, thromboplastin time and ecarinic clotting time (blood).

Indications
The drug Pradaxa is used to prevent the development of cardiovascular diseases such as:

• venous thromboembolism in patients undergoing rehabilitation after orthopedic surgery;
• strokes;
• systemic thromboembolism;
• reduction of mortality from cardiovascular disease in patients who suffer from atrial fibrillation.
• It is prescribed for the treatment of thrombosis:
• deep veins;
• pulmonary embolism;
• as a prevention of the development of these diseases.

Contraindications
It is not applied if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
Contraindicated if the patient suffers from:

• severe renal failure;
• active clinically significant bleeding, hemorrhagic diathesis, spontaneous or pharmacologically induced hemostasis disorders;
• organ damage as a result of clinically significant bleeding, including as a result of hemorrhagic stroke within six months before the start of therapy;
• severe liver dysfunctions and liver diseases;
• has an artificial heart valve that requires anticoagulant therapy.

It is not used concomitantly with ketoconazole (with its systemic use).

Children
Do not use in pediatrics until the age of 18.

Application during pregnancy and lactation
This drug is contraindicated during pregnancy. During the period of treatment with the indicated drug, pregnancy should be avoided, and reliable methods of contraception should be used.
If there is a need to use this drug during lactation, then breastfeeding should be suspended.

Method of administration and dosage
Usually, the average dosage of Pradaxa is 110 mg, taken 1-2 times a day in a capsule. The drug is taken regardless of food intake, washed down with water or other liquid.
Other possible dosages:

• for the prevention of venous thromboembolism (VTE) after surgical orthopedic interventions – 2 capsules of 110 mg, 1 time per day;
• for the prevention of VTE after the installation of a knee or hip joint endoprosthesis – 1 capsule a day, 4 hours after the operation, the next day – 2 capsules at a time, the course of administration for knee surgery – 10 days, with a hip – up to 35 days;
• in the prevention of stroke, systemic thromboembolism, to reduce mortality due to patients with atrial fibrillation – 1 capsule is taken three times a day, throughout life. For patients over 80 years old – it is enough to take 2 capsules per day, 1 capsule per dose.

With mild to moderate impairment of the liver and kidneys, dosage adjustment is not required.

Overdose
Overdose with this drug can be characterized by the occurrence of hemorrhagic complications.
If bleeding occurs, then treatment with this drug should be discontinued.
Treatment of symptoms is recommended.
An antidote that could neutralize the effect of this drug has not yet been identified.
It is possible to carry out surgical hemostasis, blood transfusion to replenish its volume.
With the development of thrombocytopenia, or in the case of the use of long-acting antiplatelet agents, it is possible to use platelet mass.
Hemodialysis is recommended.

Side effects
When using this drug, side effects have been observed such as:

• anemia, thrombocytopenia;
• allergic reactions, in particular, itching, urticaria, bronchospasm;
• intracranial bleeding may develop;
• hematomas, bleeding;
• bleeding from the nose, hemoptysis;
• bleeding from the gastrointestinal tract, pain in the abdomen, dyspeptic symptoms, vomiting, nausea, ulcers on the oral mucosa, gastroesophagitis;
• liver dysfunction;
• hemarthrosis;
• hematuria, urogenital bleeding;
• bleeding at the injection site, catheter, surgical wound.

If you experience any unusual side effects as a result of taking this drug, you should consult your doctor about possible changes in the treatment regimen.

Storage conditions and periods
Stored for up to 3 years at a temperature not exceeding 25 ° C.