Dabirom Tablet

Dabigatran
110MG
National Healthcare Pvt. Ltd.
Pack size 100'st
Dispensing mode
Source
Agent
Retail Price 70.00 NPR

Indications

Dabirom Tablet is used for: Prophylaxis of postoperative venous thromboembolism, Atrial fibrillation

Adult Dose

Oral Prophylaxis of postoperative venous thromboembolism Adult: Initially, 110 mg given w/in 1-4 hr after surgery followed by 220 mg once daily for a total of 10 days after (knee replacement) or 28-35 after (hip replacement). Reduce dose to 150 mg once daily if given concurrently w/ amiodarone, verapamil or quinidine. Atrial fibrillation Adult: 150 mg bid, reduce dose to 110 mg bid if given concurrently w/ verapamil. Elderly: >75 yr 110 mg bid.

Child Dose

Renal Dose

Renal impairment: CrCl (ml/min) Dosage Recommendation <30 Contraindicated. 30-50 110 mg bid.

Administration

May be taken with or without food. Swallow whole, do not chew/crush.

Contra Indications

Active pathological bleeding or patient at high risk for bleeding. Patients w/ prosthetic heart valve. Severe renal impairment. Concomitant use w/ antiplatelets, other anticoagulants, thrombolytics, dronedarone, P-glycoprotein inducers (e.g. carbamazepine, rifampicin, phenytoin and St John's wort) and P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, and tacrolimus).

Precautions

Increased risk of haemorrhage and stroke. Renal and hepatic impairment. Pregnancy, lactation, elderly, childn. Monitoring Parameters Monitor renal function prior to initiation and periodically thereafter.

Pregnancy-Lactation

Interactions

May increase risk of bleeding w/ NSAIDs. Clarithromycin may increase the serum levels of dabigatran. Potentially Fatal: P-glycoprotein inducers (e.g. carbamazepine, rifampicin, and phenytoin) decreases systemic exposure of dabigatran. P-glycoprotein strong inhibitors (e.g. ciclosporin, systemic ketoconazole, itraconazole, and tacrolimus) and dronedarone increases systemic exposure of dabigatran. Increased bleeding risk w/ antiplatelets, other anticoagulants and thrombolytics.

Adverse Effects

Side effects of Dabigatran : GI disturbances (e.g. diarrhoea, dyspepsia and nausea); gastritis-like symptoms (e.g. oesophagitis, GI ulcer, gastric haemorrhage, haemorrhagic gastritis, GERD, erosive gastritis, haemorrhagic erosive gastritis); urticaria, pruritus, rash, allergic oedema; elevated liver enzymes. Potentially Fatal: Anaphylaxis, anaphylactic shock, severe bleeding events.

Mechanism of Action

Dabigatran is a competitive, selective, reversible direct inhibitor of thrombin. It inhibits thrombin-induced platelet aggregation and the conversion of fibrinogen to fibrin thus preventing thrombus formation.

Note

Dabirom 110MG Tablet manufactured by National Healthcare Pvt. Ltd.. Its generic name is Dabigatran. Dabirom is availble in Nepal. Farmaco Nepal drug index information on Dabirom Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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