The generic name of Pradaxa is Dabigatran which is an anticoagulant medication orally administered to the patient. It was first developed by a pharmaceutical company named Boehringer Ingelheim. It belongs to the class of direct thrombin inhibitor. Earlier, there wasn't any way to reverse the effects of anticoagulation in case of a major bleeding event, but an antidote named idarucizumab was approved by the FDA in the year 2015. This drug belongs to the Pregnancy Category C.
Composition of Pradaxa
A single capsule of Pradaxa contains Dabigatran etexilate mesylate as the active ingredient. The inactive ingredients are mentioned below:
- Tartaric Acid
- Hydroxylpropyl Cellulose
The capsule shell contains:
- FD&C Yellow No. 6
- FD&C Blue No. 2
- Black edible ink
- Titanium dioxide
- Potassium Chloride
Uses of Pradaxa
This medication is used for the prevention of strokes and dangerous blood clots (such as in the lungs or legs) in case of a particular type of irregular heartbeat (called atrial fibrillation).
It is used for treating blood clots formed in the veins of the legs (as in deep vein thrombosis) or in the lungs (as in pulmonary embolism) for the reduction of the possibility of them occurring again. It also helps in preventing blood clots after hip replacement surgery. Pradaxa is an anticoagulant blocking thrombin (a clotting protein) in the blood. Hence, the blood keeps flowing smoothly in the body of the patient.
Side-effects of Pradaxa
In many cases the patient might suffer from certain side-effects following the consumption of this medication. Hence these side-effects must be kept in mind. The side-effects that might follow are discussed below:
- Sour or acid stomach
- Tarry, black stools
- Bloody stools
- Burning or pain in the throat
- Stomach pain, burning, upset, or discomfort
- Vomiting of blood or materials looking like coffee grounds
- Unusual weakness or tiredness
- Trouble breathing
- Tightness experienced in the chest
- Welts, itching skin, hives, or skin rash
- Redness of the skin
- Swelling or puffiness of the eyelids or near the tongue, lips, face, or eyes
- Irregular or fast breathing
- Fast heartbeat
- Loss of consciousness or fainting
- Difficulty in swallowing
- Hive-like swelling on the eyelids, sex organs, feet, legs, hands, throat, tongue, lips, or face
Contraindications of Pradaxa
Under conditions where Pradaxa is refrained to the patient are as follows:
- Liver disease or Hepatic impairment
- Active significant bleeding
- Severe renal impairment
- Allergy to the active ingredient in Pradaxa
- Prosthetic heart halves needing anticoagulant treatment
Pradaxa and Pregnancy
Pradaxa or Dabigatran is assigned to the pregnancy category C by the FDA. Hence, the risks to the foetus are not completely ruled out. There has not been any well controlled data collected on human pregnancy, but animal studies show toxicity. Therefore, childbearing women should avoid getting treated with Pradaxa.
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