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DABICLOT-110

Dosage Form:- Capsule
Generic Name:- Dabigatran 110 mg
Manufactured By:- QbD Pharmaceuticals Pvt. Ltd.

Information

Active ingredient in Dabiclot is Dabigatran Etexilate Mesilate. It belongs to a group of medicines called anticoagulants. Dabigatran is used to decrease the risk of stroke caused by blood clot in people with heart rhythm disorder.


Therapeutic Class

Antithrombotic Agents, Direct Thrombin Inhibitors, Cardiovascular, Hematologic


Dose and Direction of Use

Swallow the whole capsule by mouth with a full glass of water, usually twice a day and once a day after hip or knee replacement surgery as directed by doctor. Don't crush or chew the capsule and store it properly away from moisture. Take this medication with or without food as consulted by the doctor. Don't take antacid 24 hours after surgery or this medication might not work. Don't stop taking the medication without the direction of your doctor.


Mode of Action

Dabigatran is a potent, competitive, reversible direct thrombin inhibitor and is the main active principle in plasma. Since thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of thrombus. Dabigatran inhibits free thrombin, fibrin-bound thrombin and thrombin-induced platelet aggregation.


Uses

  • Prevention of venous thromboembolic events in adult patients who have undergone major orthopedic surgery of the lower limb (elective total hip or knee replacement).
  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of recurrent DVT and PE in adults.

Contraindications

Hypersensitivity to the Active substance or to any of the excipients

Severe renal impairment (CrCl <15 ml/min)

Mechanical prosthetic heart valve

Active pathologic bleeding


Precautions and Warning

  •  DABICLOT should be used with caution in conditions with an increased risk of bleeding or with concomitant use of medicinal products affecting hemostasis by inhibition of platelet aggregation. Bleeding can occur at any site during therapy with DABICLOT. An unexplained fall in hemoglobin and/or hematocrit or blood pressure should lead to a search for a bleeding site. In clinical trials, DABICLOT was associated with higher rates of major gastrointestinal (GI) bleeding. An increased risk was seen in the elderly (≥ 75 years) for the 150 mg twice daily dose regimen. Further risk factors comprise co-medication with platelet aggregation inhibitors such as clopidogrel and acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drugs (NSAID), as well as the presence of esophagitis, gastritis or gastro esophageal reflux.
  • This medications can cause stomach bleeing which is supported by alcohol intake. So, alcohol intake should be limited.
  • Consult with your doctor if you are breast feeding, pregnant, have medical history of mechanical heart valave, kidney problem or bleeding problem or blood disorder like anemia.
  • Don't stop taking medication unless directed by doctor.

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QbD Pharmaceuticals Pvt. Ltd.