Pradaxa

Pradaxa

dabigatran

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Dabigatran etexilate
Indications/Uses
75-mg & 110-mg cap: Primary prevention of venous thromboembolic (pVTEp) events in adult patients who have undergone elective total hip or knee replacement surgery. 110-mg & 150-mg cap: Reduce risk of stroke & systemic embolism in patients w/ non-valvular atrial fibrillation (SPAF). Treatment & prevention of recurrent deep vein thrombosis (DVT) & pulmonary embolism (PE) in adults.
Dosage/Direction for Use
Adult pVTEp events Initially two 110-mg cap w/in 1-4 hr of completed surgery w/ single cap & continue w/ 2 cap once daily thereafter for 10 days after knee replacement surgery & 28-35 days after hip replacement surgery. Delay initiation of treatment for both surgeries if haemostatis is not secured. Initiate treatment w/ 2 cap once daily if treatment is not started on surgery day. Reduce risk of stroke & SPAF 150 mg bd. Patient ≥80 yr, patient receiving concomitant verapamil 110 mg bd. DVT & PE 150 mg bd followed by parenteral anticoagulant for at least 5 days. Patient 75-80 yr, moderate renal impairment, w/ gastritis, esophagitis or gastroesophageal reflux, patient at increased risk of bleeding 300 mg or 220 mg daily based on individual assessment. pVTEp events Moderate renal impairment (CrCl 30-50 mL/min) Initially two 75-mg cap once daily w/in 1-4 hr of completed surgery w/ single cap & continue w/ two 75-mg cap once daily thereafter for 10 days after knee replacement surgery & 28-35 days after hip replacement surgery. Delay initiation of treatment for both surgeries if haemostatis is not secured. Initiate treatment w/ 2 cap once daily if treatment is not started on surgery day.
Administration
May be taken with or without food: Swallow whole w/ water, do not open cap.
Contraindications
Hypersensitivity. Clinically significant active bleeding; lesion or condition at significant risk of major bleeding; prosthetic heart valves requiring anticoagulant treatment. Concomitant use w/ other anticoagulants; strong P-gp inhibitors eg, systemic ketoconazole, cyclosporine, itraconazole, dronedarone. Severe renal impairment (CrCl <30 mL/min). Hepatic impairment or disease.
Special Precautions
Discontinue use in patients who develop acute renal failure. Not recommended in patients w/ elevated liver enzymes >2 times upper limit of normal. Increased haemorrhagic risk. Spinal & epidural anaesth; lumbar puncture; post-procedural period. Temporarily discontinue use at least 24 hr prior to surgery or invasive procedures. Patients w/ antiphospholipid syndrome. Assess renal function prior to initiation of treatment. Closely monitor patients w/ body wt <50 kg. Not recommended w/ concomitant use of dronedarone. Concomitant use of strong P-gp inducers & drugs increasing risk of bleeding. Moderate renal impairment. Not to be used in severe renal impairment. Women of childbearing potential. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr. Elderly >75 yr.
Adverse Reactions
Bleeding, anemia, thrombocytopenia, neutropenia, agranulocytosis; drug hypersensitivity eg, pruritus, rash & urticaria, bronchospasm, angioedema, anaphylactic reaction; intracranial haemorrhage; haematoma, haemorrhage; epistaxis, haemoptysis; GI haemorrhage & ulcer, abdominal pain, diarrhoea, dyspepsia, nausea, oesophageal ulcer, gastrooesophagitis, GERD, vomiting, dysphagia; abnormal hepatic function; skin haemorrhage, alopecia; haemarthosis; urogenital haemorrhage; inj & catheter site haemorrhage; traumatic & incision site haemorrhage.
Drug Interactions
Increased risk of bleeding w/ drugs acting on haemostatis or coagulation including vit K antagonists. Increased plasma conc w/ P-gp inhibitors eg, amiodarone, verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor, clarithromycin, glecaprevir/pibrentasvir. Reduced exposure w/ P-gp inducers eg, rifampicin.
ATC Classification
B01AE07 - dabigatran etexilate ; Belongs to the class of direct thrombin inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Pradaxa hard cap 110 mg
Packing/Price
30's
Form
Pradaxa hard cap 75 mg
Packing/Price
30's
Form
Pradaxa hard cap 150 mg
Packing/Price
30's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in