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About DABIGATRAN ETEXILATE

DABIGATRAN ETEXILATE belongs to a class of drugs known as anticoagulants or blood thinners used to prevent and treat the risk of stroke, heart attack in patients with atrial fibrillation (irregular heart rhythm) by reducing blood clot formation. Besides this, it is also used to prevent deep vein thrombosis (blood clots in leg veins), pulmonary embolism (blood clots in the lung), and to reduce the risk of clots in people who have undergone knee or hip replacement surgeries. 

DABIGATRAN ETEXILATE contains Dabigatran etexilate that works by inhibiting the production of clotting factor Xa, also called thrombin. This prevents the conversion of fibrinogen (soluble protein) to fibrin (insoluble protein), thereby preventing blood clots formation. It makes the blood flow easily through the veins making it less likely to form a serious blood clot. Thus, DABIGATRAN ETEXILATE helps prevent blood clots thereby reducing the risk of heart attack/stroke.

Take DABIGATRAN ETEXILATE as prescribed by your doctor. You are advised to take DABIGATRAN ETEXILATE for as long as your doctor has prescribed it for you depending on your medical conditions. You may experience bleeding, anaemia (low number of red blood cells), nausea, stomach pain, and vomiting. Most of these side effects of DABIGATRAN ETEXILATE do not require medical attention and gradually resolve over time. However, if the side effects are persistent, reach out to your doctor.

If you are known to be allergic to DABIGATRAN ETEXILATE or any other medicines, please tell your doctor. If you are pregnant or breastfeeding, it is advised to consult a doctor before using DABIGATRAN ETEXILATE. If you have a stomach ulcer, kidney or liver problems, high blood pressure, or bleeding problems, inform your doctor before taking DABIGATRAN ETEXILATE. Try not to stop taking this medicine on your own. Discontinuing DABIGATRAN ETEXILATE may worsen your condition and increase the risk of heart attack, and stroke.

Uses of DABIGATRAN ETEXILATE

Prevention of blood clot formation, deep vein thrombosis, pulmonary embolism.

Medicinal Benefits

DABIGATRAN ETEXILATE belongs to a class of drugs known as anticoagulants or blood thinners. DABIGATRAN ETEXILATE is primarily used to prevent and treat the risk of stroke and heart attack by reducing blood clot formation. Besides this, it also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries. DABIGATRAN ETEXILATE works by stopping the action of clotting factor (thrombin). This prevents the conversion of fibrinogen (soluble protein) to fibrin (insoluble protein), thereby preventing blood clots formation.

Directions for Use

Take DABIGATRAN ETEXILATE exactly as your doctor has prescribed it. Swallow it as a whole with water; do not crush or chew it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of DABIGATRAN ETEXILATE

  • Stomach pain
  • Vomiting
  • Bleeding
  • Anaemia (low number of red blood cells)
  • Nausea
  • Diarrhoea

In-Depth Precautions and Warning

Drug Warnings

If you are known to be allergic to DABIGATRAN ETEXILATE or any other medicines, please tell your doctor. If you are pregnant or breastfeeding, it is advised to consult a doctor before using DABIGATRAN ETEXILATE. DABIGATRAN ETEXILATE is not recommended for children less than 18 years of age as the Safety and effectiveness have not been established. If you have an artificial heart valve, stomach ulcer, kidney/liver problems, high blood pressure, or bleeding problems, inform your doctor before taking DABIGATRAN ETEXILATE. You should inform the doctor that you are taking DABIGATRAN ETEXILATE if you are due to undergo surgery. Avoid consumption of alcohol while taking DABIGATRAN ETEXILATE as it may increase the risk of stomach bleeding.

Drug Interactions

Drug-Drug Interactions: DABIGATRAN ETEXILATE may interact with medicines to reduce blood clotting (warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban), medicines to treat abnormal heartbeats  (amiodarone, dronedarone, quinidine, verapamil), medicines to treat fungal infections (ketoconazole, itraconazole), medicines to prevent organ rejection after transplantation (tacrolimus, cyclosporine) antiviral or HIV medicines (ritonavir, glecaprevir, pibrentasvir), antibiotics (rifampicin, clarithromycin), pain reliever (aspirin, ibuprofen, diclofenac), antiepileptic drugs (carbamazepine, phenytoin).

Drug-Food Interactions: DABIGATRAN ETEXILATE may interact with St. John’s wort, herbal medicine for depression.

Drug-Disease Interactions: DABIGATRAN ETEXILATE should be used with caution in patients with kidney, liver, or bleeding problems, heart problems, and unstable blood pressure.

Drug-Drug Interactions Checker List:

  • WARFARIN
  • PHENPROCOUMON
  • ACENOCOUMAROL
  • HEPARIN
  • CLOPIDOGREL
  • PRASUGREL
  • TICAGRELOR
  • RIVAROXABAN
  • AMIODARONE
  • DRONEDARONE
  • QUINIDINE
  • VERAPAMIL
  • ITRACONAZOLE
  • KETOCONAZOLE
  • TACROLIMUS
  • CYCLOSPORINE
  • INDINAVIR
  • RITONAVIR
  • RIFAMPICIN
  • CLARITHROMYCIN
  • GLECAPREVIR
  • PIBRENTASVIR
  • IBUPROFEN
  • DICLOFENAC
  • PHENYTOIN
  • CARBAMAZEPINE
  • Safety Advice

    • Safety Warning

      Alcohol

      unsafe

      You are recommended to avoid consumption of alcohol with DABIGATRAN ETEXILATE as it may increase the risk of bleeding.

