Dabigatran

Direct Thrombin Inhibitor·Haematology - Anticoagulants & Haemostatics

Stroke prevention in non-valvular AF, treatment and prevention of DVT/PE, VTE prophylaxis post-orthopaedic surgery

Authority requiredPBSDOACPradaxa75 mg+2

Max Dose

150 mg BD

Half-life

12-17 h

Blister Pack

MUST REMAIN

Bleeding Risk

HIGH

Rapid Summary

Overview

Direct Oral Anticoagulant (DOAC). The only DOAC that acts directly on Thrombin (Factor IIa) rather than Factor Xa. Highly effective but has strict storage and renal limitations.

Maximum Dose

Max 150 mg BD.

Clinical Focus

The capsules are extremely moisture-sensitive. If removed from the foil blister and put into a dosette box, they rapidly degrade into a useless paste. The patient will clot.

Bottom Line

Dabigatran is the only DOAC with a specific reversal agent (idarucizumab) for AF and VTE, but is predominantly renally cleared and contraindicated in severe renal impairment.

Formulation & Access

Brand Names

Pradaxa

Oral Routes

Do not crush

Capsules (75 mg, 110 mg, 150 mg). Do NOT crush, chew, or open (increases bioavailability by 75%, causing fatal bleeding).

Prescribing & PBS

Authority Required (PBS).

Indications & Use

Primary

PBSTGA

Stroke prevention in non-valvular AF, treatment and prevention of DVT/PE, VTE prophylaxis post-orthopaedic surgery.

Clinical Place

Highly effective alternative to Warfarin. Has a specific, instantaneous reversal agent (Idarucizumab).

Quick reference

Class & Role

Direct Thrombin Inhibitor — Direct Oral Anticoagulant (DOAC).

Route / Formulation

Capsules (75 mg, 110 mg, 150 mg). Do NOT crush, chew, or open (increases bioavailability by 75%, causing fatal bleeding). (Pradaxa)

Usual Dose & Max

PO 150 mg BD. Max 150 mg BD.

Key Indication Doses

Non-Valvular AF / VTE Treatment: PO 150 mg BD. Elderly (> 75 yrs) / High Bleed Risk: PO 110 mg BD. Renal Impairment: Avoid entirely if eGFR < 30 (Highly renally cleared).

Best Uses

Dabigatran is the only DOAC with a specific reversal agent (idarucizumab) for AF and VTE, but is predominantly renally cleared and contraindicated in severe renal impairment.

Avoid / Cautions

Mechanical heart valves, eGFR < 30, active bleeding, active GI ulcer. Pregnancy Category C.

Key Risks

Haematological: Major haemorrhage (especially GI bleeding in the elderly). Gastrointestinal: Dyspepsia, gastritis (The capsule contains a tartaric acid core to aid absorption, which burns the stomach).

Key Interactions

P-gp inhibitors (e.g., Amiodarone, Verapamil, Clarithromycin). These drastically increase Dabigatran absorption, causing severe bleeding. Dose reduction to 110mg BD is mandatory. NSAIDs, SSRIs, Aspirin (Additive bleeding risk).

Monitoring

Baseline and 6-monthly eGFR. Standard INR/aPTT are completely unreliable to measure efficacy. Warn the patient not to use a dosette box/pill organizer for this specific drug.

Clinical Pearl

Because of the tartaric acid core, up to 10% of patients get severe indigestion and stop taking the drug, risking a massive stroke. Taking it with a heavy meal and a large glass of water fixes this.

Access

Authority requiredPradaxa75 mg

Brand: Pradaxa
PBS status: Authority required
Formulation: Capsules (75 mg, 110 mg, 150 mg)

Dabigatran

Direct Thrombin Inhibitor·Haematology - Anticoagulants & Haemostatics

Stroke prevention in non-valvular AF, treatment and prevention of DVT/PE, VTE prophylaxis post-orthopaedic surgery

Authority requiredPBSDOACPradaxa75 mg+2

Max Dose

150 mg BD

Half-life

12-17 h

Blister Pack

MUST REMAIN

Bleeding Risk

HIGH

Rapid Summary

Overview

Direct Oral Anticoagulant (DOAC). The only DOAC that acts directly on Thrombin (Factor IIa) rather than Factor Xa. Highly effective but has strict storage and renal limitations.

Maximum Dose

Max 150 mg BD.

Clinical Focus

The capsules are extremely moisture-sensitive. If removed from the foil blister and put into a dosette box, they rapidly degrade into a useless paste. The patient will clot.

Bottom Line

Dabigatran is the only DOAC with a specific reversal agent (idarucizumab) for AF and VTE, but is predominantly renally cleared and contraindicated in severe renal impairment.

Formulation & Access

Brand Names

Pradaxa

Oral Routes

Do not crush

Capsules (75 mg, 110 mg, 150 mg). Do NOT crush, chew, or open (increases bioavailability by 75%, causing fatal bleeding).

Prescribing & PBS

Authority Required (PBS).

Indications & Use

Primary

PBSTGA

Stroke prevention in non-valvular AF, treatment and prevention of DVT/PE, VTE prophylaxis post-orthopaedic surgery.

Clinical Place

Highly effective alternative to Warfarin. Has a specific, instantaneous reversal agent (Idarucizumab).

Quick reference

Class & Role

Direct Thrombin Inhibitor — Direct Oral Anticoagulant (DOAC).

Route / Formulation

Capsules (75 mg, 110 mg, 150 mg). Do NOT crush, chew, or open (increases bioavailability by 75%, causing fatal bleeding). (Pradaxa)

Usual Dose & Max

PO 150 mg BD. Max 150 mg BD.

Key Indication Doses

Non-Valvular AF / VTE Treatment: PO 150 mg BD. Elderly (> 75 yrs) / High Bleed Risk: PO 110 mg BD. Renal Impairment: Avoid entirely if eGFR < 30 (Highly renally cleared).

Best Uses

Dabigatran is the only DOAC with a specific reversal agent (idarucizumab) for AF and VTE, but is predominantly renally cleared and contraindicated in severe renal impairment.

Avoid / Cautions

Mechanical heart valves, eGFR < 30, active bleeding, active GI ulcer. Pregnancy Category C.

Key Risks

Key Interactions

Monitoring

Baseline and 6-monthly eGFR. Standard INR/aPTT are completely unreliable to measure efficacy. Warn the patient not to use a dosette box/pill organizer for this specific drug.

Clinical Pearl

Because of the tartaric acid core, up to 10% of patients get severe indigestion and stop taking the drug, risking a massive stroke. Taking it with a heavy meal and a large glass of water fixes this.

Access

Authority requiredPradaxa75 mg

Brand: Pradaxa
PBS status: Authority required
Formulation: Capsules (75 mg, 110 mg, 150 mg)