Pradaxa

Pradaxa

dabigatran

Manufacturer:

Boehringer Ingelheim
Concise Prescribing Info
Contents
Dabigatran etexilate
Indications/Uses
Primary prevention of VTE in adult patients who have undergone elective total hip or knee replacement surgery. Prevention of stroke & systemic embolism w/ non valvular atrial fibrillation w/ at least 1 additional risk factor of stroke ie, previous ischemic stroke, TIA, systemic embolism; left ventricular dysfunction. Treatment of acute DVT &/or pulmonary embolism (PE). Dabigatran should only be given following treatment w/ a parenteral anticoagulant for at least 5 days. Reduction in the risk of recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE).
Dosage/Direction for Use
VTE prevention following knee replacement surgery 1 cap (110 mg) w/in 1-4 hr of completed surgery, followed by 2 cap/day for a total of 10 days. If treatment is not started on the day of surgery, treatment should be initiated w/ 2 cap/day. VTE prevention following hip replacement surgery 1 cap (110 mg) w/in 1-4 hr of completed surgery, followed by 2 cap/day for a total of 28-35 days. If treatment is not started on the day of surgery, treatment should be initiated w/ 2 cap/day. Prevention of stroke & systemic embolism w/ non valvular atrial fibrillation w/ at least 1 additional risk factor of stroke 150 mg 2 cap/day. Therapy should be continued life-long. DVT &/or PE Dabigatran should only be given following treatment w/ a parenteral anticoagulant for at least 5 days. 150 mg 2 cap/day following w/ a parenteral anticoagulant for at least 5 days. Therapy should be continued for up to 6 mth. Reduction in the risk of recurrent DVT or PE Recommended daily dose: 300 mg taken orally as 150 mg hard cap twice daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Severe renal impairment (CrCl <30 mL/min). Haemorrhagic manifestations, bleeding diathesis, spontaneous or pharmacological impairment of haemostatis. Prosthetic heart valve replacement; hepatic impairment or liver disease. Concomitant treatment w/ systemic ketoconazole or dronedarone. Current or recent GI ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophth surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
Special Precautions
Increased risk of bleeding. Concomitant therapy w/ strong Pgp inhibitor. Discontinue at least 24 hr before invasive or surgical procedures. Stop treatment 2-4 days pre-op in patients at higher risk of bleeding or in major surgery where complete hemostasis may be required. Decreased renal function (CrCl 30-50 mL/min). Pregnancy & lactation. Elderly ≥75 yr.
Adverse Reactions
Bleeding. Anaemia, epistaxis, GI & urogenital haemorrhage, abdominal pain, diarrhoea, dyspepsia, nausea, abnormal hepatic function, rectal haemorrhage.
Drug Interactions
Increased plasma conc w/ verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor & clarithromycin. Rifampicin reduces exposure to dabigatran.
ATC Classification
B01AE07 - dabigatran etexilate ; Belongs to the class of direct thrombin inhibitors. Used in the treatment of thrombosis.
Presentation/Packing
Form
Pradaxa cap 150 mg
Packing/Price
3 × 10's
Form
Pradaxa cap 75 mg
Packing/Price
3 × 10's
Form
Pradaxa cap 110 mg
Packing/Price
3 × 10's
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