    • Safety Warning

      Pregnancy

      caution

      Please consult your doctor if you are planning to become pregnant or already pregnant before starting DABIGATRAN ETEXILATE. Your doctor will prescribe DABIGATRAN ETEXILATE only if the benefits outweigh the risks.

    • Safety Warning

      Breast Feeding

      unsafe

      Avoid breastfeeding while taking DABIGATRAN ETEXILATE. Consult your doctor if you have nay concerns.

    • Safety Warning

      Driving

      safe if prescribed

      DABIGATRAN ETEXILATE usually does not affect your ability to drive or operate machinery.

    • Safety Warning

      Liver

      caution

      Let your doctor know if you have/had liver diseases or hepatic impairment. Your doctor will weigh the benefits and potential risks before prescribing DABIGATRAN ETEXILATE. However, it is not recommended in patients with severe liver diseases.

    • Safety Warning

      Kidney

      caution

      Let your doctor know if you have/had kidney diseases. Your doctor will weigh the benefits and potential risks before prescribing DABIGATRAN ETEXILATE. However, it is not recommended in patients with severe kidney diseases.

    • Safety Warning

      Children

      caution

      DABIGATRAN ETEXILATE is not recommended for children below the age of 18 years as the safety and efficacy of DABIGATRAN ETEXILATE have not been established in children.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Keep your cholesterol and triglyceride levels under control.
    • Eat at regular intervals, and maintain a healthy diet that includes fresh fruits, vegetables.
    • Limit alcohol intake since it raises blood pressure and increases the risk of heart diseases.
    • Keep a check on your weight and exercise regularly to keep your heart healthy.

    Special Advise

    • You should have regular platelet count, factor V assay, fibrinogen level test, prothrombin time test (PT or PT-INR), and the INR (international normalized ratio) to analyze your blood clotting time.
    • In case you miss a dose of DABIGATRAN ETEXILATE, take it as soon as possible. However, if it is too close to the next dose, revert to the original schedule.

    Patients Concern

    Disease/Condition Glossary

    Thrombosis/Blood Clot: A blood clot can occur in any part of the body and can lead to a heart attack, stroke, or damage to organs. Blood clots can reach the arteries or veins in the organs like the brain, kidney, heart, lungs, and limbs. Conditions like atherosclerosis, diabetes, heart failure, irregular heartbeat (arrhythmia), and obesity/overweight can trigger excessive blood clotting in the brain and heart. 

    Deep vein thrombosis (blood clots in legs): It is a medical condition in which blood clots form in deep veins, usually in the legs. The symptoms include leg pain or swelling. 

    Pulmonary embolism (blood clots in the lung): It is a chronic condition that occurs as the blood clots break and travel to the lungs from deep veins in the legs or other parts of the body. The symptoms of pulmonary embolism include cough, chest pain, and shortness of breath.

    Stroke (blood clots in the brain): It occurs when the supply of blood to part of your brain is stopped or reduced. This prevents brain tissue from getting nutrients and oxygen leading to the death of brain cells.

    Heart attack: A heart attack means the death of heart tissue due to a shortage of blood supply to the heart muscles. This can occur when there is an accumulation of cholesterol or fat narrowing the heart's major veins or when other substances like a blood clot are blocking the flow of blood. 

    FAQs

    How does DABIGATRAN ETEXILATE work?

    DABIGATRAN ETEXILATE is a thrombin inhibitor. The inhibition of thrombin, reduces the formation of blood-clotting material fibrin, thereby leading to fewer clots and aiding the free flow of blood.

    Can I stop taking DABIGATRAN ETEXILATE on my own?

    No, you are not recommended to stop taking DABIGATRAN ETEXILATE without consulting your doctor as it may worsen the condition. Therefore, take DABIGATRAN ETEXILATE for as long as your doctor has prescribed it.

    Does DABIGATRAN ETEXILATE need to be stopped before undergoing surgery?

    Please consult your doctor if you are due to undergo surgery. The doctor might ask you to stop taking DABIGATRAN ETEXILATE a few days before surgery since it can cause an increased risk of bleeding during surgery.

    Will DABIGATRAN ETEXILATE affect my pregnancy?

    Taking DABIGATRAN ETEXILATE during pregnancy may cause bleeding in the mother or the newborn baby. However, please consult your doctor if you are planning to become pregnant or already pregnant before starting DABIGATRAN ETEXILATE.

    Can the use of DABIGATRAN ETEXILATE increase the risk of bleeding?

    DABIGATRAN ETEXILATE may increase the risk of bleeding. It is advised to be cautious during your daily activities like shaving, cutting fingernails, or using sharp objects. Inform your doctor immediately if you notice any abnormal staining or bleeding.

    Available Medicines for

    DABIGATRAN ETEXILATE