Pradaxa Dosage & Drug Information

Concise Prescribing Info Bahasa Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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 DVT or pulmonary embolism (PE).

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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 daily 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. Cardioversion Patients can stay on Pradaxa while being cardioverted. Prevention of stroke, systemic embolism & reduction of vascular mortality in patients w/ atrial fibrillation: Catheter ablation for atrial fibrillation Catheter ablation can be conducted in patients on 150 mg twice daily Pradaxa treatment. Percutaneous coronary intervention (PCI) w/ stenting Patients w/ non valvular atrial fibrillation who undergo a PCI w/ stenting can be treated w/ Pradaxa in combination w/ antiplatelets after haemostasis is achieved.

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Overdosage

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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.

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Warnings

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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). Patients can stay on Pradaxa while being cardioverted. Treatment (150 mg twice daily) does not need to be interrupted in patients undergoing catheter ablation for atrial fibrillation. In case of emergency surgery or urgent procedures when rapid reversal of the anticoagulation effect is required the specific reversal agent Praxbind (idarucizumab) to Pradaxa is available. Pregnancy & lactation. Elderly ≥75 yr.

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Use In Pregnancy & Lactation

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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.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

ATC Classification

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

Regulatory Classification

Presentation/Packing

Form

Pradaxa cap 110 mg

Packing/Price

3 × 10's

Form

Pradaxa cap 150 mg

Packing/Price

3 × 10's

Form

Pradaxa cap 75 mg

Packing/Price

3 × 10's

Pradaxa

dabigatran

Manufacturer:

Boehringer Ingelheim