Dabigatran

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

Active pathological bleeding; bleeding diathesis; conditions or lesions at risk of clinically significant bleeding (e.g. current or recent gastrointestinal ulceration, malignant neoplasms at high risk of bleeding; recent brain, spinal, ophthalmic injury and/or surgery; recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities); haemostatic impairment. Concomitant use with parenteral anticoagulants except when given to maintain an open central venous or arterial catheter, or during catheter ablation; oral anticoagulants except when switching to oral anticoagulant therapy; antithrombin agents; strong P-glycoprotein inhibitors. Severe renal impairment CrCl <30 mL/min. Patient with mechanical prosthetic heart valves requiring anticoagulant treatment.

Patient with increased risk of bleeding (e.g. recent biopsy, major trauma, bacterial endocarditis), history of traumatic or repeated epidural/spinal punctures, spinal deformity or surgery. Not recommended in patients with valvular heart disease including the presence of bioprosthetic heart valves; history of thrombosis diagnosed with antiphospholipid syndrome. Hepatic and moderate renal impairment. Elderly. Pregnancy and lactation. Avoid abrupt discontinuation of treatment. Monitoring Parameters Assess renal function at least once a year during treatment. Monitor CBC, aPTT, prothrombin time, serum creatinine, and LFTs prior to treatment initiation, when clinically indicated, and at least annually thereafter. Closely observe for signs of bleeding or anaemia.

Significant: Thromboembolic events (premature discontinuation), bleeding, spinal or epidural haematoma resulting to long term or permanent paralysis. Blood and lymphatic system disorders: Anaemia. Gastrointestinal disorders: Dyspepsia, gastritis, nausea, diarrhoea, abdominal pain, gastrointestinal, haemorrhage. Investigations: Decreased Hb, abnormal LFT. Nervous system disorders: Intracranial haemorrhage. Renal and urinary disorders: Genitourological haemorrhage, haematuria. Skin and subcutaneous tissue disorders: Skin haemorrhage. Vascular disorders: Epistaxis.
Potentially Fatal: Severe bleeding.

Increased plasma concentration with verapamil, amiodarone, quinidine, clarithromycin, ticagrelor, posaconazole. May increase the risk of spinal or epidural haematomas with neuraxial anaesthesia. May either increase or decrease serum concentration with ritonavir. May decrease plasma levels with pantoprazole. Decreased plasma concentrations with P-gp inducers (e.g. rifampicin, carbamazepine, phenytoin).

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AE07 - dabigatran etexilate ; Belongs to the class of direct thrombin inhibitors. Used in the treatment of thrombosis.